Lenvatinib+Letrozole Versus Fulvestrant in Metastatic ER+/HER2- Breast Cancer, Post Progression on Al + CDK4/6 Inhibitor
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Based on the results of the phase Ib/II study, the investigators hypothesize that combining a RET inhibitor lenvatinib with endocrine therapy letrozole improves objective response and progression-free survival compared to fulvestrant alone in the second line setting in patients who have progressed on first line endocrine therapy incorporating a CDK4/6 inhibitor. Letrozole and fulvestrant are anti-hormonal drugs that have been proven to have activity and are considered standard therapies for hormone receptor positive breast cancer. The purpose of this study is to determine if the combination therapy of letrozole (an anti-hormonal drug) and lenvatinib (a targeted therapy), when compared to another anti-hormonal drug fulvestrant, is effective in patients with hormone receptor positive breast cancer. Preliminary studies have shown that approximately 50-60% of hormone receptor positive breast cancers over-express RET, and may therefore respond to treatment by a drug that blocks the RET pathway. An earlier study conducted at the National University Cancer Institute, Singapore (NCIS) on the combination of letrozole and Lenvatinib has shown promising results. Among patients in whom hormonal therapy and a CDK4/6 inhibitor no longer worked, about one-quarter of patients had meaningful disease control. The study also showed that patients tolerated the combination of Lenvatinib and letrozole well with manageable side effects. Based on the promising findings from the earlier study, this study seeks to compare the effectiveness of lenvatinib plus letrozole with another standard anti-hormone treatment drug called fulvestrant. In addition, investigators are studying how body reacts to the treatment as well as studying gene and protein changes in the tumour in response to treatment, which may in the future, help us tailor drug treatment for individual patients according to the patient's and/or the tumour's genetic or protein make-up.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobiety powyżej 18. roku życia.
- •Rak piersi potwierdzony badaniem histologicznym lub cytologicznym.
- •Rak piersi reagujący na hormony (receptor estrogenowy dodatni).
- •Choroba z przerzutami, która postępowała pomimo wcześniejszego leczenia hormonalnego i inhibitora CDK4/6.
- •Przerzuty widoczne w badaniach obrazowych.
- •Ogólny dobry stan zdrowia (wydolność 0-1 w skali ECOG).
- •Przewidywana długość życia co najmniej 12 tygodni.
- •Prawidłowe wyniki badań krwi (np. białe krwinki, płytki), wątroby i nerek.
✗ Disqualifies
- •Pacjentki, które otrzymały już dwa różne rodzaje chemioterapii w leczeniu choroby z przerzutami.
- •Pacjentki, które nie ukończyły 18. roku życia.
- •Pacjentki z rakiem piersi, który nie reaguje na hormony.
- •Pacjentki z chorobami serca, które nie są pod kontrolą.
- •Pacjentki z aktywnymi przerzutami do mózgu.
- •Pacjentki, które niedawno przeszły poważną operację.
- •Pacjentki w ciąży lub karmiące piersią.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 99 Years
- Last updated (source)
- July 25, 2025
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Nationa University Hospital
Singapore, Singapore
Trial contact
Soo Chin Lee
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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