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Marker-Directed Monitoring for Breast Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not in, nor planning to join, another first-line treatment trial for my metastatic breast cancer.I have not had systemic therapy for my metastatic breast cancer, except my current treatment.Your CEA levels must be tested.I was tested for breast cancer markers after my cancer spread and close to starting my first treatment.I can complete questionnaires in English or Spanish.I agree to get my disease monitored at the same place during the study.I have not had cancer before, except for certain types that are exceptions.I can make my own decisions and understand the consent form.I registered for the trial within 14 days before to 60 days after starting my first systemic treatment for metastatic disease.I have cancer that has spread to the lining of my brain.I do not have cancer spread to the brain or its linings.My breast cancer is hormone receptor positive, HER-2 negative, and has spread to other parts of my body.I have hormone-positive, HER2-negative metastatic breast cancer and am starting or planning to start my first treatment.I've had imaging tests for my breast cancer before starting treatment.My breast cancer started as metastatic or has now spread to other parts.I have cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia.I do not have cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia.You have completed the registration form.I registered for the trial within 14 days before to 60 days after starting my first treatment for metastatic disease.You must have had a test for CA 15-3 or CA 27.29.My breast cancer is either newly diagnosed as metastatic or has recurred and is now metastatic.
- Group 1: Arm I (usual care)
- Group 2: Arm II (serum tumor directed disease monitoring)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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