What side effects are associated with this type of intervention?

Common treatments for metastatic breast cancer, which may be monitored using serum tumor markers, include chemotherapy, hormone therapy, and targeted therapy. Chemotherapy can cause side effects such as fatigue, nausea, hair loss, and increased risk of infection. Hormone therapy may lead to hot flashes, mood changes, and an increased risk of blood clots. Targeted therapies, like HER2 inhibitors, can cause diarrhea, liver problems, and heart issues. These side effects vary depending on the specific drugs used and the individual patient's response.

What prior FDA approvals exist?

The FDA has approved several treatments that utilize biological markers for guiding clinical decisions in cancer management. For instance, the use of circulating tumor DNA (ctDNA) in metastatic colorectal cancer patients helps in selecting candidates for anti-EGFR therapy. Additionally, the FDA has approved the use of PD-L1 diagnostic tests to predict response to PD-1/PD-L1 checkpoint inhibitors in various cancers. These approvals highlight the growing role of tumor markers in personalizing cancer treatment and monitoring disease progression.

What other types of research exist?

Promising alternatives to Serum Tumor Marker Directed Disease Monitoring include: 1) Advanced imaging techniques such as PET/CT with novel tracers (e.g., 68Ga-PSMA for prostate cancer), 2) Circulating protein biomarker panels combined with imaging for early lung cancer detection, and 3) The integration of artificial intelligence tools to optimize biomarker panels and imaging protocols. These methods offer enhanced accuracy and early detection capabilities.

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Marker-Directed Monitoring for Breast Cancer

N/A

Recruiting

Led By Melissa Accordino

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 must be willing to obtain disease monitoring from a consistent facility for the duration of the study intervention

Must not have

Patients with known brain leptomeningeal metastases

Patients with known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 weeks after randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if using blood tests to decide when to do scans is as effective as the standard way for monitoring patients with a specific type of breast cancer that has spread. The blood tests act like an early warning system for cancer activity.

Who is the study for?

This trial is for adults with hormone receptor positive, HER2 negative metastatic breast cancer who are starting or receiving first-line systemic treatment. They must not be pregnant, have had other cancers (except certain skin/cervical cancers) in the last five years, or conditions like cirrhosis that affect tumor marker levels. Participants need decision-making capacity and can't be in another first-line treatment trial.

What is being tested?

The study compares usual care disease monitoring to serum tumor marker directed monitoring to see if using blood markers to decide when to do scans is as effective for patients with advanced breast cancer. It includes quality-of-life assessments and anxiety questionnaires.

What are the potential side effects?

Since this trial focuses on monitoring methods rather than new treatments, side effects are related to standard cancer care which may include fatigue, nausea, pain from procedures or tests, and psychological impacts such as increased anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not in, nor planning to join, another first-line treatment trial for my metastatic breast cancer.

Select...

I agree to get my disease monitored at the same place during the study.

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I can make my own decisions and understand the consent form.

Select...

I do not have cancer spread to the brain or its linings.

Select...

I have hormone-positive, HER2-negative metastatic breast cancer and am starting or planning to start my first treatment.

Select...

I do not have cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have cancer that has spread to the lining of my brain.

Select...

I have cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 weeks after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 weeks after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 weeks after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Assessment of anxiety of patients monitored with STMDDM compared to patients monitored with usual care

Assessment of quality of life of patients monitored with STMDDM versus patients monitored with usual care

Cumulative direct healthcare costs (in the United States) of patients monitored with STMDDM versus usual care

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (serum tumor directed disease monitoring)Experimental Treatment3 Interventions

Patients undergo disease specific serum tumor marker evaluation (CEA and either CA 15-3 or CA 27.29, whichever were tested at Step 1 Registration and Step 2 Registration) every 4-8 weeks (starting from randomization) without imaging until an elevation of at least one disease specific STM. In the event of an elevated STM, the patient will have imaging within 4 weeks to evaluate for disease progression. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.

Group II: Arm I (usual care)Active Control3 Interventions

Patients will have imaging studies (modality and frequency per treating physician, however at a minimum frequency of every 12 weeks) alone or in conjunction with STMs (frequency determined by treating physician). Patients will continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments involving tumor markers typically focus on detecting and monitoring specific proteins or molecules in the blood that are indicative of cancer presence or progression. These markers can guide the timing of imaging scans and other diagnostic procedures, allowing for more precise and timely interventions. For example, treatments may include targeted therapies that inhibit specific pathways or proteins associated with tumor growth, or immunotherapies that enhance the body's immune response against cancer cells. This approach is crucial for patients as it enables personalized treatment plans, early detection of relapse, and more effective management of the disease, ultimately improving outcomes and quality of life.