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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 (PAY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2009 by Fudan University
Information provided by:
Fudan University Identifier:
First received: December 3, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
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.

Condition Intervention Phase
Breast Neoplasms
Drug: A
Drug: B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: every one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: every one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1664
Study Start Date: December 2009
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: A
    epirubicin/cyclophosphamide followed weekly paclitaxel
    Drug: B
    epirubicin/paclitaxel followed by weekly paclitaxel

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01026116

Contact: Wenjin Yin 86(21)64175590 ext 8700

Department of Breast Surgery, Cancer Hospital, Fudan University Not yet recruiting
Shanghai, China, 200032
Contact: Wenjin Yin    86(21)64175590 ext 8700   
Principal Investigator: Zhimin Shao         
Department of Breast Surgery, Cancer Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: Zhimin Shao    86(21)64175590 ext 8807   
Contact: Wenjin Yin    86(21)64175590 ext 8700   
Principal Investigator: Zhimin Shao         
Sponsors and Collaborators
Fudan University
Principal Investigator: Zhimin Shao Cancer Hospital, Fudan University
  More Information

Responsible Party: Base for drug clinical trials, Cancer Hospital, Fudan University, Department of Breast Surgery, Cancer Hospital, Fudan University Identifier: NCT01026116     History of Changes
Other Study ID Numbers: SHBCC09007 
Study First Received: December 3, 2009
Last Updated: December 3, 2009
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on October 21, 2016