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Monoclonal Antibodies

Stopping Anti-HER2 Therapy for Breast Cancer

Phase 2

Recruiting

Led By Heather A Parsons, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if stopping anti-HER2 treatment is safe in patients with MBC who have had long-term success on it.

Who is the study for?

This trial is for adults over 18 with HER2-positive metastatic breast cancer who've had a great response to anti-HER2 therapy for at least 3 years. They must be able to follow the study plan and continue endocrine therapy if they have ER-positive disease. Those with certain stable brain conditions or other cancers that don't affect this study can join too.

What is being tested?

The STOP-HER2 trial is testing whether patients with an exceptional response to anti-HER2 treatment can safely stop the therapy without their cancer progressing. An 'exceptional response' means their cancer has been under control for three years or more on current treatment.

What are the potential side effects?

Since the intervention involves stopping anti-HER2 treatments, side effects may include potential cancer progression due to cessation of therapy. However, specific side effects from stopping treatment are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've been on a first-line anti-HER2 therapy for my metastatic disease for at least 3 years without my cancer getting worse.

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My breast cancer is advanced, cannot be surgically removed, and is HER2 positive.

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I am fully active or can carry out light work.

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I am 18 years old or older.

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I am willing to stop my current anti-HER2 cancer treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

1-year progression-free survival (PFS) Continued Anti-HER2 Treatment

1-year progression-free survival (PFS) Stopped Anti-HER2 Treatment

Secondary study objectives

3-year Overall survival (OS)

3-year progression-free survival (PFS)

Clinical benefit rate (CBR)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 2: - Stop Anti-HER2 TherapyExperimental Treatment1 Intervention

Participants 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.

Group II: Cohort 1: Observational Continue Anti-HER2 TherapyActive Control1 Intervention

Participants 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).

0 / 5Eligibility criteria met