OncoMatch/Clinical Trials/NCT05900206
Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer
Is NCT05900206 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast cancer.
Treatment: Trastuzumab deruxtecan · Docetaxel · Paclitaxel · Carboplatin · Trastuzumab · Pertuzumab · Ribociclib · Letrozole · Epirubicin · Cyclophosphamide — The goal of this clinical trial is to compare trastuzumab deruxtecan (T-DXd) to standard preoperative treatment in patients with non-metastatic HER2-positive breast cancer. The main questions it aims to answer are: * is T-DXd more effective than standard preoperative treatment? * are there markers in the tumor or blood of patients with HER2-positive breast cancer that can help us predict response to treatment? Participants will be divided into two groups, where one group will be treated with three courses of T-DXd and the other group will be treated with three courses standard of care treatment. Thereafter, further treatment will be decided by the tumor's molecular subtype.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ with ISH positivity)
Known HER2-positive breast cancer defined as an IHC status of 3+. If IHC is 2+, a positive in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. ISH positivity is defined as a ratio of ≥ 2 for the number of HER2 gene copies to the number of signals for chromosome 17 copies.
Required: ESR1 expression (known; cut-off for positivity is at least 10% of cell nuclei staining for ER)
Known estrogen-receptor and/or progesterone receptor status, as assessed locally by IHC. The cut-off for positivity for ER/PR for this study is at least 10% of cell nuclei staining for ER or PR, respectively.
Required: PR (PGR) expression (known; cut-off for positivity is at least 10% of cell nuclei staining for PR)
Known estrogen-receptor and/or progesterone receptor status, as assessed locally by IHC. The cut-off for positivity for ER/PR for this study is at least 10% of cell nuclei staining for ER or PR, respectively.
Disease stage
Required: Stage CN1, CN2, CN3 (clinical TNM)
invasive component measuring ≥ 20 mm and/or with morphologically confirmed spread to regional lymph nodes (stage cT2-cT4 with any cN, or cN1-cN3 with any cT)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: experimental drug
Administration of other experimental drugs, either concomitantly or during the past 30 days before treatment initiation.
Cannot have received: interventional trial participation
Participation in other interventional trials
Lab requirements
Blood counts
absolute granulocytes > 1.5 x 10^9/l; platelets > 100 x 10^9/l; hb > 90 gr/l
Kidney function
serum creatinine ≤ 1.5 x uln
Liver function
bilirubin ≤ uln; ast and alt ≤ 1.5 x uln; albumin ≥ 30 gr/l
Cardiac function
left ventricular ejection fraction (lvef) ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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