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Letrozole for Hormone Receptor-Positive Breast Cancer
Study Summary
This trial is studying letrozole to see if it is more effective than a placebo in treating postmenopausal women with hormone receptor-positive breast cancer.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 4 trial • 79 Patients • NCT02137538Trial Design
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- You cannot participate in this study if you have any of the following conditions:You have had a bone fracture in your wrist, hip, or spine that was not caused by an injury.If you have high cholesterol, you must have it under control with medication or lifestyle changes for at least one year. If you have a history of diabetes, high blood pressure, obesity, smoking, high triglycerides, heart disease, or a family history of early-onset heart disease, you may not be eligible to participate.You have had another type of cancer in the past, but you are considered to be cured for at least 5 years, and your doctor believes the cancer is unlikely to come back. However, if you had certain types of non-invasive cancers in the past 5 years, you may still be eligible.
- Group 1: Group 2 Letrozole
- Group 2: Group 1 Placebo
- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
If a patient is 55 or younger, can they join this research project?
"The age range for patients that are eligible for this study are between 18 to 120 years old."
What is the Letrozole FDA approval status?
"Letrozole has received a Phase 3 safety ranking from our team at Power. This means that, while there is some efficacy data available, there are multiple rounds of supportive safety data."
Can people with the specified medical condition still enroll in this research project?
"Unfortunately, this study is no longer enrolling patients. The clinical trial was originally posted on 8/1/2006 with the latest update being on 10/4/2021. However, if you are still interested in participating in a clinical trial, there are 2695 trials for breast cancer and 164 for Letrozole that are currently looking for participants."
What is the efficacy of Letrozole in other medical trials?
"Letrozole was first studied in 1995 at the NIH Clinical Center. So far, there have been 18,466 completed studies on this medication. Additionally, there are 164 active clinical trials involving letrozole; many of these are based out of Manitowoc, Wisconsin."
What is the Letrozole medication approved to help with?
"While letrozole is most often prescribed as a treatment for breast cancer, it can also help patients who are experiencing anovulatory cycles, tamoxifen side effects, and postmenopausal symptoms."
Is this trial widely available in city?
"Currently, this clinical trial is running at 100 sites. With locations in Manitowoc, Reading and Montreal (amongst others), it is important that you pick a location nearest to you - this will cut down on travel requirements if you choose to participate."
How many research participants are being enrolled in this trial?
"Right now, this study is not enrolling patients. It was first posted on 8/1/2006 and the most recent update was 10/4/2021. There are currently 2695 breast cancer trials and 164 Letrozole trials that are looking for participants."
Which patients fit the screening criteria for this research project?
"This clinical trial is recruiting breast cancer patients that are between 18 and 120 years old. They aim to enroll around 3966 individuals in total."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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