739 Participants Needed

Marker-Directed Monitoring for Breast Cancer

Recruiting at 662 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: SWOG Cancer Research Network
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be receiving or plan to receive first-line systemic treatment for metastatic breast cancer, which may include endocrine therapy, targeted therapy, or chemotherapy.

Is Marker-Directed Monitoring for Breast Cancer safe for humans?

The research on antibody-drug conjugates (ADCs), which are similar in concept to marker-directed monitoring, shows they are generally safe but can cause side effects like low blood cell counts, nausea, and heart issues. These side effects are usually manageable with dose adjustments and supportive care.12345

How does the treatment 'Serum Tumor Marker directed disease monitoring' differ from other treatments for breast cancer?

This treatment is unique because it uses serum tumor markers (proteins found in the blood) to monitor the progression of breast cancer and the patient's response to treatment, offering a noninvasive and potentially earlier indication of disease changes compared to traditional imaging methods.678910

What data supports the effectiveness of the treatment Serum Tumor Marker directed disease monitoring for breast cancer?

Research suggests that using serum tumor markers can help monitor treatment and detect cancer recurrence, potentially at a lower cost than traditional methods. However, while they can provide useful information for monitoring, they are not yet proven to be cost-effective or reliable enough to guide treatment decisions on their own.1112131415

Who Is on the Research Team?

MA

Melissa Accordino

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am not in, nor planning to join, another first-line treatment trial for my metastatic breast cancer.
Patients must not be pregnant
I have not had systemic therapy for my metastatic breast cancer, except my current treatment.
See 13 more

Exclusion Criteria

I have cancer that has spread to the lining of my brain.
I have cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia.
Patients must not have known progression since registration to step 1
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo either usual care disease monitoring or serum tumor marker directed disease monitoring (STMDDM) for up to 312 weeks

312 weeks
Every 4-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

102 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Serum Tumor Marker directed disease monitoring
  • Usual care disease monitoring
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (serum tumor directed disease monitoring)Experimental Treatment3 Interventions
Group II: Arm I (usual care)Active Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials
403
Recruited
267,000+

Southwest Oncology Group

Lead Sponsor

Trials
389
Recruited
260,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Serum tumor markers, particularly CA15-3, CA27.29, and c-erbB-2, can be useful for early detection of breast cancer recurrence, but their effectiveness in diagnosing cancer or determining disease progression is limited.
Currently, c-erbB-2 is the only marker with clinical evidence supporting its use for evaluating prognosis and predicting therapy response, yet no serum tumor marker is considered cost-effective or reliable for decision-making in breast cancer management.
Serum tumor markers in patients with breast cancer.Lumachi, F., Basso, SM.[2015]
Current serum tumor markers have limited sensitivity and specificity, making them unsuitable for screening asymptomatic individuals for cancer.
While tumor markers are not ideal for initial diagnosis, they are valuable for monitoring treatment effectiveness and detecting cancer recurrence, providing important prognostic information.
[Application of tumour markers in clinical practice].Keuren, JF., Thomas, CM., Bonfrรจr, JM., et al.[2015]
Establishing a pretreatment baseline and conducting regular serial testing of serum tumor markers can significantly enhance the effectiveness of patient monitoring in cancer care.
Clinical decisions regarding therapy changes should not rely solely on tumor marker measurements; confirmation with serial samples and consideration of other clinical data is essential for accurate interpretation.
Serum tumor markers for patient monitoring: a case-oriented approach illustrated with carcinoembryonic antigen.Fritsche, HA.[2019]

Citations

Serum tumor markers in patients with breast cancer. [2015]
[Application of tumour markers in clinical practice]. [2015]
Serum tumor markers for patient monitoring: a case-oriented approach illustrated with carcinoembryonic antigen. [2019]
Tumour markers: their use and misuse by clinicians. [2015]
Potential for cost economies in guiding therapy in patients with metastatic breast cancer. [2019]
Toxicity profile of antibody-drug conjugates in breast cancer: practical considerations. [2023]
Strategies for Mitigating Antibody-Drug Conjugate Related Adverse Events for Precision Therapy. [2022]
[Chinese expert consensus of antibody-drug conjugate toxicity management for breast cancer]. [2022]
Antibody drug conjugates for treatment of breast cancer: Novel targets and diverse approaches in ADC design. [2018]
Identification of a novel inhibitor of triple-negative breast cancer cell growth by screening of a small-molecule library. [2014]
11.United Statespubmed.ncbi.nlm.nih.gov
Usefulness of traditional serum biomarkers for management of breast cancer patients. [2021]
Circulating tumour markers in breast cancer. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
Tumor marker usage and medical care costs among older early-stage breast cancer survivors. [2022]
Circulating proteins as predictive and prognostic biomarkers in breast cancer. [2023]
[Considerations in rational use of tumor markers in breast carcinoma]. [2015]
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