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WITHDRAWNPHASE2

Fulvestrant + Neratinib In Breast Cancer

An Open-Label Phase II Trial of Fulvestrant And Neratinib in Previously Treated HRPositive, HER2-Negative Metastatic Breast Cancer Subjects Assessed With a Test Measuring Live Cell HER2 Signaling Function

NCT04901299•Massachusetts General Hospital

View on ClinicalTrials.gov

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

Detailed Description

* The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * This research study involves the study drug Neratinib * The standard of care drug Fulvestrant * It is expected that about 25 people will take part in this research study. * This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. * The U.S. Food and Drug Administration (FDA) has not approved Neratinib for this specific disease but it has been approved for other uses. * The FDA has approved Fulvestrant as a treatment option for this disease. Fulvestrant is a standard of care drug that will be administered.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult (≥ 18 years of age).
•Histologically or cytologically confirmed stage IV (metastatic) breast cancer. PI approval is needed for patients who do not have source documentation of histologically confirmed stage IV (metastatic) breast cancer, but otherwise have known metastatic breast cancer.
•Participants must have biopsy proven HR+, i.e ER positive (ER+) and/or PR positive (PR+), HER2 non-amplified (negative), invasive breast cancer. ER, PR, and HER2 positivity would be determined per institutional (local) testing, with HR+/HER2 nonamplified (negative) status for this trial determined as per 2020 ASCO/CAP guidelines, in a biopsy/surgical specimen analyzed for ER/PR/HER2. Patients with "ER or PR low positive" (\<10%) as per updated ASCO/CAP 2020 guidelines can be considered.Confirmation of adequate (15-20 unstained slides cut at 5-10 μm or 1 block) archival tissue (primary or metastatic) required before study entry. If adequate tissue not available, PI approval is required prior to study entry.
•Previously treated with no more than three prior chemotherapy regimens (no limit on prior endocrine-based regimens (including CDK4/6i and PI3K pathway inhibitors) or immunotherapy). In patients with disease recurrence during/within 12 months of (neo)adjuvant therapy, the (neo)adjuvant therapy would count as one prior regimen for this criterion. Radiation therapy or local therapy/surgery would not count as prior regimen for this criterion. Patient who discontinued chemotherapy during/after only one cycle and/or due to adverse effects without disease progression would not count the treatment/regimen as prior regimen for this criterion. Antibody drug conjugate and PARP inhibitor treatment would count as chemotherapy regimen for this criterion.
•Hyperactive HER2 signaling activity based on results from the CELsignia test (separate pre-screening test).
•Postmenopausal women with locally advanced or metastatic BC. Patients must be postmenopausal women as defined by one of the following:
•* Women \> 60 years OR
•* Women ≤ 60 years, and any one of the following:
•* LH and FSH level in the postmenopausal range according to institutional standards
•* s/p post bilateral surgical oophorectomy
+13 more criteria

Exclusion Criteria

•Participants who have received prior neratinib or any anti-HER2 therapy for metastatic disease will not be eligible. Participants who have received prior fulvestrant (or any other endocrine therapy) will be eligible. Patients with known HER2 activating mutations (either plasma and/or tissue-based genotyping) will not be eligible.
•Participants with increasing/progressive CNS metastatic disease. Patients with asymptomatic or stable CNS metastasis are eligible, provided metastasis radiologically non-progressing for at least two weeks, and patient is not actively taking steroids (more than 20 mg of prednisone or equivalent dose).
•Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
•Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including any of the following:
•* History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study entry.
•* Known LVEF \<50% (by ECHO or MUGA) and/or known documented cardiomyopathy.
•* History of cardiac failure, significant/symptomatic bradycardia, Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following:
•* Known risk to prolong the QT interval or induce Torsade's de Pointes.
•* On screening, QTcF \>470 screening ECG.
•HIV-positive participants on combination antiretroviral therapy are ineligible. These participants are at increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
+6 more criteria

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Key Dates

Start Date

July 1, 2023

Primary Completion Date

July 1, 2024

Completion Date

July 1, 2025

Last Updated

August 1, 2023

Conditions

Stage IV (Metastatic) Breast CancerMetastatic Breast CancerER Positive Breast CancerPR-Positive Breast CancerHER2-negative Breast CancerInvasive Breast Cancer

Interventions

NERATINIB

DRUG

FULVESTRANT

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Fulvestrant + Neratinib In Breast Cancer

Inclusion Criteria

Exclusion Criteria

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