Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0504)

CABA, Buenos Aires, Argentina

Study Coordinator · +5408003450697

RECRUITING

Hospital Británico de Buenos Aires-Oncology ( Site 0500)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · 54911563819972

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0502)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · +542234963224

RECRUITING

Instituto Alexander Fleming-Alexander Fleming ( Site 0505)

Buenos Aires, Buenos Aires F.D., Argentina

Study Coordinator · +5491138850425

RECRUITING

Sanatorio Allende - Cerro-Oncology ( Site 0506)

Córdoba, Córdoba Province, Argentina

Study Coordinator · +5403514269200E1661

RECRUITING

Instituto de Oncología de Rosario ( Site 0501)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +54 341 4218909

RECRUITING

Hospital Italiano de Córdoba ( Site 0508)

Córdoba, Argentina

Study Coordinator · +543514106500

RECRUITING

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)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Belzutifan

Fulvestrant

Everolimus

Exemestane

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0504)

Hospital Británico de Buenos Aires-Oncology ( Site 0500)

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0502)

Instituto Alexander Fleming-Alexander Fleming ( Site 0505)

Sanatorio Allende - Cerro-Oncology ( Site 0506)

Instituto de Oncología de Rosario ( Site 0501)

Hospital Italiano de Córdoba ( Site 0508)

Patrocinadores

Contactos

Toll Free Number