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Hormone Therapy

Fulvestrant + Binimetinib for Breast Cancer

Phase 2

Recruiting

Led By Bora Lim

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 14 days prior to registration

The tumor must have been determined to be estrogen receptor (ER) and/or progesterone receptor (PgR) positive assessed by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial compares 2 treatments for metastatic breast cancer with an NF1 genetic change, to see if adding binimetinib can make the treatment more effective.

Who is the study for?

This trial is for adults with hormone receptor-positive metastatic breast cancer that has an NF1 genetic change. Participants must have had prior treatment with fulvestrant, can have one chemotherapy line in the metastatic setting, and need to be able to undergo a biopsy. They should not be pregnant, have untreated brain metastasis, severe autoimmune diseases, or any condition that could affect the study's safety.Check my eligibility

What is being tested?

The study compares standard hormonal therapy (fulvestrant) alone versus combining it with binimetinib—a drug targeting enzymes involved in cell growth—in patients whose tumors carry an NF1 mutation. The goal is to see if adding binimetinib improves tumor shrinkage and delays progression compared to fulvestrant alone.See study design

What are the potential side effects?

Fulvestrant may cause injection site reactions, nausea, and fatigue. Binimetinib might lead to skin rash, high blood pressure, muscle pain or weakness; it also carries risks of eye problems like blurred vision or retinal vein occlusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been active and mostly self-sufficient in the last 2 weeks.

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My tumor is positive for estrogen or progesterone receptors.

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My cancer has spread, confirmed by scans or biopsy.

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I have previously been treated with a CDK4/6 inhibitor.

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My breast cancer diagnosis was confirmed through tissue examination.

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I am 18 years old or older.

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I have a tumor that can be measured and another that can be biopsied.

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My tumor has a specific genetic change called NF1 mutation.

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My tumor is not HER2 positive according to specific guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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 rate (ORR) (Cohort II)

Progression free survival (PFS) (Cohort I)

Secondary outcome measures

Clinical benefit rate

Incidence of adverse events

ORR (Cohort II)

+3 more

Other outcome measures

Analysis of integrated and exploratory biomarkers

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cohort II (fulvestrant, binimetinib)Experimental Treatment9 Interventions

Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study.

Group II: Cohort I (Arm I) (fulvestrant, binimetinib)Experimental Treatment9 Interventions

Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, MRI, or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study.

Group III: Cohort I (Arm II)Active Control8 Interventions

Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Echocardiography

2013

Completed Phase 4

~11670

Computed Tomography

2017

Completed Phase 2

~2720

Fulvestrant

2011

Completed Phase 3

~3690

Binimetinib

2018

Completed Phase 3

~1100

Biopsy

2014

Completed Phase 4

~1090

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER

231 Previous Clinical Trials

100,757 Total Patients Enrolled

9 Trials studying Breast Cancer

11,638 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)Lead Sponsor

13,666 Previous Clinical Trials

40,925,910 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Bora LimPrincipal InvestigatorCenterThe University of Texas MD Anderson Cancer Center

1 Previous Clinical Trials

71 Total Patients Enrolled

Media Library

Fulvestrant (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05554354 — Phase 2

Breast Cancer Research Study Groups: Cohort I (Arm II), Cohort I (Arm I) (fulvestrant, binimetinib), Cohort II (fulvestrant, binimetinib)

Breast Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT05554354 — Phase 2

Fulvestrant (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05554354 — Phase 2

Frequently Asked Questions

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

Has the administration granted authorization for Cohort I (Arm I) treatments of fulvestrant and binimetinib?

"Due to the Phase 2 trial status of Cohort I (Arm I) (fulvestrant, binimetinib), our team at Power rated it a reassuring score of two on a scale from one to three. This indicates that there is limited evidence for its efficacy but satisfactory data confirming safety."

Answered by AI

Is enrollment still open for this research endeavor?

"Affirmative. Clinicaltrials.gov documentation demonstrates that this scientific trial, initially posted on March 6th 2023, is actively recruiting participants. The study requires 95 patients to be enrolled from a single site."

Answered by AI

How many participants are included in the current iteration of this research?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical study is presently seeking out participants and was initially posted on March 6th 2023 with its most recent update taking place two days later. The trial needs 95 individuals from a sole location in order to proceed."

Answered by AI

What potential outcomes does this research endeavor hope to realize?

"The primary goal of this trial, evaluated up to five years from randomization until either progression or death due to any cause, is the Objective Response Rate (ORR) in Cohort II. Secondary objectives include assessing ORR in Cohort II which measures complete and partial response according to RECIST v1.1 after treatment start; tabulating adverse events graded by CTCAE version 5.0 with semi-annual review by a Data Monitoring Committee; and calculating Clinical Benefit Rate as proportion of patients who achieved CR, PR or stable disease based on RECIST criteria for each study arm separately with 95% exact CI using Fisher's Ex"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)

2024. "Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05554354.

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