Status:
COMPLETED
Breast Cancer Molecular Analysis Protocol
Lead Sponsor:
Yale University
Collaborating Sponsors:
Foundation Medicine
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
Brief Summary
This is a molecular testing study for patients with metastatic breast cancer. The purpose of this study is to find defects in the DNA of the cancer that could potentially be treated with US Food and D...
Eligibility Criteria
Inclusion
- All patients with metastatic breast cancer who are considered for further systemic therapy are eligible regardless of number of prior therapies.
- Patient must have a metastatic lesion that could be safely biopsied with or without image-guidance. The final arbiter to decide what lesion can be biopsied is the physician who will perform the biopsy.
- There is no age limit for this study. However, this study will not include children because metastatic breast cancer does not occur in children.
- Patients may participate in the biopsy study multiple times to repeat molecular assessment of the cancer after progression.
- Patients who undergo routine clinical biopsy of metastatic breast cancer are also eligible to participate in this study. When the routine biopsies are obtained for diagnostic or other purposes, additional biopsies will be taken during the same biopsy session for molecular analysis.
Exclusion
- 1\. Known medical contraindication for needle biopsy procedure such as bleeding disorder, low platelet count, inability to provide informed consent
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01855503
Start Date
May 1 2013
Last Update
November 17 2016
Active Locations (1)
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1
Smilow Hospital Breast Center
New Haven, Connecticut, United States, 06520-8032