Last updated 9 days ago
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
1000 patients around the world
Available in United States, Argentina, Colombia
Merck Sharp & Dohme LLC
10Research sites
1000Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Has a diagnosis of hormone receptor positive (HR+)/human epidermal growth factor receptor 2 (HER2)- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent.Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the most recent line of therapy (with certain exceptions).Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4/6 inhibitor + endocrine therapy (ET) with one of the following.Radiographic disease progression, as assessed by the investigator, on CDK4/6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer. CDK4/6 inhibitor + ET must be the only line of therapy received in the advanced setting.Disease recurrence, either radiographic and/or confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4/6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4/6 inhibitor.Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization.
- Has breast cancer amenable to treatment with curative intent.Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator.Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option.Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and/or other life-threatening complications.Has any of the following: a pulse oximeter reading <92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.Has ≥Grade 2 peripheral neuropathy.Has clinically significant corneal disease.Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer.Has received prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy.Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4/6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered.Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention.Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.Has known additional malignancy that is progressing or has required active treatment within the past 3 years.Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.Has severe hypersensitivity (≥Grade 3) to HER3-DXd and/or any of its excipients.Has severe hypersensitivity (≥Grade 3) to all the available TPC and/or any of their excipients.
Sites
Sociedad de Beneficencia Hospital Italiano - Córdoba
Recruiting
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Fundación Respirar
Recruiting
Centro Privado de RMI Río Cuarto
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Sociedad de Oncología y Hematología del César SAS - SOHEC
Recruiting
Instituto Nacional de Cancerología - Bogotá
Recruiting
Oncomédica - IMAT - Montería, Colombia
Recruiting
Instituto de Cancerología de Medellín
Recruiting
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Recruiting
StudyHERTHENA-Breast04
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07060807
