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Estrogen Receptor Antagonist

FULVESTRANT for Breast Cancer (HER2-Signal Trial)

Phase 2

Waitlist Available

Led By Aditya Bardia, MD,MPH

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 33 months

Awards & highlights

HER2-Signal Trial Summary

This trial is designed to study if adding Neratinib to Fulvestrant can improve outcomes in patients with metastatic hormone receptor positive, HER2 negative breast cancer.

Eligible Conditions

Metastatic Breast Cancer
Breast Cancer

HER2-Signal Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 33 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 33 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 33 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rates (ORR)

Secondary outcome measures

CELsignia score and CB

CELsignia score and Objective Response

CELsignia score and Progression Free Survival

+7 more

HER2-Signal Trial Design

1Treatment groups

Experimental Treatment

Group I: NERATINIB + FULVESTRANTExperimental Treatment2 Interventions

After the screening procedures confirm participation in the research study. - Each Cycle = 28 days Neratinib (oral, once daily) Fulvestrant, injection, on 2 days for cycle 1, then one time per cycle thereafter

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Celcuity, Inc.Industry Sponsor

6 Previous Clinical Trials

962 Total Patients Enrolled

3 Trials studying Breast Cancer

898 Patients Enrolled for Breast Cancer

Puma Biotechnology, Inc.Industry Sponsor

56 Previous Clinical Trials

9,792 Total Patients Enrolled

14 Trials studying Breast Cancer

4,397 Patients Enrolled for Breast Cancer

Celcuity IncIndustry Sponsor

7 Previous Clinical Trials

1,016 Total Patients Enrolled

3 Trials studying Breast Cancer

898 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical indications are typically addressed by NERATINIB?

"Neratinib is a common medication used to treat pik3ca gene mutations, as well as certain types of cancers and diseases that have progressed or been resistant to endocrine therapies."

Answered by AI

Has recruitment for this trial commenced?

"Unfortunately, this clinical trial has since closed and is no longer enrolling new participants. It was first posted on December 1st 2021 and last updated October 25th 2021. If you are searching for a different study to join, currently there are 2295 trials recruiting patients with ER Positive Breast cancer and 150 studies looking for volunteers taking neratinib."

Answered by AI

Are there any additional investigations related to the efficacy of NERATINIB?

"Currently, 150 clinical trials are running to investigate the efficacy of NERATINIB. Of those studies, 32 are in Phase 3. This treatment is being tested at 5898 different medical sites globally, with a majority located within Shanghai's city limits."

Answered by AI

What is the current participation count for this clinical research?

"The recruitment for this trial has concluded. It was first posted on December 1st 2021 and last updated October 25th 2021. However, there are currently 2295 trials looking to enrol participants with ER positive breast cancer and 150 clinical studies actively recruiting patients that intend to use NERATINIB as their treatment plan."

Answered by AI

Is the drug NERATINIB permitted by the FDA for consumer use?

"Although the clinical efficacy of neratinib is yet to be determined, its safety profile has garnered it a score of 2 on our scale. This reflects the fact that this trial is currently in Phase 2 and some data supporting safety does exist."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fulvestrant + Neratinib In Breast Cancer

Aditya Bardia 2023. "Fulvestrant + Neratinib In Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04901299.