Status:

RECRUITING

Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Metastatic Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 exem...

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

Key Trial Info

Start Date :

November 27 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 7 2028

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06428396

Start Date

November 27 2024

End Date

October 7 2028

Last Update

March 24 2026

Active Locations (41)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 11 (41 locations)

1

City of Hope - Phoenix ( Site 0006)

Goodyear, Arizona, United States, 85338

2

Cedars Sinai Medical Center ( Site 0012)

Beverly Hills, California, United States, 90211

3

Moores Cancer Center at UC San Diego Health ( Site 0025)

La Jolla, California, United States, 92093

4

USC/Norris Comprehensive Cancer Center ( Site 0013)

Los Angeles, California, United States, 90033

Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029) | DecenTrialz