A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029)
New trial tests belzutifan plus fulvestrant for advanced ER+/HER2- breast cancer
Plain English Summary
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029) is a Phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC studying Metastatic Breast Cancer. This study is testing a new combination of drugs, belzutifan and fulvestrant, against a standard treatment (everolimus plus endocrine therapy) for a specific type of advanced breast cancer. It is for adults with estrogen receptor-positive (ER+), HER2-negative (HER2-) breast cancer that has spread and cannot be removed by surgery, and has worsened after previous hormone therapy. Participants will be randomly assigned to receive either the new drug combination or the standard treatment. This involves taking pills and/or receiving injections. Alternative treatments include other forms of hormone therapy, chemotherapy, targeted therapies, and immunotherapy, depending on the patient's specific situation and prior treatments. The trial aims to enroll 120 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with ER+/HER2- breast cancer that is locally advanced or has spread to other parts of the body and cannot be cured by surgery. Patients must have had their cancer progress after at least one type of hormone therapy, and meet specific criteria regarding prior treatments with hormone therapy and CDK4/6 inhibitors. Individuals must have a good general health status (ECOG 0 or 1) and their side effects from previous treatments must have resolved to an acceptable level. People with certain conditions like active hepatitis B or C, significant heart problems, or a history of pneumonitis may not be eligible. This trial is studying Metastatic Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome, Progression-Free Survival (PFS), measures how long patients live without their cancer getting worse, indicating how effective the new treatment combination is at controlling the d The specific primary outcome measures are: Progression-free Survival (PFS) (Up to approximately 29 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a critical need for new treatment options for patients with ER+/HER2- metastatic breast cancer whose disease has progressed on standard endocrine therapy, a common challenge in ma Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Metastatic Breast Cancer, where improved treatment options are needed.
Investor Insight
This trial targets a significant market of advanced breast cancer patients, with belzutifan representing a novel approach in a competitive landscape, potentially offering a new therapeutic option if s Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the specific drugs being tested, how they are given, and what the potential benefits and risks are for your situation. Understand that you will be randomly assigned to one of two treatment groups, and participation involves regular clinic visits for assessments, blood tests, and scans. Be prepared for potential side effects from both the study drugs and the comparison drugs, and discuss any new or worsening symptoms with your healthcare team promptly. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 120 participants
Interventions
- DRUG: Belzutifan — Belzutifan 120 mg administered QD as an oral tablet.
- DRUG: Fulvestrant — Fulvestrant 500 mg administered as an IM injection.
- DRUG: Everolimus — Administered at 10mg via oral tablets QD.
- DRUG: Exemestane — Administered at 25 mg via oral tablets QD.
Primary Outcomes
- Progression-free Survival (PFS) (Up to approximately 29 months)
Secondary Outcomes
- Progression-free Survival (PFS) at 6 months (Up to approximately 29 months)
- Progression-free Survival (PFS) at 12 months (Up to approximately 29 months)
- Overall Survival (OS) (Up to approximately 29 months)
- Objective Response Rate (ORR) (Up to approximately 29 months)
- Clinical Benefit Rate (CBR) (Up to approximately 29 months)
Full Eligibility Criteria
Inclusion Criteria: * Has a diagnosis of estrogen receptor positive (ER+)/human epidermal growth factor receptor negative (HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection or metastatic disease not treatable with curative intent * Has documented radiographic confirmation of disease progression during or after the last administered endocrine therapy (ET) * Provides additional tissue from the same sample used to determine ER and HER2 status locally * Has received ET in the noncurative setting and has 1) Radiographic disease progression on 12 months or more of ET in combination with CDK4/6 inhibitor in the noncurative setting or 2) Received at least 2 lines of ET in the noncurative setting including CDK4/6 inhibitor where the CDK 4/6 inhibitor was discontinued due to intolerance * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization Exclusion Criteria: * Has Breast cancer amenable to treatment with curative intent * Is unable to receive any of the endocrine therapies (ETs) (ie, fulvestrant or exemestane) * Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications such as uncontrolled nausea or vomiting (ie, CTCAE =Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction, motility disorder, malabsorption syndrome, or prior gastric bypass * Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications * Has active, bleeding diathesis, or on oral anti-vitamin K medication * Has history of noninfectious pneumonitis/interstitial lung disease including radiation pneumonitis that required steroids or has current pneumonitis/interstitial lung disease * Has a known germline BRCA mutation (deleterious or suspected deleterious) and