Phase III trial of doxorubicin / cyclophosphamide (AC), docetaxel (D), and alternating AC and D (AC-D) as front-line chemotherapy for metastatic breast cancer: Japan Clinical Oncology Group trial (JCOG9802)

UMIN ID: C000000179

Registered date:12/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with Metatatic Breast Cancer
• Date of first enrollment: 1999/01/01
• Target sample size: 450
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles
Docetaxel 60mg/m2 every 21 days for 6 cycles
AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles

Outcome(s)

• Primary Outcome: time to treatment failure
• Secondary Outcome: overall survival, progression-free survival, response rate, adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: I. pregnant II. malignant pleural effusion, ascites, or pericardial effusion that requires emergent treatment III. Active infection IV. other cancer present within the last 5 years V. previous stem cell transplantation VI. brain metastasis that requires emergent treatment VII. relapse within 6 months after completion anthracycline or during anthracycline VIII. more than 250mg/m2 of anthracyclines IX. hypersensitivitiy of drug X. interstitial pneumonitis or pulmonary fibrosis XI. positive HBs XII. antipsychotic medication XIII. doctor's judgement

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): NCT00190489