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Hormone Therapy

Belzutifan + Fulvestrant for Breast Cancer

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

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

Must have

Has documented radiographic confirmation of disease progression during or after the last administered endocrine therapy (ET)

Provides a new or the most recently obtained core biopsy, taken from a locally advanced unresectable or from a metastatic lesion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how well belzutifan plus fulvestrant works compared to everolimus plus endocrine therapy in adults with a certain type of advanced breast cancer. The study will

Who is the study for?

This trial is for adults with ER+/HER2- metastatic breast cancer who've had disease progression after endocrine therapy (ET) and a CDK4/6 inhibitor. They should have an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Participants must have recovered from major side effects of previous treatments to ≤Grade 1, except certain endocrine-related issues or ≤Grade 2 neuropathy.

What is being tested?

The study compares the effectiveness and safety of belzutifan plus fulvestrant against everolimus combined with ET (fulvestrant or exemestane). It aims to see how well these treatments work for patients whose breast cancer has not been controlled by previous therapies. There's no formal hypothesis being tested.

What are the potential side effects?

Potential side effects may include those common to cancer medications such as fatigue, nausea, decreased appetite, skin reactions, blood count changes leading to increased infection risk or bleeding problems. Specific side effects related to each drug will be monitored.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has worsened despite hormone therapy.

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I have provided a recent biopsy from my advanced or metastatic cancer.

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My breast cancer is ER+ and HER2-, and cannot be surgically removed or cured.

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I've had hormone therapy for cancer, with it worsening or stopping due to side effects.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am hepatitis B positive but have been on HBV therapy for over 4 weeks with an undetectable viral load.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS)

Secondary study objectives

Clinical Benefit Rate (CBR)

Number of Participants Who Discontinue Study Treatment Due To an AE

Number of Participants Who Experience an Adverse Event (AE)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Belzutifan + FulvestrantExperimental Treatment2 Interventions

Participants will receive belzutifan 120 mg orally once daily (QD) PLUS fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until progressive disease or discontinuation.

Group II: Everolimus + ET (fulvestrant or exemestane)Active Control3 Interventions

Participants will receive everolimus 10 mg orally QD PLUS investigator's choice of fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter OR exemestane 25 mg orally QD until progressive disease or discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3510

Belzutifan

2018

Completed Phase 1

~50