Paclitaxel and Carboplatin in Treating Women Who Are Undergoing Surgery for Newly Diagnosed, Locally Advanced Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. Combining paclitaxel with carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating women who are undergoing surgery for newly diagnosed, locally advanced breast cancer.

Detailed Description
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OBJECTIVES: Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin. Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen. Determine the tolerability and toxicity of this regimen in these patients. OUTLINE: This is an open-label study. Patients with non-palpable lymph nodes undergo sentinel lymph node biopsy within 4 weeks before beginning neoadjuvant chemotherapy. All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo lumpectomy or modified radical mastectomy. Patients with a positive sentinel lymph node biopsy or palpable axillary adenopathy undergo axillary lymph node dissection. All patients undergoing lumpectomy or mastectomy with high-risk disease also undergo radiotherapy. Patients refusing lumpectomy or mastectomy due to persistence of disease may undergo core needle biopsy. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18 months.

Official Title
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A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast meeting the following stage criteria: T2, T3, or T4a-c N0-2 M0 Inflammatory breast cancer (stage IIIB) allowed Measurable disease by mammogram or ultrasound Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Not specified Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL Hepatic AST and ALT ≤ 1.5 times upper limit of normal (ULN) Renal Creatinine ≤ 1.2 times ULN OR Creatinine clearance ≥ 50 mL/min Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No comorbid medical condition that would preclude study participation No comorbid infection that would preclude study participation No clinically significant peripheral neuropathy (> grade 1) No prior significant allergic reaction to drugs containing Cremophor, such as teniposide, cyclosporine, or vitamin K No dementia or altered mental status that would prohibit understanding of informed consent No other primary malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent prophylactic growth factors Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy Not specified Surgery At least 3 weeks since prior surgery Other No other concurrent anticancer drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel IV followed by Carboplatin IV<br>paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. | Drug: carboplatin<br> <br> Drug: paclitaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin |  | baseline to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen |  | baseline through 18 months | 
| Determine the tolerability and toxicity of this regimen in these patients. |  | baseline to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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invasive ductal breast carcinoma, invasive lobular breast carcinoma, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, inflammatory breast cancer