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