Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00960336
- Lead Sponsor
- ARCAGY/ GINECO GROUP
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 59
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single arm pegylated liposomal doxorubicin hydrochloride -
- Primary Outcome Measures
Name Time Method Response rate 3 and 6 cures
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hotel Dieu de Paris
🇫🇷Paris, France