A Randomized Trial Comparing EC-wPversus EP-wP as Adjuvant Therapy for Operable Breast Cancer Patients Less Than 40 Years Old

Study Overview
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Brief Summary
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Manifold data revealed that young breast cancer patients are characterized by aggressive clinical history. The purpose of this study is to evaluate the efficacy and safety of different strategies incorporating paclitaxel to anthracycline-based regimens in young breast cancer patients.

Official Title
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Comparing EC-wP Versus EP-wP as Adjuvant Therapy for Breast Cancer Patients Less Than 40 Years Old

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Epirubicin
* Drug: Cyclophosphamide
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients, age 18 40 Unilateral, operable, histologically confirmed adenocarcinoma of the breast Stage I-III Primary surgery with clear margins plus axillary dissection Able to start protocol Rx within 8 weeks of surgery Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer: the immunohistochemical cut-off for ER positive status was 1% or more staining in nuclei HER-2 negative (IHC 0,1+ or 2+ with a negative in situ hybridization test by chemotherapy pathologically confirmed regional node-positive disease, or node-negative disease with high-risk factors (primary tumor diameter >10 mm when histological grade III, or tumor diameter >20 mm when histological grade II) ECOG performance status 0-1 Adequate cardiac, renal, hepatic and hematologic function Exclusion Criteria: Metastatic disease Bilateral breast cancer (synchronous or metachronous) Prior radiation therapy, hormonal therapy and chemotherapy for breast cancer Previous cancer (except treated basal cell and squamous cell carcinoma of the skin or cancer of the uterine cervix) HER-2 positive (IHC 3+ OR FISH+) and or triple-negative breast cancer Documented history of cardiac disease contradiction anthracyclines Concurrent serious illness Peripheral neuropathy of CTC grade>1 History of hypersensitivity to drugs formulated in Cremophor EL polyoxyethylated castor oil), the vehicle used for commercial paclitaxel formulations Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EC-wP<br>epirubicin/cyclophosphamide followed weekly paclitaxel | Drug: Epirubicin<br>* 75 mg/m2 every-3-week for four cycles<br>Drug: Cyclophosphamide<br>* 600 mg/m2 every-3-week for four cycles<br>Drug: Paclitaxel<br>* 175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks<br>|
| Experimental: EP-wP<br>epirubicin/paclitaxel followed by weekly paclitaxel | Drug: Epirubicin<br>* 75 mg/m2 every-3-week for four cycles<br>Drug: Cyclophosphamide<br>* 600 mg/m2 every-3-week for four cycles<br>Drug: Paclitaxel<br>* 175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | every one year | 
| menstrual resumption rate | Resumption of menses was defined as at least 2 consecutive menstruations, or at least 1 menstruation with a confirmed premenopausal level of FSH and estradiol after chemotherapy | 12 months after chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | every one year |