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Trastuzumab deruxtecan / Trastuzumab / Breast Neoplasms · Phase 3 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an active Phase 3 randomized trial comparing trastuzumab deruxtecan alone or sequenced with taxane-based chemotherapy against standard anthracycline-taxane-dual HER2-targeted therapy in HER2-positive early breast cancer. No results are posted; the study is tracking pathologic complete response as the primary endpoint with a data cutoff planned for 12 March 2025.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer; age from 18 Years. Intervention: Arm A; Arm B. Compared with: Arm C — Active Comparator. n = 927. 145 sites across 18 countries.
Planned enrollment: 927 participants Primary endpoint: Rate of Pathologic Complete Response (pCR) measured through definitive surgery or study discontinuation Setting: Neoadjuvant treatment of high-risk HER2-positive early non-metastatic breast cancer
Secondary endpoints, safety monitoring plan, and statistical power calculation are not reported here. Primary endpoint: Rate of Pathologic Complete Response (pCR) measured through definitive surgery or study discontinuation
Once results are available, this trial will inform whether trastuzumab deruxtecan—a HER2-targeted antibody-drug conjugate—can improve pathologic complete response rates compared to current standard neoadjuvant regimens in HER2-positive breast cancer. Current registry record contains no outcome data to inform clinical practice.
Phase 3 trial in active recruitment with no results posted; this registry record describes a planned study design and endpoints only, not outcomes.
As stated by the source record.
Quoted from the source exactly as published.
Once results are available, this trial will inform whether trastuzumab deruxtecan—a HER2-targeted antibody-drug conjugate—can improve pathologic complete response rates compared to current standard neoadjuvant regimens in HER2-positive breast cancer. Current registry record contains no outcome data to inform clinical practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT05113251). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 927 participants (ACTUAL). Conditions: Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer. Interventions: DRUG: Trastuzumab Deruxtecan; DRUG: Paclitaxel; DRUG: Trastuzumab; DRUG: Pertuzumab; DRUG: Doxorubicin; DRUG: cyclophosphamide. Primary outcome measures: Rate of Pathologic Complete Response (pCR). , Through to definitive surgery or discontinuation/withdrawal from study, up to a maximum of approximately 40 months from randomization to primary pCR DCO (12MAR2025). Brief summary: This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.