Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE)

What Was Tested

This registered phase 2 trial tested Goserelin.

Despite different clinical characteristics including the response to treatment and the patterns of metastatic relapse, invasive lobular breast carcinoma (ILBC) is treated like invasive ductal breast carcinoma (IDBC) carcinoma both in the clinics and in clinical trials.

A non-clinical study of CDH1 synthetic lethality interactions has identified ROS1 as a potential target.

It had 1 arm (groups): Single Arm (experimental).

The registry classes the interventions as drug.

More on the Plan

Despite clinical and pathologic differences, ILBC is still treated as IDBC.

CDK4/6 inhibitors in combination with endocrine therapy are FDA-approved for the treatment of ER-positive/HER2-negative metastatic breast cancer following the results of 7 positive phase 3 trials.

These agents are currently tested in phase 3 studies in the adjuvant setting and might achieve the status of standard of care for subjects with ER-positive/HER2-negative early breast cancer treated with curative intent.

This rate is not available for the 7 subjects with lobular breast cancer enrolled in this arm.

Who Took Part

The registry lists 65 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 18 years. Multifocal unilateral or bilateral breast adenocarcinoma tumours are allowed if all tested foci are lobular, ER+ and HER2-. HER2 negative as defined by 2018 ASCO / CAP Guidelines. A primary non metastatic or locally advanced tumour of 15 mm or more, cN0 or cN1 without prior treatment candidate for preoperative treatment. ECOG Performance Status (PS) 0 or 1.

The full record lists 22 inclusion and 17 exclusion criteria; among the exclusions: clinical t4 disease including inflammatory breast cancer and/or cn3; prior history of invasive cancer in the past 5 years except basal or squamous cell carcinoma of skin that has been definitively treated; known hypersensitivity to the study drugs or excipients.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-01-14 with completion listed for 2025-01.

It ran at 10 sites in Belgium (7) and France (3).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Goserelin in 65 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.