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

Phase 3

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Paclitaxel

• Registration Number: NCT01026116
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Primary Completion: 2016-01
• Study Completion: 2016-12-23
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-09
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 521

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EP-wP	Cyclophosphamide	epirubicin/paclitaxel followed by weekly paclitaxel
EC-wP	Paclitaxel	epirubicin/cyclophosphamide followed weekly paclitaxel
EP-wP	Epirubicin	epirubicin/paclitaxel followed by weekly paclitaxel
EC-wP	Epirubicin	epirubicin/cyclophosphamide followed weekly paclitaxel
EC-wP	Cyclophosphamide	epirubicin/cyclophosphamide followed weekly paclitaxel
EP-wP	Paclitaxel	epirubicin/paclitaxel followed by weekly paclitaxel

Primary Outcome Measures

Name	Time	Method
disease-free survival	every one year
menstrual resumption rate	12 months after chemotherapy	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

Secondary Outcome Measures

Name	Time	Method
overall survival	every one year

Trial Locations

Locations (1)

Department of Breast Surgery, Cancer Hospital, Fudan University; 🇨🇳 Shanghai, China