Status:
COMPLETED
A Trial of Doxorubicin/Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D for Metastatic Breast Cancer
Lead Sponsor:
Japan Clinical Oncology Group
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Breast Cancer
Neoplasm Metastasis
Eligibility:
FEMALE
20-75 years
Phase:
PHASE3
Brief Summary
To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer
Detailed Description
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 gr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00190489
Start Date
January 1 1999
End Date
May 1 2006
Last Update
September 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Center Hospital
Chuo-ku, Tsukiji, 5-1-1, Tokyo, Japan, 104-0045