OncoMatch/Clinical Trials/NCT06428396
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
Is NCT06428396 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Belzutifan and Fulvestrant for metastatic breast cancer.
Treatment: Belzutifan · Fulvestrant · Everolimus · Exemestane — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (positive)
estrogen receptor positive (ER+)
Required: HER2 (ERBB2) wild-type (negative)
human epidermal growth factor receptor negative (HER2-)
Excluded: BRCA1 deleterious or suspected deleterious germline mutation
known germline BRCA mutation (deleterious or suspected deleterious) and has received previous treatment with poly-ADP ribose polymerase (PARP) inhibition
Excluded: BRCA2 deleterious or suspected deleterious germline mutation
known germline BRCA mutation (deleterious or suspected deleterious) and has received previous treatment with poly-ADP ribose polymerase (PARP) inhibition
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — noncurative
disease progression during or after the last administered endocrine therapy (ET)
Must have received: CDK4/6 inhibitor — noncurative
Radiographic disease progression on 12 months or more of ET in combination with CDK4/6 inhibitor in the noncurative setting or ... 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
Cannot have received: fulvestrant (fulvestrant)
Has received prior fulvestrant in the adjuvant, unresectable locally advanced, or metastatic setting
Cannot have received: cytotoxic chemotherapy
Has received any line of cytotoxic chemotherapy ... in the unresectable or noncurative advanced/metastatic setting
Cannot have received: PARP inhibitor
Has received any line of ... PARP inhibitor in the unresectable or noncurative advanced/metastatic setting
Cannot have received: PARP inhibitor
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
Cannot have received: systemic anticancer therapy
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope - Phoenix ( Site 0006) · Goodyear, Arizona
- Cedars Sinai Medical Center ( Site 0012) · Beverly Hills, California
- Moores Cancer Center at UC San Diego Health ( Site 0025) · La Jolla, California
- USC/Norris Comprehensive Cancer Center ( Site 0013) · Los Angeles, California
- USC Norris Oncology Hematology Newport Beach ( Site 0029) · Newport Beach, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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