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Alpelisib + Endocrine Therapy for Breast Cancer
Study Summary
This trial is for patients with late-stage breast cancer who have a specific genetic mutation. They will take a daily drug (alpelisib) in combination with a standard cancer treatment. The trial will follow patients to see how well they respond to the new drug.
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.Side effects data
From 2023 Phase 3 trial • 572 Patients • NCT02437318Trial Design
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Who is running the clinical trial?
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- I agree to use effective birth control or abstain from sex during and 3 months after the study.I have had serious heart issues or very high blood pressure in the last 6 months.I am a man, or I am a woman who is postmenopausal or have been made postmenopausal.I have been treated with PI3K, mTOR, or AKT inhibitors for cancer that has spread.I have been mostly active and able to care for myself in the last 28 days.I have received chemotherapy for my advanced or metastatic disease.I do not have brain metastases causing symptoms or needing treatment.I have been treated with a CDK4/6 inhibitor for breast cancer that has spread.My cancer is severe enough that hormone therapy is not an option.I am 18 years old or older.I will use approved birth control methods if I'm not sterile.I understand and can follow the study's procedures.I have been on daily steroids for more than 14 days and need to continue.I have a tumor that can be measured or a specific type of bone lesion.I have had acute pancreatitis in the last year or suffer from chronic pancreatitis.My organ functions are within normal ranges as required.My last cancer treatment was hormone therapy, but my cancer still progressed.I have type 1 diabetes or poorly controlled diabetes with A1c > 8.0% for over a year.I do not have another cancer that could affect this trial's safety or results.My cancer has a PIK3CA mutation.I am currently on medication for an infection.My doctor thinks my stomach or intestines might not absorb medicine well.I had pneumonitis but it's now resolved and I've finished all treatments for it.I had radiation on the main cancer area less than 4 weeks ago, or for symptom relief less than 2 weeks ago.My cancer is hormone receptor positive with ER and/or PR levels at or above 1%.My breast cancer is confirmed to be HER2 negative.My breast cancer cannot be removed by surgery and has spread.I have been treated with hormone therapy for my cancer that has spread.I have had 2 or fewer hormone treatments for my cancer that has spread.I am HIV-positive, on effective treatment, and my viral load has been undetectable for the last 6 months.
- Group 1: Alpelisib + Aromatase Inhibitor or Fulvestrant
- 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 Alpelisib a proven therapy, as evidenced by past experiments?
"Presently, Alpelisib is the focus of 152 active studies with 35 in Phase 3. While Shanghai has a large number of trials involving this compound, it can be accessed at 6490 different medical centres around the world."
Does this research endeavor still have room for participants?
"According to clinicaltrials.gov, this ongoing medical study is currently recruiting subjects. Initially posted on February 12th 2021, the trial's details were most recently reviewed and updated on November 14th 2022."
Could you shed some light on the potential risks of taking Alpelisib?
"The safety of Alpelisib was assessed as a 2 due to its current standing in Phase 2 clinical trials, with evidence indicating that it is safe but no data currently affirming its efficacy."
What is the cap for enrollment in this clinical trial?
"Novartis requires 44 individuals that meet their criteria in order to run this trial. The pharmaceutical company will be hosting the study from two locations, University of Illinois Cancer Center (Chicago) and Penn State Cancer Institute (Hershey)."
What medical conditions has Alpelisib been successful in treating?
"Alpelisib is commonly employed as a response to endocrine therapy. It has also demonstrated efficacy in treating multiple other maladies such as disease, breast cancer, and pik3ca gene mutation."
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