Condition: Breast Cancer · HR+/HER2- Breast Cancer · Sponsor: West German Study Group
In this clinical trial, the Sponsor plans to investigate whether patients with HR+/HER2- eBC identified during routine clinical assessments and treatments as having intermediate to high-risk (based on Oncotype DX® or similar tests and on response assessment to 2-6 weeks of preoperative ET) achieve a survival benefit from an initial 5-years use of elacestrant (with or without a CDK 4/6 inhibitor) followed by SoC ET for further 0-2.5 years in comparison to at least 5 up to 7.5 years SoC ET therapy (+/- CDK4/6 inhibitor). Based on several studies in the metastatic setting, it is reasonable to assume that the adjuvant use of elacestrant with or without CDK 4/6 inhibitors will prevent or delay the activation of mechanisms conferring resistance to ET (e.g., ESR1 mutations).
This description comes directly from the study's public registry record.
Anja Braschoß · 004917682119153 · regulatory@wsg-online.com
Marina Mangold, Dr. · 00492161566 23-0 · marina.mangold@wsg-online.com
Always discuss trial participation with your own doctor first.
| Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus | Mönchengladbach, North Rhine-Westphalia, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07242352