Breast Cancer Clinical Trial
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)
To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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