A Trial of Doxorubicin/Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D for Metastatic Breast Cancer
NCT ID: NCT00190489
Last Updated: 2016-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
450 participants
INTERVENTIONAL
1999-01-31
2006-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles
Docetaxel 60mg/m2 every 21 days for 6 cycles
AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
75 Years
FEMALE
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
Japan Clinical Oncology Group
OTHER
Responsible Party
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Japan Clinical Oncology Group
Principal Investigators
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Shigemitsu Takashima, MD, PhD
Role: STUDY_CHAIR
National Shikoku Cancer Center
Locations
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National Cancer Center Hospital
Chuo-ku, Tsukiji, 5-1-1, Tokyo, Japan
Countries
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Related Links
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Related Info
Other Identifiers
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C000000179
Identifier Type: -
Identifier Source: secondary_id
JCOG9802
Identifier Type: -
Identifier Source: org_study_id
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