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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT04965064
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Capecitabine and Neratinib. — DRUG
    Neratinib 240 mg PO QD Daily On-going Capecitabine 750 mg/m2 PO bid Days 1-14, 7 days off On-going

Study Details

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.

Key Dates

Start date
Sep 23, 2022
Status verified
Dec 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Capecitabine and Neratinib.
    Neratinib 240 mg PO QD Daily On-going Capecitabine 750 mg/m2 PO bid Days 1-14, 7 days off On-going

Primary Outcome Measure

overall survival [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14642
Jamie Littleton
[email protected]

Find similar trials in Rochester, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Rochester· Rochester, NY

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