The ROSALINE Trial is a Phase 2 pre-operative study for people with early-stage invasive lobular carcinoma (ILC), also know as lobular breast cancer.

Name of Trial:  ROSALINE: Evaluating Efficacy of Targeting ROS1 in Combination with Endocrine Therapy in Inhibiting Invasive Lobular Carcinoma Tumor Growth NCT04551495

Eligible patients: Pre- and post-menopausal women with early stage (stages 1-3) lobular breast cancer in Belgium and France.

Summary: Patients with early stage ILC will be given Letrozole, a standard hormone therapy drug, in combination with Entrectinib, a drug that targets a protein called ROS1 for four months before undergoing breast surgery. Entrectinib is manufactured by ROCHE and is FDA and EMA approved for a type of lung cancer and other cancers with a specific biomarker.

Why this trial is important: This trial will test whether the new combination of two approved drugs will be an effective therapy for inhibiting lobular breast cancer tumor growth. The pre-operative setting allows for the collection of samples from the initial biopsy and subsequent surgery to study the changes induced by the treatment.

Background: A defect in the CDH1 gene that results in the loss of the protein (E-cadherin) that causes tumor cells to form lumps, is commonly seen in lobular breast cancer.  A laboratory study has shown that a drug that targets (i.e., inhibits) ROS1 triggers destruction of lobular cancer cells with the CDH1 defect. ROSALINE aims to test this concept in an early-stage setting. The advantages of conducting the study before treatment with any drug is that the tumor is “treatment-naive” and has not accumulated resistance mechanisms. The pre-operative setting also allows for the collection of samples with which to conduct additional studies in the lab.

Principal Investigator: Philippe Aftimos, MD., Institut Jules Bordet

More information: https://clinicaltrials.gov/ct2/show/NCT04551495/

Trial Locations: Belgium and France

How to learn more about whether participating in this trial is right for you: Send inquiries to ctsu.ROSALINE@bordet.be

An abstract titled ROSALINE: a phase II, neoadjuvant study targeting ROS1 in combination with endocrine therapy in invasive lobular carcinoma of the breast about the study is now available.