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

NCT ID: NCT00525642

Last Updated: 2007-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 603 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2015-06-30

Brief Summary

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.

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.

Conditions

Breast Neoplasms; Adjuvant; Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

six cycles of adjuvant TAC

Group Type: EXPERIMENTAL

Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

Intervention Type: DRUG

Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles

B

four cycles of T followed by 4 cycles of AC

Group Type: EXPERIMENTAL

Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

Intervention Type: DRUG

Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles

Interventions

Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles

Intervention Type: DRUG

Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles

Intervention Type: DRUG

Other Intervention Names

Docetaxel=Taxotere®; Docetaxel= Taxotere®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Principal Investigators

Zhenzhou Shen, M.D.

Role: STUDY_CHAIR

Cancer Hospital / Institute, Fudan University

Zhiming Shao, M.D.

Role: STUDY_DIRECTOR

Cancer Hospital / Institute, Fudan University

Locations

Beijing 307 Hospital

Beijing, Beijing Municipality, China

No2 affiliated hospital of Sun Yat-sen medical Univesity

Guangzhou, Guangdong, China

Liaoning Province Cancer Hospital

Shenyang, Liaoning, China

Cancer Hospital / Institute, Fudan University

Shanghai, Shanghai Municipality, China

Shanghai No.6 hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.

Reference Type: BACKGROUND

PMID: 15761078 (View on PubMed)

Yang L, Li LD, Chen YD, Parkin DM. [Time trends, estimates and projects for breast cancer incidence and mortality in China]. Zhonghua Zhong Liu Za Zhi. 2006 Jun;28(6):438-40. Chinese.

Reference Type: BACKGROUND

PMID: 17152490 (View on PubMed)

Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. doi: 10.1056/NEJMoa043681.

Reference Type: BACKGROUND

PMID: 15930421 (View on PubMed)

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).

Reference Type: BACKGROUND

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)

Reference Type: BACKGROUND

Other Identifiers

TAX-619

Identifier Type: -

Identifier Source: org_study_id