Docetaxel, Carboplatin, and Pegfilgrastim in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer

OBJECTIVES:

Primary

• Determine the pathological complete response rate in patients with stage II or III breast cancer treated with neoadjuvant docetaxel, carboplatin, and pegfilgrastim.

Secondary

• Determine the toxicity profile of this regimen in these patients.
• Determine the rate of breast-conserving surgery in patients treated with this regimen.
• Determine the clinical response rate in patients treated with this regimen.
• Determine the feasibility of drug administration, in terms of the percent of planned dose actually administered per course, in patients treated with this regimen.
• Determine the proportion of patients with negative pathologic lymph node status after treatment with this regimen.
• Determine the proportion of patients with residual ductal carcinoma in situ after treatment with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

No more than 6 weeks after completion of chemotherapy, patients undergo definitive surgery.

After completion of study therapy, patients are followed every 6 months until disease progression and then annually for up to 5 years. Patients who do not complete all 4 courses of chemotherapy or do not undergo surgery are followed every 6 months for up to 5 years.

DISEASE CHARACTERISTICS:

• Diagnosis of breast cancer

• Clinical stage II or III disease (including T2-4, N0-3)
• No clinical or radiological evidence of distant metastases

• Isolated supraclavicular lymph node involvement allowed

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10.0 g/dL

Hepatic

• Bilirubin normal
• Meets 1 of the following criteria:

• AST or ALT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase normal
• AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
• AST or ALT normal AND alkaline phosphatase ≤ 5 times ULN

Renal

• Creatinine clearance ≥ 30 mL/min

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after study treatment
• No active unresolved infection
• No history of severe hypersensitivity reaction to docetaxel, carboplatin, or any other drug formulated with polysorbate 80
• No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or pegfilgrastim
• No peripheral neuropathy ≥ grade 2
• No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Surgery

• No prior surgical resection for invasive breast cancer

Other

• No other prior therapy for invasive breast cancer