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STOP-HER2: Stopping Trastuzumab in HER2+ MBC

NCT05721248 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-02-20

No results posted yet for this 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.

Conditions

Interventions

OTHER

Cessation of anti-HER2 treatment

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gateway for Cancer Research

    collaborator OTHER

  • Susan G. Komen Breast Cancer Foundation

    collaborator OTHER

  • Translational Breast Cancer Research Consortium

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Nancy U Lin, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2026-06-30
Completion
2036-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05721248 on ClinicalTrials.gov