Study on Lenvatinib, Pembrolizumab, and Fulvestrant for Breast Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06110793

Provider View

This clinical trial is testing a combination of three drugs—lenvatinib, pembrolizumab, and fulvestrant—to see if they are safe and effective for treating people with a specific type of advanced breast cancer (ER+/HER2-).

Patient Parameters

Program Overview

The aim of this study is to determine if the combination of lenvatinib, pembrolizumab, and fulvestrant is a safe and effective treatment for people with ER+/HER2- metastatic breast cancer, with minimal side effects.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with advanced breast cancer that cannot be surgically removed.
  • Men and premenopausal women must be on hormone therapy for at least four weeks before starting the trial and continue it during the study.
  • Diagnosed with ER+ (estrogen receptor positive) and HER2- (human epidermal growth factor receptor 2 negative) breast cancer.
  • Cancer has progressed after at least one hormone therapy combined with a CDK 4/6 inhibitor.
  • No more than two previous chemotherapy treatments for metastatic cancer.
  • Stable brain metastases that have not worsened for at least four weeks.
  • Life expectancy of at least 12 weeks.
  • A new biopsy of the tumor is needed before starting the study, unless previous samples are available.
  • Must have measurable disease based on specific criteria.
  • Good overall health with a performance status score of 0 or 1.
  • Blood pressure must be controlled, with or without medication.
  • Adequate organ function based on lab tests.
  • Women must not be pregnant or breastfeeding and must use effective birth control during the study and for a specified time after.
  • Men must agree to use contraception or be abstinent during the study and for a short period after.
  • Participants with hepatitis B or C must have controlled viral loads.
  • Specific blood and organ function levels must be met.

Exclusion Criteria

  • Previous treatment with certain immune therapies or lenvatinib.
  • Recent cancer treatments or participation in other clinical trials.
  • Active infections or other serious medical conditions.
  • Known additional cancers requiring treatment in the past three years.
  • Active brain metastases or certain lung diseases.
  • Pregnant or breastfeeding women.
  • History of severe allergic reactions to study drugs.
  • Significant heart or blood vessel problems.
  • Active autoimmune diseases requiring treatment in the past two years.
  • Major surgery within the past three weeks.
  • Certain kidney or liver function issues.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.