Badanie rybocyklibu w skojarzeniu z terapią hormonalną w zaawansowanym lub przerzutowym raku piersi HR+/HER2
Badanie dowodów z rzeczywistego świata dotyczące bezpieczeństwa i skuteczności rybocyklibu w skojarzeniu z terapią hormonalną u pacjentów z zaawansowanym lub przerzutowym rakiem piersi HR+/HER2 w regionie Bliskiego Wschodu
This is a non-interventional, ambispective, observational cohort study describing the real-world safety data of approximately 550 Hormone receptor / Human epidermal growth factor receptor 2 (HR+/HER2-) advanced/metastatic breast cancer patients who have received ribociclib combined with hormonal therapy in pre-and postmenopausal women or men in Middle Eastern countries.
Przegląd badań
Szczegółowy opis
The investigators will have a six-month recruitment period to include the eligible subjects as per the protocol selection criteria. Retrospective patients should have been on Ribociclib in combination with hormonal therapy for at least 18 months and stopped the medication before the patient's recruitment.
Ambispective patients should have initiated Ribociclib, in combination with hormonal therapy, for at least 12 months before the patient's recruitment date and are still on Ribociclib in combination with hormonal therapy at recruitment. These patients will be followed up till progression, death, Ribociclib discontinuation due to adverse events, or till a maximum period of 6 months, whichever comes first.
Data will be collected from patient electronic medical records in the sites chosen for patients who received Ribociclib, in combination with hormonal therapy, in the first or second-line setting available in the relevant institutions.
A total of 550 patients is planned for this study. The planned sample size should capture very common adverse events reported in previous studies as well as adverse events ≥ 10% occurring in grade 3 and grade 4 with precision ±2.5%.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Amman, Jordania, 11941
- Novartis Investigative Site
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Muscat, Oman, 111
- Novartis Investigative Site
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Al Ain Abu Dhabi, Zjednoczone Emiraty Arabskie
- Novartis Investigative Site
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
HR+/HER2- advanced/metastatic breast cancer patients who have received Ribociclib in combination with hormonal therapy in pre-and postmenopausal women or men in Middle Eastern countries
Opis
Inclusion Criteria:
- Adult patients ≥ 18 years old at the time of receiving Ribociclib in combination with hormonal therapy.
- Advanced /metastatic breast cancer
- Estrogen-receptor-positive and/or progesterone receptor-positive breast cancer.
- HER2-negative breast cancer.
- Patients who received or currently receiving Ribociclib in combination with hormonal therapy in the first or second-line settings as per the routine practice.
- For the ambispective part, patients should have initiated the Ribociclib, in combination with hormonal therapy, line of treatment at least 12 months before the patient's recruitment date and still continuingcontinuing the drug at the baseline visit.
- For retrospective patients only, the patients should have been on Ribocilib, in combination with hormonal therapy, for at least 18 months and stopped Ribociclib before the SIV date.enrollment
- For ambispective part, patients agree to sign informed consent before their enrollment.
Exclusion Criteria:
- Ribociclib-based treatment regimen beyond the second line.
- Patients are currently participating in any other clinical trials.
- Patient with a known hypersensitivity to any of the excipients of Ribociclib.
- Patients who previously received any other CDK4/6 inhibitor .
- For ambispective patients, patients who refuse to sign the informed consent
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: OTHER
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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ribociclib ambispective
Ambispective patients should have initiated Ribociclib, in combination with hormonal therapy, for at least 12 months before the patient's recruitment date and are still on Ribociclib in combination with hormonal therapy at recruitment. These patients will be followed up till progression, death, Ribociclib discontinuation due to adverse events, or till a maximum period of 6 months, whichever comes first. |
There is no treatment allocation for NIS trials, patients on administered ribociclib by prescription will be enrolled. Treatment plan represents the prescription.
Inne nazwy:
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ribociclib retrospective
Retrospective patients should have been on Ribociclib in combination with hormonal therapy for at least 18 months and stopped the medication before the patient's recruitment |
There is no treatment allocation for NIS trials, patients on administered ribociclib by prescription will be enrolled. Treatment plan represents the prescription.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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AEs/SAEs/ severity and frequency
Ramy czasowe: 18 months
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Frequency/ severity of adverse events and lab abnormalities of HR+/HER2- advanced/metastatic breast cancer patients who have received Ribociclib in combination with hormonal therapy at 6and 18 months. |
18 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Proportion of patients who are progression-free
Ramy czasowe: 6 months, 18 months
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Percentage of progression-free patients (at 18 months following the start date of ribociclib and at the end of ribociclib treatment), |
6 months, 18 months
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Proportion of patients with clinical benefit response
Ramy czasowe: 18 months
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Tthe proportion of patients who have a partial or complete response or stable disease(CBR) with Ribociclib at 18 months based on Response Evaluation Criteria in Solid Tumors RECIST v1.1 |
18 months
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Ribociclib line of therapy treatment pattern
Ramy czasowe: 18 months
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Ribociclib line of therapy treatment pattern at 18 months |
18 months
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CLEE011AIC01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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