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: Phase II trial to study the effectiveness of combination chemotherapy and filgrastim followed by radiation therapy in treating patients who have stage II or stage IIIA breast cancer.

Condition	Treatment or Intervention	Phase
stage II breast cancer stage IIIA breast cancer Male Breast Cancer	Drug: cyclophosphamide  Drug: doxorubicin  Drug: filgrastim  Drug: paclitaxel  Drug: tamoxifen  Procedure: adjuvant therapy  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: antiestrogen therapy  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: endocrine therapy  Procedure: growth factor antagonist therapy  Procedure: hormone therapy  Procedure: radiation therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the feasibility of administering adjuvant paclitaxel, dose-intensive cyclophosphamide, and filgrastim (G-CSF), followed by doxorubicin and then radiotherapy in patients with stage II or IIIA breast cancer involving at least 10 lymph nodes.
• Determine the incidence of febrile neutropenia in these patients during the first course of therapy.
• Compare the incidence of febrile neutropenia and duration of neutropenia in patients treated with this regimen with that seen in patients treated on protocol CWRU-4194.
• Determine the disease-free and overall survival of patients treated with this regimen.
• Evaluate the quality of life of these patients.
• Determine the prognostic significance of occult bone marrow metastases in these patients.
• Correlate HER-2/neu overexpression with disease-free and overall survival in these patients.

OUTLINE: Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.

Patients with hormone receptor positive disease also receive oral tamoxifen daily for 5 years beginning at the completion of chemotherapy.

Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed days 1 and 4 of the first course of chemotherapy, day 1 of the second course, the last day of the final course, and at 6 months after the completion of treatment.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage II or IIIA breast cancer
• At least 10 positive 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

Ohio
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-5055,  United States; Recruiting

Study chairs or principal investigators

Brenda W. Cooper, MD,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000068341; CWRU-1100; CWRU-050023; NCI-G00-1877; NCT00007904
Record last reviewed:  January 2001
Last Updated:  December 6, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00007904
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08