Chemotherapy Plus Surgery in Treating Women With Breast Cancer

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy plus surgery in treating women who have breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Doxorubicin; Fluorouracil; Liposomal doxorubicin; Methotrexate; Paclitaxel; Tamoxifen

Criteria

DISEASE CHARACTERISTICS:

• Unilateral carcinoma of the breast that has not been previously treated with standard therapies

• Tumor greater than 2 cm in its maximum diameter as assessed by mammography, except:

• No locally advanced disease, i.e., no tumor with direct extension to the chest wall or skin

• No metastatic disease

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 to 70

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Karnofsky 80-100%

Hematopoietic:

• Granulocyte count at least 2,000/mm^3

• Platelet count at least 150,000/mm^3

Hepatic:

• Bilirubin within upper limits of normal (ULN)

• Alkaline phosphatase no greater than 1.5 times ULN

• AST no greater than 1.5 times ULN

• No chronic active hepatitis

Renal:

• Creatinine within ULN

Cardiovascular:

• No prior atrial or ventricular arrhythmias

• No history of congestive heart failure

• No myocardial infarction within the past 6 months

• No uncontrolled hypertension

Neurologic:

• No pre-existing motor or sensory neuropathy greater than grade 1

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No active infection

• No history of second malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• No prior endocrine therapy

Radiotherapy:

• No prior radiotherapy

Surgery:

• No prior surgery

• No prior surgical biopsy of breast nodule