Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 must be on the same or current anti-HER-2 directed therapy for at least 36 months.
Archived tumor biopsy available.
Disqualifiers
Patients with uncontrolled 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 or in situ cancer 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.
Trial design
Design model
Single group
Treatments tested in this trial
Discontinuation of Anti-HER-2 Maintenance Treatment
Other interventionPatients assigned to this group will be asked to discontinue anti-HER-2 maintenance treatment.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: anti-HER-2 GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 72 monthsSecondary outcomes
1
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.
Time frame
Up to 72 months2
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.
Time frame
Up to 72 months3
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.
Time frame
Up to 72 monthsSponsors and contacts
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Source ClinicalTrials.gov