Last updated 17 days ago
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
250 patients around the world
Available in Brazil, United States
The primary endpoint of interest in this study is time to next treatment (TTNT), a
measure that will determine how long T-DXd allows patients to derive clinical benefit
from the study drug.
Daiichi Sankyo
9Research sites
250Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Sign and date the main informed consent form.Must agree to provide a newly obtained or archival baseline biopsy from primary and/or metastatic lesion.Pathologically documented Breast Cancer (BC) tumor.Is unresectable and/or metastatic.Is hormone receptor-negative or hormone receptor-positive.Must include percentage of positively stained cells to characterize if hormone receptor-positive or -negative.Has confirmed HER2 IHC 1+ or IHC 2+/ISH- (HER2-low) status or HER2 IHC 0 status as determined according to ASCO CAP 2018 guidelines1 based on sample collected during Tissue Screening as described above.Was never previously HER2-positive (IHC 3+ or IHC 2+/ISH+) on prior pathology testing (per ASCO CAP guidelines).Was never previously treated with anti-HER2 therapy in the metastatic setting.Has had at least one and up to two prior lines of therapy in the metastatic setting.In participants with hormone receptor-positive HER2-low metastatic BC (Cohort 3):Has recurrent disease <2 years from the initiation of adjuvant ET OR.Has disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor OR.Has disease progression within the first 12 months of CDK4/6 in the first line metastatic setting.Presence of at least one measurable lesion based on computed tomography or magnetic resonance imaging.Participants with brain metastases are allowed in the study. The brain lesion(s) should be small (<2 cm), untreated, asymptomatic, not requiring urgent medical intervention, and are asymptomatic and clinically stable.Has an Eastern Cooperative Oncology Group performance status of 0 or 1.Has a minimum life expectancy of 12 weeks at Screening.Has a left ventricular ejection fraction ≥50% within 28 days before enrollment.Has adequate organ and bone marrow function within 28 days before enrollment.Has adequate treatment washout period before enrollment.Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception.
- Prior treatment with an antibody drug conjugate (ADC).Uncontrolled or significant cardiovascular disease.Has a corrected QT interval prolongation.Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.Has spinal cord compression or clinically active central nervous system metastases.Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral BC.Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.Has a history of severe hypersensitivity reactions to other monoclonal antibodies.Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.Has history of receiving a live, attenuated vaccine (messenger RNA and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study drug.Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.Is pregnant or breastfeeding or planning to become pregnant.Lung-specific intercurrent clinically significant illnesses.Any autoimmune, connective tissue, or inflammatory disorders.Prior complete pneumonectomy.
Sites
Hospital Erasto Gaertner
Recruiting
Centro Pesquisas Oncologicas - CEPON
Recruiting
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Recruiting
Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho
Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Recruiting
Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Recruiting
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária
Recruiting
SponsorDaiichi Sankyo
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05950945
