Study of Suitable Schedule of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy of Beast Cancer
Primary Purpose
Breast Neoplasms, Adjuvant, Chemotherapy
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast-adjuvant, Breast-chemotherapy, Combination chemotherapy regimens
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
Sites / Locations
- Beijing 307 Hospital
- No2 affiliated hospital of Sun Yat-sen medical Univesity
- Liaoning Province Cancer Hospital
- Cancer Hospital / Institute, Fudan University
- Shanghai No.6 hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
six cycles of adjuvant TAC
four cycles of T followed by 4 cycles of AC
Outcomes
Primary Outcome Measures
Disease Free Survival
Grade III/IV Adverse Event,Severe Adverse Event
Secondary Outcome Measures
Overall Survival
Distant disease free Survival
Time to treatment failure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00525642
Brief Title
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
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Adjuvant, Chemotherapy
Keywords
Breast-adjuvant, Breast-chemotherapy, Combination chemotherapy regimens
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
603 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
six cycles of adjuvant TAC
Arm Title
B
Arm Type
Experimental
Arm Description
four cycles of T followed by 4 cycles of AC
Intervention Type
Drug
Intervention Name(s)
Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Other Intervention Name(s)
Docetaxel=Taxotere®
Intervention Description
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 six cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Other Intervention Name(s)
Docetaxel= Taxotere®
Intervention Description
Docetaxel 100mg/m2 four cycles; Doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2) four cycles
Primary Outcome Measure Information:
Title
Disease Free Survival
Time Frame
5 years and 10 years
Title
Grade III/IV Adverse Event,Severe Adverse Event
Time Frame
during chemotherapy and 30 days after treatment
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
5 years and 10 years
Title
Distant disease free Survival
Time Frame
5 years and 10 years
Title
Time to treatment failure
Time Frame
5 years and 10 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenzhou Shen, M.D.
Organizational Affiliation
Cancer Hospital / Institute, Fudan University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zhiming Shao, M.D.
Organizational Affiliation
Cancer Hospital / Institute, Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Beijing 307 Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
No2 affiliated hospital of Sun Yat-sen medical Univesity
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Liaoning Province Cancer Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Cancer Hospital / Institute, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai No.6 hospital
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
15761078
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.
Results Reference
background
PubMed Identifier
17152490
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.
Results Reference
background
PubMed Identifier
15930421
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.
Results Reference
background
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).
Results Reference
background
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)
Results Reference
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Study of Suitable Schedule of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy of Beast Cancer
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