RecruitingNot ApplicableNCT05959291

Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer

Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer


Sponsor

University of Miami

Enrollment

20 participants

Start Date

Jul 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this preliminary research study is to see if patients discontinuing maintenance Herceptin and/or other anti-HER-2 treatments with monitoring in addition to radiologic imaging and routine blood work will stay in complete radiological remission and to determine how long patients are able to stay in complete radiological remission without treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether it is safe to stop HER2-targeted maintenance therapy in people with HER2-positive stage IV breast cancer who have been in complete remission for at least 3 years and show no signs of cancer in their blood (no circulating tumor DNA). The goal is to find out if some patients can safely take a treatment break without the cancer coming back. **You may be eligible if...** - You are 18 or older with HER2-positive metastatic (stage IV) breast cancer in complete radiological remission - You have been on the same anti-HER2 therapy for at least 36 months - You have no detectable circulating tumor DNA (ctDNA) in your blood, confirmed by the Signatera test - Your disease has been stable (including any brain metastases) for at least 36 months **You may NOT be eligible if...** - Your cancer is not in remission or has been controlled for less than 36 months - You have detectable circulating tumor DNA in your blood - You are currently being treated for a second cancer (other than certain skin cancers) - You have impaired decision-making capacity Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDiscontinuation of Anti-HER-2 Maintenance Treatment

Patients assigned to this group will be asked to discontinue anti-HER-2 maintenance treatment.


Locations(1)

University of Miami

Miami, Florida, United States

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NCT05959291


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