STOP-HER2: Stopping Trastuzumab in HER2+ MBC

Last updated: September 24, 2024
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Metastatic Cancer

Breast Cancer

Cancer

Treatment

Cessation of anti-HER2 treatment

Clinical Study ID

NCT05721248
22-655
1K08CA252639-01A1
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 82
Treatment Group(s): 1
Primary Treatment: Cessation of anti-HER2 treatment
Phase: 2
Study Start date:
April 19, 2023
Estimated Completion Date:
February 29, 2036

Study Description

This is a single arm, phase II study of cessation of anti-HER2 systemic therapy in exceptional responders with HER2-positive metastatic breast cancer (MBC), defined as individuals free of disease progression after at least 3 years of first-line treatment.

This research study will include two different groups (cohorts) of patients. Those not wanting to stop anti-HER2 maintenance treatment will be included in a non-randomized, observational cohort (cohort 1). Those willing to stop maintenance anti-HER2 treatment you will be included in cohort 2.

This study is trying to understand whether blood samples that may contain traces of DNA from cancer, known as "circulating tumor DNA" or "ctDNA" are able to help identify which patients can successfully stop treatment without a change in their cancer.

The research study procedures include: an initial screening phase followed by periodic visits with blood work, questionnaires, and body scans.

It is expected that about 82 people will take part in this research study (52 in cohort 2 (stopping treatment), 30 in cohort 1 (continuing treatment). This study is expected to last 1 year with 10 years of follow up.

The Susan G. Komen Foundation, the Gateway for Cancer Research - both nonprofit foundations supporting cancer research - and the National Institutes of Health are supporting this research study by providing funds. This study is also being supported by Johns Hopkins University on behalf of the Translational Breast Cancer Research Consortium (TBCRC). The TBCRC is a group of academic medical centers across the United States that work together to conduct breast cancer research.

Connect with a study center

  • Mayo Clinic Hospital Arizona

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Georgetown University Medical Center

    Washington, District of Columbia 02809
    United States

    Active - Recruiting

  • Mayo Clinical Hospital Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Dana-Farber Cancer Insitute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • DFCI @ Foxborough

    Foxboro, Massachusetts 02035
    United States

    Site Not Available

  • DFCI @ Foxborough

    Foxborough, Massachusetts 02035
    United States

    Active - Recruiting

  • DFCI @ Merrimack Valley

    Methuen, Massachusetts 01844
    United States

    Active - Recruiting

  • DFCI @ Milford Regional Hospital

    Milford, Massachusetts 01757
    United States

    Active - Recruiting

  • DFCI @ South Shore Hospital

    South Weymouth, Massachusetts 02190
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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