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

NCT00493350 | Completed

• 1 other identifier: 2005-0278
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 1.To validate the prognostic significance of circulating tumor cells (CTCs) in patients with newly diagnosed metastatic breast cancer (MBC).
2. 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. 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Circulating Tumor Cells; Gene Profiling; International Stage Stratification Study; Blood Sample; ISSS

Outcome Measures

Primary Outcomes (1)

• To detect and count cancer cells in the blood of patients who have recently been diagnosed with a recurrent breast cancer.

  26 Months

Secondary Outcomes (1)

• To learn if the detection of circulating cancer cells is a predictor for a worse disease prognosis.

  26 Months

Study Arms (1)

1

Patients with newly diagnosed stage IV breast cancer scheduled to start systemic therapy.

Procedure: Blood Sample

Interventions

Blood Sample PROCEDURE

1x4 ml (Serum Tube); 2x10 ml (CellSave Tube); 1x10 ml EDTA (Selected Centers)

1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with newly diagnosed stage IV breast cancer scheduled to start systemic therapy.

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Janssen Diagnostics, LLC: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood collected prior to the initiation of chemotherapy as follows: 1 x 4 ml (serum tube), 2x10 ml (CellSave Tube), and 1x10 ml EDTA (selected centers); To perform global gene profiling on selected specimens and correlate the profiles with clinical outcomes.

MeSH Terms

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Massimo Cristofanilli, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 28, 2007
• Study Start: October 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

US (1)