A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Dato-DXd: Experimental drug IV infusion

Durvalumab: Experimental drug IV Infusion

Pembrolizumab: IV Infusion Active comparator

Doxorubicin: IV infusion Experimental/Active Comparator

Epirubicin: IV Infusion Experimental/Active Comparator

Cyclophosphamide: IV infusion Experimental/Active Comparator

Paclitaxel: IV infusion Experimental/Active Comparator

Carboplatin: IV infusion Experimental/Active Comparator

Capecitabine: Tablet Oral route of administration Experimental/Active Comparator

Olaparib: Tablet Oral route of administration Experimental/Active Comparator

Study summary

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Eligibility

Primary outcome measure(s)

• Event-free survival (EFS) in the experimental vs control arms — Date of randomization to date of the EFS event, up to 93 months after the first subject randomized
  EFS is defined as the time from the date of randomisation until the date of the first occurrence of any of the following events: disease progression precluding surgery, disease recurrence (local, regional, distant, or contralateral), second primary invasive cancer (other than squamous or basal cell skin cancer), or relapse from prior malignancy, or death by any cause (in the absence of recurrence). Non-invasive breast cancers and positive margins in the surgical sample do not count as an event for EFS. EFS will be determined by the investigator based on all available clinical assessments. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. The measure of interest will be the Hazard Ratio of EFS.

Trial sites (283)

+ 243 more sites — see the full list on the official registry below.

On this site

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