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Recruiting NCT03723928

S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer

Trial Parameters

Condition Anatomic Stage IV Breast Cancer AJCC v8
Sponsor SWOG Cancer Research Network
Study Type INTERVENTIONAL
Phase N/A
Enrollment 739
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2018-09-17
Completion 2030-12-01
Interventions
Usual care disease monitoringSerum Tumor Marker directed disease monitoringQuality-of-Life Assessment

Brief Summary

This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.

Eligibility Criteria

Inclusion Criteria: * STEP 1 REGISTRATION * Patients must have a diagnosis of hormone receptor positive (estrogen receptor positive \[ER+\] and/or progesterone receptor positive \[PR+\]), HER-2 negative, metastatic (M1) breast cancer and must be receiving or plan to receive first-line systemic treatment for metastatic disease. (Systemic treatment is any treatment meant to treat the whole body such as endocrine therapy +/- targeted therapy +/- chemotherapy). * NOTE: Participants are eligible if they have either de-novo metastatic breast cancer and/or recurrent breast cancer from an earlier stage that is now metastatic * Patients must be registered to step 1 between 14 days prior to and 60 days after start of first-line systemic treatment for metastatic disease * Patients must have been tested for the following breast cancer specific STMs after diagnosis of metastatic disease and within +/-14 days of initiation of first-line systemic treatment for metastatic disease: * CEA (must be teste

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