Dato-DXd for HR-positive, HER2 IHC 0 Breast Cancer
This study is testing Dato-DXd in people with breast cancer that has spread (metastatic) or cannot be removed by surgery (inoperable). Your cancer must be hormone receptor-positive (HR-positive) and have a HER2 IHC 0 score, meaning it has very low levels of the HER2 protein. All participants will receive Dato-DXd through an IV every three weeks. The main goal is to see how long people live without their cancer growing or spreading (progression-free survival). The study aims to enroll about 100 participants aged 18 or older. The current recruitment status is unclear.
- Study design
- This is a Phase IIIb, single-arm, open-label study, meaning all participants receive the same treatment and both you and your doctors will know which treatment you are getting. Approximately 100 participants will be included.
- What's involved
- You will receive Dato-DXd intravenously every three weeks until your cancer progresses, you experience unacceptable side effects, or you choose to stop. You will also need to provide tumor biopsies and liquid biopsy samples at different times during the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcome of the study, progression-free survival, will be assessed for up to approximately 24 months from the start of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
At a glance
Conditions
Where it's being run
40 sites across 11 statesWho to contact
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What this trial measures
- Progression Free Survival (PFS) per RECIST 1.1 as assessed by the investigatorFrom date of first dose of study intervention until disease progression per RECIST 1.1 or death from any cause, whichever occurs first, assessed up to approximately 24 months
PFS is defined as time from date of first dose of study intervention until progression per RECIST 1.1 as assessed by the investigator or death due to any cause.