Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases
- To determine the time to progression in subjects with breast cancer metastatic to bone only treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT).
- To determine the overall survival at one year.
- To determine the efficacy of 153Sm-EDTMP at 6 months.
- To assess pain in subjects treated with 153Sm-EDTMP.
- To determine the safety of 153Sm-EDTMP.
Drug: 153 Sm-EDTMP
Procedure: Stem Cell Transplant
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of 153 Sm-EDTMP Followed by Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases|
- Time to Progression [ Time Frame: 10 Years ] [ Designated as safety issue: Yes ]Time to progression is measured as the time from study entry to the development of disease progression.
|Study Start Date:||March 2007|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Samarium 153-EDTMP + Stem Cell Transplant
Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose. Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP. Questionnaires taking about 15 minutes to complete.
Drug: 153 Sm-EDTMP
Tracer dose = 30 mCi by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.
Other Name: Samarium 153-EDTMPBehavioral: Questionnaire
Questionnaires taking about 15 minutes to complete.
Other Name: SurveyProcedure: Stem Cell Transplant
Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429507
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naoto Ueno, MD, PhD||M.D. Anderson Cancer Center|