Study on Simvastatin and Dual Anti-HER2 Therapy for Metastatic Breast Cancer

Sponsor: Baylor Breast Care Center

Sponsor score: 0

ClinicalTrials ID:NCT03324425

Provider View

This clinical trial is exploring whether adding simvastatin to the current dual anti-HER2 therapy can help control metastatic breast cancer that has stopped responding to treatment. All participants will receive simvastatin along with their existing anti-HER2 therapy.

Patient Parameters

Program Overview

This study is for patients with metastatic breast cancer that is HER2-positive, meaning the cancer cells have too many HER2 receptors, which help them grow. The study aims to see if adding simvastatin, a drug usually used to lower cholesterol, can make the cancer respond again to HER2-targeted therapies. These therapies work by blocking the HER2 protein, stopping cancer cells from growing. However, some tumors find ways to grow even when HER2 is blocked. Researchers believe simvastatin might help stop this and make the cancer shrink again.

Description

This study is for people with HER2-positive metastatic breast cancer, which means the cancer has spread beyond the breast and has too many HER2 receptors. HER2-targeted therapies are used to block these receptors and stop cancer growth. However, some cancers find ways to grow despite this treatment. This study is testing if adding simvastatin, a cholesterol-lowering drug, can help the cancer respond to HER2 therapies again. Simvastatin has shown promise in lab studies when combined with HER2-targeted therapies. Participants will receive simvastatin along with their current anti-HER2 treatment to see if it helps control the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed informed consent.
  • Have confirmed metastatic breast cancer that cannot be cured.
  • Cancer must be HER2-positive.
  • Must have shown disease progression while on dual anti-HER2 therapy.
  • Must be female and at least 18 years old.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have measurable disease according to specific criteria.
  • Must not have had major surgery or radiation within 28 days before starting simvastatin.
  • Must have a life expectancy of at least 12 weeks.
  • Must be able to swallow pills.
  • Must have adequate organ function based on blood tests.
  • Must have a heart function of at least 50%.
  • If there is brain involvement, it must be stable for at least 3 months.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study.

Exclusion Criteria

  • Currently taking or have recently taken a statin drug.
  • Allergic to statins.
  • History of muscle breakdown (rhabdomyolysis).
  • Consume more than 3 alcoholic drinks per day.
  • Have digestive issues that prevent taking oral medications.
  • Have uncontrolled high blood pressure or significant heart disease.
  • Have severe, uncontrolled health conditions.
  • Have HIV, Hepatitis B, or Hepatitis C.
  • Have had IV antibiotics for infection within 7 days before joining the study.
  • Have had other cancers in the last 2 years, except certain skin or cervical cancers.
  • Have only bone disease unless there is a measurable lesion.
  • Have a medical or psychiatric condition that affects participation.
  • Participating in other interventional studies.

Locations

FACILITYZIPCITYSTATE
Harris Health System - Smith Clinic77054HoustonTexas
O'Quinn Medical Tower - McNair Campus; Dan L Duncan Comprehensive Cancer Center77054HoustonTexas

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