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Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole in the Advanced Setting - a Phase II Study

NCT05286437•National Cancer Centre, Singapore

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

21 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male/female participants who are at least 21 years of age on the day of signing informed consent, with histologically or cytologically confirmed diagnosis of metastatic or locally advanced carcinoma of the breast not amenable to treatment with curative intent, will be enrolled in this study.
•2. Disease progression after treatment with at least 1 line of palliative endocrine therapy in the metastatic setting.
•1. There is no limit to the number of lines of prior palliative endocrine therapy.
•2. Prior targeted therapy in the locally advanced (recurrent or progressed) or metastatic setting, such as CDK4/6 inhibitors, mTOR inhibitors, PI3K inhibitors, is allowed with no limit to the number of lines of targeted therapy (prior lenvatinib is not allowed).
•3. Maximum of 1 line of palliative chemotherapy is allowed.
•* A chemotherapy line in advanced disease is an anticancer regimen(s) that contains at least 1 cytotoxic chemotherapy agent and was discontinued due to progression. If a cytotoxic chemotherapy regimen was discontinued for a reason other than disease progression then this regimen does not count as a "prior line of chemotherapy".
•* Antibody-drug conjugate will be considered as cytotoxic chemotherapy in the assessment of the lines of treatment.
•3. ER positive and/or PgR positive breast cancer (based on most recent tumor biopsy or archived tumor specimen) according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, assessed locally and defined as at least 1% of tumor cells stained positive.
•4. HER2-negative tumor assessed locally and defined as meeting one of the following sets of criteria:
•* HER2 IHC score of 0 or 1+
+20 more criteria

Exclusion Criteria

•1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
•Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.
•2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
•3. Has received prior lenvatinib.
•4. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (or 5 times the half-life, whichever is shorter) prior to allocation. Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
•5. Subjects must have recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy.
•6. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
•7. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
•8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
•9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
+18 more criteria

Locations (1)

National Cancer Centre Singapore

Singapore, Singapore

Key Dates

Start Date

February 15, 2023

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2027

Last Updated

December 30, 2025

Enrollment

ESTIMATED participants

Conditions

Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer

Interventions

Oral lenvatinib + Intravenous (IV) pembrolizumab + Oral letrozole

DRUG

Contacts

Dr. Yoon-Sim YAP

CONTACT

+65 63065912 yap.yoon.sim@singhealth.com.sg