BRE-03: Window of Opportunity Trial of Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)
University of Illinois at Chicago
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
Description
This is a single arm study of a window of opportunity study in which participants with previously untreated triple negative breast cancers (TNBC) who are candidates for potentially curative surgery will receive therapy prior to surgery, consisting of lenvatinib 12 mg daily for 7 days and pembrolizumab 200 mg IV on day 1. Subjects will either have curative surgery 7-10 days after last dose of lenvatinib, and post-operative adjuvant therapy as per institution guidelines or have a research core biopsy of the breast tumor 7-10 days after last dose of lenvatinib, and standard of care neoadjuvant ch…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years of age at time of consent 2. Histologically confirmed invasive breast carcinoma documented by core needle biopsy or incisional biopsy (excisional biopsy is not allowed). AJCC 8th edition clinical stage T1b-T3/N0-N3/M0 by physical exam or radiologic studies 3. Must be candidates for curative surgical resection 4. Have an FFPE diagnostic core biopsy specimen available that is determined by the study pathologist to be adequate for planned analyses 5. Definitive surgical excision of the primary breast tumor (either partial mastectomy or total mastectomy) and…
Interventions
- DrugLenvatinib
Lenvatinib 12mg daily for 7 days prior to surgery
- DrugPembrolizumab
Pembrolizumab 200 mg IV on day 1
Location
- University of IllinoisChicago, Illinois