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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

Must not have

Patients with impaired decision-making capacity

Patients with uncontrolled metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to make my own medical decisions.

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My cancer has spread and is not under control.

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My blood test shows cancer markers.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Ability of re-attain remission after ctDNA+ status

Diagnostic Accuracy of ctDNA Monitoring Assay to Identify Disease Progression

Duration of response (DOR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 9Eligibility criteria met