Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
- Trial number:
-
NCT04494425
- Trial phase:
- 3
- Study type:
- Targeted therapy, Biomarker
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
Key
Patients must be ≥18 years of age
Pathologically documented breast cancer that:
is advanced or metastatichas a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) has HER2-low or HER2 IHC >0 <1+ expression as determined by the central laboratory result established on a tissue sample taken in the metastatic setting was never previously HER2-positive is documented HR+ disease in the metastatic setting. No prior chemotherapy for advanced or metastatic breast cancer. Has adequate tumor samples for assessment of HER2 status
Must have either:
disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor ordisease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting. Of note with regards to the ≥2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting. Has protocol-defined adequate organ and bone marrow function
Key
Ineligible for all options in the investigator's choice chemotherapy armLung-specific intercurrent clinically significant illnesses Uncontrolled or significant cardiovascular disease or infection Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening. Patients with spinal cord compression or clinically active central nervous system metastases Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable)