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CompletedNCT00190489Updated Sep 2, 2016

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

A Phase 3 interventional study of AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles and Docetaxel 60mg/m2 every 21 days for 6 cycles in Breast Cancer and Neoplasm Metastasis, sponsored by Japan Clinical Oncology Group. Completed at 1 site in Japan. Open to female participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-09-02.

Sponsored by Japan Clinical Oncology Group · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Breast Cancer
  • Neoplasm Metastasis

Keywords

  • metastatic breast cancer
  • drug therapy
  • doxorubicin
  • docetaxel
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 450 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Japan Clinical Oncology Group is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
450 participants

Interventions

  • DrugAC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles
  • DrugDocetaxel 60mg/m2 every 21 days for 6 cycles
  • DrugAC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles
06

What researchers measure

Primary outcomes

  1. time to treatment failure

Secondary outcomes

  1. overall survival

  2. progression-free survival

  3. response rate

  4. adverse events

07

Study locations

1 site
  • National Cancer Center Hospital
    Chuo-ku, Tsukiji, 5-1-1, Tokyo 104-0045, Japan
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00190489
Lead sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan
First posted
Sep 19, 2005
Start date
Jan 1999
Primary completion
May 2006
Completion
May 2006
Last update
Sep 2, 2016

Study contacts

Shigemitsu Takashima, MD, PhD
study chair · National Shikoku Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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