Phase
Condition
Metastatic Cancer
Breast Cancer
Cancer
Treatment
Cessation of anti-HER2 treatment
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years
Participants must have histologically or cytologically confirmed unresectablelocally advanced or metastatic invasive breast carcinoma that is HER2-positive byAmerican Society of Clinical Oncology/College of American Pathologists 2018criteria, as assessed by standard institutional guidelines (central testing is notrequired). Both estrogen receptor (ER)-positive/HER2-positive andER-negative/HER2-positive will be eligible.
Participants with ER-positive disease should continue endocrine therapy.
Participants must be currently receiving first-line anti-HER2 therapy (any regimen)for metastatic disease and must have been on this therapy for at least 3 yearswithout evidence of progressive disease according to RECIST 1.1 criteria. Thefollowing exceptions apply:
Patients with history of brain-only progressive disease previously treated withlocal therapy (surgery and/or radiation therapy) are eligible, provided they meetall the following study criteria:
Asymptomatic
Not requiring anti-convulsant for symptomatic control
Not requiring corticosteroids
No evidence of interim central nervous system (CNS) progression between thecompletion of CNS-directed therapy and screening radiographic study
Minimum of 2 years (24 months) between completion of CNS-directed therapy andstudy start
Participants with history of oligo-progression (i.e., progressive disease of asingle lesion) outside CNS treated with local treatment and/or change of endocrinetherapy only are eligible, provided they meet the following criteria:
No evidence of interval progression between completion of local treatment orendocrine therapy change and screening radiographic study
Minimum 2 years (24 months) between completion of local therapy or treatmentswitch and study start
CT scan within 30 days of study start without definite evidence of progressivedisease in the opinion of the treating investigator.
Available, representative archival formalin-fixed paraffin-embedded (FFPE) tumortissue block from primary and/or metastatic site. If tissue block is unavailable, 20unstained 10uM slides will be accepted (less than 20 slides may be acceptable withdocumentation of Sponsor-Investigator approval and would not require an eligibilityexception). Tumor tissue must be received by coordinating site prior to studyenrollment.
ECOG performance status 0-1
For intervention arm only (cohort 2): willingness to stop anti-HER2 systemic therapy
Willingness and ability to comply with scheduled visits, treatment plan, laboratorytests, and other study procedures
Ability to understand the study requirements and document informed consentindicating awareness of the investigational nature and the risks of this study
Participants with another prior or concurrent malignancy whose natural history ortreatment does not have the potential to interfere with the safety or efficacyassessment of this trial are eligible
Exclusion
Exclusion Criteria:
Participants who are receiving any investigational agents to treat breast cancer
Participants with psychiatric illness/social situations that would limit compliancewith study requirements.
All English- speaking patients will participate in the PRO measures. Patients thatdo not read or understand English are eligible to participate but will be exemptfrom the patient completed questionnaires
Study Design
Study Description
Connect with a study center
Mayo Clinic Hospital Arizona
Phoenix, Arizona 85054
United StatesActive - Recruiting
Georgetown University Medical Center
Washington, District of Columbia 02809
United StatesActive - Recruiting
Mayo Clinical Hospital Florida
Jacksonville, Florida 32224
United StatesActive - Recruiting
Dana-Farber Cancer Insitute
Boston, Massachusetts 02215
United StatesActive - Recruiting
DFCI @ Foxborough
Foxboro, Massachusetts 02035
United StatesSite Not Available
DFCI @ Foxborough
Foxborough, Massachusetts 02035
United StatesActive - Recruiting
DFCI @ Merrimack Valley
Methuen, Massachusetts 01844
United StatesActive - Recruiting
DFCI @ Milford Regional Hospital
Milford, Massachusetts 01757
United StatesActive - Recruiting
DFCI @ South Shore Hospital
South Weymouth, Massachusetts 02190
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
Duke University
Durham, North Carolina 27710
United StatesActive - Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Baylor College of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United StatesActive - Recruiting


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