SERAFA-1: A Single arm, Open label, Multicentre, Phase IIIb Study Of Camizestrant plus Ribociclib in 1st line Treatment of ER-positive, HER2-negative Advanced Breast Cancer Patients

Breast Cancer

TTNT is defined as time from the date of the first administration of study treatment to the earliest start date of subsequent anti-cancer medication or death. Discontinuation of ribociclib does not affect the TTNT duration. Analysis will include all participants who received at least one dose of study treatment. The primary measure of interest is the TTNT event-free rate at 2 years.

1. TTD is defined as time from the date of the first administration of study treatment to the earliest date of camizestrant treatment discontinuation or death. Discontinuation of ribociclib does not affect the TTD duration. Analysis will include all participants who received at least one dose of study treatment. The primary measure of interest is the TTD event-free rate at 2 years., 2. PFS is the time from first study dose to progression per RECIST 1.1 as assessed by Investigator or death. All events are counted, including those after treatment discontinuation, new anticancer therapy, or clinical progression before RECIST progression. If progression or death occurs after two or more missed visits, the participant is censored at the last evaluable assessment; the primary measure is the PFS event free rate at 1 & 2 years., 3. Incidence of Grade ≥ 3 CTCAEs within first 6 months of study treatment. Analysis will include all participants who received at least one dose of study treatment., 4. Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical laboratory results, other diagnostic tests.. Analysis will include all participants who received at least one dose of study treatment.

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