Идёт набор NCT06830720

A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence

— Наблюдательное Breast Neoplasms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ribociclib + AI ± LHRH, abemaciclib + ET ± LHRH, ET mono ± LHRH.
Кому может быть актуально: Состояния в реестре: Breast Neoplasms. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австрия, Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence to Evaluate Real-world Effectiveness, Safety Profile, Patient Compliance and Quality of Life

Обзор

This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer at high risk of recurrence, as well as patient compliance and quality of life.

Подробное описание

This non-interventional study aims to provide information on real-world effectiveness, safety and tolerability, management of adverse events, QoL and patient compliance of patients with HR+/HER2- early breast cancer at high risk of recurrence treated with ribociclib in combination with an aromatase inhibitor (AI) ± luteinizing hormone-releasing hormone (LHRH) with curative intent according to the current effective local summary of product characteristics.

In order to put the results of patients treated with ribociclib into perspective, socio-economic data, data on QoL and patient compliance will also be collected from patients treated with abemaciclib + endocrine therapy (ET) ± LHRH as described in the current effective local summary of product characteristics.

To understand reasons for treatment decision, and to analyze the clinical adoption of ribociclib + AI ± LHRH after EU approval over time, baseline data will be collected from cohorts of ribociclib + AI ± LHRH, abemaciclib + ET ± LHRH, and additionally from patients treated with ET monotherapy ± LHRH and analyzed cross-sectionally.

The study is planned to be rolled out into a broad set of German and Austrian breast centers and gynecological practices to describe clinical routine in a representative subset of the local healthcare eco-system. It will gather insights into the potential benefits and risks associated with ribociclib + AI ± LHRH in the adjuvant treatment of HR+/HER2- eBC patients at high risk of recurrence. This knowledge will inform about clinical decision-making and contribute to improved patient outcomes in routine practice.

Вмешательства

Препарат ribociclib + AI ± LHRH
ribociclib in combination with an aromatase inhibitor ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Препарат abemaciclib + ET ± LHRH
abemaciclib in combination with an endocrine therapy ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
Препарат ET mono ± LHRH
endocrine monotherapy ± LHRH. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

Первичные конечные точки

Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence [Срок оценки: 36 months]

Вторичные конечные точки (12)

Number of participants per Baseline parameters [Срок оценки: baseline]
Reasons for treatment decision by treating physician [Срок оценки: baseline]
Patients' individual perception of risk of recurrence and treatment decision [Срок оценки: baseline]
Invasive disease-free survival (iDFS) (ribociclib cohort) [Срок оценки: 12 and 24 months]
Invasive breast cancer-free survival (iBCFS) (ribociclib cohort) [Срок оценки: 12, 24 and 36 months]
Recurrence-free survival (RFS) (ribociclib cohort) [Срок оценки: 12, 24 and 36 months]
Distant disease-free survival (DDFS) (ribociclib cohort) [Срок оценки: 12, 24 and 36 months]
Incidence and severity of adverse events (ribociclib cohort) [Срок оценки: up to 36 months]
Dose modification rates (ribociclib cohort) [Срок оценки: up to 36 months]
Treatment interruption rates (ribociclib cohort) [Срок оценки: up to 36 months]
Discontinuation rates (ribociclib cohort) [Срок оценки: up to 36 months]
Time to discontinuation (TTD) (ribociclib cohort) [Срок оценки: up to 36 months]

Критерии участия

Критерии включения

Histological diagnosis of HR+/HER2- early breast cancer with curative intent
Patients must have an indication for a treatment with ribociclib + AI ± LHRH as described in the current SmPC/"Fachinformation" of ribociclib (to be included into the cohorts of ribociclib + AI ± LHRH and ET mono ± LHRH) or abemaciclib + ET ± LHRH as described in the current SmPC/"Fachinformation" of abemaciclib (to be included into the abemaciclib + ET ± LHRH cohort) in the adjuvant setting
Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either

ribociclib + AI ± LHRH, or
ET mono ± LHRH, or
abemaciclib + ET ± LHRH and baseline is no longer than 2 weeks (14 days) prior to written informed consent for this study.

Baseline = for ribociclib + AI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: within 4 weeks after therapy start or within 4 weeks after last non-endocrine based therapy, whichever is last.

≥18 years of age
Written informed consent

Критерии исключения

\- Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет