Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05959291
Status
Recruiting
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Conditions

  • HER2-positive Metastatic Breast Cancer
  • Stage IV Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Discontinuation of Anti-HER-2 Maintenance Treatment — OTHER
    Patients assigned to this group will be asked to discontinue anti-HER-2 maintenance treatment.

Study Details

The purpose of this preliminary research study is to see if patients discontinuing maintenance Herceptin and/or other anti-HER-2 treatments with monitoring in addition to radiologic imaging and routine blood work will stay in complete radiological remission and to determine how long patients are able to stay in complete radiological remission without treatment.

Key Dates

Start date
Jul 17, 2023
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: anti-HER-2 Group
    Participants in this group will be monitored to see if patients discontinuing maintenance of anti-HER-2 treatments with ctDNA monitoring in addition to radiologic imaging and routine blood work will stay in complete radiological remission. Participants will be in this group for up to 3 years.

Primary Outcome Measure

Feasibility of maintaining remission after discontinuing use of anti-HER-2 [ Time Frame: Up to 72 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Elisa Krill Jackson, MD
[email protected]
305-689-6500
Elisa Krill Jackson, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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