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NCT04965064 · ClinicalTrials.gov registry record · Phase 2

Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling

A Phase 2 study of Breast Cancer, sponsored by University of Rochester.

Recruiting
Registry status
Phase 2
Development phase
22
Enrollment target
1
Study location

NCT04965064: Recruiting Phase 2 study of Breast Cancer, sponsored by University of Rochester.

NCT04965064 is a Phase 2 study of Breast Cancer that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 22 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% 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

NCT04965064, a Phase 2 study of Breast Cancer, is actively recruiting participants, sponsored by University of Rochester.

RECRUITING
Registry status
Phase 2
Development phase
22 participants
Enrollment target
1
Study location

Study Summary

The purpose of this research is to look at the safety and effectiveness of a HER2-targeted therapy neratinib when given with capecitabine, a chemotherapy, for breast cancer patients with brain metastases whose tumors were HER2-negative by standard tests but showed abnormal HER2 activity based on the CELsignia results.

Primary Outcome

The study will assess how long participants with HER2 negative metastatic breast cancer with brain metastasis and abnormal HER2 signalling will survive if treated with capecitabine and neratinib

Conditions Studied

Interventions

  • DRUG Capecitabine and Neratinib.

Study Locations (1)

New York

  • University of Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2022-09-23
Est. Completion 2027-09-01
Phase Phase 2
University of Rochester

636 total trials

What NCT04965064 shows while recruiting

NCT04965064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Capecitabine and Neratinib. is the first listed.

NCT04965064 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT04965064 about?

NCT04965064 is a clinical study titled "Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling". The purpose of this research is to look at the safety and effectiveness of a HER2-targeted therapy neratinib when given with capecitabine, a chemotherapy, for breast cancer patients with brain metastases whose tumors were HER2-negative by standard tests but showed abnormal HER2 activity based on the...

What is the current status of trial NCT04965064?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2022-09-23. Estimated completion is 2027-09-01.

What conditions does trial NCT04965064 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT04965064?

The interventions under investigation include: Capecitabine and Neratinib. (DRUG).

Who is sponsoring clinical trial NCT04965064?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04965064 being conducted?

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

Similar trials for 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 NCT04965064's enrollment target sits among peer trials

22 1063rd of 1224 higher than 153 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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 NCT04965064, the US trial registry maintained by the National Library of Medicine. NCT04965064 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.