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

Fudan University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Chemotherapy; Adjuvant; Breast Neoplasms

Treatments: Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00525642

TAX-619

Details and patient eligibility

About

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.

Full 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.

Enrollment: 603 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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603 participants in 2 patient groups

A

Experimental group

Description:

six cycles of adjuvant TAC

Treatment:

Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

B

Experimental group

Description:

four cycles of T followed by 4 cycles of AC

Treatment:

Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide

Drug: Docetaxel, Doxorubicin or Epirubicin, Cyclophosphamide