Center for Global Research Data

Statin use and clinical outcomes on ado-trastuzumab emtansine (T-DM1) in HER2-positive metastatic breast cancer

Lead Investigator: Joshua Drago, Memorial Sloan Kettering Cancer Center
Title of Proposal Research: Statin use and clinical outcomes on ado-trastuzumab emtansine (T-DM1) in HER2-positive metastatic breast cancer
Vivli Data Request: 7535
Funding Source: None
Potential Conflicts of Interest: Honoraria: OncLive
Advisory Board: Biotheranostics
Funded Research: AstraZeneca
These declared conflicts are not relevant to the proposed project but will nonetheless be declared on any future publications of these data.

Summary of the Proposed Research:

Membrane epidermal growth factor receptor 2 (HER2) expression levels strongly influence the activity of therapies that target HER2 in cancers, including breast cancer. A protein called caveolin-1 (CAV-1) regulates the amount of HER2 expressed on cancer cells, and this expression can be modulated with cholesterol-depleting drugs, such as statins. In cell models, statins can increase the effectiveness of HER2-targeted therapies. One such therapy is ado-trastuzumab emtansine (T-DM1), which is commonly used in metastatic breast cancer that over-expresses HER2. We have initial evidence from a small sample size that taking patients who take statins along with T-DM1 have better cancer-related outcomes. We hope to confirm these findings using a larger sample size from the KAMILLA trial, in which over 2000 patients with metastatic HER2-positive breast cancer were treated with T-DM1. If we observe the same relationship, that will support the conduct of a prospective clinical trial combining statins with HER2-targeted therapies in breast cancer.

Requested Studies:

A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment
Data Contributor: Roche
Study ID: NCT01702571
Sponsor ID: MO28231