Neoadjuvant Treatment of Locally-advanced Breast Cancer Patients With Ribociclib and Letrozole

What Was Tested

The trial (phase 2) is built around Goserelin.

It had 1 arm (groups): Ribociclib and Letrozole Arm (experimental).

The registry classes the interventions as drug.

More on the Plan

It is the general opinion that aromatase inhibitors of the "third-generation" (letrozole, anastrozole, exemestane) are the preferable drugs for neoadjuvant endocrine therapy in ER-positive, postmenopausal breast cancer patients.

All three drugs are currently used as standard care in the neoadjuvant, adjuvant and metastatic setting worldwide, including in Norway.

In 2015, a new class of anti-cancer drugs was introduced known as cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors.

Following pivotal trials showing dramatic effects when combined with aromatase inhibitors or steroidal antiestrogens like fulvestrant, these compounds are now well established in distinct combinations during therapy for metastatic breast cancer.

Who Took Part

The registry lists 85 actual participants took part.

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: Females ≥ 18 years old at the time of the ICF signature. Histologically confirmed locally advanced breast carcinoma, defined as either large T2 (\>3cm in diameter) or T3-T4, and/or N2-3 primary breast cancer. Performance status: Eastern Cooperative Oncology Group (ECOG) score 0-1. Ability and willingness to comply with study visits, treatment, testing and to comply with the protocol.

The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: any prior treatment for primary invasive breast cancer; patient with a known hypersensitivity to any of the excipients of ribociclib or letrozole; patient with known hypersensitivity to peanuts or soya-products.

How the Study Was Run

It was run as a single-group and open-label study.

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 2022-12-01 with completion listed for 2024-07-30.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To study the change in levels of direct and indirect immunologic biomarkers of targeted cancer therapy with letrozole and ribociclib given in combination for patients with locally-advanced, ER-positive, HER-2 negative, luminal A7B breast cancer (time frame: Baseline, Day 21 and at time of surgery (Day 180)).

It also tracked 12 secondary outcomes, for example Measurement of changes in the tumor through DNA profiling throughout the treatment cycle with letrozole and ribociclib, Confirmation of the breast cancer subtype, Changes in neoantigens and single T-cell receptor function after treatment with letrozole and ribociclib, Determination of the histopathological sub-type and status of the tumour, Determination of the early and late mechanisms of adaptation and/or resistance to letrozole in combination with ribociclib and Change in PEPI status from baseline in response to targeted neoadjuvant therapy with letrozole and ribociclib.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Goserelin in 85 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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