Statement: Participants in the primary trial administered with Fulvestrant 500mg via intramuscular injection had a higher % of clinical benefit than participants who were administered an additional 800mg of Venetoclax orally.
Primary_evidence: Outcome Measurement:    Clinical Benefit Defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) Lasting >= 24 Weeks, as Determined by the Investigator According to RECIST v1.1   Clinical Benefit was defined as CR, PR, or SD lasting more than equal to 24 weeks from randomization in participants with measurable disease at baseline, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions assessed by CT or MRI: CR, Disappearance of all target lesions; PR, PR >= 30% decrease in the sum of diameters of target lesions (TL) taking as reference the baseline sum of diameters; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Disease Progression (PD), PD>= 20% increase in the sum of diameters of TL taking as reference the smallest sum on study(Nadir). In addition to the relative increase of 20% sum must have demonstrate an absolute increase of at least 5mm.   Time frame: Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months) Results 1:    Arm/Group Title: Venetoclax + Fulvestrant   Arm/Group Description: Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).   Overall Number of Participants Analyzed: 51   Measure Type: Number   Unit of Measure: Percentage of Participants  11.8        (4.44 to 23.87) Results 2:    Arm/Group Title: Fulvestrant   Arm/Group Description: Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).   Overall Number of Participants Analyzed: 51   Measure Type: Number   Unit of Measure: Percentage of Participants  13.7        (5.70 to 26.26)