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Afuresertib + Fulvestrant for Breast Cancer
Study Summary
This trial is testing a new combination therapy for patients with breast cancer who have failed 1-2 other treatments.
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 2016 Phase 2 & 3 trial • 12 Patients • NCT02116803Trial Design
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Who is running the clinical trial?
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- The doctor thinks you will live for at least 24 weeks.My breast cancer is positive for hormone receptors and negative for HER2.I have a history of seizures or conditions that may lead to seizures, or I have brain arteriovenous malformation or intracranial masses.My liver disease is moderately to severely advanced.My breast cancer is hormone receptor positive and HER2 negative.I haven't had major surgery or used IV antibiotics for an infection in the last 6 and 2 months, respectively.I am 18 years or older and can provide my own consent.I have recovered from side effects of my previous treatments to a mild level.I am a post-menopausal woman or I am pre-/peri-menopausal and willing to undergo ovarian suppression therapy.I agree to use birth control during and for 3 months after the study.I am fully active or can carry out light work.Your heart's electrical activity takes longer than normal to recharge.I am a woman who can have children and my pregnancy test before the study was positive.I will use effective birth control during and for 4 months after the study.I haven't had serious heart problems or blood clots in the last 6 months.I am currently taking medication that strongly affects liver enzymes.You have tested positive for HIV with certain criteria.I have an active Hepatitis B or C infection.I agree to tests for specific genetic changes in my cancer.I have waited the required time after my last cancer treatment before starting a new one.I can safely receive fulvestrant treatment.I have other cancers that are growing or needed treatment in the last 3 years.My high blood pressure is not under control.My blood, kidney, liver, clotting ability, and sugar levels are all within normal ranges.I can swallow pills and don't have stomach issues affecting medication absorption.I have previously been treated with medications targeting estrogen receptors or specific cancer growth pathways.I have active brain metastases or carcinomatous meningitis.
- Group 1: Afuresertib and Fulvestrant Safety Run In
- Group 2: Afuresertib and 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
Are researchers presently recruiting participants for this experiment?
"Affirmative, the clinicaltrials.gov database unveils that this experiment is actively seeking applicants. It was first advertised on February 18th 2022 and later edited on May 17th 2022. The research requires 20 participants at 6 different sites for completion."
Has Afuresertib been granted official sanction by the Food and Drug Administration?
"Due to the limited clinical data available, our team at Power has assigned Afuresertib a safety score of 1. This is because this particular drug is currently in Phase One trials and there are few studies that demonstrate its efficacy or security."
How many test sites are conducting this experiment?
"This clinical trial has 6 sites enrolling patients, including Providence St. Johns Health Center in Santa Monica and Piedmont Cancer Institute in Atlanta. Additionally, University of Iowa in Iowa City is also participating along with 3 other medical centres around the country."
What maladies has Afuresertib been proven to address effectively?
"Afuresertib is usually employed to address pik3ca gene mutation, but it can also have a positive effect on malignant neoplasms, disease progression and those who have undergone prior endocrine treatment."
Are there any prior research initiatives that have utilized Afuresertib?
"Afuresertib was initially investigated in 2004 at Lowell General Hospital, and since then 97 studies have been concluded. At present 135 trials are being conducted with a significant proportion taking place out of Santa Monica, California."
How many individuals are presently participating in this clinical investigation?
"To commence this medical trial, 20 appropriate individuals must be recruited. Participants can join from various locations including Providence St. Johns Health Center in Santa Monica and University of Iowa in Iowa City."
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