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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 have a diagnosis of hormone receptor positive, HER-2 negative, metastatic breast cancer and must be receiving or plan to receive first-line systemic treatment for metastatic disease
Patients with known brain leptomeningeal metastases are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 weeks after randomization
Awards & highlights
No Placebo-Only Group

Study Summary

This trial studies how well using markers to prompt when scans should be ordered works in monitoring patients with hormone receptor positive Her2 negative breast cancer.

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.Check my eligibility
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.See study design
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 have hormone-positive, HER2-negative metastatic breast cancer and am starting or planning to start my first treatment.
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I do not have cancer spread to the brain or its linings.
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I am not in, nor planning to join, another first-line treatment trial for my metastatic breast cancer.
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I can make my own decisions and understand the consent form.
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I agree to get my disease monitored at the same place during the study.
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I do not have cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,871 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,586 Previous Clinical Trials
41,241,279 Total Patients Enrolled
25 Trials studying Progesterone Receptor Positive
4,913 Patients Enrolled for Progesterone Receptor Positive
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,512 Total Patients Enrolled

Media Library

Serum Tumor Marker directed disease monitoring Clinical Trial Eligibility Overview. Trial Name: NCT03723928 — N/A
Progesterone Receptor Positive Research Study Groups: Arm I (usual care), Arm II (serum tumor directed disease monitoring)
Progesterone Receptor Positive Clinical Trial 2023: Serum Tumor Marker directed disease monitoring Highlights & Side Effects. Trial Name: NCT03723928 — N/A
Serum Tumor Marker directed disease monitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT03723928 — N/A
Progesterone Receptor Positive Patient Testimony for trial: Trial Name: NCT03723928 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolling in this clinical research?

"Indeed, the data accessible from clinicaltrials.gov indicates that this investigation is in search of participants at present. It was first listed on July 16th 2018 and has most recently been revised on March 8th 2022. A total of 1320 patients need to be enrolled across 100 unique sites."

Answered by AI

How many medical facilities are currently conducting this research project?

"This research project is being conducted at 100 different medical centres, which include Sewell, Orland Park and Louisville. In order to better facilitate participant involvement, it is advisable that individuals select the closest clinic location in their vicinity."

Answered by AI

Are there remaining vacancies in this medical research endeavor?

"As per information available on clinicaltrials.gov, this medical experiment is currently recruiting individuals. The trial was first posted on July 16th 2018 and underwent its most recent update in March of 2022."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Kentucky
How old are they?
18 - 65
What site did they apply to?
Commonwealth Cancer Center-Corbin
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I am interested in being monitored more closely, I have DCIS, and had surgery but no radiation.
PatientReceived no prior treatments
~493 spots leftby Jan 2035