Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases

NCT05866432 | Recruiting Phase 2

• 1 other identifier: TUXEDO-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Datopotamab-deruxtecan in triple-negative breast cancer patients with newly diagnosed or progressing brain metastases.

Conditions

Breast Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• Intracranial response rate to datopotamab-deruxtecan

  Measured according to RANO-BM criteria

  From date of inclusion until the date of firstdocumented progression or date of death from any cause or treatmentdiscontinuation from any other reason, whichever came first, assessedup to 36 months]

Secondary Outcomes (4)

• Entracranial response rate to datopotamab-deruxtecan

  From date of inclusion until the date of firstdocumented progression or date of death from any cause or treatmentdiscontinuation from any other reason, whichever came first, assessedup to 36 months]

• Progression-free survival

  From date of inclusion until the date of firstdocumented progression or date of death from any cause or treatmentdiscontinuation from any other reason, whichever came first, assessedup to 36 months]

• Overall Survival

  From date of inclusion until the date of firstdocumented progression or date of death from any cause or treatmentdiscontinuation from any other reason, whichever came first, assessedup to 36 months]

• Safety & tolerability of datopotamab-deruxtecan in terms of haematologic and non-haematologic side effect

  From date of inclusion until the date of firstdocumented progression or date of death from any cause or treatmentdiscontinuation from any other reason, whichever came first, assessedup to 36 months]

Study Arms (1)

Datopotamab-deruxtecan

EXPERIMENTAL

Datopotamab-deruxtecan (DS-1062a) 6.0 mg/kg body weight i.v. on day 1 once every three weeks

Drug: Datopotamab deruxtecan

Interventions

Datopotamab deruxtecan DRUG

Will be given until PD or withdraw

Also known as: S-1062a

Datopotamab-deruxtecan

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed breast cancer
• Triple-negative disease as defined by immunohistochemistry (IHC) and/or c-erb-B2 gene amplification status. 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
• Newly diagnosed untreated brain metastases or brain metastases progressing after prior local therapy
• Measurable disease (RANO-BM criteria)
• No indication for immediate local treatment
• Accompanying type II leptomeningeal disease allowed (suspected LMD by clinical findings and neuroimaging)
• KPS ≥70%, ECOG ≤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
• Patient must be able to tolerate therapy
• Adequate bone-marrow, liver and kidney function
• Adequate treatment washout period before enrolment, defined as:
• Major Surgery: ≥3 weeks
• Radiation therapy to the chest: ≥4 weeks

You may not qualify if:

• Known hypersensitivity to Dato-DXd or any of the drug components
• Use of any investigational agent within 28 days prior to initiation of treatment
• History of malignancies other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years including contralateral breast cancer
• 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
• Concomitant radiotherapy
• A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
• 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)
• Inadequate bone marrow function at baseline prior to study entry
• Inadequate kidney 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
• Participants with known hepatitis B and C are eligible if they:
• Have been curatively treated for HCV infection as demonstrated clinically and by viral serologies
• Have received HBV vaccination with only anti-HBs positivity and no clinical signs of hepatitis
• Are HBsAg- and anti-HBc+ (i.e., those who have cleared HBV after infection) and meet conditions i-iii below:
• Are HBsAg+ with chronic HBV infection (lasting 6 months or longer) and meet conditions 1-3 below:

Sponsors & Collaborators

• Medical University of Vienna: lead
• Daiichi Sankyo: collaborator

Study Sites (1)

AKH Universitaetsklinikum Vienna, Department f. Internal medicine I, oncology

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rupert Rupert, MD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rupert Rupert, MD

CONTACT

+43140400; rupert.bartsch@meduniwien.ac.at

Marika Rosner

CONTACT

+43140400; marika.rosner@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.-Prof. PD Dr.

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): May 23, 2026
• Study Completion (Estimated): May 23, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)