Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

Draft scope assessment: unclear. Attached because the study's own record names HER2. 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

Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.

ITT population.

→

secondary · POSTED

Disease free survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.

ITT population.

→

secondary · POSTED

Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method.

ITT population.

→

Reported safety

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

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-faslodex-9a71fc64
nct id: NCT00021255
trial label: Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
applicability: unclear
applicability note: Attached because the study's own record names HER2. 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: 3
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-9a71fc64
nct id
NCT00021255
outcome key
om-0000
source section id
NCT00021255-om-0000
source outcome index
0
endpoint
Percentage of Participants With Disease Free Survival at 5 Years
endpoint definition
Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
time origin
From randomization until relapse or death or up to 5 years
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-9a71fc64
nct id
NCT00021255
outcome key
om-0001
source section id
NCT00021255-om-0001
source outcome index
1
endpoint
Percentage of Participants With Disease Free Survival at 10 Years
endpoint definition
Disease free survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
time origin
From randomization until relapse or death or up to 10 years
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-9a71fc64
nct id
NCT00021255
outcome key
om-0002
source section id
NCT00021255-om-0002
source outcome index
2
endpoint
Overall Survival- Percentage of Participants Who Survived at 10 Years
endpoint definition
Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method.
time origin
From randomization until death or up to 10 years
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-9a71fc64
nct id
NCT00021255
outcome key
om-0000
arm key
OG000
arm label
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)
regimen
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
analyzed count
1073
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00021255-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-9a71fc64
nct id
NCT00021255
outcome key
om-0000
arm key
OG001
arm label
AC Followed by Docetaxel + Herceptin (AC→TH)
regimen
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
analyzed count
1074
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00021255-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-9a71fc64
nct id
NCT00021255
outcome key
om-0000
arm key
OG002
arm label
Docetaxel + Carboplatin + Herceptin (TCH)
regimen
Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
analyzed count
1075
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00021255-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-9a71fc64
nct id
NCT00021255
outcome key
om-0001
arm key
OG000
arm label
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)
regimen
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
analyzed count
1073
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00021255-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-9a71fc64
nct id
NCT00021255
outcome key
om-0001
arm key
OG001
arm label
AC Followed by Docetaxel + Herceptin (AC→TH)
regimen
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
analyzed count
1074
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00021255-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-9a71fc64
nct id
NCT00021255
outcome key
om-0001
arm key
OG002
arm label
Docetaxel + Carboplatin + Herceptin (TCH)
regimen
Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
analyzed count
1075
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00021255-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-9a71fc64
nct id
NCT00021255
outcome key
om-0002
arm key
OG000
arm label
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)
regimen
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
analyzed count
1073
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00021255-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-9a71fc64
nct id
NCT00021255
outcome key
om-0002
arm key
OG001
arm label
AC Followed by Docetaxel + Herceptin (AC→TH)
regimen
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
analyzed count
1074
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00021255-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-9a71fc64
nct id
NCT00021255
outcome key
om-0002
arm key
OG002
arm label
Docetaxel + Carboplatin + Herceptin (TCH)
regimen
Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
analyzed count
1075
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00021255-om-0002#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-9a71fc64
nct id
NCT00021255
harm key
EG000
source section id
NCT00021255-ae
event group key
EG000
event group label
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)
serious affected
218
serious at risk
1018
other affected
1017
other at risk
1018
frequency threshold
5
collection period
All Adverse Events (AE) were collected from the time the participant started treatment with study drug until 30 days after the last infusion of study treatment (chemotherapy or Herceptin).
event definition
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug until 30 days after the last infusion of study drug). Safety population included all treated participants. Source vocabulary used to define AE term: Pooled NCI-CTC version 2.0 and COSTART version 5.0
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-9a71fc64
nct id
NCT00021255
harm key
EG001
source section id
NCT00021255-ae
event group key
EG001
event group label
AC Followed by Docetaxel + Herceptin (AC→TH)
serious affected
298
serious at risk
1100
other affected
1100
other at risk
1100
frequency threshold
5
collection period
All Adverse Events (AE) were collected from the time the participant started treatment with study drug until 30 days after the last infusion of study treatment (chemotherapy or Herceptin).
event definition
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug until 30 days after the last infusion of study drug). Safety population included all treated participants. Source vocabulary used to define AE term: Pooled NCI-CTC version 2.0 and COSTART version 5.0
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-9a71fc64
nct id
NCT00021255
harm key
EG002
source section id
NCT00021255-ae
event group key
EG002
event group label
Docetaxel + Carboplatin + Herceptin (TCH)
serious affected
283
serious at risk
1056
other affected
1052
other at risk
1056
frequency threshold
5
collection period
All Adverse Events (AE) were collected from the time the participant started treatment with study drug until 30 days after the last infusion of study treatment (chemotherapy or Herceptin).
event definition
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug until 30 days after the last infusion of study drug). Safety population included all treated participants. Source vocabulary used to define AE term: Pooled NCI-CTC version 2.0 and COSTART version 5.0
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

setting source links

Preserved source evidence · Not medical advice