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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026116
• Other study ID #: SHBCC09007
• Status: Completed
• Phase: Phase 3
• Start date: December 2009
• Est. completion date: December 23, 2016

Study information

• Verified date: May 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: December 23, 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Epirubicin
75 mg/m2 every-3-week for four cycles
• Cyclophosphamide
600 mg/m2 every-3-week for four cycles
• Paclitaxel
175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks

Locations

Country	Name	City	State
China	Department of Breast Surgery, Cancer Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival		every one year
Primary	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	overall survival		every one year