A Trial of Doxorubicin/Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D for Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00190489|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 2, 2016
|Condition or disease||Intervention/treatment||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 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||January 1999|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
- time to treatment failure
- overall survival
- progression-free survival
- response rate
- adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190489
|National Cancer Center Hospital|
|Chuo-ku, Tsukiji, 5-1-1, Tokyo, Japan, 104-0045|
|Study Chair:||Shigemitsu Takashima, MD, PhD||National Shikoku Cancer Center|