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Stopping HER-2 Directed Therapy for Breast Cancer (Free-HER Trial)

N/A

Recruiting

Led By Elisa Krill Jackson, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

Patients in complete radiological remission (CRR), including a stable bone scan, as determined by computed tomography (CT), positron-emission tomography (PET), or PET-CT

Patients with a diagnosis of HER-2 positive metastatic (Stage IV) breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 months

Awards & highlights

Free-HER Trial Summary

This trial looks at whether patients with HER-2 cancer can stay in complete remission without treatment and how long they can remain in remission.

Who is the study for?

This trial is for adults over 18 with HER-2 positive metastatic breast cancer in complete radiological remission. They must have been on anti-HER-2 therapy for at least 3 years, have no evidence of circulating tumor DNA, and be able to consent. Those with stable treated brain metastasis may join, but not those with recent other cancers or uncontrolled disease.Check my eligibility

What is being tested?

The study tests if stopping maintenance anti-HER-2 treatments like Herceptin in long-term survivors leads to continued remission. Participants will be closely monitored through imaging and blood work to track their cancer status after discontinuing the treatment.See study design

What are the potential side effects?

Since this trial involves discontinuing treatment rather than administering new drugs, there are no direct side effects from interventions being tested; however, potential risks include the return of cancer without ongoing treatment.

Free-HER Trial Eligibility Criteria

Inclusion Criteria

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

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My scans show no signs of cancer currently.

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I have Stage IV breast cancer that is HER-2 positive.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

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My blood test for cancer DNA (Signatera assay) was negative.

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I have been on the same HER2-targeted therapy for at least 3 years.

Free-HER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 72 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of maintaining remission after discontinuing use of anti-HER-2

Secondary outcome measures

Ability of re-attain remission after ctDNA+ status

Diagnostic Accuracy of ctDNA Monitoring Assay to Identify Disease Progression

Duration of response (DOR)

Free-HER Trial Design

1Treatment groups

Experimental Treatment

Group I: anti-HER-2 GroupExperimental Treatment1 Intervention

Participants in this group will be monitored to see if patients discontinuing maintenance of anti-HER-2 treatments with ctDNA monitoring in addition to radiologic imaging and routine blood work will stay in complete radiological remission. Participants will be in this group for up to 3 years.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

410,056 Total Patients Enrolled

17 Trials studying Breast Cancer

1,551 Patients Enrolled for Breast Cancer

Elisa Krill Jackson, MDPrincipal InvestigatorUniversity of Miami

Media Library

anti-HER-2 Group Clinical Trial Eligibility Overview. Trial Name: NCT05959291 — N/A

Breast Cancer Research Study Groups: anti-HER-2 Group

Breast Cancer Clinical Trial 2023: anti-HER-2 Group Highlights & Side Effects. Trial Name: NCT05959291 — N/A

anti-HER-2 Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05959291 — N/A

Frequently Asked Questions

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

Are applications for the study currently being accepted?

"Indeed, clinicaltrials.gov shows that this trial is open for recruitment since October 1st 2023 and was most recently revised on July 17th 2023. The research requires enrollment of twenty participants from one medical site."

Answered by AI

How many participants have thus far enrolled in the experiment?

"Affirmative. Information on clinicaltrials.gov confirms that this trial, which was initially posted October 1st 2023, is actively seeking patients to enrol in the study. There is a need for 20 participants at one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Elisa Krill Jackson 2023. "Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05959291.