Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole (LaPemERLA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05286437|
Recruitment Status : Not yet recruiting
First Posted : March 18, 2022
Last Update Posted : March 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer||Drug: Oral lenvatinib + Intravenous (IV) pembrolizumab + Oral letrozole||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole in the Advanced Setting - a Phase II Study|
|Estimated Study Start Date :||April 1, 2022|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||March 31, 2026|
Oral lenvatinib + Intravenous (IV) pembrolizumab + Oral letrozole
Drug: Oral lenvatinib + Intravenous (IV) pembrolizumab + Oral letrozole
Lenvatinib and letrozole will be given orally (PO) daily from Day -14, while pembrolizumab will be administered intravenously during week 1 of each 6-weekly cycle from Cycle 1 Day 1 (C1D1), with daily lenvatinib and letrozole.
- Objective Response Rate (ORR) [ Time Frame: Up to 2 years. ]
The efficacy of Pembrolizumab, Lenvatinib and Letrozole.
ORR is defined as the proportion of subjects who have best objective response (BOR) of CR or PR at the time of data cutoff.
- Progression-Free Survival (PFS) [ Time Frame: Up to 3 years after End of Treatment (estimated). ]PFS is defined as the time from the first study dose date (at the D-14 lenvatinib + letrozole run-in phase) to the date of first documentation of confirmed disease progression or death (whichever occurs first).
- Duration of Response (DOR) [ Time Frame: Up to 3 years after End of Treatment (estimated). ]DOR is defined as the time from the date the criteria are met for an CR or PR (whichever is recorded first) to the date the disease progression is objectively documented. If a subject has no record of disease progression, then the subject's data will be censored at the last available tumour assessment.
- Clinical Benefit Rate (CBR) [ Time Frame: Up to 3 years after End of Treatment (estimated). ]CBR is defined as the percentage of patients with CRs, PRs, and durable (≥24 weeks) stable disease (SD).
- Overall Survival (OS) [ Time Frame: Up to 3 years after End of Treatment (estimated). ]OS is measured from the start date of the treatment period (at the D-14 lenvatinib + letrozole run-in phase) until date of death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05286437
|Contact: Dr. Yoon-Sim YAP||+65 firstname.lastname@example.org|
|National Cancer Centre Singapore|
|Singapore, Singapore, 169610|
|Contact: Dr. Yoon-Sim YAP +65 64368000 email@example.com|
|Principal Investigator:||Dr. Yoon-Sim YAP||National Cancer Centre, Singapore|