Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
Recruiting · NCT05950945 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
60 locations listed across 3 US states.
- Mount Sinai Medical Center - Miami Beach, Florida, United States
- USF College of Medicine - Tampa, Florida, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Beth Israel Lahey Health - Burlington, Massachusetts, United States
- Overlook Medical Center - Summit, New Jersey, United States
- GenesisCare St Andrews Hospital - Adelaide, Australia
- Amsterdam UMC, Locatie VUMC - Amsterdam, Netherlands
- Institut Jules Bordet - Anderlecht, Belgium
- GZA Ziekenhuizen - Antwerp, Belgium
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- ICO l'Hospitalet - Hospital Duran i Reynals - Barcelona, Spain
- Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari - Bari, Italy
- Beijing Hospital - Beijing, China
- 307 Hospital of PLA - Beijing, China
- Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS - Bologna, Italy
- Hospital de Braga - Braga, Portugal
- Centro de Oncologia - Unidade Brasília - Hospital Sírio Libanês - Brasília, Brazil
- Amphia Ziekenhuis Molengracht - Breda, Netherlands
- Universitair Ziekenhuis Brussel - Brussels, Belgium
- Cliniques Universitaires Saint-Luc - Brussels, Belgium
- Cork University Hospital - Cork, Ireland
- CIONC-Centro Integrado de Oncologia de Curitiba - Curitiba, Brazil
- Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer - Curitiba, Brazil
- Hospital Universitario Donostia - Donostia / San Sebastian, Spain
- St Vincent's University Hospital - Dublin, Ireland
- St James Hospital - Dublin, Ireland
- Beaumont Hospital - Dublin, Ireland
- CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Florianópolis, Brazil
- Fujian Cancer Hospital - Fujian, China
- Galway University Hospital - Galway, Ireland
- Istituto Nazionale per la Ricerca sul Cancro di Genova - Genova, Italy
- Hospital Universitario Virgen de las Nieves - Granada, Spain
- Sun Yat sen University Cancer Center - Guangzhou, China
- Zhejiang Cancer Hospital - Hangzhou, China
- Anhui Provincial Cancer Hospital - Hefei, China
- Oncosite - Centro de Pesquisa Clinica e Oncologia - Ijuí, Brazil
- Fundação Doutor Amaral Carvalho - Jaú, Brazil
- Shandong Cancer Hospital - Jinan, China
- Yunnan Cancer Hospital - Kunming, China
- Complejo Hospitalario Universitario Insular Materno-Infantil - Las Palmas de Gran Canaria, Spain
- Medisch Centrum Leeuwarden - Leeuwarden, Netherlands
- Alrijne Ziekenhuis Leiden - Leiden, Netherlands
- UZ Leuven - Leuven, Belgium
- Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE - Lisbon, Portugal
- Fundação Champalimaud - Lisbon, Portugal
- Centro Hospitalar de Lisboa Norte E P E Hospital de Santa Maria - Lisbon, Portugal
- Centre Hospitalier Universitaire de Liege Sart-Tilman - Liège, Belgium
- Instituto de Cancer de Londrina - Londrina, Brazil
- Maastricht University Medical Center - Maastricht, Netherlands
- Hospital Beata Maria Ana - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Hospital Universitario Puerta de Hierro Majadahonda - Majadahonda, Spain
- Ospedale San Raffaele - Milan, Italy
- Humanitas Istituto Clinico Catanese - Misterbianco, Italy
- Hospital General Universitario Morales Meseguer - Murcia, Spain
- Fiona Stanley Hospital - Murdoch, Australia
- Nanchang People's Hospital - Nanchang, China
- Jiangxi Cancer Hospital - Nanchang, China
- Istituto Nazionale Tumori Fondazione G Pascale - Naples, Italy
- IOV - Istituto Oncologico Veneto IRCCS - Padova, Italy
Showing 60 of 88 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →