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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00190489

Enrollment

450

Registered

2005-09-19

Start date

1999-01-31

Completion date

2006-05-31

Last updated

2016-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Neoplasm Metastasis

Keywords

metastatic breast cancer, drug therapy, doxorubicin, docetaxel

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 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.

Interventions

DRUGAC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles

DRUGAC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles

DRUGDocetaxel 60mg/m2 every 21 days for 6 cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
time to treatment failure	—

Secondary

Measure	Time frame
overall survival	—
progression-free survival	—
response rate	—
adverse events	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026