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

Fudan University

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: Epirubicin; Drug: Paclitaxel; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01026116

SHBCC09007

Details and patient eligibility

About

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.

Enrollment: 521 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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521 participants in 2 patient groups

EC-wP

Active Comparator group

Description:

epirubicin/cyclophosphamide followed weekly paclitaxel

Treatment:

Drug: Cyclophosphamide

Drug: Paclitaxel

Drug: Epirubicin

EP-wP

Experimental group

Description:

epirubicin/paclitaxel followed by weekly paclitaxel

Treatment:

Drug: Cyclophosphamide

Drug: Paclitaxel

Drug: Epirubicin