A multicentre study DOGMES: Liposomal doxorubicin in geriatric oncology - Metastatic breast cancer - first line treatment by pegylated liposomal doxorubicin in patients of more than 70 years old with metastatic breast cancer. - DOGMES

Phase 1

• Conditions: Breast cancer metastatic; MedDRA version: 9.1Level: LLTClassification code 10055113Term: Breast cancer metastatic

• Registration Number: EUCTR2007-002736-28-FR
• Lead Sponsor: ARCAGY-GINECO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-19
• Study Completion: 2012-01-13
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

- age > 70 years
- HER2-negative breast adenocarcinoma
- metastases cytologically or histoogically proven
- measurable or assessable disease
- life expectancy of at least 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- metastatic evolution < 6 months
- Previous malignancies in last 5 years
- patient having received more than 300 mg/m² of Doxorubicin ou more than 300 mg/m² of epirubicin in adjuvant
- congestive heart failure or LVEF < 50%

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the efficacy of the treatment in term of response rate to a treatment by caelyx administered every 28 days<br>;Secondary Objective: - Practicability of the treatment<br>- toxicity of chemotherapy<br>- survival analysis <br>- oncologic-geriatric covariables <br>- predictive covariables of hematopoietic reserve and risk of neutropenic fever in old patient<br>;Primary end point(s): Response rate assessed by imagery according to RECIST criteria and the measurement of CA 15-3, and expressed as percent of patients having a response, a stability or a progression.