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About
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
Full description
Eligible patients will be those patients who have had disease progression on at least 2 previous lines of endocrine therapies given for the treatment of metastatic disease or disease progression within 6 months of starting first line treatment for metastatic disease with an endocrine therapy combined with a CDK4/6 inhibitor. All patients must have historically confirmed HR positive (either estrogen receptor and/or progesterone receptor positive), HER2-low (defined as IHC2+/ISH- and IHC 1+) or HER2 IHC >0 <1+ expression, as determined by central laboratory testing results, advanced or metastatic breast cancer.
The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy. This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Patients must be ≥18 years of age
Pathologically documented breast cancer that:
No prior chemotherapy for advanced or metastatic breast cancer.
Has adequate tumor samples for assessment of HER2 status
Must have either:
Has protocol-defined adequate organ and bone marrow function
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
866 participants in 2 patient groups
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Central trial contact
AZ Breast Cancer Study Navigators; AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
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