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NCT06428396 | RECRUITING | Metastatic Breast Cancer

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

Merck Sharp & Dohme LLC

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 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.

Condition or disease

Metastatic Breast Cancer

Intervention/treatment

Belzutifan

Fulvestrant

Everolimus

Exemestane

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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)
Actual Study Start Date : 2024-11-27
Estimated Primary Completion Date : 2027-05-05
Estimated Study Completion Date : 2028-10-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)

Location Details

NCT06428396

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

City of Hope - Phoenix ( Site 0006)

Goodyear, Arizona, United States, 85338

RECRUITING

United States, California

Cedars Sinai Medical Center ( Site 0012)

Beverly Hills, California, United States, 90211

RECRUITING

United States, California

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

THE JOLLA, California, United States, 92093

RECRUITING

United States, California

USC/Norris Comprehensive Cancer Center ( Site 0013)

Los Angeles, California, United States, 90033

RECRUITING

United States, California

USC Norris Oncology Hematology Newport Beach ( Site 0029)

Newport Beach, California, United States, 92663

RECRUITING

United States, Georgia

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011)

Marietta, Georgia, United States, 30060

RECRUITING

United States, Georgia

Southeastern Regional Medical Center ( Site 0010)

Newnan, Georgia, United States, 30265

RECRUITING

United States, Louisiana

CHRISTUS Highland ( Site 0005)

Shreveport, Louisiana, United States, 71105

RECRUITING

United States, Nevada

Renown Regional Medical Center ( Site 0018)

Reno, Nevada, United States, 89502

RECRUITING

United States, Texas

Mays Cancer Center ( Site 0022)

San Antonio, Texas, United States, 78229

RECRUITING

Argentina, Buenos Aires

Metabolic Research Center (CINME) -Oncology (Site 0504)

CABA, Buenos Aires, Argentina, C1056ABI

RECRUITING

Argentina, Buenos Aires

British Hospital of Buenos Aires-Oncology (Site 0500)

Autonomous City of Buenos Aires, Buenos Aires, Argentina, C1280AEB

RECRUITING

Argentina, Buenos Aires

Mar del Plata Clinical Research Institute (Site 0502)

Mar del Plata, Buenos Aires, Argentina, B7600FZO

RECRUITING

Argentina, CABA

Instituto Alexander Fleming-Alexander Fleming ( Site 0505)

Autonomous City of Buenos Aires, CABA, Argentina, 1426ANZ

RECRUITING

Argentina, Cordoba

ALLENDE SANATORIO - Cerro -Oncology (Site 0506)

Córdoba, Cordoba, Argentina, 5000

RECRUITING

Argentina, Santa Fe

Rosario Oncology Institute (Site 0501)

Rosario, Santa Fe, Argentina, S2000KZE

RECRUITING

Canada, Quebec

Jewish General Hospital ( Site 0400)

Montreal, Quebec, Canada, H3T 1E2

RECRUITING

Chile, Maule

Maule Research Center (Site 4106)

Talca, Maule, Chile, 3460000

RECRUITING

Chile, Region M. Of Santiago

Bradfordhill ( Site 4100)

Santiago., Region M. Of Santiago, Chile, 8420383

RECRUITING

Chile, Region M. Of Santiago

FALP ( Site 4102)

Santiago, Region M. Of Santiago, Chile, 7500921

RECRUITING

Chile, Region M. Of Santiago

Pontifical Catholic University of Chile (Site 4108)

Santiago, Region M. Of Santiago, Chile, 8330024

RECRUITING

Colombia, Cordoba

Have SA (CITE 1205)

Monteria, Cordoba, Colombia, 230002

RECRUITING

Colombia, Risaralda

Oncologists of the West (Site 1200)

Pereira, Risaralda, Colombia, 660001

RECRUITING

Colombia, Valle del Cauca

Valle del Lili Foundation (Site 1204)

Cali, Valle del Cauca, Colombia, 760032

RECRUITING

Korea, Republic of,

Seoul National University Hospital ( Site 3100)

Seoul, Korea, Republic of, 03080

RECRUITING

Korea, Republic of,

Samsung Medical Center ( Site 3101)

Seoul, Korea, Republic of, 06351

RECRUITING

Taiwan,

National Cheng If University Hospital (site 3300)

Tainan, Taiwan, 704302

RECRUITING

Taiwan,

National Taiwan University Hospital ( Site 3301)

Taipei, Taiwan, 100

RECRUITING

Taiwan,

National Taiwan University Cancer Center ( Site 3302)

Taipei, Taiwan, 106

RECRUITING

Thailand, Khon kaen

Faculty of Medicine - Khon Kaen University ( Site 3502)

Muang, Khon kaen, Thailand, 40002

RECRUITING

Thailand, Thep Thep Thep Mahachon

Faculty of Medicine Siriraj Hospital ( Site 3500)

Bangkoknoi, The Thep Thep Maha Nakhon, Thailand, 10700

RECRUITING

Thailand, Songkhla

Songklanagarind Hospital ( Site 3501)

Six yai, Songkhla, Thailand, 90110

RECRUITING

United Kingdom, England

The Royal Cornwall Hospital ( Site 1904)

Truro, England, United Kingdom, T1 3lj

RECRUITING

United Kingdom, London, City Of

St Bartholomews Hospital ( Site 1900)

London, London, City Of, United Kingdom, Ec1a 7be

RECRUITING

United Kingdom, Manchester

The Christie Hospital NHS Foundation Trust ( Site 1902)

Withington, Manchester, United Kingdom, M20 4BX

RECRUITING

United Kingdom, Suffolk

Ipswich Hospital ( Site 1911)

Ipswich, Suffolk, United Kingdom, IP4 5PD