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

Plain English Summary

S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer is a Not Applicable clinical trial sponsored by SWOG Cancer Research Network studying 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. This trial tests if using blood tests (serum tumor markers) to decide when to get scans is as good as the usual way of monitoring for advanced breast cancer. It is for patients with metastatic hormone receptor-positive, HER2-negative breast cancer who are starting their first treatment for the spread of their cancer. Participation involves being randomly assigned to either the usual monitoring method or the serum tumor marker-guided method, with regular blood tests and scans. Alternatives include standard monitoring practices guided by your doctor's judgment and regular imaging. The trial aims to enroll 739 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have metastatic hormone receptor-positive, HER2-negative breast cancer and are starting your first treatment for it. You cannot join if you have brain metastases that require regular monitoring, or certain conditions that can affect tumor marker levels like cirrhosis. You must be able to provide informed consent and complete questionnaires in English or Spanish. You must not be pregnant due to potential harm to the fetus from radiation exposure. This trial is studying 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, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures whether the new monitoring method, using blood markers to guide scans, results in patients living just as long as those who receive standard monitoring. The specific primary outcome measures are: Assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care (Up to 312 weeks after randomization). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it could establish a less frequent imaging approach for monitoring metastatic breast cancer, potentially reducing patient burden and healthcare costs while maintaining survi This research targets 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 improved treatment options are needed.

Investor Insight

This trial addresses a significant unmet need in managing metastatic breast cancer by exploring a potentially more efficient monitoring strategy, which could impact the market for diagnostic tools and The large enrollment target of 739 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your tumor markers are suitable for this monitoring approach and what the frequency of blood tests and scans will be. Be prepared for regular blood draws and imaging scans as determined by the study group you are assigned to. You will be asked to complete questionnaires about your quality of life and anxiety levels. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 739 participants

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

Primary Outcomes

• Assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care (Up to 312 weeks after randomization)

Secondary Outcomes

• Cumulative direct healthcare costs (in the United States) of patients monitored with STMDDM versus usual care (Up to 48 weeks after randomization)
• Assessment of anxiety of patients monitored with STMDDM compared to patients monitored with usual care (Up to 102 weeks after randomization)
• Assessment of quality of life of patients monitored with STMDDM versus patients monitored with usual care (Up to 102 weeks after randomization)

Full 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 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

Trial Locations

• 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
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Metastatic Breast Cancer
• Hormone Receptor Positive Breast Cancer
• HER2 Negative Breast Cancer
• Stage IV Breast Cancer
• Estrogen Receptor Positive Breast Cancer
• Progesterone Receptor Positive Breast Cancer
• Cancer Monitoring
• Disease Management
• Oncology

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