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
Qualifiers
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
Treatments tested in this trial
- Discontinuation of Anti-HER-2 Maintenance Treatment
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov