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NCT05959291 · ClinicalTrials.gov registry record · NA

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

A NA study of Stage IV Breast Cancer and HER2-positive Metastatic Breast Cancer, sponsored by University of Miami.

Recruiting
Registry status
NA
Development phase
20
Enrollment target
1
Study location

NCT05959291: Recruiting NA study of Stage IV Breast Cancer and HER2-positive Metastatic Breast Cancer, sponsored by University of Miami.

NCT05959291 is a NA study of Stage IV Breast Cancer and HER2-positive Metastatic Breast Cancer that is actively recruiting participants, run by University of Miami. The registered enrollment target is 20 participants, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05959291, a NA study of Stage IV Breast Cancer and HER2-positive Metastatic Breast Cancer, is actively recruiting participants, sponsored by University of Miami.

RECRUITING
Registry status
NA
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

The feasibility of maintaining remission of HER-2 will be measured as the proportion of patients who discontinue anti-HER-2 therapy and who remain in remission is assessed by monitoring ctDNA in the blood.

Interventions

  • OTHER Discontinuation of Anti-HER-2 Maintenance Treatment

Study Locations (1)

Florida

  • University of Miami - Miami

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2023-07-17
Est. Completion 2029-07-31
Phase NA
University of Miami

721 total trials

What NCT05959291 shows while recruiting

NCT05959291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (70% lower).

The record links to 2 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Discontinuation of Anti-HER-2 Maintenance Treatment is the first listed.

NCT05959291 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT05959291 about?

NCT05959291 is a clinical study titled "Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer". 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 abl...

What is the current status of trial NCT05959291?

This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2023-07-17. Estimated completion is 2029-07-31.

What conditions does trial NCT05959291 study?

This clinical trial studies the following conditions: Stage IV Breast Cancer, HER2-positive Metastatic Breast Cancer.

What interventions are being tested in trial NCT05959291?

The interventions under investigation include: Discontinuation of Anti-HER-2 Maintenance Treatment (OTHER).

Who is sponsoring clinical trial NCT05959291?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05959291 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stage IV Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05959291's enrollment target sits among peer trials

20 25th of 30 higher than 6 of 30 other Stage IV Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05959291, the US trial registry maintained by the National Library of Medicine. NCT05959291 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.