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Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer

NCT03289039 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-01-22

Study results available
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Summary

This research study is studying a drug called Neratinib with and without Fulvestrant as possible treatments for HER2-positive breast cancer .

The interventions involved in this study are:

* Neratinib and Fulvestrant
* Neratinib alone

Conditions

Interventions

DRUG

Neratinib

Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2)

DRUG

Fulvestrant

Fulvestrant, works in treating breast cancer that has spread to other parts of the body

Sponsors & Collaborators

Principal Investigators

  • Jose Leone, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2021-07-20
Completion
2021-07-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03289039 on ClinicalTrials.gov