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

Stage IV Breast Cancer Clinical Trial

— Free-HER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959291
• Other study ID #: 20221166
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: July 31, 2029

Study information

• Verified date: September 2023
• Source: University of Miami
• Contact: Elisa Krill Jackson, MD
• Phone: 305-689-6500
• Email: ekrill[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 31, 2029
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

a. Patients with brain metastasis are allowed to participate as long as their disease has been treated and radiologically stable for at least 36 months.

3. Patients must be on the same or current anti-HER-2 directed therapy for at least 36 months.

4. Archived tumor biopsy available.

5. Patients with no evidence of circulating tumor deoxyribonucleic acid (ctDNA) as determined by the Signatera assay.

6. Patients willing to stop maintenance anti-HER-2 directed therapy with close monitoring.

7. Patients with an Eastern Cooperative Oncology Group (ECOG) performance score from 0 to 2.

8. Patients = 18 years of age.

9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients with uncontrolled metastatic disease.

2. Patients whose disease has been controlled for less than 36 months on the same or current anti-HER-2 therapy.

3. Patients who are currently receiving or have received treatment for a secondary cancer other than resected non-melanoma skin cancer lesions or in situ cancer within the past 24 months.

4. Patients positive for ctDNA (which occurs when a patient's blood sample contains =2 target markers) with the Signatera assay.

5. Use of investigational drugs = 28 days prior to study enrollment and during the study.

6. 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.

7. Patients with impaired decision-making capacity.

Patients who are found to be ctDNA+ at study entry will be recorded as a screen failure (Section 5.4). Their Signatera testing results will be provided to their treating physician to aid in clinical decision-making for disease management and treatment.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Metastatic Breast Cancer
• Stage IV Breast Cancer

Intervention

Other:
• Discontinuation of Anti-HER-2 Maintenance Treatment
Patients assigned to this group will be asked to discontinue anti-HER-2 maintenance treatment.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of maintaining remission after discontinuing use of anti-HER-2	The feasibility of maintaining remission of HER-2 will be measured as the proportion of patients who discontinue anti-HER-2 therapy and who remain in remission is assessed by monitoring ctDNA in the blood.	Up to 72 months
Secondary	Ability of re-attain remission after ctDNA+ status	Ability to re-attain remission after ctDNA+ status is defined as returning to ctDNA- status within 6 months after testing ctDNA+ during the study. This is assessed by the monitoring of ctDNA in the blood of participants that have tested ctDNA positive after stopping anti-HER-2 maintenance therapy and chose to restart anti-HER-2 therapy.	Up to 72 months
Secondary	Duration of response (DOR)	The duration of response (DOR) in study participants that have restarted anti-HER-2 therapy measures the time from is ctDNA+ status to overall response rate (ORR). This includes study participants that have ctDNA+ status and have chosen to either restart their previous anti-HER-2 maintenance therapy or have started a new anti-HER-2 therapy. The ORR is determined by blood and imaging monitoring.	Up to 72 months
Secondary	Diagnostic Accuracy of ctDNA Monitoring Assay to Identify Disease Progression	Diagnostic accuracy is evaluated by comparing disease relapse and/or progression confirmed by imaging compared to study participants ctDNA status.	Up to 72 months