Trial | NCT00190489  Report issue

Title

A Trial of Doxorubicin/Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D for Metastatic Breast Cancer
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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    doxorubicin cyclophosphamide docetaxel ...

  • Study Participants

    450
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.
Study Started
Jan 31
1999
Primary Completion
May 31
2006
Study Completion
May 31
2006
Last Update
Sep 02
2016
Estimate

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

Criteria 

Inclusion Criteria:

Hormonal therapy-resistant MBC
ER (-), failure of hormonal therapy for MBC, or relapse within 6 months after adjuvant hormonal therapy
No anthracyclines for MBC and no prior taxanes
At least 6 months from the completion of adjuvant chemotherapy
Measurable or evaluable lesions
Age: 20 to 75 years
PS: 0-3
WBC >= 4,000 /mm3 or ANC >=1,000 /mm3, Platelet >= 100,000 /mm3, SGOT/SGPT <= 1.5 x ULN, T-Bil <= 1.5 mg/dL, Cr <= 1.5 mg/dL
normal ECG
Written informed consent

Exclusion Criteria:

pregnant
malignant pleural effusion, ascites, or pericardial effusion that requires emergent treatment
Active infection
other cancer present within the last 5 years
previous stem cell transplantation
brain metastasis that requires emergent treatment
relapse within 6 months after completion anthracycline or during anthracycline
more than 250mg/m2 of anthracyclines
hypersensitivity of drug
interstitial pneumonitis or pulmonary fibrosis
positive HBs
antipsychotic medication
doctor's judgement
No Results Posted