Study of Suitable Schedule of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy of Beast Cancer

September 4, 2007 updated by: Fudan University

A Chinese Multi-Center,Randomized Study of Combination or Sequential Use of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy for Node Positive Breast Cancer

Anthracycline based regimens followed by a taxane (CALGB-9344 trial and NSABP-B28) or reversed (MD Anderson Adjuvant Trial) has already accepted as adjuvant therapy for node positive breast cancer. Also in this group of patients, data from BCIRG-001 trial had shown that six cycles of adjuvant TAC (docetaxel, doxorubicin and cyclophosphamide) is superior to standard FAC (5-FU, doxorubicin and cyclophosphamide ) combination in terms of both disease free and overall survival, while associated with a higher rate of febrile neutropenia. Then question arose whether it is better to use docetaxel and anthracycline in combination or sequence.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this national wide study, women with node positive operable breast cancer are eligible for inclusion.Patients were designed to randomize to six cycles of adjuvant TAC (Taxotere® 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2), and four cycles of T(100mg/m2), followed by 4 cycles of AC(doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2). Prophylaxis with G-CSF was allowed for two arms when febrile neutropenia occurred in the first cycle of the study treatment. The second endpoint of this study is disease free survival. The primary objective is to compare the disease free survival rate and safety profiles of the above mentioned two arms.

Study Type

Interventional

Enrollment (Actual)

603

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing 307 Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • No2 affiliated hospital of Sun Yat-sen medical Univesity
    • Liaoning
      • Shenyang, Liaoning, China
        • Liaoning Province Cancer Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Cancer Hospital / Institute, Fudan University
      • Shanghai, Shanghai, China
        • Shanghai No.6 hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pT1-3,pN1-3,M0, operable breast cancer
  • Karnofsky >=80
  • Pregnant test negative

Exclusion Criteria:

  • Prior Chemotherapy with anthracyclines and / or Taxanes, except for Neoadjuvant therapy
  • Prior breast radiation
  • Bilateral breast cancer
  • in-operable breast cancer
  • Other health condition which may be contraindications for chemotherapy
  • contraindications for Dexamethasone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
six cycles of adjuvant TAC
Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles
Other Names:
  • Docetaxel=Taxotere®
Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles
Other Names:
  • Docetaxel= Taxotere®
Experimental: B
four cycles of T followed by 4 cycles of AC
Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles
Other Names:
  • Docetaxel=Taxotere®
Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles
Other Names:
  • Docetaxel= Taxotere®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease Free Survival
Time Frame: 5 years and 10 years
5 years and 10 years
Grade III/IV Adverse Event,Severe Adverse Event
Time Frame: during chemotherapy and 30 days after treatment
during chemotherapy and 30 days after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 5 years and 10 years
5 years and 10 years
Distant disease free Survival
Time Frame: 5 years and 10 years
5 years and 10 years
Time to treatment failure
Time Frame: 5 years and 10 years
5 years and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Study Chair: Zhenzhou Shen, M.D., Cancer Hospital / Institute, Fudan University
  • Study Director: Zhiming Shao, M.D., Cancer Hospital / Institute, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

September 4, 2007

First Posted (Estimate)

September 6, 2007

Study Record Updates

Last Update Posted (Estimate)

September 6, 2007

Last Update Submitted That Met QC Criteria

September 4, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAX-619

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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