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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00525642
• Other study ID #: TAX-619
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 4, 2007
• Last updated: September 4, 2007
• Start date: June 2003
• Est. completion date: June 2015

Study information

• Verified date: August 2007
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Chinese Breast Cancer Society,Chinese Anti-Cancer Association
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 603
• Est. completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Adjuvant
• Breast Neoplasms
• Chemotherapy

Intervention

Drug:
• Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles
• Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (5)

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)

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. — View Citation

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).

Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival		5 years and 10 years
Primary	Grade III/IV Adverse Event,Severe Adverse Event		during chemotherapy and 30 days after treatment
Secondary	Overall Survival		5 years and 10 years
Secondary	Distant disease free Survival		5 years and 10 years
Secondary	Time to treatment failure		5 years and 10 years