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Fulvestrant + Neratinib In Breast Cancer

NCT04901299 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-08-01

No results posted yet for this study

Summary

This is a Phase 2 open label, multi-center non-randomized interventional study designed to evaluate the safety and efficacy of combining Neratinib plus Fulvestrant in previously treated metastatic HR-positive, HER2-negative breast cancer.

* This research study involves the study drug Neratinib
* The standard of care drug Fulvestrant

Conditions

Interventions

DRUG

NERATINIB

Neratinib will be given orally once daily on a continuous daily dosing schedule i.e., no break in dosing. Dosage per protocol

DRUG

FULVESTRANT

Fulvestrant will be given via injection every two weeks for the first 28-day cycle and every four weeks thereafter, dosage per protocol

Sponsors & Collaborators

  • Celcuity Inc

    collaborator INDUSTRY

  • Puma Biotechnology, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Aditya Bardia, MD,MPH · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2024-07-01
Completion
2025-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04901299 on ClinicalTrials.gov