Prospective Validation Trial of Circulating Tumor Cells (CTCs) in Women With Metastatic Breast Cancer

Completed

Conditions studied: Breast Cancer

In brief

Primary Objectives: 1. To validate the prognostic significance of circulating tumor cells (CTCs) in patients with newly diagnosed metastatic breast cancer (MBC). 2. To prospectively determine if assessment of CTCs can be used to stratify patients with MBC into two prognostic groups independent of existing methods i.e. hormone-receptor status, site of metastasis (e.g. visceral vs. non visceral) and treatment administered (e.g. chemotherapy vs. hormonal therapy). 3. To incorporate this information into the current TNM staging system by sub-classifying stage IV disease into two prognostic groups, Stage IVA and Stage IVB. Secondary Objective: 1\. To perform global gene profiling on selected specimens and correlate the profiles with clinical outcomes.

Key facts

Study ID

NCT00493350

Run by

M.D. Anderson Cancer Center

People needed

660

Starts

2005-10-01

Expected to finish

2007-12-01

Last updated by the study team

2012-07-31

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed invasive breast cancer. Patients must have clinical and/or radiologic evidence of stage IV disease. Tumor may be of any hormone receptor type.
• Patients must have newly diagnosed stage IV breast cancer that is scheduled to start a new systemic therapy.
• Patients may have measurable or non-measurable disease.
• Extent of disease will be determined by physical examination and imaging studies as per the primary physician. The tests utilized may include: (bone scans, PET/CT scans, CT of the abdomen, chest radiograph and/or CT of the chest for visceral metastases, sonogram and/or MRI for soft tissue disease). Patients with skin lesions will have photographs to evaluate their lesions.
• ECOG performance status 0-2.
• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol.

You may not qualify if…

• Patients with evidence of local regional recurrence only are excluded.
• Patients who have received prior therapy for their metastatic breast disease.
• Patients with known evidence of brain metastases (unless previously treated or stable) or carcinomatous meningitis.
• Patients with history of any prior malignancies that have not been disease-free for at least 5 years prior to study entry.
• Patients unwilling or unable to give consent.
• Patients unwilling or unable to provided follow-up on their condition.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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