Breast Cancer Molecular Analysis Protocol
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| Contact: | Noelle Sowers, RN |
| Email: | noelle.sowers@yale.edu |
| Phone: | 203-737-3472 |
Breast Cancer Molecular Analysis Prior to Investigational Therapy
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 Drug Administration (FDA)approved or investigational drugs. For example, if
your cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation
is a change int he DNA sequence of a gene) that makes this receptor "superactive" a drug
that inhibits this receptor may also inhibit the growth of the cancer. If this genetic
defect is not present in the cancer the same drug may not work. This EGFR gene mutation
based patient selection for treatment has worked in lung cancer and we are testing its value
in breast cancer. What drugs may be available against particular genetic abnormalities in
the context of this clinical study will change over time.
this study is to find defects in the DNA of the cancer that could potentially be treated
with US Food and Drug Administration (FDA)approved or investigational drugs. For example, if
your cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation
is a change int he DNA sequence of a gene) that makes this receptor "superactive" a drug
that inhibits this receptor may also inhibit the growth of the cancer. If this genetic
defect is not present in the cancer the same drug may not work. This EGFR gene mutation
based patient selection for treatment has worked in lung cancer and we are testing its value
in breast cancer. What drugs may be available against particular genetic abnormalities in
the context of this clinical study will change over time.
Inclusion Criteria:
1. All patients with metastatic breast cancer who are considered for further systemic
therapy are eligible regardless of number of prior therapies.
2. 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.
3. There is no age limit for this study. However, this study will not include children
because metastatic breast cancer does not occur in children.
4. Patients may participate in the biopsy study multiple times to repeat molecular
assessment of the cancer after progression.
5. 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 Criteria:
1. Known medical contraindication for needle biopsy procedure such as bleeding disorder,
low platelet count, inability to provide informed consent
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