Neoadjuvant Lenvatinib Combined With Letrozole in Hormone Receptor Positive Breast Cancer

What this trial studies

This is a single-centre study comprising two phases: a lead-in phase Ib and a phase II randomized portion. Lead-in Phase Ib study A lead-in phase I study will be built into this protocol to confirm the dose of lenvatinib that can safely be combined with letrozole. We expect that the optimal phase II dose level will be determined after recruiting 12-18 subjects into phase Ib. This dose level will be the one to be tested in the phase II portion of the study.

Conditions in scope

• Breast Cancer

Interventions

• Lenvatinib + Letrozole (Drug) — 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…

Who can join

Women only · Ages 18 Years and up

Inclusion criteria

• Female, age ≥ 18 years.
• Histologic or cytologic diagnosis of breast carcinoma.
• Part A: T1-4 breast cancer with measurable primary breast tumor, defined as palpable tumor with both diameters 2.0cm or greater as measured by caliper. Newly diagnosed metastatic patients with measurable primary breast tumor ≥2cm are eligible provided that there are plans for toilet mastectomy after completing 14 weeks of pre-operative drug therapy. Patients must not have received prior chemotherapy or hormonal therapy for the treatment of the current breast cancer.
• Part B: Patients with metastatic breast cancer with measurable tumor by RECIST criteria.Patients previously treated with letrozole are eligible if they progressed on letrozole ≥1 year after adjuvant treatment, or ≥ 6 months in the metastatic setting.
• ECOG 0-1.
• Estimated life expectancy of at least 12 weeks.
• Adequate organ function including the following:
• Bone marrow:

Exclusion criteria

• Treatment within the last 30 days with any investigational drug.
• Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
• Major surgery within 28 days of study drug administration.
• Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
• 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.
• Active bleeding disorder or bleeding site.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: PHASE1, PHASE2
• Start date: 2015-10-02
• Primary completion: 2027-01
• Last update posted: 2025-09-25
• First posted: 2015-09-29

Sponsor & contact

Lead sponsor: National University Hospital, Singapore (Other)

Collaborators: Eisai Co., Ltd.

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Rates of clinical response (2-3 weeks)
  Complete and partial clinical response, including confidence intervals.

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