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LEE011 + BYL719 + Letrozole for Breast Cancer
Study Summary
This trial will help researchers learn more about how effective and safe two investigational agents are in treating ER+ breast cancer.
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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- My heart does not function properly.I had early-stage breast cancer treatment and have been disease-free for over a year.I have diabetes or had gestational diabetes.I may have had multiple hormone treatments but only one chemotherapy for advanced cancer.I have pancreatitis.I haven't had systemic treatment for advanced cancer, except possibly letrozole for up to a month.I am on hormone replacement therapy that I cannot stop.My tumor has high levels of HER2.I have active brain metastases.I am eligible for Phase Ib dose expansions in Arms 1, 2, or 3.I have not had another cancer in the last 3 years.My cancer has spread throughout both lungs.I have not had major surgery in the last 2 weeks.I am postmenopausal with hormone-receptor positive breast cancer.
- Group 1: LEE011 + letrozole Arm 1
- Group 2: BYL719 + letrozole Arm 2
- Group 3: LEE011 + BYL719 + letrozole Arm 3
- Group 4: LEE011+ BYL719+letrozole Arm 4
- 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
How is LEE011 most commonly employed?
"LEE011 is most often used to treat different types of cancer. However, it can also be given to patients with anovulatory cycles, advanced hr+ her2- breast cancer, and those that are tamoxifen resistant."
Is LEE011 a new medication or has it been studied before?
"LEE011 was first studied over 25 years ago at the National Institutes of Health Clinical Center. To date, there have been 240 completed studies with 226 more currently underway. A large number of these ongoing trials are based in Boston, Massachusetts."
What are the objectives of this clinical research?
"The primary outcome of this medical trial, which will be assessed over an 18-month period, is the PK profiles of LEE011 and letrozole. Additionally, secondary outcomes being evaluated include Plasma concentration-time profiles of LEE011, BYL719 and letrozole, ORR (Overall Response Rate), and PFS (Progression Free Survival)."
Are there still open slots for this research project?
"No, this particular clinical trial is not currently enrolling patients. The original posting date was October 22nd, 2013 with the most recent update on October 3rd, 2022. There are 2924 other medical studies that are actively recruiting right now."
Where can I find a list of facilities where this research is being conducted?
"So far, this trial has enrolled patients from the following locations: Massachuetts General Hospital SC-5 in Boston, University of California at San Diego, Moores Cancer Ctr Dept. of Moores Cancer Center in San Diego, UCSF Medical Center in San Francisco, and 9 other sites."
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