RecruitingPhase 1NCT04427293

Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)

BRE-03: Window of Opportunity Trial of Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)


Sponsor

University of Illinois at Chicago

Enrollment

12 participants

Start Date

Jul 9, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is single arm study of a window of opportunity in which participants with previously untreated triple negative breast cancers (TNBC) who are candidates for potentially curative surgery will receive lenvatinib 12 mg daily for 7 and pembrolizumab 200 mg IV on day 1 prior to surgery


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving two drugs — lenvatinib (a targeted therapy) and pembrolizumab (an immunotherapy) — before surgery can shrink tumors and improve outcomes for women with early-stage triple-negative breast cancer (TNBC), a type of breast cancer that lacks certain hormone receptors and is harder to treat. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with triple-negative breast cancer (estrogen receptor-negative, progesterone receptor-negative, HER2-negative) confirmed by biopsy - Your cancer is at stage T1b–T3 with or without lymph node involvement, but has not spread to distant organs - Surgery (partial or full mastectomy) is planned after pre-surgery chemotherapy - Your overall health is adequate (ECOG 0–2) and organ function meets minimum levels **You may NOT be eligible if...** - Your tumor was removed by excisional biopsy (surgical removal of the whole tumor during biopsy) - You have another active cancer - You are pregnant or breastfeeding - Your organ function is insufficient for the medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenvatinib

Lenvatinib 12mg daily for 7 days prior to surgery

DRUGPembrolizumab

Pembrolizumab 200 mg IV on day 1


Locations(1)

University of Illinois

Chicago, Illinois, United States

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NCT04427293


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