Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Re… (NCT03281902) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
United States68 participantsStarted 2017-11-13
Plain-language summary
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and endocrine therapy. Examining the genetic changes associated with the cancer and comparing the genetic material from the cancer tissue with the genetic material found in the blood may help doctors to develop customized treatment for breast cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
PRE-REGISTRATION INCLUSION CRITERIA
* Women who have disease that is amenable to biopsy and agree to undergo a standard of care and /or research biopsy
* Note: If a standard of care biopsy was recently obtained =\< 2 months of pre-registration, eligible patients should agree to a research biopsy of recurrent or metastatic breast cancer prior to the start of protocol treatment to collect additional core samples for research purposes
* Patients must satisfy one of the following criteria for prior therapy:
* First line setting: No prior endocrine therapy in the metastatic setting with no more than one prior line of chemotherapy in the advanced/metastatic setting
* Second line setting: Progression on one prior line of endocrine based therapy monotherapy either in the adjuvant or advanced/metastatic setting; either one or two prior lines of chemotherapy in the advanced setting are allowed
* Note: Patients receiving bisphosphonate or denosumab therapy prior to registration may continue at the same intervals used prior to study registration
* First line therapy setting only: The intention to begin palbociclib and letrozole as treatment for locally advanced or metastatic breast cancer
* Second line therapy setting only: The intention to begin palbociclib and fulvestrant as treatment for metastatic breast cancer (after progression on first line endocrine therapy)
* Note: Patients who are to receive second line endocrine therapy are allowed to remain …