OncoMatch/Clinical Trials/NCT05866432
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Is NCT05866432 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Datopotamab deruxtecan for breast cancer stage iv.
Treatment: Datopotamab deruxtecan — Datopotamab-deruxtecan in triple-negative breast cancer patients with newly diagnosed or progressing brain metastases.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative expression (<10% tumour cells with positive staining) (<10% tumour cells with positive staining)
For the definition of hormone-receptor negative disease, a cut-off of <10% tumour cells with positive staining of oestrogen- and progresteron-receptors is required
Required: PR (PGR) negative expression (<10% tumour cells with positive staining) (<10% tumour cells with positive staining)
For the definition of hormone-receptor negative disease, a cut-off of <10% tumour cells with positive staining of oestrogen- and progresteron-receptors is required
Required: HER2 (ERBB2) negative amplification
Triple-negative disease as defined by immunohistochemistry (IHC) and/or c-erb-B2 gene amplification status
Disease stage
Required: Stage IV
Metastatic disease required
Prior therapy
Cannot have received: investigational agent
Use of any investigational agent within 28 days prior to initiation of treatment
Cannot have received: cytotoxic chemotherapy
Exception: adequate washout period required
Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment with the exception of osteoprotective therapies such as denosumab or bisphosphonates
Cannot have received: targeted agent
Exception: adequate washout period required
Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment with the exception of osteoprotective therapies such as denosumab or bisphosphonates
Cannot have received: immunotherapy
Exception: adequate washout period required
Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment with the exception of osteoprotective therapies such as denosumab or bisphosphonates
Cannot have received: antibody
Exception: adequate washout period required
Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment with the exception of osteoprotective therapies such as denosumab or bisphosphonates
Cannot have received: retinoid
Exception: adequate washout period required
Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment with the exception of osteoprotective therapies such as denosumab or bisphosphonates
Cannot have received: anti-cancer hormonal treatment
Exception: adequate washout period required
Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment with the exception of osteoprotective therapies such as denosumab or bisphosphonates
Cannot have received: radiotherapy
Exception: concomitant radiotherapy excluded; adequate washout period required for prior therapy
Concomitant radiotherapy
Lab requirements
Blood counts
Adequate bone-marrow function required; Inadequate bone marrow function at baseline prior to study entry [excluded]
Kidney function
Inadequate kidney function [excluded]
Liver function
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease including active or uncontrolled infections with hepatitis B and C)
Cardiac function
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), left ventricular ejection fraction <50%, arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, and long QT syndrome (QTc interval >470 ms)
Adequate bone-marrow, liver and kidney function; Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), left ventricular ejection fraction <50%, arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, and long QT syndrome (QTc interval >470 ms)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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