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Benralizumab to Prevent Rash in Breast Cancer Patients on Alpelisib

Phase 2

Waitlist Available

Led By Mario Lacouture, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Exclusion Criteria: Known hypersensitivity to alpelisib, fulvestrant or AIs, benralizumab, cetirizine, or to any of the excipients of alpelisib, fulvestrant or AIs, benralizumab, or cetirizine, Concurrent malignancy (basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that have undergone curative intent therapy are allowed), Individuals with impaired decision making capacity, Concurrent use of another investigational drug or device for the rash (i.e., outside of study treatment) during, or within 4 weeks of treatment, Known use of anti-IL-5 agents or other biologics for the treatment of asthma which are known to decrease blood eosinophil levels within the past 12 weeks, Known history of anaphylaxis to benralizumab therapy, A helminthic parasitic infection diagnosed within 24 weeks prior to the first treatment, and assent when applicable, was obtained that had not been treated with, or has failed to respond to, standard of care therapy, Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy, Active infection that would impair the ability of the patient to receive study treatment, Women who are pregnant or breast-feeding, Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation, Oral corticosteroids at a dose of ≥20mg/day prednisone or equivalent within 14 days expected to continue during alpelisib therapy, More than 2 lines of endocrine-based therapy in the metastatic setting

Adequate organ and marrow function as defined below: Hemoglobin ≥8.0 g/dL, Absolute neutrophil count ≥1.0 × 10^9 /L, Platelet count ≥50 × 10^9 /L, Total bilirubin (TB) ≤1.0 × institutional upper limit of normal (ULN; Patients with known Gilbert's disease who have TB ≤3 × ULN may be enrolled), Aspartate transaminase/alanine transaminase ≤2.5 × ULN with normal alkaline phosphatase (≤5 × ULN for patients with liver metastases) OR ≤1.5 × ULN in conjunction with alkaline phosphatase >2.5 × ULN, Creatinine ≤1.5 mg/dL, Able to swallow oral medication, Willing to be randomized to any of the treatment arms and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, Women must be of postmenopausal status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if adding benralizumab to standard-of-care treatment can help prevent skin rash in people with metastatic breast cancer taking alpelisib.

Who is the study for?

This trial is for adults with metastatic HR-positive, HER2-negative breast cancer who are about to start alpelisib treatment. They must have a life expectancy of at least 6 months, good organ and marrow function, and be able to take oral medication. Pregnant or breastfeeding women, those with certain other cancers or infections, or on high-dose steroids can't participate.

What is being tested?

Researchers are testing if benralizumab can prevent skin rashes in patients starting alpelisib for breast cancer treatment. The study involves adding benralizumab to standard hormone therapy (fulvestrant or AIs) plus alpelisib to see if it reduces the incidence of this common side effect.

What are the potential side effects?

Potential side effects include reactions related to benralizumab such as headache, fever, fatigue, and allergic reactions. Alpelisib commonly causes skin rash which the study aims to prevent using benralizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You must have normal levels of hemoglobin, white blood cells, and platelets. Your liver and kidney functions should be within normal range. You should be able to swallow pills and be willing to follow the study's plan. If you are a woman, you should be past the age of natural childbearing.

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I have a visible tumor or a bone lesion that can be measured.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My breast cancer is HR-positive, HER2-negative with ER status over 10%.

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I am scheduled for standard hormone therapy for my cancer.

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My cancer has a PIK3CA mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Benralizumab and PI3K inhibition (alpelisib)Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Benralizumab

2016

Completed Phase 4

~10320

0 / 7Eligibility criteria met