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NCT Number: NCT01026116

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Department of Breast Surgery, Cancer Hospital, Fudan University

Shanghai, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epirubicin

Drug

75 mg/m2 every-3-week for four cycles

Cyclophosphamide

Drug

600 mg/m2 every-3-week for four cycles

paclitaxel

Drug

175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks

Primary outcomes

  1. disease-free survival

    Time frame: every one year

  2. menstrual resumption rate

    Time frame: 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 outcomes

  1. overall survival

    Time frame: every one year

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2009
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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