Eine Studie zu Ribociclib in Kombination mit einer Hormontherapie bei HR+/HER2- fortgeschrittenem oder metastasiertem Brustkrebs
Praxisnahe Evidenzstudie zur Sicherheit und Wirksamkeit von Ribociclib in Kombination mit einer Hormontherapie bei Patientinnen mit HR+/HER2- fortgeschrittenem oder metastasiertem Brustkrebs im Nahen Osten
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.
Studienübersicht
Detaillierte Beschreibung
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%.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Amman, Jordanien, 11941
- Novartis Investigative Site
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Muscat, Oman, 111
- Novartis Investigative Site
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Al Ain Abu Dhabi, Vereinigte Arabische Emirate
- Novartis Investigative Site
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: OTHER
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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.
Andere Namen:
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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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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AEs/SAEs/ severity and frequency
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Proportion of patients who are progression-free
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 18 months
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Ribociclib line of therapy treatment pattern at 18 months |
18 months
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CLEE011AIC01
Plan für individuelle Teilnehmerdaten (IPD)
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