← FASLODEX: metastatic Breast cancer with HR positive, HER2 negative after prior therapy

NCT01120184 · STUDY IN CONTEXT

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)

Draft scope assessment: unclear. Attached because the study's own record names HER2 and describes metastatic disease. The study record does not state negative, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.

ITT Population.

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primary · POSTED

Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method.

ITT Population.

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secondary · POSTED

The percentage of participants who died prior to clinical cutoff was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.

ITT Population.

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secondary · POSTED

OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.

ITT Population.

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secondary · POSTED

Tumor assessments were performed by the investigator according to RECIST version 1.1. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.

ITT Population.

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secondary · POSTED

Tumor assessments were performed by the investigator according to RECIST version 1.1. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.

ITT Population.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

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Quality of life and patient-reported measures

FACT · Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-faslodex-f8107dd2
nct id: NCT01120184
qol key: qol-0021
source section id: NCT01120184-om-0021
source outcome index: 21
instrument: FACT
instrument basis: matched 'fact' in the study's own wording
scale title: Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score
measure definition: The FACT-Taxane is a self-reported instrument which measures the health-related quality of life (HRQOL) of participants receiving taxane-containing chemotherapy. The FACT-TaxS consists of 16 items including 11 neurotoxicity-related questions and 5 additional questions assessing arthralgia, myalgia, and skin discoloration. Items are rated from 0 (not at all) to 4 (very much) and a total score is inversely derived. Scores may range from 0 to 64, with higher scores indicating fewer/no symptoms. A minimally clinically important difference in treatment-related symptoms was defined as a ≥5% decrease (ie, 3.2 points) in FACT-TaxS score from Baseline. The percentage of participants with treatment-related symptoms was calculated using following formula: \[number of participants meeting the above threshold divided by the number analyzed\] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.
time frame: Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: ITT Population (Protocol Amendment C Subpopulation): All randomized participants who entered the study after Protocol Amendment C.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

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FACT · Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-faslodex-f8107dd2
nct id: NCT01120184
qol key: qol-0022
source section id: NCT01120184-om-0022
source outcome index: 22
instrument: FACT
instrument basis: matched 'fact' in the study's own wording
scale title: Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module
measure definition: The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with nausea was calculated using following formula: \[number of participants with any level of either symptom divided by the number analyzed\] multiplied by 100.
time frame: At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

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FACT · Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-faslodex-f8107dd2
nct id: NCT01120184
qol key: qol-0023
source section id: NCT01120184-om-0023
source outcome index: 23
instrument: FACT
instrument basis: matched 'fact-c' in the study's own wording
scale title: Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module
measure definition: The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with diarrhea was calculated using following formula: \[number of participants with any level of either symptom divided by the number analyzed\] multiplied by 100.
time frame: At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

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FACT · Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-faslodex-f8107dd2
nct id: NCT01120184
qol key: qol-0024
source section id: NCT01120184-om-0024
source outcome index: 24
instrument: FACT
instrument basis: matched 'fact' in the study's own wording
scale title: Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score
measure definition: The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. The percentage of participants with deterioration was calculated as \[number of participants meeting the above threshold divided by the number analyzed\] multiplied by 100.
time frame: Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher scores indicating better
population note: ITT Population. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

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FACT · Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-faslodex-f8107dd2
nct id: NCT01120184
qol key: qol-0025
source section id: NCT01120184-om-0025
source outcome index: 25
instrument: FACT
instrument basis: matched 'fact-b' in the study's own wording
scale title: Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score
measure definition: The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including PWB, SWB, EWB, FWB, and BCS. The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. Time to deterioration was defined as the time from Baseline until the first decrease in FACT-B TOI-PFB score. Median time to deterioration was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
time frame: Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher scores indicating better
population note: ITT Population. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

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Patient-reported symptom or function measure · Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-faslodex-f8107dd2
nct id: NCT01120184
qol key: qol-0027
source section id: NCT01120184-om-0027
source outcome index: 27
instrument: Patient-reported symptom or function measure
instrument basis: matched 'patient-reported' in the study's own wording
scale title: Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
measure definition: The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect)
time frame: Baseline, Cycle 7 (Week 18)
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Number of participants analysed=participants from ITT population who were employed at baseline. Here, 'n' signifies the number of participants with available data at specified category.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

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Patient-reported symptom or function measure · Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-faslodex-f8107dd2
nct id: NCT01120184
qol key: qol-0028
source section id: NCT01120184-om-0028
source outcome index: 28
instrument: Patient-reported symptom or function measure
instrument basis: matched 'patient-reported' in the study's own wording
scale title: Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
measure definition: The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect).
time frame: Baseline, Cycle 7 (Week 18)
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Number of participants analysed=participants from ITT population who reported conduct of daily activities. Here, 'n' signifies the number of participants with available data at specified category.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

