OncoMatch/Clinical Trials/NCT05900206
Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer
Is NCT05900206 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Endocrine / hormonal
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.
Frequently asked questions
Is NCT05900206 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior experimental drug, interventional trial participation disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage CN1 or CN2 or CN3 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify