Conditions: Breast Cancer
Keywords: Alpelisib Benralizumab Metastatic HR-positive HER2-negative breast cancer Rash 22-276
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief summary:
The researcher are doing this study to find out whether benralizumab is effective at preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin rash is a common side effect of alpelisib. Researchers think adding benralizumab to the standard-of-care hormone treatment and alpelisib may prevent the patient from getting a rash.

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: Benralizumab intervention 2: fulvestrant or AIs) and PI3K inhibition (alpelisib)
Intervention descriptions: intervention 1: Benralizumab 30mg subcutaneously on day -1. intervention 2: SOC endocrine therapy (fulvestrant or AIs) and PI3K inhibition (alpelisib)

Protocol document:
Prot_SAP_000.pdf: