Trial results for Trastuzumab Deruxtecan (Enhertu) in patients with metastatic triple-negative breast cancer were posted on ClinicalTrials.gov on 2026-02-02. The Phase 1/Phase 2 study reported an Objective Response Rate (ORR) as high as 81.8% in one treatment arm.

Background

This study investigated novel anti-cancer agents for metastatic triple-negative breast cancer (mTNBC). Trastuzumab Deruxtecan was one of the interventions explored in this setting, alongside other therapies.

Trial design

This Phase 1/Phase 2 study (NCT03742102) is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies, with or without paclitaxel, and durvalumab + paclitaxel for first-line metastatic triple-negative breast cancer. It enrolled 243 participants with Triple Negative Breast Neoplasms. Interventions included durvalumab, capivasertib, oleclumab, paclitaxel, and trastuzumab deruxtecan. The study evaluated Dose Limiting Toxicity (DLT) events and Objective Response Rate (ORR).

Key results

Key results from the trial included:

What this means

The posted results indicate promising efficacy signals for some treatment arms in metastatic triple-negative breast cancer, particularly Arm 8, which achieved an Objective Response Rate of 81.8%. The absence of Dose Limiting Toxicity (DLT) events in several arms (Arm 2, Arm 5, Arm 6, and Arm 7) suggests a favorable safety profile for those specific combinations or monotherapies at the doses studied in this early-phase trial. These findings warrant further investigation in later-phase studies for metastatic triple-negative breast cancer.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03742102, titled "A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer," were posted on 2026-02-02 on clinicaltrials.gov.