Breast Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing.
PURPOSE: This phase II trial is studying how well doxorubicin hydrochloride liposome works
as first-line therapy in treating older women with metastatic breast cancer.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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