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RecruitingAnatomic Stage IV Breast Cancer AJCC v8Estrogen Receptor PositiveHER2/Neu Negative

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

Eligible age

18+ yrs

Accepts

All genders

Locations

45 states

Healthy volunteers

No

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About this study

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.

Sponsor: SWOG Cancer Research Network

You may qualify if…

  • 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 tested)
  • CA 15-3 or CA 27.29 (at least one of these must be tested)
  • At least one of the tested STMs must have been \>= 1.5 x the institutional upper limit of normal at this time.

Where it's recruiting

Alaska

Anchorage · Fairbanks

Arizona

Kingman · Phoenix · Tucson

Arkansas

Fort Smith · Hot Springs · Jonesboro · Little Rock

California

Anaheim · Arroyo Grande · Baldwin Park · Bellflower

Colorado

Aurora · Boulder · Centennial · Colorado Springs

Connecticut

Derby · Fairfield · Glastonbury · Greenwich

Florida

Aventura · Deerfield Beach · Fort Lauderdale · Lakeland

Georgia

Atlanta · Savannah

Hawaii

Honolulu · Kahului · Kailua · Lihue

Idaho

Boise · Caldwell · Coeur d'Alene · Emmett

Illinois

Alton · Aurora · Bloomington · Burr Ridge

Indiana

Indianapolis · Lafayette · Mooresville · Muncie

Source: ClinicalTrials.gov · NCT03723928 · last updated 2026-04-02