Clinical trial · Interventional
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)
NCT00190489CI-TRIAL-00023758completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Neoplasm Metastasis | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles | Drug | — | UNRESOLVED |
| AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles | Drug | — | UNRESOLVED |
| Docetaxel 60mg/m2 every 21 days for 6 cycles | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- time to treatment failure
Secondary outcomes (4)
- measure
- overall survival
- measure
- progression-free survival
- measure
- response rate
- measure
- adverse events
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.