ACTIVE_NOT_RECRUITING

STOP-HER2: Stopping Trastuzumab in HER2+ MBC

Conditions

Breast Cancer Metastatic Breast Cancer HER2-positive Breast Cancer

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab - Outcomes in Patients With HER2+ Metastatic Breast Cancer

Quick Facts

Study Start:2023-04-19

Study Completion:2036-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05721248

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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, laboratory tests, and other study procedures * Ability to understand the study requirements and document informed consent indicating awareness of the investigational nature and the risks of this study * Participants with another prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of this trial are eligible	* 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

Inclusion Criteria

Exclusion Criteria

* 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.
* 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, laboratory tests, and other study procedures
* Ability to understand the study requirements and document informed consent indicating awareness of the investigational nature and the risks of this study
* Participants with another prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of this trial are eligible

* 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

Contacts and Locations

Principal Investigator

Nancy U Lin, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Mayo Clinic Hospital Arizona

Phoenix, Arizona, 85054

United States

Georgetown University Medical Center

Washington, 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

Foxboro, 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

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Nancy U Lin, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-19

Study Completion Date2036-02

Study Record Updates

Study Start Date2023-04-19

Study Completion Date2036-02

Terms related to this study

Keywords Provided by Researchers

Breast Cancer
Metastatic Breast Cancer
HER2-positive Breast Cancer

Additional Relevant MeSH Terms

Breast Cancer
Metastatic Breast Cancer
HER2-positive Breast Cancer