Klinische Studie
A phase IIIb study to characterize the effectiveness and safety of ADJUVANT ribociclib in broad real-World patIent populations in stage II anD stage III Early breast canceR (ADJUVANT WIDER)(ADJUVANT WIDER)Eine Phase-IIIb-Studie zur Charakterisierung der Wirksamkeit und Sicherheit von ADJUVANT Ribociclib bei breiten realen Patientengruppen im frühen Stadium II und III von Brustkrebs (ADJUVANT WIDER)
Krankheitsentität(en)
Brust
StudientypInterventionsstudiePhase IIIB
StudientypInterventionsstudiePhase IIIB
Wesentliche Einschlusskriterien- Participant is an adult, male or female ≥ 18 years of age at the time of informed consent signature (ICF).
- Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory prior to enrolment.
- Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample.
- Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene, at the time of informed consent signature, but enrolment should occur within 24 months and the participant has at least 3 years remaining of endocrine adjuvant therapy.
- Participant has no contraindication for the adjuvant ET in the trial. Participant is allowed up to 24 months of prior ET with a capping of 1000 participants who have taken prior ET between 12 and 24 months prior to first study treatment (C1D1). Participant should have at least 3 years remaining of planned ET at first treatment dose (C1D1).
Wesentliche Ausschlusskriterien- Participant with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- Participant is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET.
- Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol or limit life expectancy to ≤5 years.
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
Statusin Vorbereitung
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgFrauenheilkunde und Geburtshilfe Krankenhaus St JosefStudienzentrale0941 7823403fhk-studienzentrum(at)csj.de