Actively Recruiting
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Led by Medical University of Vienna · Updated on 2025-09-25
20
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
M
Medical University of Vienna
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Datopotamab-deruxtecan in triple-negative breast cancer patients with newly diagnosed or progressing brain metastases.
CONDITIONS
Official Title
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed breast cancer
- Triple-negative disease defined by immunohistochemistry and/or gene amplification with less than 10% positive hormone receptor staining
- Newly diagnosed untreated brain metastases or brain metastases progressing after prior local therapy
- Measurable disease according to RANO-BM criteria
- No immediate need for local treatment
- Accompanying type II leptomeningeal disease allowed
- Karnofsky performance status of 70% or higher, ECOG status 0 to 2
- Indication for systemic anti-cancer treatment
- Prior exposure to PD-1, PD-L1 inhibitors, and TROP-2 targeted agents allowed
- Life expectancy of at least 3 months
- Age 18 years or older
- Ability to tolerate therapy
- Adequate bone marrow, liver, and kidney function
- Adequate treatment washout periods before enrollment: major surgery at least 3 weeks, chest radiation at least 4 weeks, palliative radiation at least 2 weeks, chemotherapy or small-molecule targeted agents at least 3 weeks, antibody-based treatment at least 4 weeks
- Ability to understand the study and provide written informed consent
You will not qualify if you...
- Known hypersensitivity to datopotamab-deruxtecan or its components
- Use of any investigational agent within 28 days before treatment
- History of other malignancies within 3 years except certain skin and cervical cancers and contralateral breast cancer
- Other anticancer therapies except osteoprotective treatments
- Concurrent radiotherapy
- History of uncontrolled seizures, significant CNS disorders, or psychiatric disability affecting compliance
- Clinically significant cardiac disease including recent heart attack, unstable angina, heart failure, low ejection fraction, uncontrolled arrhythmia, or long QT syndrome
- Inadequate bone marrow or kidney function at baseline
- Active hepatic or biliary disease except certain conditions
- Active opportunistic infections
- Uncontrolled HIV infection
- Pregnant or lactating women
- Women of childbearing potential unwilling or unable to use contraception during and one year after treatment
- Male subjects unwilling or unable to use contraception
- Known substance abuse or significant medical conditions interfering with participation
- Use of chronic systemic corticosteroids above 8 mg dexamethasone daily except for managing adverse events
- Significant corneal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AKH Universitaetsklinikum Vienna, Department f. Internal medicine I, oncology
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
Research Team
R
Rupert Rupert, MD
CONTACT
M
Marika Rosner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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