Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes

• Status: Completed
• Trial end date: 1969-12-31
• 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. It is not yet known which regimen of chemotherapy is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.

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

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborators: Cancer and Leukemia Group B; National Cancer Institute (NCI); North Central Cancer Treatment Group; Southwest Oncology Group
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Tamoxifen

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the breast with histologically involved lymph nodes (T1, 2, or 3; N1 or 2; M0) OR high-risk node-negative disease (T2 or 3; N0)

• Primary tumor at least 2.1 cm in diameter for node-negative disease

• Bilateral breast disease allowed if at least 1 primary tumor meets the criteria above

• Must have had at least 6 axillary lymph nodes removed at dissection and at least one node positive for metastasis OR

• Sentinel node biopsy negative for metastasis (sentinel node biopsy positive allowed if enrolled on American College of Surgery Trial Z0011 and have beenrandomized to receive no axillary dissection)

• Additional axillary nodes may be obtained provided they are also negative for metastasis

• Complete tumor removal by either a modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy

• Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed)

• Concurrent enrollment on American College of Surgery Trial Z0010, Z0011, or NSABP B-32 allowed

• Hormone receptor status:

• Estrogen receptor status positive, negative, or unknown

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/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• SGOT no greater than 2 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No history of myocardial infarction

• No congestive heart failure

• No significant ischemic or valvular heart disease

Other:

• No other prior invasive malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

• No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs (with Cremophor or polysorbate)

• Not pregnant or nursing

• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for breast cancer

Endocrine therapy:

• Prior tamoxifen of no more than 4 weeks duration for breast cancer allowed

• Prior tamoxifen or other selective estrogen receptor modulator (SERM) for chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (e.g., osteoporosis) allowed

• No concurrent tamoxifen or other SERMs

Radiotherapy:

• No prior radiotherapy for this malignancy

• At least 2 weeks since prior radiotherapy to the breast for ductal carcinoma in situ

Surgery:

• See Disease Characteristics

• Less than 84 days since prior surgical procedure to adequately treat primary tumor