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FACT · Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-faslodex-f8107dd2
nct id: NCT01120184
qol key: qol-0029
source section id: NCT01120184-om-0029
source outcome index: 29
instrument: FACT
instrument basis: matched 'factor' in the study's own wording
scale title: Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels
measure definition: Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to \<10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as \[number of participants meeting the respective criteria divided by the number analyzed\] multiplied by 100.
time frame: Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: ITT Population (High HER2 mRNA Subpopulation): All randomized participants with above-the-median HER2 mRNA expression (value greater than \[\>\] 59.71). Only participants with measurable disease at Baseline were included in the analysis.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

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Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-faslodex-f8107dd2
nct id: NCT01120184
trial label: A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
applicability: unclear
applicability note: Attached because the study's own record names HER2 and describes metastatic disease. The study record does not state negative, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 3
qol Count: 8

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0000
source section id
NCT01120184-om-0000
source outcome index
0
endpoint
Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment
endpoint definition
Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
time origin
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0001
source section id
NCT01120184-om-0001
source outcome index
1
endpoint
Progression-Free Survival (PFS) According to IRF Assessment
endpoint definition
Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method.
time origin
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0002
source section id
NCT01120184-om-0002
source outcome index
2
endpoint
Percentage of Participants Who Died Prior to Clinical Cutoff
endpoint definition
The percentage of participants who died prior to clinical cutoff was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
time origin
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0003
source section id
NCT01120184-om-0003
source outcome index
3
endpoint
Overall Survival (OS) at Clinical Cutoff
endpoint definition
OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
time origin
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0004
source section id
NCT01120184-om-0004
source outcome index
4
endpoint
Percentage of Participants With Death or Disease Progression According to Investigator Assessment
endpoint definition
Tumor assessments were performed by the investigator according to RECIST version 1.1. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
time origin
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0005
source section id
NCT01120184-om-0005
source outcome index
5
endpoint
PFS According to Investigator Assessment
endpoint definition
Tumor assessments were performed by the investigator according to RECIST version 1.1. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
time origin
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0000
arm key
OG000
arm label
Trastuzumab + Taxane
regimen
Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
analyzed count
365
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01120184-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0000
arm key
OG001
arm label
Trastuzumab Emtansine + Placebo
regimen
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
analyzed count
367
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01120184-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0000
arm key
OG002
arm label
Trastuzumab Emtansine + Pertuzumab
regimen
Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
analyzed count
363
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01120184-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0001
arm key
OG000
arm label
Trastuzumab + Taxane
regimen
Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
analyzed count
365
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01120184-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0001
arm key
OG001
arm label
Trastuzumab Emtansine + Placebo
regimen
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
analyzed count
367
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01120184-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0001
arm key
OG002
arm label
Trastuzumab Emtansine + Pertuzumab
regimen
Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
analyzed count
363
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01120184-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0002
arm key
OG000
arm label
Trastuzumab + Taxane
regimen
Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
analyzed count
365
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01120184-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0002
arm key
OG001
arm label
Trastuzumab Emtansine + Placebo
regimen
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
analyzed count
367
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01120184-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0002
arm key
OG002
arm label
Trastuzumab Emtansine + Pertuzumab
regimen
Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
analyzed count
363
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01120184-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0003
arm key
OG000
arm label
Trastuzumab + Taxane
regimen
Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
analyzed count
365
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01120184-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0003
arm key
OG001
arm label
Trastuzumab Emtansine + Placebo
regimen
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
analyzed count
367
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01120184-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
outcome key
om-0003
arm key
OG002
arm label
Trastuzumab Emtansine + Pertuzumab
regimen
Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
analyzed count
363
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01120184-om-0003#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
harm key
EG000
source section id
NCT01120184-ae
event group key
EG000
event group label
Trastuzumab + Taxane
serious affected
81
serious at risk
353
other affected
342
other at risk
353
frequency threshold
5
collection period
Up to 70 months from randomization until clinical cutoff of 16 September 2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination).
event definition
Safety Population: All randomized participants who received at least one dose of study treatment and the participants were analyzed based on the treatment they actually received (N=353 in Trastuzumab + Taxane arm, N=361 in Trastuzumab Emtansine, Pertuzumab-placebo arm, N=366 in Trastuzumab emtansine + pertuzumab arm).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
