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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00525642
First received: September 4, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Adjuvant
Chemotherapy
 Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Chinese Multi-Center,Randomized Study of Combination or Sequential Use of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy for Node Positive Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fudan University:

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

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 5 years and 10 years ]
  • Distant disease free Survival [ Time Frame: 5 years and 10 years ]
  • Time to treatment failure [ Time Frame: 5 years and 10 years ]

Enrollment: 603
Study Start Date: June 2003
Estimated Study Completion Date: June 2015
Arms Assigned Interventions
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 Name: Docetaxel=Taxotere®
Experimental: B
four cycles of T followed by 4 cycles of AC
 Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles
Other Name: Docetaxel= Taxotere®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525642

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

Publications:
Nabholtz JM, Falkson G, Campos D, et al. A phase III trial comparing doxorubicin (A) and docetaxel (T) (AT) to doxorubicin and cyclophosphamide (AC) as first line chemotherapy for MBC. Proc. Amer. Soc. Clin. Oncol. (1999) 18: 127a (Abstr 485).
I.B.Ambulkaar, et al.Neoadjuvant sequential chemotherapy with docetaxel followed by epirubicin and cyclophosphamide in locally advanced breast cancer. Proc. Amer. Soc. Clin. Oncol. 2003 (Abstr 226)

ClinicalTrials.gov Identifier: NCT00525642     History of Changes
Other Study ID Numbers: TAX-619
Study First Received: September 4, 2007
Last Updated: September 4, 2007
Health Authority: China:Chinese Breast Cancer Society,Chinese Anti-Cancer Association

Keywords provided by Fudan University:
Breast-adjuvant
Breast-chemotherapy
Combination chemotherapy regimens

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Cyclophosphamide
Docetaxel
Doxorubicin
Epirubicin
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on May 23, 2013