Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer
The goal of this clinical research study is to learn the relationship of high-dose chemotherapy (HDCT) and circulating tumor cells (CTCs) in controlling metastatic breast cancer. The study also will investigate the role of CTCs in breast cancer.
Metastatic Breast Carcinoma
Invasive Breast Carcinoma
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 II Study of Purging of Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer Patients|
- Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products [ Time Frame: Baseline to 1 month post AHST ] [ Designated as safety issue: No ]Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.
- Median Progression Free Survival (PFS) [ Time Frame: Overall study (baseline to disease progression) ] [ Designated as safety issue: No ]Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. PFS time measured in months.
|Study Start Date:||June 2007|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: High-dose chemotherapy
Carboplatin + Cyclophosphamide + Thiotepa
Target Area Under the Curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.
Other Name: ParaplatinDrug: Cyclophosphamide
1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Other Names:Drug: Thiotepa
120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.Procedure: Stem Cell Transplant
Stem Cell Transplant on Day 0.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00429182
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naoto Ueno, MD, PhD||M.D. Anderson Cancer Center|