Developing Plasma DNA as a Surrogate for Tumor Biopsy to Identify Tumor Genetic Alterations in Patients With Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01836640|
Recruitment Status : Terminated (Primary goal not achievable)
First Posted : April 22, 2013
Last Update Posted : August 16, 2016
There are three major subtypes of breast cancer:
- Hormone receptor positive (contain cells that express the estrogen receptor or progesterone receptor).
- Tumors that express the epidermal growth factor receptor gene ( HER-2)
- Triple negative (cancer cells that lack the hormone receptors and the epidermal growth factor receptor gene HER-2.
While effective therapies exist for most cases of breast cancer at first occurrence, many patients eventually exhibit disease that does not respond to all standard breast therapies, particularly in the metastatic setting.
There are therapies that are used to treat other types of cancers with genetic mutations that are in the process of being evaluated for use in breast cancer. The current techniques used for detecting mutations in the genes of breast cancer patients, which can be treated with drugs specific for the genetic mutations, are invasive and identifying effective diagnostic non-invasive procedures are the next challenge for physicians. This study will compare the ability to detect genetic mutations samples from non-invasive procedures such as a blood draw, to more invasive procedures such as tissue taken from a biopsy sample.
There is also a concern with current techniques used to detect genetic mutations that cells from a single tissue sample may not be representative of the types of cells present in all the tumors in the body and therapies selected using a single tissue sample may not be effective for all of the cancer in the body. This study will use blood drawn from participants prior to any drug therapy and compare the genes from this blood to tissue samples from multiple sites of disease.
The study will also compare the genetic profile of the metastatic tumors to the genetic profile of the original breast cancer to determine if there are any changes in the genetics of the tumor cells.
The participants that have newly diagnosed metastatic disease will provide tissue from their primary site of disease via an image guided biopsy. These participants will also provide tissue from at least 2 other distant metastatic sites (lung, pleural/peritoneal, liver, brain, or skin). Each biopsy procedure will attempt to obtain 2-3 samples for research purposes.
Participants that have locally recurrent disease in the breast will have the tissue from the site of re-occurrence biopsied as well as two distant metastatic sites (lung, pleural/peritoneal, liver, brain, or skin). Participants that have either multi-centric disease or bilateral disease will have all tumors sampled with the intention of providing 2-3 samples/tumor for research purposes. Participants with multi-centric and bilateral disease will also have 2 distant sites of distant disease sampled (lung, pleural/peritoneal, liver, brain, or skin).
Prior to any scheduled biopsy procedures all participants will have a blood draw used to examine the genetics of the tumor cells in the blood. The participants will have 8 tubes of blood drawn for the test and then they will proceed onto the tissue sampling portion of the study.
|Condition or disease|
|Advanced Breast Cancer|
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|Official Title:||Developing Plasma DNA as a Surrogate for Tumor Biopsy to Identify Tumor Genetic Alterations in Patients With Advanced Breast Cancer|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
- Genetic Lesion detection [ Time Frame: baseline ]To determine whether the genetic mutations in plasma DNA are reflective of the genetic mutations present in biopsies of tumor tissue obtained from ≥ 3 tumors within patients with metastatic breast cancer.
- Somatic genetic mutations in tumor samples [ Time Frame: baseline ]To determine the amount of plasma DNA required to capture all somatic genetic mutations as represented in biopsied tumor samples.
- Genetic heterogeneity among metastatic tumors. [ Time Frame: baseline ]To determine the extent of genetic heterogeneity among biopsies of different metastatic tumors within patients with metastatic breast cancer.
- Genetic heterogeneity between primary and metastatic breast tumors [ Time Frame: baseline ]To determine the degree of genetic heterogeneity between primary and metastatic breast tumors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836640
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|