Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery (NCT05914792) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
United States49 participantsStarted 2022-04-19
Plain-language summary
This prospective study recruits patients with ER+/HER2-, non-metastatic breast cancer who omit upfront surgery in favor of primary endocrine therapy for sample collection and prospective circulating tumor DNA (ctDNA) measurement to guide disease surveillance.
Who can participate
Age range70 Years
SexFEMALE
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Inclusion Criteria:
* early-stage (stages I-III) breast cancer
* estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) and HER2 receptor negative
* able to provide blood samples
* decision made by treating physician and patient to forego upfront surgery in favor of medical management with endocrine therapy
* non-metastatic disease at diagnosis (patients need not have staging scans; patients at higher risk for de novo stage IV disease should not have any symptoms concerning for metastatic disease)
* patients may be taking any endocrine therapy
* patients may be taking any CDK4/6 inhibitor as deemed necessary by their treating physician
* any ECOG Performance Status allowed
* if patients have synchronous bilateral ER+ breast cancer, tissue from both sites should be submitted to Natera to perform ctDNA testing
* patients with multifocal/multicentric tumors are eligible and the largest focus of cancer should be submitted for testing
Exclusion Criteria:
* under 70 years of age
* breast cancer that is not estrogen receptor positive (ER+) or progesterone receptor (PR+)
* unable to provide blood samples or insufficient tumor tissue for Signatera testing