Belzutifan + Fulvestrant for Breast Cancer
Recruiting in Palo Alto (17 mi)
+25 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Endocrine therapy
Must not be taking: CYP3A4 inhibitors/inducers
Disqualifiers: Curative cancer, Oral medication issues, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) unresectable metastatic breast cancer. There is no formal hypothesis testing in this study.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking strong inhibitors or inducers of CYP3A4 that cannot be stopped during the study. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Belzutifan + Fulvestrant for breast cancer?
Research shows that Fulvestrant is effective in treating advanced hormone receptor-positive breast cancer, often used after other treatments have been tried. While there is no direct data on Belzutifan for breast cancer, Fulvestrant's proven effectiveness in similar conditions suggests potential benefits when combined with other treatments.
12345What makes the drug Belzutifan + Fulvestrant unique for breast cancer treatment?
Belzutifan, also known as Welireg or MK-6482, is unique because it targets a specific pathway involved in cancer cell survival, which is different from traditional hormone therapies like fulvestrant that block estrogen receptors. This combination could offer a novel approach for treating breast cancer by attacking the cancer cells through multiple mechanisms.
13678Eligibility Criteria
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.Inclusion Criteria
My cancer has worsened despite hormone therapy.
My breast cancer is ER+ and HER2-, and cannot be surgically removed or cured.
My side effects from past cancer treatments are mild or gone, except for some hormone issues or slight nerve pain.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive belzutifan plus fulvestrant or everolimus plus endocrine therapy until disease progression or discontinuation
Up to approximately 29 months
IM injections on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to approximately 17 months
Participant Groups
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.
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.
Belzutifan is already approved in United States for the following indications:
🇺🇸 Approved in United States as Welireg for:
- Advanced renal cell carcinoma (RCC) following a PD-1 or PD-L1 inhibitor and a VEGF TKI
- Von Hippel-Lindau disease-associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011)Marietta, GA
Renown Regional Medical Center ( Site 0018)Reno, NV
USC/Norris Comprehensive Cancer Center ( Site 0013)Los Angeles, CA
USC Norris Oncology Hematology Newport Beach ( Site 0029)Newport Beach, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLCLead Sponsor
References
Fulvestrant plus goserelin versus anastrozole plus goserelin versus goserelin alone for hormone receptor-positive, HER2-negative tamoxifen-pretreated premenopausal women with recurrent or metastatic breast cancer (KCSG BR10-04): a multicentre, open-label, three-arm, randomised phase II trial (FLAG study). [2019]We investigated the efficacy and safety of fulvestrant plus goserelin (F + G) versus anastrozole plus goserelin (A + G) in comparison with goserelin (G) alone in premenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), tamoxifen-pretreated metastatic breast cancer (MBC).
A meta-analysis of clinical benefit rates for fulvestrant 500 mg vs. alternative endocrine therapies for hormone receptor-positive advanced breast cancer. [2020]Fulvestrant, a selective estrogen receptor degrader, is approved for first- and second-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer (ABC).
Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. [2022]To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) and anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment.
Activity of fulvestrant 500 mg versus anastrozole 1 mg as first-line treatment for advanced breast cancer: results from the FIRST study. [2022]To compare the clinical activity of the pure antiestrogen fulvestrant at 500 mg/mo (double the approved dose) with the aromatase inhibitor anastrozole as first-line endocrine therapy for advanced hormone receptor-positive breast cancer in postmenopausal women.
Fulvestrant in the treatment of advanced breast cancer: a systematic review and meta-analysis of randomized controlled trials. [2018]To compare efficacy and tolerability of fulvestrant with aromatase inhibitors and tamoxifen that actually represent the standard of care in hormone-sensitive breast cancer.
Efficacy of fulvestrant in treating postmenopausal patients with estrogen receptor-positive metastatic breast cancer and prognostic analysis. [2021]To explore the efficacy and safety of 500 mg of fulvestrant for the postmenopausal patients with estrogen receptor (ER)-positive metastatic breast cancer, and to analyze the factors affecting the prognosis of patients.
Patterns of treatment and outcome with 500-mg fulvestrant in postmenopausal women with hormone receptor-positive/HER2-negative metastatic breast cancer: a real-life multicenter Italian experience. [2022]Fulvestrant 500 mg (F500) is the most active endocrine single agent in hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (MBC). Few data are available regarding the effectiveness of the drug in a real-world setting.
Fulvestrant ('Faslodex') in heavily pretreated postmenopausal patients with advanced breast cancer: single centre clinical experience from the compassionate use programme. [2018]Fulvestrant (Faslodex) is an oestrogen receptor (ER) antagonist with demonstrated efficacy in patients with advanced and pretreated breast cancer.