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Breast Cancer Stage IVPhase 2TUXEDO-2NCT05866432

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

A Phase 2 study testing Datopotamab deruxtecan in people with Breast Cancer Stage IV, run by Medical University of Vienna at 1 site in Austria.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Datopotamab-deruxtecan in triple-negative breast cancer patients with newly diagnosed or progressing brain metastases. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Breast Cancer Stage IV
What is being tested?
Datopotamab deruxtecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteAustria
Study dates
1 Jul 2023to 1 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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
  • Palliative radiation therapy to other areas: ≥2 weeks
  • Chemotherapy, small-molecule targeted agents: ≥3 weeks
  • Antibody-based treatment: ≥4 weeks (concurrent therapy with denosumab allowed)
  • Patient must be capable of understanding the purpose of the study and have given written informed consent

Who cannot join

  • 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
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  • 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:
  • HBV DNA viral load <2000 IU/mL
  • Have normal transaminase values, or, if liver metastases are present, abnormal transaminases, with a result of AST/ALT <3 × ULN, which are not attributable to HBV infection
  • Start or maintain antiviral treatment
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Has a history of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
  • Patients with active opportunistic infections
  • Known human immunodeficiency virus (HIV) infection that is not well controlled
  • Pregnant or lactating women
  • Women with childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy.
  • Male subjects unable or unwilling to use adequate contraception methods
  • Patients with known substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results
  • Patients requiring concomitant use of chronic systemic (IV or oral) corticosteroids at doses higher than 8 mg dexamethasone per day or other immunosuppressive medications except for managing adverse events; (inhaled steroids or intra articular steroid injections are permitted in this study)
  • Patients with significant corneal disease

Trial locations and contacts

1 site in 1 country.

Austria1 site

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

    Vienna, 1090

Other trials in Austria

About this study

Official title: Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases

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

Read the detailed description

Datopotamab-deruxtecan will be administered at a dose of 6.0 mg/kg body weight i.v. on day

1 once every three weeks in triple-negative breast cancer patients with newly diagnosed or progressing brain metastases. Response rate by RANO-BM criteria is definied as primary endpoint.

Being tested
Datopotamab deruxtecan
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Datopotamab deruxtecanDrug

    Also called S-1062a

    Will be given until PD or withdraw

Study groups in NCT05866432
Study groupRoleWhat they receive
Datopotamab-deruxtecanExperimentalDatopotamab-deruxtecan (DS-1062a) 6.0 mg/kg body weight i.v. on day 1 once every three weeks
Receives: Drug: Datopotamab deruxtecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracranial response rate to datopotamab-deruxtecan

    Measured according to RANO-BM criteria

    Measured: 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)

  1. Entracranial response rate to datopotamab-deruxtecan

    Measured according to RECIST 14.1 criteria

    Measured: 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]

  2. Progression-free survival

    Time from inclusion until progression

    Measured: 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]

  3. Overall Survival

    Time from inclusion until progression

    Measured: 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]

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

    Assessment of clinical adverse events \& laboratory parameters

    Measured: 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]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2023
  2. Study start1 Jul 2023
  3. Primary completion1 Jul 2026
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05866432
Sponsor's protocol ID
TUXEDO-2
Acronym
TUXEDO-2
Status last verified
Oct 2026
First submitted
10 May 2023
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Datopotamab deruxtecan in people with Breast Cancer Stage IV, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial response rate to datopotamab-deruxtecan (time frame: 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]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05866432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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