Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer
NCT00429182 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2013-04-10
Summary
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.
Conditions
- Breast Cancer
- Metastatic Breast Carcinoma
- Invasive Breast Carcinoma
Interventions
- DRUG
-
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.
- DRUG
-
1.5 gm/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
- 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.
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Naoto Ueno, MD, PhD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2012-02-29
- Completion
- 2012-02-29
Countries
- United States
Study Locations
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