Actively Recruiting
Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole
Led by National Cancer Centre, Singapore · Updated on 2026-04-06
40
Participants Needed
1
Research Sites
306 weeks
Total Duration
On this page
Sponsors
N
National Cancer Centre, Singapore
Lead Sponsor
M
MSD Pharma (Singapore) Pte Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 21 years or older at consent with confirmed metastatic or locally advanced breast cancer not curable by surgery
- Disease progression after at least one line of palliative endocrine therapy for metastatic breast cancer
- Prior targeted therapies allowed except prior Lenvatinib; maximum of one line of palliative chemotherapy allowed
- Estrogen receptor (ER) positive and/or progesterone receptor (PgR) positive breast cancer per ASCO/CAP guidelines
- HER2-negative tumor confirmed by local testing
- Women must be postmenopausal or willing to use LHRH-agonist therapy if premenopausal/perimenopausal; men must be willing to use LHRH-agonist therapy
- Women must not be pregnant or breastfeeding and agree to contraceptive guidance if of childbearing potential
- Men must agree to use contraception during and after treatment
- Written informed consent provided
- Measurable disease by RECIST 1.1 criteria
- Willing to undergo tumor biopsy at screening unless waived by investigator
- ECOG performance status 0 or 1
- Life expectancy greater than 12 weeks
- Adequately controlled blood pressure (≤150/90 mmHg)
- Adequate organ and blood function as defined in the protocol
You will not qualify if you...
- Positive pregnancy test in women of childbearing potential within 72 hours prior to allocation
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents or similar immune therapies
- Prior treatment with Lenvatinib
- Systemic anti-cancer therapy within 4 weeks prior to allocation
- Incomplete recovery from toxicity of previous treatments
- Radiotherapy within 2 weeks prior to study intervention
- Live vaccine within 30 days before first dose
- Participation in another investigational study within 4 weeks
- Immunodeficiency or recent use of immunosuppressive therapy
- Active malignancies requiring treatment within past 3 years except certain skin or in situ cancers
- Active central nervous system metastases or carcinomatous meningitis
- Severe hypersensitivity to study drugs or their components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Significant proteinuria (≥1 g/24-hour)
- Gastrointestinal conditions affecting absorption of Lenvatinib
- Significant cardiac conditions or arrhythmias
- Prolonged QTc interval (>480 msec)
- Active bleeding (hemoptysis) recently
- Serious nonhealing wounds or fractures
- Active infection requiring systemic therapy
- Known HIV infection
- Active or uncontrolled Hepatitis B or C infection
- Other conditions or therapies interfering with study participation
- Psychiatric or substance abuse disorders interfering with trial compliance
- Pregnancy, breastfeeding, or planning pregnancy during study
- History of allogenic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Centre Singapore
Singapore, Singapore, 169610
Actively Recruiting
Research Team
D
Dr. Yoon-Sim YAP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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