- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00190489
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)
Study Overview
Status
Conditions
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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Tokyo
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Chuo-ku, Tsukiji, 5-1-1, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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time to treatment failure
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Secondary Outcome Measures
Outcome Measure |
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adverse events
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overall survival
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response rate
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progression-free survival
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Shigemitsu Takashima, MD, PhD, National Shikoku Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JCOG9802
- C000000179
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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