Phase II Study of Single Agent Lenvatinib

• Status: Unknown status
• Trial end date: 2021-03-28
• Target enrollment: 0
• Participant gender: Female

Summary

The Investigators hypothesize that single agent lenvatinib has biological activity in estrogen receptor positive breast cancer, and that the effects are more pronounced in patients with positive RET expression in the tumor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Collaborators: Eisai Co., Ltd.; Tan Tock Seng Hospital
• Treatments: Lenvatinib

Criteria

Inclusion Criteria:

Patients must fulfill ALL the following inclusion criteria

• Female ≥18 years

• Histological or cytological diagnosis of breast carcinoma

• No prior treatment for current breast carcinoma

• Scheduled for upfront definitive breast cancer surgery (breast conserving surgery or mastectomy with or without sentinel lymph node biopsy or axillary lymph node clearance)

• Estrogen receptor positive (>1%)

• Adequate bone marrow, renal and liver function

• Adequate organ function including the following:

• Bone marrow:

• Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 109/L

• Platelets >= 100 x 109/L

• Hepatic:

• Bilirubin < = 1.5 x upper limit of normal (ULN),

• ALT or AST < = 2.5x ULN, (or < = 5 X with liver metastases)

• Renal:

• Creatinine < = 1.5x ULN

• Normal thyroid function

• Able to swallow pills

• Able to sign informed consent

• Able to comply with study-related procedures

Exclusion Criteria:

Patients will be excluded from the study for any of the following reasons:

• Scheduled for neoadjuvant systemic therapy

• Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.

• Treatment within the last 28 days with any investigational drug.

• Major surgery within 28 days of study drug administration.

• Pregnancy.

• Breast feeding.

• Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.

• Poorly controlled diabetes mellitus.

• Second primary malignancy that is clinically detectable at the time of consideration for study enrollment

• Symptomatic brain metastasis.

• History of significant neurological or mental disorder, including seizures or dementia.