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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Clinical Oncology Group
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

1. Hormonal therapy-resistant MBC

2. ER (-), failure of hormonal therapy for MBC, or relapse within 6 months after adjuvant hormonal therapy

3. No anthracyclines for MBC and no prior taxanes

4. At least 6 months from the completion of adjuvant chemotherapy

5. Measurable or evaluable lesions

6. Age: 20 to 75 years

7. PS: 0-3

8. 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

9. normal ECG

10. Written informed consent

Exclusion Criteria:

1. pregnant

2. malignant pleural effusion, ascites, or pericardial effusion that requires emergent treatment

3. Active infection

4. other cancer present within the last 5 years

5. previous stem cell transplantation

6. brain metastasis that requires emergent treatment

7. relapse within 6 months after completion anthracycline or during anthracycline

8. more than 250mg/m2 of anthracyclines

9. hypersensitivity of drug

10. interstitial pneumonitis or pulmonary fibrosis

11. positive HBs

12. antipsychotic medication

13. doctor's judgement