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| Sponsor: | Japan Clinical Oncology Group |
|---|---|
| Collaborator: |
Ministry of Health, Labour and Welfare, Japan |
| Information provided by: | Japan Clinical Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00190489 |
Purpose
To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Neoplasm Metastasis |
Drug: AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles Drug: Docetaxel 60mg/m2 every 21 days for 6 cycles Drug: AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
| Estimated Enrollment: | 450 |
| Study Start Date: | January 1999 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
power to detect a 50% increase in median TTF at 0.025 one-sided alpha in AC vs. D and AC vs. AC-D.
Results: 441pts (146 in AC, 147 in D, 148 in AC-D) were randomized between 01/99 and 05/03. Major grade 3-4 toxicities were neutropenia (26/45/46% for AC/D/AC-D), febrile neutropenia (3/4/6%), nausea/vomiting (3/3/4%). There was no toxic death. One grade 4 diarrhea in AC-D and 1 secondary leukemia (APL) in D were reported. Response (CR/PR) rates were 30, 41, and 35% for AC, D, and AC-D respectively. Median TTF (AC, D, and AC-D) are 6.4, 6.4, and 6.7 months (p =.255 for AC vs. D, p =.275 for AC vs. AC-D), and median overall survival are 22.4, 25.7, and 25.0 months (p=.092 for AC vs. D, p=.076 for AC vs. AC-D). The same difference was shown by the adjusted Cox model.
Conclusions: No benefit was demonstrated in D and AC-D over AC in TTF, however, D and AC-D tended to be superior to AC in response rate and overall survival. Survival benefit of front-line docetaxel should be re-evaluated by further long follow-up.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Japan | |
| National Cancer Center Hospital | |
| 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045 | |
| Study Chair: | Shigemitsu Takashima, MD, PhD | National Shikoku Cancer Center |
More Information
| Responsible Party: | Japan Clinical Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00190489 History of Changes |
| Other Study ID Numbers: | JCOG9802, C000000179 |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 2, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
metastatic breast cancer drug therapy doxorubicin docetaxel |
|
Breast Neoplasms Neoplasms Neoplasm Metastasis Neoplasms by Site Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes Cyclophosphamide Docetaxel Doxorubicin Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic |
