A Phase 3, Open-label, Randomized Study of Dato-DXd Versus Investigator*s Choice of Chemotherapy in Participants With Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
- Conditions
- HER2-Negative Breast Cancer/ Breastcancer that cannot be removed by surgery or has spread to other parts of your bodyInoperable or Metastatic Hormone Receptor-Positive10006291
- Registration Number
- NL-OMON52270
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
- Inoperable or metastatic HR-positive / HER2*negative breast cancer.
- Progressed on and not suitable for endocrine therapy per investigator
assessment, and previously treated with 1 or 2 lines of chemotherapy in the
inoperable / metastatic setting. Participant must have documented progression
on most recent line of chemotherapy. Targeted agents (such as mTOR inhibitors,
PD-1/PDL1 inhibitors), endocrine therapies, and CDK4/6 inhibitors on their own
do not contribute to the count of prior lines of chemotherapy; however,
regimens with such agents in combination with metastatic chemotherapy should be
classified as one line of chemotherapy.
- At least 1 measurable lesion not previously irradiated. Participants with
bone-only metastases are not permitted. Participants with clinically inactive
brain metastases may be included
- Adequate organ and bone marrow function; LVEF >= 50% by echocardiogram or MUGA
- All participants must have available a FFPE tumor sample
- Uncontrolled medical conditions E.g. Cardiac Disease, leptomeningeal
carcinomatosis, systemic infections
- History of ILD, severe Pulmonary compromise
- Prior anticancer therapy with another ADC, TROP2-targeted therapy (e.g.,
Trodelvy), same ICC chemotherapy
- Concurrent anticancer treatment or hormonal therapy for non-cancer related
conditions
- Receipt of live, attenuated vaccine within 30 days before C1D1.
- Prior participation in any Enhertu (T-Dxd) study (regardless if received
T-DXd or not)
- Known hypersensitivity to Dato-DXd or any of the excipients of the product
(including, but not limited to, polysorbate 80), or any other monoclonal
antibodies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- The target population of interest in this study is participants with<br /><br>inoperable or metastatic HR-positive, HER2-negative breast cancer who have been<br /><br>treated with one or two prior lines of systemic chemotherapy in the<br /><br>inoperable/metastatic setting.<br /><br>- To demonstrate the superiority of Dato-DXd compared to ICC by assessment of<br /><br>OS in participants with inoperable or metastatic HR-positive, HER2-negative<br /><br>breast cancer, who have been treated with 1 or 2 lines of chemotherapy in the<br /><br>inoperable/metastatic setting.</p><br>
- Secondary Outcome Measures
Name Time Method