Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole

This is a phase II study testing the combination of Pembrolizumab with Lenvatinib, a multi-kinase inhibitor that has activity against vascular endothelial growth factor receptors 1-3 (VEGFR1-3), fibroblast growth factor receptors 1-4 (FGFR1-4), ret protooncogene (RET), platelet-derived growth factor receptor-alpha (PDGFR-alpha) and KIT (a stem cell factor receptor), and letrozole, a non-steroidal aromatase inhibitor, in advanced hormone receptor (HR) positive human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC) that has progressed on/after standard endocrine therapy.

Trial Details

NCT ID
NCT05286437
Phase
PHASE2
Sponsor
National Cancer Centre, Singapore
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Oral Lenvatinib + Intravenous (IV) Pembrolizumab + Oral Letrozole
Locations (sample)
  • Singapore, Singapore|1.28967,103.85007

Key Eligibility Criteria

  • Male/female participants who are at least 21 years of age on the day of signing informed consent, with histologically or cytologically confirmed di…
  • Disease progression after treatment with at least 1 line of palliative endocrine therapy in the metastatic setting.
  • There is no limit to the number of lines of prior palliative endocrine therapy. (Prior aromatase inhibitor in the curative and/or palliative settin…
  • Prior targeted therapy in the locally advanced (recurrent or progressed) or metastatic setting, such as CDK4/6 inhibitors, mTOR inhibitors, PI3K in…

For full eligibility, visit ClinicalTrials.gov.

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