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

NCT00525642 | Unknown Phase 2 DMC

• 1 other identifier: TAX-619
• Study Type: interventional
• Target: 603
• Locations: 1 country
• Sites: 5

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.

Conditions

Breast Neoplasms; Adjuvant; Chemotherapy

Keywords

Breast-adjuvant; Breast-chemotherapy; Combination chemotherapy regimens

Outcome Measures

Primary Outcomes (2)

• Disease Free Survival

  5 years and 10 years

• Grade III/IV Adverse Event,Severe Adverse Event

  during chemotherapy and 30 days after treatment

Secondary Outcomes (3)

• 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

Study Arms (2)

A

EXPERIMENTAL

six cycles of adjuvant TAC

Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

B

EXPERIMENTAL

four cycles of T followed by 4 cycles of AC

Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

Interventions

Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide DRUG

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

Also known as: Docetaxel=Taxotere®

A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pT1-3,pN1-3,M0, operable breast cancer
• Karnofsky \>=80
• Pregnant test negative

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (5)

Beijing 307 Hospital

Beijing, Beijing Municipality, China

Location

No2 affiliated hospital of Sun Yat-sen medical Univesity

Guangzhou, Guangdong, China

Location

Liaoning Province Cancer Hospital

Shenyang, Liaoning, China

Location

Cancer Hospital / Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai No.6 hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (5)

• 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.

  PMID: 15761078 BACKGROUND

• 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.

  PMID: 17152490 BACKGROUND

• 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.

  PMID: 15930421 BACKGROUND

• 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).

  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)

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Doxorubicin; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Zhenzhou Shen, M.D.

  Cancer Hospital / Institute, Fudan University

  STUDY CHAIR

• Zhiming Shao, M.D.

  Cancer Hospital / Institute, Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 6, 2007
• Study Start: June 1, 2003
• Study Completion: June 1, 2015
• Last Updated: September 6, 2007

Record last verified: 2007-08

Locations

CN (5)