None listed
Conditions
Interventions
Adriamycin Type of group
Four cycles of adriamycin 50 mg / m2 post-operatively will be administered.
Group name:TAXOTERE Type of group
Four cycles of post-operative taxotere 75 mg / m2 will be administered.
Sponsors
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
Eligibility
Inclusion criteria
Inclusion criteria: Patients must consent to participate in the study and must have signed an approved consent. The interval belween the last surgery for breast cancer treatment and randomization must be less than or cqual to 84 days. Patients must have undergonc either a total maslectomy and axillary dissection, or lumpectomy and axillary dissection. Patients must have a life expectancy of at least 10 years, excluding their diagnosis of cancer.
Exclusion criteria
Exclusion criteria: Patients with diffuse tumors that would not be considered surgically amenabie to lumpectomy. Patients treated with lumpectomy in whom there is anolher dominant mass within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins. Patients who receive breast radiation therapy foilowing lumpectomy but prior to randomization. Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins in the breast are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo a total mastectomy to be eligible for entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated | — |
Countries
Peru, United States
Outcome results
None listed