harm key
EG001
source section id
NCT01120184-ae
event group key
EG001
event group label
Trastuzumab Emtansine + Placebo
serious affected
86
serious at risk
361
other affected
352
other at risk
361
frequency threshold
5
collection period
Up to 70 months from randomization until clinical cutoff of 16 September 2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination).
event definition
Safety Population: All randomized participants who received at least one dose of study treatment and the participants were analyzed based on the treatment they actually received (N=353 in Trastuzumab + Taxane arm, N=361 in Trastuzumab Emtansine, Pertuzumab-placebo arm, N=366 in Trastuzumab emtansine + pertuzumab arm).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
harm key
EG002
source section id
NCT01120184-ae
event group key
EG002
event group label
Trastuzumab Emtansine + Pertuzumab
serious affected
93
serious at risk
366
other affected
352
other at risk
366
frequency threshold
5
collection period
Up to 70 months from randomization until clinical cutoff of 16 September 2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination).
event definition
Safety Population: All randomized participants who received at least one dose of study treatment and the participants were analyzed based on the treatment they actually received (N=353 in Trastuzumab + Taxane arm, N=361 in Trastuzumab Emtansine, Pertuzumab-placebo arm, N=366 in Trastuzumab emtansine + pertuzumab arm).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
qol key
qol-0021
source section id
NCT01120184-om-0021
source outcome index
21
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score
measure definition
The FACT-Taxane is a self-reported instrument which measures the health-related quality of life (HRQOL) of participants receiving taxane-containing chemotherapy. The FACT-TaxS consists of 16 items including 11 neurotoxicity-related questions and 5 additional questions assessing arthralgia, myalgia, and skin discoloration. Items are rated from 0 (not at all) to 4 (very much) and a total score is inversely derived. Scores may range from 0 to 64, with higher scores indicating fewer/no symptoms. A minimally clinically important difference in treatment-related symptoms was defined as a ≥5% decrease (ie, 3.2 points) in FACT-TaxS score from Baseline. The percentage of participants with treatment-related symptoms was calculated using following formula: \[number of participants meeting the above threshold divided by the number analyzed\] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.
time frame
Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT Population (Protocol Amendment C Subpopulation): All randomized participants who entered the study after Protocol Amendment C.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
qol key
qol-0022
source section id
NCT01120184-om-0022
source outcome index
22
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module
measure definition
The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with nausea was calculated using following formula: \[number of participants with any level of either symptom divided by the number analyzed\] multiplied by 100.
time frame
At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
qol key
qol-0023
source section id
NCT01120184-om-0023
source outcome index
23
instrument
FACT
instrument basis
matched 'fact-c' in the study's own wording
scale title
Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module
measure definition
The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with diarrhea was calculated using following formula: \[number of participants with any level of either symptom divided by the number analyzed\] multiplied by 100.
time frame
At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
qol key
qol-0024
source section id
NCT01120184-om-0024
source outcome index
24
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score
measure definition
The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. The percentage of participants with deterioration was calculated as \[number of participants meeting the above threshold divided by the number analyzed\] multiplied by 100.
time frame
Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores indicating better
population note
ITT Population. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
qol key
qol-0025
source section id
NCT01120184-om-0025
source outcome index
25
instrument
FACT
instrument basis
matched 'fact-b' in the study's own wording
scale title
Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score
measure definition
The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including PWB, SWB, EWB, FWB, and BCS. The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. Time to deterioration was defined as the time from Baseline until the first decrease in FACT-B TOI-PFB score. Median time to deterioration was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
time frame
Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores indicating better
population note
ITT Population. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
qol key
qol-0027
source section id
NCT01120184-om-0027
source outcome index
27
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient-reported' in the study's own wording
scale title
Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
measure definition
The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect)
time frame
Baseline, Cycle 7 (Week 18)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Number of participants analysed=participants from ITT population who were employed at baseline. Here, 'n' signifies the number of participants with available data at specified category.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
qol key
qol-0028
source section id
NCT01120184-om-0028
source outcome index
28
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient-reported' in the study's own wording
scale title
Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
measure definition
The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect).
time frame
Baseline, Cycle 7 (Week 18)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Number of participants analysed=participants from ITT population who reported conduct of daily activities. Here, 'n' signifies the number of participants with available data at specified category.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01120184
qol key
qol-0029
source section id
NCT01120184-om-0029
source outcome index
29
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels
measure definition
Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to \<10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as \[number of participants meeting the respective criteria divided by the number analyzed\] multiplied by 100.
time frame
Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT Population (High HER2 mRNA Subpopulation): All randomized participants with above-the-median HER2 mRNA expression (value greater than \[\>\] 59.71). Only participants with measurable disease at Baseline were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice