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Lasofoxifene vs Fulvestrant for Breast Cancer
Study Summary
This trial evaluates the activity of a drug (lasofoxifene) to treat pre- and postmenopausal women with advanced breast cancer caused by an ESR1 mutation. It will measure progression free survival, clinical benefit, response rate, overall survival, QoL and safety.
Timeline
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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- You have taken everolimus or other similar medications, unless you stopped for reasons other than your condition getting worse.You have a serious and urgent medical need that requires chemotherapy.You have only had one round of chemotherapy for advanced breast cancer.You are able to perform daily activities with little to no difficulty.Your organs need to work well, as shown by specific blood test results.You have advanced or spreading breast cancer that has not responded to a specific combination of medications.You have advanced or spread-out breast cancer with spots that can or cannot be measured.You have specific mutations in the ESR1 gene that can be detected in a blood test.You have a history of long QTC syndrome or a QTC measurement of more than 480 milliseconds.You have cancer that has spread to your brain.Cancer has spread to the lungs.You have previously tested positive for HIV, HBV, or HCV.You can be either before or after menopause.Women who have gone through menopause or have had their ovaries removed.You have had a blood clot in your lungs or legs in the past 6 months, or have a condition that makes blood clots more likely.You have had cancer, except for breast cancer, in the last 5 years.You have experienced vaginal bleeding in the past year, unless it was caused by something other than the uterus.Your high blood pressure is not under control.You have a history of not following your doctor's instructions for taking medicine.You need to have a biopsy to confirm your cancer is estrogen receptor positive and HER2 negative, or the tissue obtained at the time of your original diagnosis confirms this.
- Group 1: Fulvestrant
- Group 2: Lasofoxifene
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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
What is the Lasofoxifene approval status by the FDA?
"Lasofoxifene is a medication that, while having no efficacy data yet, has some evidence supporting its safety."
What do we already know about Lasofoxifene from other research?
"Lasofoxifene was first researched in 2004 at Lowell General Hospital. So far, 93 clinical trials have been completed with 140 more ongoing. Many of these live trials are based in Montreal, Quebec."
Out of how many people who express interest, how many are typically chosen to participate in this trial?
"As of October 24th, 2022 this clinical trial is no longer recruiting patients. It was first posted on September 20th, 2019. If you are interested in alternative studies, there are 2372 trials actively searching for breast cancer patients and 140 for Lasofoxifene."
How is Lasofoxifene most often used to improve patient care?
"Lasofoxifene can not only manage endocrine therapy-resistant disease but also conditions such as breast cancer and pik3ca gene mutation."
Are there any vacant slots in this experiment for new volunteers?
"According to clinicaltrials.gov, this study has already completed recruitment for participants. The trial was initially posted on September 20th, 2019 and updated last on October 24th, 2020; however, there are still 2512 other trials recruiting patients at the moment."
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