A Phase 3 clinical trial investigating Trastuzumab Deruxtecan (T-DXd) for HER2-positive early breast cancer reached primary completion on 2025-03-12. This study, NCT05113251, is evaluating T-DXd alone or in sequence with other therapies against standard treatment in this patient population.
Background
Trastuzumab Deruxtecan (Enhertu) is an antibody-drug conjugate (ADC) that targets HER2. It is being investigated for its potential role in the treatment of HER2-positive early breast cancer. This condition is a subtype of breast cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein, which can drive aggressive tumor growth.
Trial design
The study, identified as NCT05113251, is a Phase 3 trial with an enrollment of 927 participants. It is designed to evaluate Trastuzumab Deruxtecan (T-DXd) alone or in sequence with trastuzumab, pertuzumab, and paclitaxel. This is compared against a standard treatment arm that includes doxorubicin, paclitaxel, trastuzumab, and pertuzumab, for patients with HER2-positive early non-metastatic breast cancer in a neoadjuvant setting.
What this means
The primary completion of this Phase 3 trial signifies that data collection for the study's primary endpoint has concluded. While specific results are not yet available, the completion of this phase is a critical step towards understanding the efficacy and safety profile of Trastuzumab Deruxtecan in the neoadjuvant treatment of HER2-positive early breast cancer. Future announcements will provide insights into the trial's findings.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT05113251, titled "Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer," was posted on 2025-03-12 on clinicaltrials.gov.