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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Biological: pegfilgrastim; Procedure: conventional surgery; Drug: docetaxel; Drug: carboplatin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00107510

NCCTG-N0338

CDR0000420834 (Registry Identifier)

NCI-2012-02650 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and carboplatin together with pegfilgrastim before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with pegfilgrastim works in treating patients who are undergoing surgery for stage II or stage III breast cancer.

Full description

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

docetaxel + carboplatin + pegfilgrastim + surgery

Experimental group

Description:

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.

Treatment:

Drug: docetaxel

Drug: carboplatin

Procedure: conventional surgery

Biological: pegfilgrastim