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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
Must not have
Concurrent anticancer therapy
History of or evidence of specific retinal pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether adding binimetinib to the usual treatment of fulvestrant can help patients with a specific type of advanced breast cancer. Fulvestrant works by blocking estrogen receptors on cancer cells, while binimetinib stops enzymes that help cancer grow. The goal is to see if this combination can better control the cancer compared to using fulvestrant alone.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently receiving any cancer treatments.
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I have a history of specific eye retina problems.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR) (Cohort II)
Progression free survival (PFS) (Cohort I)
Secondary study objectives
Clinical benefit rate
Incidence of adverse events
ORR (Cohort II)
+3 more
Other study objectives
Analysis of integrated and exploratory biomarkers

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Computed Tomography
2017
Completed Phase 2
~2740
Echocardiography
2013
Completed Phase 4
~11580
Bone Scan
2015
Completed Phase 2
~50
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Fulvestrant
2011
Completed Phase 3
~3890
Binimetinib
2018
Completed Phase 3
~1250
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Multigated Acquisition Scan
2015
Completed Phase 3
~270

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Breast cancer treatments often target specific mechanisms to inhibit tumor growth. Fulvestrant works by binding to estrogen receptors on tumor cells, leading to their destruction and reducing estrogen binding, which is crucial for the growth of estrogen-sensitive tumors. Binimetinib, a targeted therapy, inhibits specific enzymes necessary for cell growth, thereby halting tumor progression. These mechanisms are vital for breast cancer patients as they offer targeted approaches that can be more effective and have fewer side effects compared to traditional chemotherapy. Other common treatments include CDK4/6 inhibitors, which block proteins involved in cell division, and HER2 inhibitors, which target the HER2 protein overexpressed in some breast cancers. Understanding these mechanisms helps in personalizing treatment plans, improving outcomes, and managing resistance to therapies.
Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.An evidence-based review of the outcome of fulvestrant plus a targeted agent versus fulvestrant alone in treating hormone receptor-positive endocrine therapy-resistant metastatic breast cancer.ErbB family receptor inhibitors as therapeutic agents in breast cancer: current status and future clinical perspective.

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER
237 Previous Clinical Trials
102,679 Total Patients Enrolled
9 Trials studying Breast Cancer
11,639 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)Lead Sponsor
13,879 Previous Clinical Trials
41,013,151 Total Patients Enrolled
946 Trials studying Breast Cancer
1,544,013 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
~63 spots leftby Nov 2026