Clinical trial • Phase I/II • Oncology

HER3-DXd for Inoperable advanced breast cancer|HER2-positive breast cancer|HER2-low breast cancer

Phase I/II trial of HER3-DXd for Inoperable advanced breast cancer|HER2-positive breast cancer|HER2-low breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Inoperable advanced breast cancer|HER2-positive breast cancer|HER2-low breast cancer
Trial Stage
Phase I/II
Drug Modality
ADC

Key dates

Initial CTIS Submission Date
07-09-2023
First CTIS Authorization Date
10-01-2024

Trial design

open-label, none/not specified-controlled Phase I/II trial across 5 sites in France.

Open Label
Yes
Comparator
None/Not specified
Biomarker Stratified
True, biomarker: HER2 expression status (HER2-positive vs HER2-low)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
150

Eligibility

Recruits 150 adults.

Inclusion criteria

  • {"criterion_text":"- Patients with HER2-positive (HER2-pos) (cohort 1) or HER2-low defined as a score 1+ on immunohistochemistry [IHC] or as an IHC score 2+ and negative results on in situ hybridization (ISH) (cohort 2) ABC, and any hormone receptor (HR) status, who have progressed on trastuzumab deruxtecan (T-DXd)."}
  • {"criterion_text":"- In addition to previous T-DXd, patients with HER2-pos tumors must have received prior treatment with trastuzumab (+/- pertuzumab) and taxanes and may have received T-DM1."}
  • {"criterion_text":"- Patients with HER2-low tumors must have received prior treatment with taxanes."}
  • {"criterion_text":"- Patients with HR-positive (HR+) and HER2-low tumor must have received prior treatment with endocrine therapy and CDK4/6 inhibitors."}

Recruitment

Planned Sample Size
150
Recruitment Window Months
81

Geography

Total Number Of Sites
5
Total Number Of Participants
150

France

Earliest CTIS Part Ii Submission Date
27-11-2023
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
890
Number Of Sites
5
Number Of Participants
150

Sites

Site Name
Institut Paoli Calmettes
Department Name
ONCOLOGY
Contact Person Name
Arthur GERAUX-CREMIEUX
Site Name
Centre Antoine Lacassagne
Department Name
ONCOLOGY
Contact Person Name
Fatima CARDOSO
Site Name
Institut Gustave Roussy
Department Name
SENOLOGY
Contact Person Name
Barbara PISTILLI
Site Name
Centr Georges Francois Leclerc
Department Name
ONCOLOGY
Contact Person Name
Courèche KADERBHAI
Contact Person Email
cgkaderbhai@cgfl.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
ONCOLOGY
Contact Person Name
Antoine DELEUZE
Contact Person Email
a.deleuze@rennes.unicancer.fr

Sponsor

Primary sponsor

Full Name
Institut Gustave Roussy
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
HER3-DXd
Active Substance
HER3-DXd
Modality
ADC
Combination Treatment
Yes

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