Weekly Docetaxel and CMF in the Adjuvant Treatment of Elderly Women With High-Risk Breast Cancer
A Randomized Multicenter Trial Comparing Weekly Docetaxel and CMF in the Adjuvant Treatment of Women With High-Risk Breast Cancer Who Are > 65 Years Old or Are Not Candidates for Anthracycline-Based Adjuvant Therapy
2 other identifiers
interventional
150
0 countries
N/A
Brief Summary
This trial will evaluate the effectiveness of standard adjuvant treatment with CMF chemotherapy versus treatment with weekly docetaxel in patients with high-risk breast cancer who are 65 years of age and older or are poor candidates for anthracycline-containing regimens. This CMF regimen has decreased dose intensity and may be slightly less active in patients with metastatic breast cancer; however, the patient population in this trial has tolerated more intensive CMF regimens poorly in other trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Mar 2002
Shorter than P25 for phase_3 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedMay 3, 2011
May 1, 2011
2.4 years
September 12, 2005
May 2, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
disease-free survival
18 months
Secondary Outcomes (2)
overall survival
18 months
toxicity
18 months
Study Arms (2)
1
EXPERIMENTALDocetaxel
2
EXPERIMENTALCyclophosphamide + Methotrexate + 5-fluorouracil
Interventions
Eligibility Criteria
You may qualify if:
- To be included in this study, you must meet the following criteria:
- Female patients with adenocarcinoma of the breast confirmed by biopsy
- Age 65 or older
- Under age 65 must have significant medical illness, or general frailty
- Adequate bone marrow, liver or kidney function
- Normal heart function
- Less than 84 days from mastectomy/lumpectomy or axillary dissection
- Signed consent obtained prior to initiation of any study procedures
You may not qualify if:
- You cannot participate in this study if any of the following apply to you:
- Received neo-adjuvant therapy
- Primary tumor is locally advanced at diagnosis
- Received prior chemotherapy within five years
- Received previous radiation therapy within 5 years
- Peripheral neuropathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Aventis Pharmaceuticalscollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denise Yardley, MD
SCRI Development Innovations, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
March 1, 2002
Primary Completion
August 1, 2004
Study Completion
August 1, 2004
Last Updated
May 3, 2011
Record last verified: 2011-05