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

NCT05966584 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 22-276
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer

Keywords

Alpelisib; Benralizumab; Metastatic HR-positive; HER2-negative breast cancer; Rash; 22-276

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects That Have a Grade ≤1 Rash

  4 weeks

Study Arms (1)

Benralizumab and PI3K inhibition (alpelisib)

EXPERIMENTAL

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.

Drug: Benralizumab; Drug: fulvestrant or AIs) and PI3K inhibition (alpelisib)

Interventions

Benralizumab DRUG

Benralizumab 30mg subcutaneously on day -1.

Benralizumab and PI3K inhibition (alpelisib)

fulvestrant or AIs) and PI3K inhibition (alpelisib) DRUG

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

Benralizumab and PI3K inhibition (alpelisib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic HR-positive, HER2-negative breast cancer. HR positive is defined by ER status \>10% immunohistochemical (IHC) staining of any intensity.
• Must be scheduled to receive SOC endocrine therapy (alpelisib plus fulvestrant or AIs)
• Presence of one or more activating PIK3CA mutations in tumor tissue.
• Measurable disease per RECIST v1.1 OR at least one predominantly lytic bone lesion must be present.
• Written informed consent provided
• Female or male ≥18 years of age
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Life expectancy ≥6 months.
• Adequate organ and marrow function as defined below:
• Hemoglobin ≥8.0 g/dL (without blood transfusion within 7 days of laboratory test used to determine eligibility)
• Absolute neutrophil count ≥1.0 × 10\^9 /L (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
• Platelet count ≥50 × 10\^9 /L (without transfusion within 2 weeks of laboratory test used to determine eligibility)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• AstraZeneca: collaborator
• Novartis Pharmaceuticals: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville (Limited Protocol Activities)

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Exanthema

Interventions

benralizumab; Fulvestrant; Alpelisib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Alina Markova, MD
• Organization: Memorial Sloan Kettering Cancer Center

markovaa@mskcc.org

646-608-2380

Study Officials

• Alina Markova, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multi-center, open-label, phase 2 trial

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: July 6, 2023
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2024
• Last Updated: August 29, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

US (7)