Status:
COMPLETED
PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Breast Cancer
Eligibility:
FEMALE
70+ years
Phase:
NA
Brief Summary
PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric intervention on treatment compliance, measured regularly by blood dosing of drug metabolites. Patients in the interve...
Eligibility Criteria
Inclusion
- Age ≥ 70 years old
- Non metastatic breast cancer, with or without node metastases
- Hormone Receptor (HR) positive breast cancer patients
- Women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery or radiotherapy
- Introduce an hormonal therapy during 5 years
- Life expectancy \> 6 months (at the discretion of the investigator)
- Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
- Patient must be available for follow-up
- Having given written informed consent prior to any procedure related to the study
Exclusion
- No other primary malignant tumor \< 5-years old except cured in situ cancer of the cervix, in situ urothelial cancer, or basocellular cancer
- Patient with an experimental treatment in the 30 days prior to the enrollment
- Evidence of metastatic disease
- Not under any administrative or legal supervision
Key Trial Info
Start Date :
April 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02216162
Start Date
April 11 2014
End Date
February 4 2019
Last Update
October 2 2025
Active Locations (1)
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1
Claire Falandry
Lyon, France