Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00429182
Recruitment Status : Completed
First Posted : January 31, 2007
Results First Posted : April 10, 2013
Last Update Posted : April 10, 2013
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

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)
Primary Purpose: Treatment
Official Title: Phase II Study of Purging of Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer Patients
Study Start Date : June 2007
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Carboplatin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: High-dose chemotherapy
Carboplatin + Cyclophosphamide + Thiotepa
Drug: Carboplatin
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: Paraplatin
Drug: Cyclophosphamide
1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Other Names:
  • Cytoxan
  • Neosar
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.
Other Names:
  • SCT
  • Autologous hematopoietic stem cell transplantation
  • AHST

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 18 to 55 years old
  2. Metastatic breast carcinoma.
  3. Histological confirmation of invasive breast carcinoma
  4. Complete or partial response to pre-transplant standard-dose chemotherapy, or hormonal therapy. For bone disease, stable disease (SD) is allowed.
  5. Patient must have tumor assessed for estrogen-receptor (ER) and progesterone-receptor (PR).
  6. Persistent detectable or non-detectable CTCs by Veridex Technology after completion of standard therapy.
  7. Zubrod performance status 0 or 1.
  8. Patients must have adequate hematological parameters (White Blood Count/WBC >= 3,000/mm3; platelet count >= 100,000/mm3)
  9. Adequate renal function (serum creatinine <= 1.5mg/dl)
  10. Adequate liver function (total bilirubin, serum glutamate pyruvate transaminase (SGPT) <= 2 times normal).
  11. Adequate cardiac function (Left ventricular ejection fraction (LVEF)>= 50%).
  12. Adequate pulmonary function (Carbon Monoxide Diffusing Capacity (DLCO)>= 50% of predicted value).
  13. Females of childbearing (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent) potential must use adequate contraception.
  14. Patients must sign an informed consent.

Exclusion Criteria:

  1. Prior HDCT with Autologous hematopoietic stem cell transplantation (AHST) in adjuvant setting.
  2. History or presence of brain/leptomeningeal metastasis.
  3. History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ.
  4. Presence of other severe medical illnesses or conditions. Severe heart disease, (myocardial ischemia, myocardial infarction, etc.) Pulmonary disease (COPD, asthma,etc). Renal failure and hepatic failure.
  5. Clinically significant active infections (patient requiring IV antibiotics, uncontrolled infections, or hospitalized due to infections).
  6. HIV infection.
  7. Pregnant or lactating women.
  8. Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00429182

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Naoto Ueno, MD, PhD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00429182     History of Changes
Other Study ID Numbers: 2006-0280
First Posted: January 31, 2007    Key Record Dates
Results First Posted: April 10, 2013
Last Update Posted: April 10, 2013
Last Verified: February 2013

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
breast carcinoma
Purged Autologous Stem Cells
Circulating Tumor Cells

Additional relevant MeSH terms:
Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists