Trial Outcomes & Findings for A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer (NCT NCT05966584)

Last Updated: 2024-08-29

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

4 weeks

Results posted on

2024-08-29

Participant milestones
Measure	Benralizumab and PI3K Inhibition (Alpelisib) Patients will receive fulvestrant or AIs and PI3K inhibition (alpelisib) per SOC (fulvestrant on days 1, 15, 29 and monthly thereafter; Ais on a daily continuous basis). Participants will receive one injection of benralizumab 30mg subcutaneously on day -1. Benralizumab: Benralizumab 30mg subcutaneously on day -1. fulvestrant or AIs) and PI3K inhibition (alpelisib): SOC endocrine therapy (fulvestrant or AIs) and PI3K inhibition (alpelisib)
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Benralizumab and PI3K Inhibition (Alpelisib) Patients will receive fulvestrant or AIs and PI3K inhibition (alpelisib) per SOC (fulvestrant on days 1, 15, 29 and monthly thereafter; Ais on a daily continuous basis). Participants will receive one injection of benralizumab 30mg subcutaneously on day -1. Benralizumab: Benralizumab 30mg subcutaneously on day -1. fulvestrant or AIs) and PI3K inhibition (alpelisib): SOC endocrine therapy (fulvestrant or AIs) and PI3K inhibition (alpelisib)
Overall Study Lost to Follow-up	1

A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer

Baseline characteristics by cohort
Measure	Benralizumab and PI3K Inhibition (Alpelisib) n=1 Participants Patients will receive fulvestrant or AIs and PI3K inhibition (alpelisib) per SOC (fulvestrant on days 1, 15, 29 and monthly thereafter; Ais on a daily continuous basis). Participants will receive one injection of benralizumab 30mg subcutaneously on day -1. Benralizumab: Benralizumab 30mg subcutaneously on day -1. fulvestrant or AIs) and PI3K inhibition (alpelisib): SOC endocrine therapy (fulvestrant or AIs) and PI3K inhibition (alpelisib)
Age, Continuous	70 years n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	1 Participants n=99 Participants

Timeframe: 4 weeks

Outcome measures
Measure	Benralizumab and PI3K Inhibition (Alpelisib) n=1 Participants Patients will receive fulvestrant or AIs and PI3K inhibition (alpelisib) per SOC (fulvestrant on days 1, 15, 29 and monthly thereafter; Ais on a daily continuous basis). Participants will receive one injection of benralizumab 30mg subcutaneously on day -1. Benralizumab: Benralizumab 30mg subcutaneously on day -1. fulvestrant or AIs) and PI3K inhibition (alpelisib): SOC endocrine therapy (fulvestrant or AIs) and PI3K inhibition (alpelisib)
Proportion of Subjects That Have a Grade ≤1 Rash	0 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Memorial Sloan Kettering Cancer Center

Phone: 646-608-2380