Adjuvant Stage 2-3A Breast Cancer With Positive Lymph Nodes

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Citric Acid; Cyclophosphamide; Doxorubicin; Lenograstim; Liposomal doxorubicin; Paclitaxel; Sargramostim; Tamoxifen

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage II or IIIA breast cancer

• At least 5 axillary lymph nodes

• No T4 or N3 disease

• No distant metastases by CT scan of the chest, abdomen, and pelvis; bone scan; and bone marrow evaluation

• No more than 8 weeks since prior lumpectomy or mastectomy with axillary node dissection

• Negative surgical margins

• Hormone receptor status:

• Hormone receptor status known

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Male or female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm^3

• Granulocyte count at least 1,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT no greater than 1.5 times ULN

• Alkaline phosphatase no greater than 1.5 times ULN

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No poorly controlled ischemic heart disease or congestive heart failure

Pulmonary:

• No severe chronic obstructive or restrictive pulmonary disease

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No severe diabetes mellitus

• No other severe concurrent medical or psychiatric illness that would preclude study participation

• No other malignancy within past 5 years except curatively treated ductal carcinoma in situ, lobular carcinoma in situ, or breast cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics