Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer
|ClinicalTrials.gov Identifier: NCT00003352|
Recruitment Status : Completed
First Posted : June 27, 2003
Last Update Posted : December 11, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of doxorubicin, cyclophosphamide, and docetaxel in treating women with stage IIIB or stage IV breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: cyclophosphamide Drug: Taxotere Drug: Adriamycin||Phase 2|
OBJECTIVES: I. Determine the overall response rate to doxorubicin, docetaxel, and cyclophosphamide (ATC) in women with metastatic or locally advanced breast cancer. II. Determine survival, time to first response, time to progression, and duration of response in these patients. III. Evaluate the feasibility of administering ATC for at least 4 courses. IV. Evaluate the toxicity profile of ATC and its effect on cardiac function.
OUTLINE: Patients receive intravenous doxorubicin over 15 minutes on day 0, followed by intravenous cyclophosphamide over 30 minutes. An hour after the end of the doxorubicin infusion, intravenous docetaxel is administered over 1 hour. Patients receive courses every 21 days until disease progression or unacceptable toxic effects are observed. When the maximum dose of doxorubicin is reached, treatment continues with docetaxel and cyclophosphamide. Patients with locally advanced breast cancer receive chemotherapy for at least 2 courses after documented response. Patients are followed every 6 weeks.
PROJECTED ACCRUAL: Approximately 89 patients will be accrued to this study within 14 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study in Patients With Metastatic or Locally Advanced Breast Cancer to Evaluate the Worth of the Combination of Adriamycin (Doxorubicin), Taxotere (Docetaxel), and Cyclophosphamide (ATC)|
|Study Start Date :||June 1998|
|Actual Primary Completion Date :||September 2000|
|Actual Study Completion Date :||December 2002|
- Best over-all tumor response that occurs during 6 cycles of chemotherapy [ Time Frame: 18 weeks ]
- Survival [ Time Frame: 18 weeks ]
- Time to first response [ Time Frame: 18 weeks ]
- Time to progression [ Time Frame: 18 weeks ]
- Duration of response [ Time Frame: 18 weeks ]
- Completion of at least four cycles of chemotherapy [ Time Frame: 12 weeks ]
- Toxicity profile [ Time Frame: 18 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003352
Show 166 Study Locations
|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation Inc|