A Randomized Trial Comparing Epirubicin/Cyclophosphamide Followed by Weekly Paclitaxel Versus Epirubicin/Paclitaxel Followed by Weekly Paclitaxel as Adjuvant Therapy for Operable Breast Cancer Patients Less Than 40 Years Old
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: A Type: Drug
Name: B Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 40 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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 4 weeks of surgery

- HER-2 positive (IHC 3+ OR FISH+) and sequential use of trastuzumab followed by chemotherapy

- Occult breast cancer with histologically confirmed primary invasive carcinoma or DICS with microinvasion in the ipsilateral breast after surgery

- 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 concurrence use of adjuvant chemotherapy and trastuzumab

- 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
Locations
Department of Breast Surgery, Cancer Hospital, Fudan University
Shanghai, China
Status: Not yet recruiting
Contact: Wenjin Yin - 86(21)64175590 - followroad@yahoo.com.cn
Department of Breast Surgery, Cancer Hospital, Fudan University
Shanghai, China
Status: Recruiting
Contact: Zhimin Shao - 86(21)64175590 - zhimingshao1962@yahoo.com.cn
Start Date
December 2009
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page