Breast Cancer Clinical Trial
Official title:
Longitudinal ctDNA Monitoring in Older Women With ER+ Breast Cancer Who Forego Upfront Surgery in Favor of Primary Endocrine Therapy
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 70 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Magee Womens Hospital - Surgical Oncology | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of ctDNA positivity | Proportion of patients with ER+/HER2- breast cancer who omit upfront surgery in favor of primary endocrine therapy who have any ctDNA positivity using Signatera assay. | Up to 5 years | |
Secondary | Progression-free survival (PFS) | The length of time after treatment initiation that patient is alive and without any evidence of tumor progression as defined by RECIST1.1 criteria. Per RECISIT v1.1: Progressive Disease (PD): =20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of =5 mm. The appearance =1 new lesion(s) is considered progression. | Up to 5 years | |
Secondary | Breast cancer-specific survival (BCSS) | BCSS is defined as the length of time from the date of diagnosis through the end of follow up that patients are free from breast cancer-related mortality. | Up to 5 years | |
Secondary | Overall survival (OS) | The length of time from the date of diagnosis through the end of follow up that patients are still alive. | Up to 5 years | |
Secondary | Longitudinal quality of life assessment using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Breast Cancer Symptom Index - 16 Item Version (NCCN NFBSI-16) | This assessment is a 16 item questionnaire using Likert scale (0-4) measured with each ctDNA blood draw. Score ranges from 0-64 with higher scores indicative of higher quality of life / asymptomatic from cancer-related therapy. | Up to 5 years |
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