Combination Chemotherapy in Treating Women With Breast Cancer

Overview

About this study

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. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

DISEASE CHARACTERISTICS:

Histologically confirmed resectable adenocarcinoma of the breast
Histologically positive lymph nodes (1 to 3) OR Lymph node negative and high risk disease Tumor greater than 1.0 cm diameter
May have undergone an axillary dissection with at least 6 nodes removed and examined or a sentinel node biopsy
Patients who are positive by sentinel node biopsy will receive an axillary dissection
No locally advanced or inflammatory or metastatic breast cancer
Hormone receptor status: Not specified

PATIENT CHARACTERISTICS:

Age: 18 and over
Sex: Female
Menopausal status: Not specified
Performance status: Not specified
Life expectancy: Not specified
Hematopoietic:
- Neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Adequate hepatic function
- Bilirubin no greater than upper limit of normal
Renal: Adequate renal function
Cardiovascular:
- Adequate cardiac function
- Normal MUGA or echocardiogram
Other:
- Not pregnant or nursing
- Fertile patients must use effective barrier method contraception
- At least 5 years since prior invasive malignancies, except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy: Not specified
Chemotherapy: No prior chemotherapy for this malignancy
Endocrine therapy:
- No concurrent tamoxifen
- Up to 4 weeks of tamoxifen treatment for this malignancy allowed
Radiotherapy:
- No prior radiotherapy for this malignancy
- Prior radiotherapy to the breast for ductal carcinoma in situ allowed
Surgery:
- Tumor should be removed by either a modified radical mastectomy and/or a segmental mastectomy plus axillary lymph node dissection or sentinel node biopsy before beginning treatment on protocol
- No greater than 84 days since last surgical procedure that constitutes or completes definitive surgical therapy (mastectomy; axillary dissection/sentinel node biopsy; or resection of primary site to obtain a negative margin)

More information

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