USO 22332
A phase IIIb study to characterize the efficacy and safety of ADJUVANT ribociclib plus endocrine therapy in a close-to-clinical practice patient population with HR+ HER2- early breast cancer (ADJUVANT WIDER) (CLEE011O12001)
Disease Types: Breast Cancer Research
Eligibility Requirements:
• Histologically/cytologically confirmed ER+, PR+, HER2- BC (IHC = 0, 1+
or 2+ (negative FISH, CISH, or SISH) – local testing
• After surgical resection, radiotherapy and/or adjuvant or neoadjuvant
chemotherapy
• Anatomic Stage Group IIA, IIB, and III
• Prior neoadjuvant and/or adjuvant ET is allowed if started within 36
months from enrollment and pt is eligible for 3 years of remaining ET
• Pt with prior ET > 12 months, restaging is highly recommended
• Ovarian suppression or short-term ET for fertility preservation is NOT
considered prior ET
• Pts receiving tamoxifen or toremifene need a washout period of 35 days prior
to first treatment (AI is allowed during this period)
• Prior chemotherapy (except neoadj/adj chemo)or CDK4/6i are excluded
• Prior tx with CDK4/6i (except ribociclib) for ≤ 6 months from first dose and
discontinued due to toxicity is allowed
• Tissue must be provided
• ECOG 0, 1, or 2
For more details on this trial CLICK HERE .
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