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

{ "Monitoring Metastatic Breast Cancer with Serum Tumor Markers", "This study is for patients with hormone receptor positive, HER2 negative metastatic breast cancer. It compares two ways of monitoring your cancer: usual care, which includes imaging (scans) at least every 12 weeks, and a new approach called Serum Tumor Marker Directed Disease Monitoring (STMDDM). With STMDDM, your blood will be checked for tumor markers every 4-8 weeks, without routine imaging. The main goal is to see if monitoring with STMDDM is just as effective as usual care in terms of how long patients live. Researchers will also look at healthcare costs, your anxiety levels, and your quality of life. You may be eligible if you are 18 or older, have this type of breast cancer, and are receiving or planning to receive first-line treatment for metastatic disease. The study is currently unclear on its recruitment status and plans to enroll 739 participants.", "design": "This is a randomized study, meaning participants are randomly assigned to one of two groups: usual care monitoring or serum tumor marker directed monitoring. The study plans to enroll 739 participants.", "commitments": "If you are in the usual care group, you will have imaging at least every 12 weeks for up to 312 weeks. If you are in the STMDDM group, you will have blood tests for tumor markers every 4-8 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for overall survival for up to 312 weeks (about 6 years) after being assigned to a group.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

NAAges 18+InterventionalHealth services

SWOG Cancer Research Network

~739 participants

Updated 2026-04-02 on ClinicalTrials.gov

What's tested:Usual care disease monitoringSerum Tumor Marker directed disease monitoringQuality-of-Life AssessmentAnxiety Questionnaire Administration

At a glance

Recruiting sites

592 of 723 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care

Measured over Up to 312 weeks after randomization

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

Where it's being run

723 sites across 47 states

Ohio71

Michigan61

Colorado48

Nevada45

Illinois44

California41

Washington41

Minnesota28

Study leadership

Melissa Accordino · PRINCIPAL_INVESTIGATOR · SWOG Cancer Research Network

Who to contact

Site Public Contact

[email protected]

907-212-6871

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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.

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)

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)

What this trial measures

Assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual careUp to 312 weeks after randomization
The assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care will be based on multivariable Cox regression, adjusting for intervention assignment (intention-to-treat) and the stratification factor (bone only versus visceral disease). If at the time of final analysis the study shows notably fewer events than anticipated, extended follow-up will be examined for its potential to allow examination of the primary endpoint with full power.

Trialytics