Trial Title:
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
NCT ID:
NCT05950945
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Trastuzumab deruxtecan
Conditions: Keywords:
Trastuzumab Derextecan
Enhertu®
DS8201-a
Breast Cancer
Anti-HER2-Antibody Drug Conjugate
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trastuzumab Deruxtecan
Description:
Intravenous administration, 5.4 mg/kg on Day 1 of each 21-day cycle until radiographic
disease progression as assessed by the investigator, unacceptable toxicity, other
discontinuation criteria are met, or 2 years after first dose of study drug
Arm group label:
Cohort 1: HR-negative, HER2-low
Arm group label:
Cohort 2: HR-negative, HER2 IHC 0
Arm group label:
Cohort 3: HR-positive, HER2-low
Arm group label:
Cohort 4: HR-positive, HER2 IHC 0
Other name:
T-DXd
Other name:
DS-8201a (trastuzumab derextecan)
Other name:
Enhertu®
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mount Sinai Medical Center
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
USF College of Medicine
Address:
City:
Tampa
Zip:
33602
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Beth Israel Lahey Health
Address:
City:
Burlington
Zip:
01805
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Institut Jules Bordet
Address:
City:
Anderlecht
Zip:
1070
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
GZA Ziekenhuizen
Address:
City:
Wilrijk
Zip:
2610
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Centro de Oncologia - Unidade Brasília - Hospital Sírio Libanês
Address:
City:
Brasilia
Zip:
71635-610
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
CIONC-Centro Integrado de Oncologia de Curitiba
Address:
City:
Curitiba
Zip:
80810-050
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Address:
City:
Curitiba
Zip:
81520-060
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
Address:
City:
Florianopolis
Zip:
88034-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Oncosite - Centro de Pesquisa Clinica e Oncologia
Address:
City:
Ijuí
Zip:
98700-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Fundação Doutor Amaral Carvalho
Address:
City:
Jaú
Zip:
17.210 - 080
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Instituto de Cancer de Londrina
Address:
City:
Londrina
Zip:
86015-520
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital das Clínicas FMRP-USP
Address:
City:
Riberão Preto
Zip:
14015-010
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Hospital Nossa Senhora da Conceicao
Address:
City:
Rio Grande Do Sul
Zip:
88701-160
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Ensino e Terapia de Inovação Clínica AMO-ETICA
Address:
City:
Salvador
Zip:
41810-570
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Catarina Pesquisa Clinica
Address:
City:
Santa Catarina
Zip:
88301-220
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Address:
City:
Santo André
Zip:
09060-650
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
Address:
City:
Sao Jose do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
Address:
City:
São Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
Address:
City:
São Paulo
Zip:
01317-001
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Ospedale San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Humanitas Istituto Clinico Catanese
Address:
City:
Misterbianco
Zip:
95045
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Nuovo Ospedale di Prato
Address:
City:
Prato
Zip:
59100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Ospedale Santa Chiara
Address:
City:
Trento
Zip:
38123
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Maastricht University Medical Center
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Hospital de Braga
Address:
City:
Braga
Zip:
4710-243
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
ICO l'Hospitalet - Hospital Duran i Reynals
Address:
City:
Barcelona
Zip:
08908
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Hospital Universitario Virgen de las Nieves
Address:
City:
Granada
Zip:
18014
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Complejo Hospitalario Universitario Insular Materno-Infantil
Address:
City:
Las Palmas de Gran Canaria
Zip:
35016
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Hospital Universitario Puerta de Hierro Majadahonda
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Hospital General Universitario Morales Meseguer
Address:
City:
Murcia
Zip:
30008
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Hospital Universitario Donostia
Address:
City:
San Sebastian
Zip:
20014
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Complejo Hospitalario Universitario de Santiago
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Hospital Clinico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Start date:
December 30, 2023
Completion date:
October 1, 2027
Lead sponsor:
Agency:
Daiichi Sankyo
Agency class:
Industry
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Source:
Daiichi Sankyo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05950945
