Clinical trial NCT00525642: Study of Suitable Schedule of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy of Beast Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Breast Neoplasms
Adjuvant
Chemotherapy
Keywords: Breast-adjuvant
Breast-chemotherapy
Combination chemotherapy regimens
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2007-09-06
Enrollment: 603
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disease Free Survival
timeFrame: 5 years and 10 years
measure: Grade III/IV Adverse Event,Severe Adverse Event
timeFrame: during chemotherapy and 30 days after treatment
Secondary outcomes:
measure: Overall Survival
timeFrame: 5 years and 10 years
measure: Distant disease free Survival
timeFrame: 5 years and 10 years
measure: Time to treatment failure
timeFrame: 5 years and 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing 307 Hospital
state: Beijing
city: Guangzhou
country: China
facility: No2 affiliated hospital of Sun Yat-sen medical Univesity
state: Guangdong
city: Shenyang
country: China
facility: Liaoning Province Cancer Hospital
state: Liaoning
city: Shanghai
country: China
facility: Cancer Hospital / Institute, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai No.6 hospital
state: Shanghai
Study officials:
affiliation: Cancer Hospital / Institute, Fudan University
name: Zhenzhou Shen, M.D.
role: STUDY_CHAIR
affiliation: Cancer Hospital / Institute, Fudan University
name: Zhiming Shao, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
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.
citation: 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.
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).
citation: 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)