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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190489
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 2, 2016
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group

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

Condition or disease Intervention/treatment Phase
Breast Cancer Neoplasm Metastasis Drug: AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles Drug: Docetaxel 60mg/m2 every 21 days for 6 cycles Drug: AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : January 1999
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. time to treatment failure

Secondary Outcome Measures :
  1. overall survival
  2. progression-free survival
  3. response rate
  4. adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00190489

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National Cancer Center Hospital
Chuo-ku, Tsukiji, 5-1-1, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
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Study Chair: Shigemitsu Takashima, MD, PhD National Shikoku Cancer Center

Additional Information:
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Responsible Party: Japan Clinical Oncology Group Identifier: NCT00190489    
Other Study ID Numbers: JCOG9802
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Keywords provided by Japan Clinical Oncology Group:
metastatic breast cancer
drug therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors