Multicenter Study of PEGylated Liposomal Doxorubicin in Geriatric Oncology - Metastatic Breast Cancer - First-line Treatment PEGylated Liposomal Doxorubicin in Patients Older Than 70 Years, Breast Cancer Metastasis
OBJECTIVES:
Primary
- Evaluate the effectiveness of pegylated liposomal doxorubicin hydrochloride, in terms
of objective response rate, in elderly women with metastatic breast cancer.
Secondary
- Determine the feasibility of this drug in these patients.
- Evaluate chemotherapy-induced toxicities in these patients.
- Assess the disease-free survival and overall survival of these patients.
- Study the geriatric covariates.
- Assess the covariates predictive of the hematopoietic reserve and the risk of febrile
neutropenia in these patients.
OUTLINE: This is a multicenter study.
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60-90 minutes on day
1. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity or
progressive disease.
After completion of study therapy, patients are followed up periodically for 2 years.
Interventional
Allocation: Non-Randomized, Primary Purpose: Treatment
Response rate
No
Laure Chauvenet, MD
Principal Investigator
Hotel Dieu de Paris
United States: Federal Government
CDR0000633600
NCT00960336
March 2008
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