Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00960336|
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : October 29, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: pegylated liposomal doxorubicin hydrochloride||Phase 2|
- Evaluate the effectiveness of pegylated liposomal doxorubicin hydrochloride, in terms of objective response rate, in elderly women with metastatic breast cancer.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||May 2011|
|Experimental: single arm||
Drug: pegylated liposomal doxorubicin hydrochloride
- Response rate [ Time Frame: 3 and 6 cures ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960336
|Hotel Dieu de Paris|
|Paris, France, 75181|
|Principal Investigator:||Laure Chauvenet, MD||Hotel Dieu de Paris|