Status:
COMPLETED
Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Breast Cancer
Metastatic Breast Carcinoma
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 i...
Detailed Description
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. Carboplat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00429182
Start Date
June 1 2007
End Date
February 1 2012
Last Update
April 10 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030