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Clinical Trials in Mexico / NCT03723928
Recruiting Not applicable

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

NCT03723928 · tracked via the Priya Life Science Mexico tracker
Phase
Not applicable
Started
2018-09-17
Last updated
2026-04-02

Condition(s) studied

Anatomic Stage IV Breast Cancer AJCC v8Estrogen Receptor PositiveHER2/Neu NegativeProgesterone Receptor PositivePrognostic Stage IV Breast Cancer AJCC v8Elevated CA15-3 or CEA or CA27-29

Investigational drug(s) / intervention(s)

Usual care disease monitoringSerum Tumor Marker directed disease monitoringQuality-of-Life AssessmentAnxiety Questionnaire Administration

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).

Serum Tumor Marker directed disease monitoring: Serum tumor markers every 4-8 weeks without imaging

Quality-of-Life Assessment: Ancillary studies

Anxiety Questionnaire Administration: Ancillary studies

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (723)

FacilityCityRegionStatus
Anchorage Associates in Radiation Medicine Anchorage Alaska Recruiting
Anchorage Radiation Therapy Center Anchorage Alaska Recruiting
Alaska Breast Care and Surgery LLC Anchorage Alaska Recruiting
Alaska Oncology and Hematology LLC Anchorage Alaska Recruiting
Alaska Women's Cancer Care Anchorage Alaska Recruiting
Anchorage Oncology Centre Anchorage Alaska Recruiting
Katmai Oncology Group Anchorage Alaska Recruiting
Providence Alaska Medical Center Anchorage Alaska Recruiting
Fairbanks Memorial Hospital Fairbanks Alaska Recruiting
Kingman Regional Medical Center Kingman Arizona Recruiting
Cancer Center at Saint Joseph's Phoenix Arizona Recruiting
University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona Recruiting
Banner University Medical Center - Tucson Tucson Arizona Recruiting
University of Arizona Cancer Center-North Campus Tucson Arizona Recruiting
Mercy Hospital Fort Smith Fort Smith Arkansas Recruiting
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas Suspended
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
Kaiser Permanente-Anaheim Anaheim California Recruiting
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California Recruiting
PCR Oncology Arroyo Grande California Recruiting
Kaiser Permanente-Baldwin Park Baldwin Park California Recruiting
Kaiser Permanente-Bellflower Bellflower California Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California Recruiting
Marshall Cancer Center Cameron Park California Recruiting
Mercy Cancer Center �� Carmichael Carmichael California Recruiting
Mercy San Juan Medical Center Carmichael California Recruiting
Epic Care-Dublin Dublin California Recruiting
Mercy Cancer Center - Elk Grove Elk Grove California Recruiting
Bay Area Breast Surgeons Inc Emeryville California Recruiting
Epic Care Partners in Cancer Care Emeryville California Recruiting
Kaiser Permanente-Fontana Fontana California Recruiting
Kaiser Permanente-Irvine Irvine California Recruiting
Kaiser Permanente Los Angeles Medical Center Los Angeles California Recruiting
Los Angeles County-USC Medical Center Los Angeles California Active Not Recruiting
USC / Norris Comprehensive Cancer Center Los Angeles California Active Not Recruiting
Kaiser Permanente West Los Angeles Los Angeles California Recruiting
Contra Costa Regional Medical Center Martinez California Recruiting
Providence Queen of The Valley Napa California Recruiting
USC Norris Oncology/Hematology-Newport Beach Newport Beach California Active Not Recruiting

+ 683 more sites — see the full list on the official registry below.

More SWOG Cancer Research Network trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03723928 on ClinicalTrials.gov ↗ ← All trials in Mexico