NIPH Clinical Trials Search

UMIN ID: C000000179

Registered date:12/09/2005

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)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPatients with Metatatic Breast Cancer
Date of first enrollment1999/01/01
Target sample size450
Countries of recruitmentJapan
Study typeInterventional
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


Primary Outcometime to treatment failure
Secondary Outcomeoverall survival, progression-free survival, response rate, adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
Include criteria
Exclude criteriaI. 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


public contact
Name Noriyuki Katsumata ,MD
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN Japan
Affiliation JCOG9802 Coordinating Office Medical Oncology Division, National Cancer Center Hospital
scientific contact
Name Shigemitsu Takashima, MD, PhD
Address 13 Horinouchi, Matsuyama, Ehime 790-0007,Japan Japan
Affiliation National Shikoku Cancer Center Surgery Division