Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer, Metastatic Breast Carcinoma, Invasive Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT00429182

Run by

M.D. Anderson Cancer Center

People needed

32

Starts

2007-06-01

Expected to finish

2012-02-01

Last updated by the study team

2013-04-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 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.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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