Neoadjuvant Lenvatinib Combined With Letrozole in Hormone Receptor Positive Breast Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 2, 2015

Primary Completion Date

January 31, 2027

Study Completion Date

June 30, 2027

Conditions
Breast Cancer
Interventions
DRUG

Lenvatinib + Letrozole

Single agent lenvatinib daily continuously x 2 weeks, followed by letrozole 2.5mg daily + lenvatinib x 12 weeks. Lumpectomy or mastectomy should be considered after completing 14 weeks of pre-operative lenvatinib + letrozole for curative intent in non-metastatic patients and for local control for patients with metastatic disease. If surgery is planned, it should preferably be performed within 2-12 weeks after completing neoadjuvant endocrine therapy, and after toxicities (if any) from the neoadjuvant endocrine therapy have resolved. If the patient is deemed inoperable after 14 weeks of lenvatinib + letrozole, a final biopsy will be obtained, and the patient discontinued from the study and treated as per standard clinical practice by the treating physician.

Trial Locations (1)

119228

National University Hospital, Singapore

All Listed Sponsors
collaborator

Eisai Co., Ltd.

INDUSTRY

lead

National University Hospital, Singapore

OTHER

NCT02562118 - Neoadjuvant Lenvatinib Combined With Letrozole in Hormone Receptor Positive Breast Cancer | Biotech Hunter | Biotech Hunter