STOP-HER2: Stopping Trastuzumab in HER2+ MBC
The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab - Outcomes in Patients With HER2+ Metastatic Breast Cancer
2 other identifiers
interventional
82
1 country
13
Brief Summary
This study is being done to see if anti-HER2 treatment be safely stopped in patients with HER2-positive metastatic breast cancer (MBC) that have had exceptional response to treatment. Exceptional response" is considered as cancer progression being controlled for three years or more since starting anti-HER2 treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Apr 2023
Longer than P75 for phase_2 breast-cancer
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2023
CompletedFirst Posted
Study publicly available on registry
February 9, 2023
CompletedStudy Start
First participant enrolled
April 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2036
February 20, 2026
February 1, 2026
3.1 years
February 1, 2023
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
1-year progression-free survival (PFS) Stopped Anti-HER2 Treatment
The primary endpoint is one-year progression-free survival (PFS) per RECIST 1.1 assessed separately in the participants who agree to stop HER2 therapy and those who continue HER2 therapy.
Up to 1 year
1-year progression-free survival (PFS) Continued Anti-HER2 Treatment
The primary endpoint is one-year progression-free survival (PFS) per RECIST 1.1 assessed separately in the participants who agree to stop HER2 therapy and those who continue HER2 therapy.
Up to 1 year
Secondary Outcomes (4)
Clinical benefit rate (CBR)
Up to 1 year
3-year Overall survival (OS)
Up to 3 years
3-year progression-free survival (PFS)
Up to 3 years
Probability of restarting anti-HER2 Treatment
Up to 1 year
Study Arms (2)
Cohort 1: Observational Continue Anti-HER2 Therapy
NO INTERVENTIONParticipants will have scans 30 days prior to starting study then undergo clinical follow-up 4-6 weeks after study initiation, at 12 weeks, and every 12 weeks thereafter. Visits will include interval history, physical exam, concomitant medications and blood draw for tumor marker assessment and research blood. Participants will undergo restaging scans every 12 weeks (+/- 2 weeks).
Cohort 2: - Stop Anti-HER2 Therapy
EXPERIMENTALParticipants will have scans 30 days prior to starting study. Week 1 participants will stop anti-HER2 therapy then undergo clinical follow-up every 4-6 weeks, at 12 weeks, and every 12 weeks thereafter. Visits will include interval history, physical exam, concomitant medications and blood draw for tumor marker assessment and research blood. Participants will undergo restaging scans every 12 weeks (+/- 2 weeks). Participants remaining progression-free after one year off treatment, may continue off anti-HER2 therapy indefinitely, with imaging surveillance suggested to be every 3-6 months at the discretion of the treating oncologist and will be followed up to 10 years Participants with disease progression after stopping anti-HER2 therapy, treatment is at discretion of the treating physician but resuming the pre-study regimen is strongly encouraged.
Interventions
Cessation of anti-HER2 treatment with standard treatment described as trastuzumab (Herceptin) with or without pertuzumab (Perjeta) continued as long as it is working or significant side effects occur.
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- Participants must have histologically or cytologically confirmed unresectable locally advanced or metastatic invasive breast carcinoma that is HER2-positive by American Society of Clinical Oncology/College of American Pathologists 2018 criteria, as assessed by standard institutional guidelines (central testing is not required). Both estrogen receptor (ER)-positive/HER2-positive and ER-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 years without evidence of progressive disease according to RECIST 1.1 criteria. The following exceptions apply:
- Patients with history of brain-only progressive disease previously treated with local therapy (surgery and/or radiation therapy) are eligible, provided they meet all 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 the completion of CNS-directed therapy and screening radiographic study
- Minimum of 2 years (24 months) between completion of CNS-directed therapy and study start
- Participants with history of oligo-progression (i.e., progressive disease of a single lesion) outside CNS treated with local treatment and/or change of endocrine therapy only are eligible, provided they meet the following criteria:
- No evidence of interval progression between completion of local treatment or endocrine therapy change and screening radiographic study
- Minimum 2 years (24 months) between completion of local therapy or treatment switch and study start
- CT scan within 30 days of study start without definite evidence of progressive disease in the opinion of the treating investigator.
- Available, representative archival formalin-fixed paraffin-embedded (FFPE) tumor tissue block from primary and/or metastatic site. If tissue block is unavailable, 20 unstained 10uM slides will be accepted (less than 20 slides may be acceptable with documentation of Sponsor-Investigator approval and would not require an eligibility exception). Tumor tissue must be received by coordinating site prior to study enrollment.
- +5 more criteria
You may not qualify if:
- Participants who are receiving any investigational agents to treat breast cancer
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- All English- speaking patients will participate in the PRO measures. Patients that do not read or understand English are eligible to participate but will be exempt from the patient completed questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
- Gateway for Cancer Researchcollaborator
- Susan G. Komen Breast Cancer Foundationcollaborator
- Translational Breast Cancer Research Consortiumcollaborator
- Johns Hopkins Universitycollaborator
Study Sites (13)
Mayo Clinic Hospital Arizona
Phoenix, Arizona, 85054, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 02809, United States
Mayo Clinical Hospital Florida
Jacksonville, Florida, 32224, United States
Dana-Farber Cancer Insitute
Boston, Massachusetts, 02215, United States
DFCI @ Foxborough
Foxborough, Massachusetts, 02035, United States
DFCI @ Merrimack Valley
Methuen, Massachusetts, 01844, United States
DFCI @ Milford Regional Hospital
Milford, Massachusetts, 01757, United States
DFCI @ South Shore Hospital
South Weymouth, Massachusetts, 02190, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Duke University
Durham, North Carolina, 27710, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy U Lin, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 1, 2023
First Posted
February 9, 2023
Study Start
April 19, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2036
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.