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

ConditionBreast Cancer Stage IV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorMedical University of Vienna

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Datopotamab deruxtecan

    Drug

    Will be given until PD or withdraw

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Datopotamab-deruxtecanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intracranial response rate to datopotamab-deruxtecan

Measured according to RANO-BM criteria

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]

Secondary outcomes

1

Entracranial response rate to datopotamab-deruxtecan

Measured according to RECIST 14.1 criteria

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]
2

Progression-free survival

Time from inclusion until progression

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]
3

Overall Survival

Time from inclusion until progression

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]
4

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

Assessment of clinical adverse events \& laboratory parameters

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]

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Vienna

Lead sponsor

Daiichi Sankyo

Collaborator

Source ClinicalTrials.gov
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