Trial · NCT00087178

Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer

NCT00087178, Phase 3, Completed, NSABP Foundation Inc; results first posted 2022-08-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer. Trials, record NCT00087178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00087178

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer
NCT number: NCT00087178
Status: Completed
Phases: Phase 3
Enrollment: 2,722 participants, actual
Lead sponsor: NSABP Foundation Inc
Conditions: Breast Cancer
Interventions: cyclophosphamide, adriamycin, epirubicin, fluorouracil
First posted: 2004-07-12
Last updated: 2022-08-11
Results first posted: 2022-08-11

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease Free Survival	9 years	Percentage of patients free from DFS event. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer
Secondary	Survival	9 years	Percentage of patients alive
Secondary	Adverse Events	9 years	Percentage of patients with at least one grade 2 or higher adverse event reported
Secondary	Quality of Life-Functional Assessment of Cancer Therapy	12 months	Functional Assessment of Cancer Therapy (FACT-B) trial outcome index (TOI) score. FACT-B TOI score ranges from 0 to 92, with a higher score indicating better QOL.
Secondary	Post Chemotherapy Amenorrhea	18 months	Percent with post chemotherapy amenorrhea
Secondary	Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation	12 months	Change in LVEF from randomization to 12 months
Secondary	HER-2 and Topo II Gene Amplification	6 years
Secondary	Recurrence-free Interval	9 years	Percentage of patients with local-regional recurrence or distant recurrence
Secondary	Distant Recurrence-free Interval	9 years	Percentage of patients with distant recurrence

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease Free Survival	9 years		percentage of participants	NUMBER
SECONDARY	Survival	9 years	Patients with any type of follow-up.	percentage of participants alive	NUMBER
SECONDARY	Adverse Events	9 years	Patients with follow-up and available adverse event information.	percentage of participants	NUMBER
SECONDARY	Quality of Life-Functional Assessment of Cancer Therapy	12 months	Patients who participated in the QOL sub-study	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Post Chemotherapy Amenorrhea	18 months	Patients who participated in the Menstrual History sub-study	percentage of participants	NUMBER
SECONDARY	Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation	12 months	Patients who participated in the cardiac function sub-study	Change in percent ejection fraction	MEAN
SECONDARY	HER-2 and Topo II Gene Amplification	6 years	Data were not collected. Gene amplification analysis was not performed on the submitted blocks.
SECONDARY	Recurrence-free Interval	9 years		percentage of participants	NUMBER
SECONDARY	Distant Recurrence-free Interval	9 years		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Disease Free Survival	Arm 1: Adriamycin + Cyclophosphamide		80.1		percentage of participants
Disease Free Survival	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide		79.4		percentage of participants
Survival	Arm 1: Adriamycin + Cyclophosphamide		89.8		percentage of participants alive
Survival	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide		89.9		percentage of participants alive
Adverse Events	Arm 1: Adriamycin + Cyclophosphamide		28.5		percentage of participants
Adverse Events	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide		45.0		percentage of participants
Quality of Life-Functional Assessment of Cancer Therapy	Arm 1: Adriamycin + Cyclophosphamide	Score day 1 cycle 4	61.7	95% Confidence Interval 60.9 to 62.7	score on a scale
Quality of Life-Functional Assessment of Cancer Therapy	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide	Score day 1 cycle 4	60.3	95% Confidence Interval 59.4 to 61.2	score on a scale
Quality of Life-Functional Assessment of Cancer Therapy	Arm 1: Adriamycin + Cyclophosphamide	Score 6 months	69.2	95% Confidence Interval 68.3 to 70.1	score on a scale
Quality of Life-Functional Assessment of Cancer Therapy	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide	Score 6 months	66.9	95% Confidence Interval 66.0 to 67.8	score on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1: Adriamycin + Cyclophosphamide	1,361
Overall Study	STARTED	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide	1,361
Overall Study	COMPLETED	Arm 1: Adriamycin + Cyclophosphamide	1,355
Overall Study	COMPLETED	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide	1,343
Overall Study	NOT COMPLETED	Arm 1: Adriamycin + Cyclophosphamide	6
Overall Study	NOT COMPLETED	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide	18

Source ClinicalTrials.gov

Adverse events90

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Adriamycin + Cyclophosphamide	106	1,351
other	Anemia	Blood and lymphatic system disorders	Fluorouracil + Epirubicin + Cyclophosphamide	147	1,337
other	Fatigue	General disorders	Adriamycin + Cyclophosphamide	118	1,351
other	Fatigue	General disorders	Fluorouracil + Epirubicin + Cyclophosphamide	165	1,337
other	Febrile neutropenia	Blood and lymphatic system disorders	Adriamycin + Cyclophosphamide	50	1,351
other	Febrile neutropenia	Blood and lymphatic system disorders	Fluorouracil + Epirubicin + Cyclophosphamide	127	1,337
other	Mucositis oral	Gastrointestinal disorders	Adriamycin + Cyclophosphamide	42	1,351
other	Mucositis oral	Gastrointestinal disorders	Fluorouracil + Epirubicin + Cyclophosphamide	81	1,337
other	Nausea	Gastrointestinal disorders	Adriamycin + Cyclophosphamide	94	1,351
other	Nausea	Gastrointestinal disorders	Fluorouracil + Epirubicin + Cyclophosphamide	121	1,337

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Adriamycin + Cyclophosphamide
Total, all-cause mortality	Fluorouracil + Epirubicin + Cyclophosphamide
Total, other adverse events	Adriamycin + Cyclophosphamide	290	1,351
Total, other adverse events	Fluorouracil + Epirubicin + Cyclophosphamide	454	1,337
Total, serious adverse events	Adriamycin + Cyclophosphamide	12	1,351
Total, serious adverse events	Fluorouracil + Epirubicin + Cyclophosphamide	26	1,337

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35112166	DERIVED	PubMed
35230585	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA012027	NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT	WOLMARK, NORMAN	NSABP FOUNDATION, INC.	NATIONAL CANCER INSTITUTE	1985 to 2012

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Adriamycin + Cyclophosphamide vs Fluorouracil + Epirubicin + Cyclophosphamide: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00087178

GET https://conductscience.org/api/trials/v1/NCT00087178/events?page=2

API reference For AI assistants