The ROLO trial is a targeted therapy clinical trial in the United Kingdom for patients with advanced or metastatic lobular breast cancer.

Name of the trial: ROLO– A phase 2 study for advanced lobular breast cancer  NCT03620643

Eligible patients: Citizens of the United Kingdom with advanced or metastatic lobular breast cancer

Summary:  The ROLO trial will test the effectiveness of Crizotinib combined with the drug Fulvestrant in patients with E-cadherin defective, ER+ advanced or metastatic lobular breast cancer. Crizotinib is manufactured by Pfizer and already approved by the FDA to treat a type of lung cancer.

Why is this Trial Important: This trial will test whether an existing FDA approved drug will be an effective targeted therapy for Lobular Breast Cancer.

Background:  This trial will test whether Crizotinib can target an alteration in the CDH1 gene that is commonly seen in lobular breast cancer. The defect in the CDH1 gene causes a loss of a protein called E-cadherin, which then allows lobular breast cancer cells to grow abnormally. Cells with defective CDH1 genes can continue to survive, but not when a protein called ROS-1 is defective or missing. Cells cannot survive when both E-cadherin and ROS-1 are not functional. Crizotinib acts to inactivate ROS-1. In cells in the laboratory, Crizotinib inactivated ROS-1 and killed E-cadherin defective cells. The ROLO trial will test if the same effect is seen in humans.

Clinical Trial location: United Kingdom (This trial is only accepting patients from the United Kingdom)

How to learn more about whether participating in this trial is right for you:  Send inquiries to ROLO.trial@rmh.nhs.uk

The Lobular Breast Cancer Alliance shares information about ongoing clinical for lobular breast cancer.  LBCA does not sponsor or run the clinical trials, and the scientific validity and safety of the trials is the responsibility of the trial investigators. Learn more by contacting the clinical trial coordinators listed above directly.

Patients should always discuss their participation in any clinical trial directly with their doctor – these Questions to Ask your Doctor may help. Learn more about participating in clinical trials.  Learn about other lobular breast cancer clinical trials and studies.