Trial · NCT00070564

S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer

NCT00070564, Phase 3, Active not recruiting, SWOG Cancer Research Network; results first posted 2017-04-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer. Trials, record NCT00070564. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00070564

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Trial

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

Title: S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
NCT number: NCT00070564
Status: Active not recruiting
Phases: Phase 3
Enrollment: 3,294 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Breast Cancer
Interventions: pegfilgrastim, AC regimen, cyclophosphamide, doxorubicin hydrochloride, paclitaxel
First posted: 2003-10-07
Last updated: 2026-08-28
Results first posted: 2017-04-17

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	every 6 months (annually for mammograms) for 5 years	Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Primary	Overall Survival	Every 6 months for 5 years	Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Secondary	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Toxicity assessment was evaluated every 4 weeks while on protocol therapy.	Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Secondary	Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years	Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Secondary	Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years	Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Secondary	Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years	Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Secondary	Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years	Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Secondary	Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group	Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years	Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Secondary	Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.	Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years	Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.

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	every 6 months (annually for mammograms) for 5 years	Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.	percentage of participants	NUMBER
PRIMARY	Overall Survival	Every 6 months for 5 years	Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.	percentage of participants	NUMBER
SECONDARY	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Toxicity assessment was evaluated every 4 weeks while on protocol therapy.	Limited to patients who started treatment, who did not have a major deviation in the treatment protocol, and whose toxicity profile has been completed.	Participants	NUMBER
SECONDARY	Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years	Patients with HR-positive, HER-2 negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.	percentage of participants	NUMBER
SECONDARY	Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years	Patients with HR-positive, HER-negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.	percentage of participants	NUMBER
SECONDARY	Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years	Patients with HR-negative, HER-2 negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.	percentage of participants	NUMBER
SECONDARY	Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years	Patients with HR-negative, HER2-negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.	percentage of participants	NUMBER
SECONDARY	Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group	Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years	Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.	percentage of participants	NUMBER
SECONDARY	Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.	Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years	Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group1,584

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

Outcome	Group	Value	Spread	Units
Disease-free Survival	Arm I	83	95% Confidence Interval 80 to 86	percentage of participants
Disease-free Survival	Arm II	79	95% Confidence Interval 76 to 82	percentage of participants
Disease-free Survival	Arm III	81	95% Confidence Interval 78 to 84	percentage of participants
Disease-free Survival	Arm IV	81	95% Confidence Interval 78 to 84	percentage of participants
Disease-free Survival	Arm V	84	95% Confidence Interval 79 to 88	percentage of participants
Disease-free Survival	Arm VI	85	95% Confidence Interval 80 to 89	percentage of participants
Overall Survival	Arm I	90	95% Confidence Interval 87 to 92	percentage of participants
Overall Survival	Arm II	87	95% Confidence Interval 84 to 90	percentage of participants
Overall Survival	Arm III	87	95% Confidence Interval 84 to 89	percentage of participants
Overall Survival	Arm IV	87	95% Confidence Interval 84 to 90	percentage of participants

1 to 10 of 1,584Source ClinicalTrials.gov

See all 1,584 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I	678
Overall Study	STARTED	Arm II	693
Overall Study	STARTED	Arm III	697
Overall Study	STARTED	Arm IV	648
Overall Study	STARTED	Arm V	282
Overall Study	STARTED	Arm VI	296
Overall Study	COMPLETED	Arm I	478
Overall Study	COMPLETED	Arm II	490
Overall Study	COMPLETED	Arm III	526
Overall Study	COMPLETED	Arm IV	481

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events330

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	Febrile neutropenia	Blood and lymphatic system disorders	ARM I	49	654
other	Febrile neutropenia	Blood and lymphatic system disorders	ARM II	9	663
other	Febrile neutropenia	Blood and lymphatic system disorders	ARM III	38	674
other	Febrile neutropenia	Blood and lymphatic system disorders	ARM IV	20	624
other	Febrile neutropenia	Blood and lymphatic system disorders	ARM V	15	275
other	Febrile neutropenia	Blood and lymphatic system disorders	ARM VI	12	291
other	Hemoglobin	Blood and lymphatic system disorders	ARM I	87	654
other	Hemoglobin	Blood and lymphatic system disorders	ARM II	48	663
other	Hemoglobin	Blood and lymphatic system disorders	ARM III	101	674
other	Hemoglobin	Blood and lymphatic system disorders	ARM IV	47	624

1 to 10 of 330Source ClinicalTrials.gov

See all 330 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ARM I
Total, all-cause mortality	ARM II
Total, all-cause mortality	ARM III
Total, all-cause mortality	ARM IV
Total, all-cause mortality	ARM V
Total, all-cause mortality	ARM VI
Total, other adverse events	ARM I	381	654
Total, other adverse events	ARM II	412	663
Total, other adverse events	ARM III	389	674
Total, other adverse events	ARM IV	391	624

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21766209	RESULT	PubMed
25422488	RESULT	PubMed
37935109	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
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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.

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