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

Phase 2

• Conditions: Breast Neoplasms; Adjuvant; Chemotherapy
• Interventions: Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

• Registration Number: NCT00525642
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2003-06
• Status Verified: 2007-08
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Last Update Submitted: 2007-09-04
• Study First Posted: 2007-09-06
• Last Update Posted: 2007-09-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 603

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide	six cycles of adjuvant TAC
B	Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide	four cycles of T followed by 4 cycles of AC

Primary Outcome Measures

Name	Time	Method
Disease Free Survival	5 years and 10 years
Grade III/IV Adverse Event,Severe Adverse Event	during chemotherapy and 30 days after treatment

Secondary Outcome Measures

Name	Time	Method
Overall Survival	5 years and 10 years
Distant disease free Survival	5 years and 10 years
Time to treatment failure	5 years and 10 years

Trial Locations

Locations (5)

No2 affiliated hospital of Sun Yat-sen medical Univesity; 🇨🇳 Guangzhou, Guangdong, China

Beijing 307 Hospital; 🇨🇳 Beijing, Beijing, China

Liaoning Province Cancer Hospital; 🇨🇳 Shenyang, Liaoning, China

Cancer Hospital / Institute, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Shanghai No.6 hospital; 🇨🇳 Shanghai, Shanghai, China