Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00429182|
Recruitment Status : Completed
First Posted : January 31, 2007
Results First Posted : April 10, 2013
Last Update Posted : April 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Breast Carcinoma Invasive Breast Carcinoma||Drug: Carboplatin Drug: Cyclophosphamide Drug: Thiotepa Procedure: Stem Cell Transplant||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Purging of Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer Patients|
|Study Start Date :||June 2007|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
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.
- 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 ]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) ]Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. PFS time measured in months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|