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

NCT00190489 | Completed Phase 3 DMC

• 2 other identifiers: JCOG9802C000000179
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Neoplasm Metastasis

Keywords

metastatic breast cancer; drug therapy; doxorubicin; docetaxel

Outcome Measures

Primary Outcomes (1)

• time to treatment failure

Secondary Outcomes (4)

• overall survival

• progression-free survival

• response rate

• adverse events

Interventions

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 DRUG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Japan Clinical Oncology Group: lead
• Ministry of Health, Labour and Welfare, Japan: collaborator

Study Sites (1)

National Cancer Center Hospital

Chuo-ku, Tsukiji, 5-1-1, Tokyo, 104-0045, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Shigemitsu Takashima, MD, PhD

  National Shikoku Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: January 1, 1999
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: September 2, 2016

Record last verified: 2016-08

Locations

JP (1)