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

Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190489
• Other study ID #: JCOG9802
• Secondary ID: C000000179
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: August 31, 2016
• Start date: January 1999
• Est. completion date: May 2006

Study information

• Verified date: August 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo-ku, Tsukiji, 5-1-1	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Oncology Group	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to treatment failure
Secondary	overall survival
Secondary	progression-free survival
Secondary	response rate
Secondary	adverse events

External Links

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