T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases (NCT06048718) | Clinical Trial Compass
Active — Not RecruitingPhase 2
T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases
Austria, Spain28 participantsStarted 2024-06-05
Plain-language summary
TUXEDO-4 is an international, multicentric, single arm, phase II study aiming to gather additional solid evidence of Trastuzumab-Deruxtecan (T-DXd) activity in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-low breast cancer with active brain metastases.
This study will analyze the efficacy of T-DXd as determined by overall response rate (ORR) at any timepoint as judged by best CNS response according to RANO-BM criteria.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient must be capable to understand the purpose of the Study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.
✓. Female or male patients ≥ 18 years of age at the time of signing ICF.
✓. Radiologically documented metastatic breast cancer with locally documented HER2-low status according to the 2018 ASCO/CAP guidelines.
✓. Life expectancy ≥ 12 weeks.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
✓. Participants with contraindications to T-DXd therapy cannot be enrolled to the Study.
✓. Newly diagnosed or progressive BM without indication for immediate local therapy.
✓. Presenting with ≥1 brain lesion (≥10 mm per local radiological assessment), measurable disease by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Note: Patients may or may not have untreated type II LMD per European Association of Neuro-Oncology (EANO)- European Society for Molecular Oncology (ESMO) criteria.
Exclusion criteria
✕. Current participation in another therapeutic clinical trial.
✕. Treatment with approved or investigational cancer therapy such as antibody treatment within 4 weeks prior to initiation of Study drug; or targeted agents, chemotherapy, small molecule, or anti-cancer hormonal therapy within 3 weeks prior to initiation of Study drug.
What they're measuring
1
ORR at any time point as judged by best central nervous system (CNS) response in all patients.
Timeframe: From baseline until approximately 11 months after the last patient included in the study starts treatment.
. Patients have a concurrent malignancy or malignancy within five years of Study enrolment with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage I uterine cancer or contralateral breast cancer within the last 3 years. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.
✕. Prior treatment with T-DXd.
✕. Patients with type I LMD or previously treated type II LMD.
✕. Known allergy or hypersensitivity to T-DXd or any of the drug components.
✕. Medical history of myocardial infarction (MI) within 6 months before enrolment, symptomatic congestive heart failure (New York Heart Association Class II to IV).
✕. LVEF \< 50% as determined by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within 28 days prior to treatment.