NCT00070564|Active Not RecruitingPhase 3ResultsDMC

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

Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000334899S0221U10CA032102

Study Type

interventional

Target

3,294

Locations

3 countries

Sites

542

Timeline

RegisteredOct 2003

StartedNov 2003

CompletionJan 2027

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer. PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

3,294

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline

5mo left

Started Nov 2003

Longer than P75 for phase_3 breast-cancer

Geographic Reach

3 countries

542 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

23.2 years study duration

Study Progress98%

Nov 2003Jan 2027

First Submitted

Initial submission to the registry

October 3, 2003

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed

25 days until next milestone

Study Start

First participant enrolled

November 1, 2003

Completed

11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed

2.3 years until next milestone

Results Posted

Study results publicly available

April 17, 2017

Completed

9.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

11.2 years

First QC Date

October 3, 2003

Results QC Date

January 9, 2017

Last Update Submit

July 29, 2025

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IA breast cancerstage IB breast cancerstage IIIC breast cancermale breast cancerHER2-positive breast cancerestrogen receptor-negative breast cancerestrogen receptor-positive breast cancerprogesterone receptor-negative breast cancerprogesterone receptor-positive breast cancer

Outcome Measures

Primary Outcomes (2)

Disease-free Survival
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.
every 6 months (annually for mammograms) for 5 years
Overall Survival
Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Every 6 months for 5 years

Secondary Outcomes (7)

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.
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
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
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
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
+2 more secondary outcomes

Study Arms (6)

Arm I

ACTIVE COMPARATOR

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.