Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Exanthema

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Respiratory System Agents

Hormones

Fulvestrant

Benralizumab

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Anti-Asthmatic Agents

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 30mg subcutaneously on day -1.

SOC endocrine therapy (fulvestrant or AIs) and PI3K inhibition (alpelisib)

fulvestrant or AIs) and PI3K inhibition (alpelisib)

Shari Goldfarb, MD

Pedram Razavi, MD,PhD

Lisa Zaba, MD, PhD

Nicole LeBoeuf, MD

Pedram Razavi, MD, PhD

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.

A multi-center, open-label, phase 2 trial

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

RETENTION: An Open-Label Phase 2 Trial of InteRlEukin (5) InhibiTion for the prEveNTION of Alpelisib Rash in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

AstraZeneca

Novartis Pharmaceuticals

Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for fulvestrant or ais) and pi3k inhibition (alpelisib)