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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Trial of Docetaxel and Carboplatin Administered Every Two Weeks as Induction Therapy for Stage II or III Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: pegfilgrastim
* Drug: carboplatin
* Drug: docetaxel
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: docetaxel + carboplatin + pegfilgrastim + surgery<br>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. | Biological: pegfilgrastim<br> <br> Drug: carboplatin<br> <br> Drug: docetaxel<br> <br> Procedure: conventional surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response rate by histologic evaluation at definitive surgery |  | Up to 5.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity profile by CTCAE v3.0 at baseline and each subsequent evaluation |  | Up to 5.5 years | 
| Rate of breast conserving surgery at definitive surgery after neoadjuvant chemotherapy |  | Up to 5.5 years | 
| Clinical response rate by clinical examination prior to definitive surgery |  | Up to 5.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, male breast cancer