NCT00429182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Jun 2007

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 10, 2013

Completed
Last Updated

April 10, 2013

Status Verified

February 1, 2013

Enrollment Period

4.7 years

First QC Date

January 29, 2007

Results QC Date

February 28, 2013

Last Update Submit

February 28, 2013

Conditions

Breast CancerMetastatic Breast CarcinomaInvasive Breast Carcinoma

Keywords

Breast Cancerbreast carcinomaCarboplatinParaplatinCyclophosphamideNeosarCytoxanThiotepaPurged Autologous Stem CellsCirculating Tumor CellsCTCs

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products

    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.

    Baseline to 1 month post AHST

Secondary Outcomes (1)

  • Median Progression Free Survival (PFS)

    Overall study (baseline to disease progression)

Study Arms (1)

High-dose chemotherapy

EXPERIMENTAL

Carboplatin + Cyclophosphamide + Thiotepa

Drug: CarboplatinDrug: CyclophosphamideDrug: ThiotepaProcedure: Stem Cell Transplant

Interventions

CarboplatinDRUG

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.

Also known as: Paraplatin
High-dose chemotherapy
CyclophosphamideDRUG

1.5 gm/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.

Also known as: Cytoxan, Neosar
High-dose chemotherapy
ThiotepaDRUG

120 mg/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.

High-dose chemotherapy
Stem Cell TransplantPROCEDURE

Stem Cell Transplant on Day 0.

Also known as: SCT, Autologous hematopoietic stem cell transplantation, AHST
High-dose chemotherapy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Prior HDCT with Autologous hematopoietic stem cell transplantation (AHST) in adjuvant setting.
  • History or presence of brain/leptomeningeal metastasis.
  • History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ.
  • 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.
  • Clinically significant active infections (patient requiring IV antibiotics, uncontrolled infections, or hospitalized due to infections).
  • HIV infection.
  • Pregnant or lactating women.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeoplastic Cells, Circulating

Interventions

CarboplatinCyclophosphamideThiotepaStem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Results Point of Contact

Title
Naoto Ueno, MD / Professor
Organization
University of Texas MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org

Study Officials

  • Naoto Ueno, MD, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 31, 2007

Study Start

June 1, 2007

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 10, 2013

Results First Posted

April 10, 2013

Record last verified: 2013-02

Locations

US(1)