Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, 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 epirubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Giving chemotherapy drugs after surgery may kill any remaining tumor cells. PURPOSE: Pilot trial to study the effectiveness of neoadjuvant or adjuvant epirubicin, cyclophosphamide, and paclitaxel in treating women who have stage I, stage II, or stage III breast cancer.

Detailed Description
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OBJECTIVES: Determine the feasibility and safety of neoadjuvant or adjuvant epirubicin, cyclophosphamide, and paclitaxel, in terms of the absence of any grade 3 or higher toxicity (aside from alopecia), in women with high-risk stage I-III breast cancer. OUTLINE: This is a pilot study. Neoadjuvant or adjuvant EC therapy: Patients receive epirubicin IV over 3-5 minutes and cyclophosphamide IV (EC) on day 1 and filgrastim (G-CSF) subcutaneously on days 2-9 or 10. Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity. Neoadjuvant or adjuvant paclitaxel therapy: After the completion of EC therapy, patients receive paclitaxel IV over 3 hours on day 1. Patients also receive G-CSF as in EC therapy. Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who have not had prior surgery undergo definitive surgery after the completion of chemotherapy. Patients also may receive adjuvant radiotherapy and/or hormonal therapy at the discretion of the treating physician. Patients are followed every 4 months for 3 years and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 11-38 patients will be accrued for this study within 1 year.

Official Title
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Pilot Study of Epirubicin and Cyclophosphamide Followed by Paclitaxel at 10-11 Days Interval for Women With Early Breast Carcinoma

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: filgrastim
* Drug: cyclophosphamide
* Drug: epirubicin hydrochloride
* Drug: paclitaxel
* Procedure: adjuvant therapy
* Procedure: neoadjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Stage I, II, or III Inflammatory breast cancer allowed 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 at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) AND alkaline phosphatase no greater than ULN OR SGOT/SGPT no greater than ULN AND alkaline phosphatase no greater than 4 times ULN Renal Not specified Cardiovascular LVEF at least lower limit of normal by MUGA or echocardiogram No unstable angina No congestive heart failure No arrhythmia requiring medical therapy No myocardial infarction within the past year Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergy/hypersensitivity to any of the study drugs or other drugs formulated with Cremophor EL No psychiatric illness that would preclude understanding of the nature of the study or study compliance No active unresolved infection No peripheral neuropathy greater than grade 1 No other nonmammary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix No concurrent medical condition that would preclude study participation in the judgment of the investigator PRIOR CONCURRENT THERAPY: Biologic therapy More than 12 months since prior immunotherapy for prior breast cancer No prior or concurrent biologic therapy or immunotherapy for this breast cancer Chemotherapy More than 12 months since prior chemotherapy for prior breast cancer No prior anthracycline (i.e., doxorubicin or epirubicin) and taxane therapy No prior or other concurrent chemotherapy for this breast cancer Endocrine therapy No concurrent hormonal therapy for chemoprevention Prior hormonal therapy for chemoprevention allowed No concurrent sex hormonal therapy (e.g., birth control pills or ovarian hormonal replacement therapy) Radiotherapy No prior radiotherapy No other concurrent radiotherapy for this breast cancer Surgery Not specified Other No concurrent digitalis, beta-blockers, or calcium channel blockers for congestive heart failure

Ages Eligible for Study
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Minimum Age: 18 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: cyclophosphamide|nan|
|Drug: epirubicin hydrochloride|nan|
|Drug: paclitaxel|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: neoadjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

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