Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. 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

Overall survival (OS) was defined as time from randomization to death from any cause. All patients will be followed for survival through 5 years. Cases with incomplete follow-up or without record of vital status will be censored at the date of last contact. 3-year OS rate was estimated using Kaplan-Meier method.

All randomized patients at step 2

→

secondary · POSTED

For patients in arm II (early local therapy), time to locoregional recurrence was defined as time from randomization to date of locoregional recurrence; for patients in arm A (continued systemic therapy), time to locoregional progression was defined as time from randomization to date of locoregional progression. In this study, locoregional recurrence was defined as the new development or clinically significant increase in size of any supraclavicular, infraclavicular, internal mammary or axillary adenopathy or chest wall disease or invasive in-breast recurrence for patients on arm B; for patients on arm A, locoregional progression was defined as the development of symptoms leading to a decision for local therapy. Locoregional recurrence/progression and distant progression were followed separately in the study, and the occurrence of one did not preclude the other getting reported. 3-year cumulative incidence of locoregional recurrence/progression was estimated.

All randomized patients at step 2

→

secondary · POSTED

The Functional Assessment of Cancer Therapy-Breast Trial Outcome Index (FACT-B TOI) was used as the primary HRQL endpoint, measured by the prorated aggregate score of the 24 items from the FACT-B (7 functional well-being, 7 physical well-being, 10 breast cancer specific items). The theoretical range of the prorated aggregate score was 0-96, higher scores indicate better quality of life.

All randomized patients at step 2 who reported quality of life data at 18 months after randomization

→

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

FACT · Health-related Quality of Life (HRQL)

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-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id: NCT01242800
qol key: qol-0002
source section id: NCT01242800-om-0002
source outcome index: 2
instrument: FACT
instrument basis: matched 'fact-b' in the study's own wording
scale title: Health-related Quality of Life (HRQL)
measure definition: The Functional Assessment of Cancer Therapy-Breast Trial Outcome Index (FACT-B TOI) was used as the primary HRQL endpoint, measured by the prorated aggregate score of the 24 items from the FACT-B (7 functional well-being, 7 physical well-being, 10 breast cancer specific items). The theoretical range of the prorated aggregate score was 0-96, higher scores indicate better quality of life.
time frame: Assessed at 18 months after randomization
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher scores indicate better
population note: All randomized patients at step 2 who reported quality of life data at 18 months after randomization
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id: NCT01242800
trial label: Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. 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: 2
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01242800
outcome key
om-0000
source section id
NCT01242800-om-0000
source outcome index
0
endpoint
3-year Overall Survival Rate
endpoint definition
Overall survival (OS) was defined as time from randomization to death from any cause. All patients will be followed for survival through 5 years. Cases with incomplete follow-up or without record of vital status will be censored at the date of last contact. 3-year OS rate was estimated using Kaplan-Meier method.
time origin
Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All randomized patients at step 2
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-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01242800
outcome key
om-0001
source section id
NCT01242800-om-0001
source outcome index
1
endpoint
3-year Cumulative Incidence of Locoregional Recurrence/Progression
endpoint definition
For patients in arm II (early local therapy), time to locoregional recurrence was defined as time from randomization to date of locoregional recurrence; for patients in arm A (continued systemic therapy), time to locoregional progression was defined as time from randomization to date of locoregional progression. In this study, locoregional recurrence was defined as the new development or clinically significant increase in size of any supraclavicular, infraclavicular, internal mammary or axillary adenopathy or chest wall disease or invasive in-breast recurrence for patients on arm B; for patients on arm A, locoregional progression was defined as the development of symptoms leading to a decision for local therapy. Locoregional recurrence/progression and distant progression were followed separately in the study, and the occurrence of one did not preclude the other getting reported. 3-year cumulative incidence of locoregional recurrence/progression was estimated.
time origin
Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized patients at step 2
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-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01242800
outcome key
om-0002
source section id
NCT01242800-om-0002
source outcome index
2
endpoint
Health-related Quality of Life (HRQL)
endpoint definition
The Functional Assessment of Cancer Therapy-Breast Trial Outcome Index (FACT-B TOI) was used as the primary HRQL endpoint, measured by the prorated aggregate score of the 24 items from the FACT-B (7 functional well-being, 7 physical well-being, 10 breast cancer specific items). The theoretical range of the prorated aggregate score was 0-96, higher scores indicate better quality of life.
time origin
Assessed at 18 months after randomization
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized patients at step 2 who reported quality of life data at 18 months after randomization
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-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01242800
outcome key
om-0000
arm key
OG000
arm label
Arm I (Continued Systemic Therapy)
regimen
Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy
analyzed count
131
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01242800-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01242800
outcome key
om-0000
arm key
OG001
arm label
Arm II (Early Local Therapy)
regimen
Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
analyzed count
125
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01242800-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01242800
outcome key
om-0001
arm key
OG000
arm label
Arm I (Continued Systemic Therapy)
regimen
Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy
analyzed count
131
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01242800-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01242800
outcome key
om-0001
arm key
OG001
arm label
Arm II (Early Local Therapy)
regimen
Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
analyzed count
125
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01242800-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01242800
outcome key
om-0002
arm key
OG000
arm label
Arm I (Continued Systemic Therapy)
regimen
Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy
analyzed count
65
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01242800-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01242800
outcome key
om-0002
arm key
OG001
arm label
Arm II (Early Local Therapy)
regimen
Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
analyzed count
66
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01242800-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01242800
harm key
EG000
source section id
NCT01242800-ae
event group key
EG000
event group label
Arm I (Continued Systemic Therapy)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
The trial involved standard of care systemic therapies and there could be many options of systemic therapies, adverse events data were not collected in the trial. For all-cause mortality, it was assessed every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years.
event definition
The trial involved standard of care systemic therapies and there could be several options of systemic therapies, adverse events data were not collected in the trial.
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-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01242800
harm key
EG001
source section id
NCT01242800-ae
event group key
EG001
event group label
Arm II (Early Local Therapy)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
The trial involved standard of care systemic therapies and there could be many options of systemic therapies, adverse events data were not collected in the trial. For all-cause mortality, it was assessed every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years.
event definition
The trial involved standard of care systemic therapies and there could be several options of systemic therapies, adverse events data were not collected in the trial.
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-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01242800
qol key
qol-0002
source section id
NCT01242800-om-0002
source outcome index
2
instrument
FACT
instrument basis
matched 'fact-b' in the study's own wording
scale title
Health-related Quality of Life (HRQL)
measure definition
The Functional Assessment of Cancer Therapy-Breast Trial Outcome Index (FACT-B TOI) was used as the primary HRQL endpoint, measured by the prorated aggregate score of the 24 items from the FACT-B (7 functional well-being, 7 physical well-being, 10 breast cancer specific items). The theoretical range of the prorated aggregate score was 0-96, higher scores indicate better quality of life.
time frame
Assessed at 18 months after randomization
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores indicate better
population note
All randomized patients at step 2 who reported quality of life data at 18 months after randomization
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