has received previous treatment with poly-ADP ribose polymerase (PARP) inhibition either in the adjuvant or metastatic setting * Has received prior fulvestrant in the adjuvant, unresectable locally advanced, or metastatic setting * Has received any line of cytotoxic chemotherapy or PARP inhibitor in the unresectable or noncurative advanced/metastatic setting * Has received prior radiotherapy for non-central nervous system (CNS) disease or required corticosteroids for radiation-related toxicities including radiation pneumonitis, within 14 days of the first dose of study intervention * Is currently receiving either a strong inhibitor or inducer of CYP3A4 that cannot be discontinued for the duration of the study * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has concurrent active Hepatitis B and Hepatitis C virus infection * Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study medication administration, or New York Heart Association Class III or Class IV congestive heart failure * Has not adequately recovered from major surgery or have ongoing surgical complications
Trial Locations
- City of Hope - Phoenix ( Site 0006), Goodyear, Arizona, United States
- Cedars Sinai Medical Center ( Site 0012), Beverly Hills, California, United States
- Moores Cancer Center at UC San Diego Health ( Site 0025), La Jolla, California, United States
- USC/Norris Comprehensive Cancer Center ( Site 0013), Los Angeles, California, United States
- USC Norris Oncology Hematology Newport Beach ( Site 0029), Newport Beach, California, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011), Marietta, Georgia, United States
- Southeastern Regional Medical Center ( Site 0010), Newnan, Georgia, United States
- CHRISTUS Highland ( Site 0005), Shreveport, Louisiana, United States
- Renown Regional Medical Center ( Site 0018), Reno, Nevada, United States
- MD Anderson Cancer Center at Cooper ( Site 0024), Camden, New Jersey, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06428396?
NCT06428396 is a Phase 2 INTERVENTIONAL study titled "Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 120 participants.
What conditions does NCT06428396 study?
This trial investigates treatments for Metastatic Breast Cancer. The primary condition under study is Metastatic Breast Cancer.
What treatments are being tested in NCT06428396?
The interventions being studied include: Belzutifan (DRUG), Fulvestrant (DRUG), Everolimus (DRUG), Exemestane (DRUG). Belzutifan 120 mg administered QD as an oral tablet.
What does Phase 2 mean for NCT06428396?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06428396?
This trial is currently "Recruiting." It started on 2024-11-27. The estimated completion date is 2028-10-07.
Who is sponsoring NCT06428396?
NCT06428396 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06428396?
The trial aims to enroll 120 participants. The trial is currently recruiting and accepting new participants.
How is NCT06428396 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06428396?
The primary outcome measures are: Progression-free Survival (PFS) (Up to approximately 29 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06428396 being conducted?
This trial is being conducted at 20 sites, including Goodyear, Arizona; Beverly Hills, California; La Jolla, California; Los Angeles, California and 16 more sites (United States, Argentina).
Where can I find official information about NCT06428396?
The official record for NCT06428396 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06428396. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06428396 testing in simple terms?
This study is testing a new combination of drugs, belzutifan and fulvestrant, against a standard treatment (everolimus plus endocrine therapy) for a specific type of advanced breast cancer. It is for adults with estrogen receptor-positive (ER+), HER2-negative (HER2-) breast cancer that has spread and cannot be removed by surgery, and has worsened after previous hormone therapy.
Why is this trial significant?
This trial addresses a critical need for new treatment options for patients with ER+/HER2- metastatic breast cancer whose disease has progressed on standard endocrine therapy, a common challenge in ma
What are the potential risks of participating in NCT06428396?
Common side effects may include fatigue, nausea, diarrhea, and mouth sores, which are typical for cancer treatments. Belzutifan can cause anemia, low oxygen levels, and potential effects on vision or kidney function. Fulvestrant can cause injection site reactions and hot flashes. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06428396?
Ask your doctor about the specific drugs being tested, how they are given, and what the potential benefits and risks are for your situation. Understand that you will be randomly assigned to one of two treatment groups, and participation involves regular clinic visits for assessments, blood tests, and scans. Be prepared for potential side effects from both the study drugs and the comparison drugs, and discuss any new or worsening symptoms with your healthcare team promptly. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06428396 signal from an investment perspective?
This trial targets a significant market of advanced breast cancer patients, with belzutifan representing a novel approach in a competitive landscape, potentially offering a new therapeutic option if s This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will be randomly assigned to receive either the new drug combination or the standard treatment. This involves taking pills and/or receiving injections. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.