S0221: 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
Study Status
Closed to Enrollment
Study Description
The purpose of this study is to compare two different treatment regimens in patients with high-risk breast cancer. The treatments used in this study are approved medications that are known to be effective for treating breast cancer.
The researchers would also like to determine whether there is any link between DNA or protein patterns from racial/ethnic groups and how your body metabolizes drugs and hormones. By analyzing your DNA or protein, we may be able to predict whether racial/ethnic groups with breast cancer will respond to specific drug therapies and whether this information can predict breast cancer survival.
Patients will be randomized to 1 of 2 study arms:
- Arm 1: Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV infusion and cyclophosphamide IV infusion on day 1 and pegfilgrastim SC on day 2. 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.
- Arm 2: Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim as above. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV infusion over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
We expect that initial treatment will take about 20 weeks. Patients with estrogen receptor-positive or progesterone receptor-positive tumors will receive 5 years of hormonal therapy after initial treatment. After initial treatment is completed we would like to examine you every 6 months for the first 5 years and then once a year for a maximum of 15 years.
Disease Status and/or Stage
Operable Stage 1, II or II Invasive Breast Cancer
Sponsor
SouthWest Oncology Group (SWOG) and The Cancer Support Trials Unit (CTSU)
Key Eligibility
- Age 18 and older
- Operable Stage 1, II or III invasive breast cancer
- Patients must have had either a modified radical mastectomy or local excision of all tumors plus an axillary lymph node dissection or sentinel node resection
- No prior cytotoxic chemotherapy for this breast cancer
- No prior radiation therapy for the current malignancy except for partial breast irradiation following lumpectomy
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Martarita Maxwell
- (212) 821-0644
Healthy Volunteers
As a healthy volunteer in a clinical trial you may make a significant contribution to the discovery of medical knowledge and new treatments that could impact people around the world.
Click here for studies seeking healthy volunteers.
Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
roh2026@med.cornell.edu
