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

Status: active

This clinical trial evaluates whether it is possible for patients with HER-2 positive breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) to discontinue their maintenance anti-HER-2 therapy and remain disease free, as evaluated using a blood test (Signatera assay) to detect changes in a marker of disease recurrence (circulating tumor deoxyribonucleic acid [ctDNA]) in addition to standard of care monitoring. HER-2 is a protein that may be present on the surface of cancer cells. In the United States patients with HER-2 positive metastatic breast cancer receive anti-HER-2 treatments indefinitely and undergo periodic imaging and disease monitoring for the same length of time as standard of care. Long-term survivors of HER-2 positive metastatic breast cancer may achieve complete radiological remission while receiving HER-2 therapy, meaning they show no detectable disease changes on imaging scans. These patients may be able to discontinue anti-HER-2 therapy without their disease coming back. Because many types of tumors, including breast cancer, tend to lose cells or release different types of cellular products into the bloodstream before changes can be seen on scans, health care providers can measure the level of these tumor cell products in blood, tissue, or other clinical samples to determine which patients are at higher risk for disease progression. Patients in this study will discontinue their anti-HER-2 therapy and undergo periodic ctDNA testing with the Signatera assay in addition to standard of care disease monitoring and imaging studies. The Signatera assay identifies and measures the levels of ctDNA in a patient’s blood, allowing researchers to identify disease relapse (cancer that has come back) or progression earlier than standard of care imaging tests and either restart or change a patient's treatment before the cancer becomes unresponsive to treatment. This study may help researchers learn whether or not it is feasible for metastatic HER-2 positive breast cancer patients to discontinue anti-HER-2 treatment and remain disease free and may provide evidence for the usefulness of Signatera ctDNA testing in monitoring for disease relapse.

Inclusion Criteria

Patients with a diagnosis of HER-2 positive metastatic (stage IV) breast cancer
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 brain metastasis are allowed to participate as long as their disease has been treated and radiologically stable for at least 36 months
Patients must be on the same or current anti-HER-2 directed therapy for at least 36 months
Archived tumor biopsy available * NOTE: For patients with no archived tumor specimen available, an alternative tumor-agnostic ctDNA assay (such as by Guardant) will be used. In this circumstance, patients will only provide a blood sample for ctDNA testing
Patients with no evidence of ctDNA as determined by the Signatera assay or alternative tumor-agnostic ctDNA assay (such as by Guardant)
Patients willing to stop maintenance anti-HER-2 directed therapy with close monitoring
Patients with an Eastern Cooperative Oncology Group (ECOG) performance score from 0 to 2
Patients >= 18 years of age
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Patients with uncontrolled, active metastatic disease
Patients whose disease has been controlled for less than 36 months on the same or current anti- HER-2 therapy
Patients who are currently receiving or have received treatment for a secondary cancer other than resected non-melanoma skin cancer lesions, in situ cancer, or chronic myelogenous leukemia (CML) within the past 24 months
Patients positive for ctDNA (which occurs when a patient's blood sample contains >= 2 target markers) with the Signatera assay or alternative tumor-agnostic ctDNA assay (such as by Guardant) * Patients who are found to be ctDNA+ at study entry will be recorded as a screen failure. Their Signatera testing or alternative tumor-agnostic ctDNA testing results (such as by Guardant) will be provided to their treating physician to aid in clinical decision-making for disease management and treatment
Use of investigational drugs =< 28 days prior to study enrollment and during the study
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or that makes participation in the trial to be not in the best interest of the patient in the opinion of the investigator
Patients with impaired decision-making capacity

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05959291.

United States

Email: ekrill@med.miami.edu

University of Miami Miller School of Medicine-Sylvester Cancer Center

Status: Active

Contact: Elisa Krill-Jackson

Phone: 305-689-6500

Email: ekrill@med.miami.edu

Plantation

UM Sylvester Comprehensive Cancer Center at Plantation

Status: Active

Contact: Elisa Krill-Jackson

Phone: 305-689-6500

Email: ekrill@med.miami.edu

PRIMARY OBJECTIVE:

I. Determine the feasibility of maintaining remission and possibility of cure in patients who are long-term survivors of HER-2 positive metastatic (stage IV) breast cancer when discontinuing anti-HER-2 maintenance therapy.

SECONDARY OBJECTIVES:

I. Determine the ability to re-attain remission as defined by conversion to ctDNA negative (ctDNA-) status in patients who become ctDNA positive (ctDNA+) by restarting anti-HER-2 therapy.

II. Evaluate the duration of response (DOR) in patients who restart anti-HER-2 therapy.

III. Evaluate the ability of ctDNA testing to identify patients who experience disease relapse or progression and facilitate earlier initiation of therapy to achieve a second remission.

EXPLORATORY OBJECTIVES:

I. Describe the economic risks and benefits associated with discontinuing anti-HER-2 maintenance therapy.

II. Describe any changes in quality of life (QoL) measures in patients who discontinue anti-HER-2 maintenance therapy.

III. Characterize the genomic and clinical factors of the archived tumor sample collected from patients and correlate them with maintenance of ctDNA negativity in patients who discontinue treatment and stay in remission versus those who are not in remission and/or do not remain in remission.

OUTLINE:

Patients discontinue standard of care (SOC) maintenance anti-HER-2 therapy and then undergo blood sample collection for analysis via Signatera assay at 6 and 12 weeks, then every 12 weeks for 3 years. Patients also undergo SOC radiologic examination throughout the study. Patients who become ctDNA+ but who do not have evidence of disease progression on radiologic examination have the option to restart SOC anti-HER-2 therapy and continue undergoing blood sample collection for analysis via Signatera assay every 12 weeks for up to 6 months after restarting anti-HER-2 therapy or change in ctDNA status.

Have a question?
We're here to help

Chat with us: LiveHelp
Call us: 1-800-4-CANCER
(1-800-422-6237)

Which trials are right for you?

Use the checklist in our guide to gather the information you’ll need.

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

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

Have a question?We're here to help

Which trials are right for you?

Have a question?
We're here to help