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RECRUITING

NCT03723928

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

Sponsor: SWOG Cancer Research Network

View on ClinicalTrials.gov

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.

Official title: Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

739

Start Date

2018-09-17

Completion Date

2036-12-01

Last Updated

2026-10-23

Healthy Volunteers

Conditions

Anatomic Stage IV Breast Cancer AJCC v8 Estrogen Receptor Positive HER2/Neu Negative Progesterone Receptor Positive Prognostic Stage IV Breast Cancer AJCC v8 Elevated CA15-3 or CEA or CA27-29

Interventions

OTHER

Usual care disease monitoring

Imaging and serum tumor markers are at the discretion of the treating physician (however imaging must be performed at least every 12 weeks).

OTHER

Serum Tumor Marker directed disease monitoring

Serum tumor markers every 4-8 weeks without imaging

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Anxiety Questionnaire Administration

Ancillary studies

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 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. Testing all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring. * Patients must have systemic radiographic imaging prior to initiation of systemic therapy or within 30 days of initiation of treatment for metastatic breast cancer and prior to step 1 registration. Modality of imaging is at the discretion of the treating physician. * Note: the treating physician can order additional imaging tests at any point prior to randomization at their discretion * Patients must be willing to obtain disease monitoring (imaging and/or serum tumor markers) from a consistent facility in which the registering site has access to the results for the duration of the study intervention (312 weeks after step 2 randomization). Imaging and STMs do not need to be completed at the same facility. * Patients with known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia are not eligible as these could cause falsely elevated STM levels * Patients with known brain leptomeningeal metastases are not eligible as they may require regular radiographic monitoring to assess treatment response * Patients must not be currently enrolled or plan to participate in a first-line treatment trial for metastatic breast cancer with a defined monitoring schedule * Patients who are able to complete questionnaires in English or Spanish must participate in patient-reported outcome (PRO) assessments * Patients must not be pregnant due to the potential harm to the fetus from radiation exposure from radiographic imaging * Except for breast cancer (and previous history of breast cancer), no other prior malignancy is allowed with the following exceptions: * Adequately treated basal (or squamous cell) skin cancer * Any cancer from which the patient has been disease free for five years * Prior Stage 0 or pre-cancerous lesions that have been removed with clear margins * Patients must not have received prior systemic therapy for metastatic breast cancer, except for their current line of therapy. * Patients must have decision making capacity and be able to provide informed consent * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; use of legally-authorized representative is not permissible for this study. Remote consent is allowed with adequate documentation. * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * STEP 2 RANDOMIZATION * Patients must be tested for the breast cancer specific STMs that were tested prior to STEP 1 Registration between 56 and 140 days after initiation of first-line systemic therapy for metastatic disease: * CEA (must be tested) * CA 15-3 or CA 27.29 (whichever was tested prior to Step 1) Testing all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring. * At least one of the STMs that was previously elevated must have decreased from the assessment at step 1 by \>= 10% at this time. * Patients must not have known progression since registration to step 1 * Patients must be registered to step 2 randomization between 56 days and 140 days after the initiation of first-line systemic therapy for metastatic disease; This window is inclusive; patients may be registered to Step 2 on day 56 or Day 140. Patients must have been eligible for Step 1 in order to be eligible for Step 2 Randomization * Baseline questionnaires must be completed within 28 days prior to step 2 randomization; (Note: Those patients who cannot complete the PRO questionnaires in English or Spanish can be registered to step 2 without contributing to PRO research)

Locations (723)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Anchorage Oncology Centre

Anchorage, Alaska, United States

Katmai Oncology Group

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

PCR Oncology

Arroyo Grande, California, United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Marshall Cancer Center

Cameron Park, California, United States

Mercy Cancer Center �� Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Epic Care-Dublin

Dublin, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Kaiser Permanente-Fontana

Fontana, California, United States

Kaiser Permanente-Irvine

Irvine, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Kaiser Permanente West Los Angeles

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Providence Queen of The Valley

Napa, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Kaiser Permanente-Ontario

Ontario, California, United States

Desert Regional Medical Center

Palm Springs, California, United States

Kaiser Permanente - Panorama City

Panorama City, California, United States

Keck Medical Center of USC Pasadena

Pasadena, California, United States

Kaiser Permanente-Riverside

Riverside, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Kaiser Permanente-San Diego Mission

San Diego, California, United States

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Kaiser Permanente-San Marcos

San Marcos, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Providence Medical Foundation - Santa Rosa

Santa Rosa, California, United States

Providence Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Saint Joseph's Medical Center

Stockton, California, United States

Epic Care Cyberknife Center

Walnut Creek, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

Cancer Center of Colorado at Sloan's Lake