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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.
. 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.