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Benralizumab to Prevent Rash in Breast Cancer Patients on Alpelisib
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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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.I have a visible tumor or a bone lesion that can be measured.I am 18 years old or older.You are expected to live for at least 6 more months.I am fully active or restricted in physically strenuous activity but can do light work.My breast cancer is HR-positive, HER2-negative with ER status over 10%.I am scheduled for standard hormone therapy for my cancer.My cancer has a PIK3CA mutation.
- Group 1: Benralizumab and PI3K inhibition (alpelisib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there a potential risk with utilizing Benralizumab and PI3K inhibition (alpelisib)?
"The safety of Benralizumab and PI3K inhibition (alpelisib) has been rated at a 2 on the scale, due to its current status as Phase 2. While there is some evidence for their safety, no data exists yet that can verify their efficacy."
To what extent are local healthcare facilities performing this experiment?
"At present, this research project is occurring in 9 different clinics. These include Boston, Basking Ridge and Middletown, among other locations. Therefore, participants should select the clinic closest to them for convenience's sake when considering taking part in the trial."
How many participants are you accepting for this clinical trial?
"AstraZeneca necessitates 63 participants that meet the specified inclusion criteria to proceed with their study. In order to do this, they have chosen Dana Farber Cancer Institute in Boston and Memorial Sloan Kettering Basking Ridge (All Protocol Activities) in New jersey as two of many enrolment sites."
Are recruitment efforts still ongoing for this medical trial?
"Affirmative. According to information made available via clinicaltrials.gov, this research endeavour was first posted on July 6th 2023 and is currently enrolling suitable candidates. The study requires 63 test subjects from 9 distinct medical facilities."
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