Clinical trial · Interventional
Study of Suitable Schedule of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy of Beast Cancer
A Chinese Multi-Center,Randomized Study of Combination or Sequential Use of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy for Node Positive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- six cycles of adjuvant TAC
- interventionNames
- Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
- type
- EXPERIMENTAL
- label
- B
- description
- four cycles of T followed by 4 cycles of AC
- interventionNames
- Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide
Primary outcomes (2)
- measure
- Disease Free Survival
- timeFrame
- 5 years and 10 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDParkin 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
- BACKGROUNDYang 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
- BACKGROUNDMartin 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
- BACKGROUNDNabholtz 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).
- BACKGROUNDI.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)