ClinicaliQ Trial Snapshot
- Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype — Recruiting • Phase II • Oncology • NCT06486883.
- What is being tested: Trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate, is being compared against standard CDK4/6 inhibitor-based endocrine therapy as first-line treatment for HR-positive/HER2-low or ultralow advanced breast cancer with non-luminal molecular subtype.
- Patient eligibility overview: Adults with advanced HR-positive/HER2-negative breast cancer confirmed as non-luminal subtype by PAM50 gene expression profiling, with no prior systemic therapy for advanced disease, are eligible for randomisation.
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What This Trial Is Studying
This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50). Patients will be treated with trastuzumab deruxtecan (T-DXd) or with physician's choice of CDK4/6 inhibitor (CDK4/6i) plus endocrine therapy (ET). The main purpose of the study is to analyze the efficacy of T-DXd in patients who have HR-positive and HER2-low/ultralow advanced breast cancer classified as non-luminal subtype.
Eligibility Snapshot
- : 1. Patients must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures. 2. Female or male patients ≥ 18 years of age at the time of signing ICF. 3. ECOG performance status of 0-1. 4. Minimum life expectancy of ≥ 12 weeks at screening. 5. Evidence of HER2-low expression (1+ by immunohistochemistry (IHC) or 2+ and negative by an in situ hybridization [ISH] test) or HER2-ultralow (IHC 0 with faint membrane staining and in ≤ 10% of tumor cells) breast cancer according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines determined by a MEDSIR's designated central laboratory, using Ventana 4B5 antibody. This assessment has to be done on the most recently available (archived or newly collected) formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (≤ 6 weeks or FFPE of a tumor sample obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion, excluding bone metastases. 6. Non-luminal breast cancer subtype as per central PAM50 analysis determined in the most recently available (archived or newly…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.