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ARRY-380 + Trastuzumab for Breast Cancer
Study Summary
This trial will test the safety of different doses of ARRY-380 in combination with trastuzumab to see if the combination is safe for people to take.
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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- You are able to perform daily activities without much difficulty.You can have been treated with trastuzumab or lapatinib before, and there's no limit to how many treatments you've had before.You have had chemotherapy or radiotherapy within the last 14 days, or you have not fully recovered from side effects of previous treatments.You can participate if you had brain surgery before, as long as there are still measurable or growing lesions in your brain.You haven't increased your corticosteroid dose in the week before the brain MRI.Participants must have aggressive breast cancer that tests positive for a specific protein called HER2. They don't need to have their HER2 status confirmed by a central laboratory.You have new or growing lesions in your brain, as determined by your doctor.You have not received radiation treatment to the head before, and if you have cancer that has spread to the brain, you do not have symptoms and do not need corticosteroids.You are pregnant or breastfeeding.You have to meet certain health requirements, such as having a certain level of white blood cells and platelets, normal liver function, and a healthy heart.You can still participate if you had certain types of radiation treatment before and your condition got worse afterwards.You have a severe illness or mental health condition that could make it hard for you to follow the study's rules.You have had severe allergic reactions to drugs similar to ARRY-380 or trastuzumab.You have cancer that has spread to the covering of the brain and spinal cord, but nowhere else in the central nervous system.You have had more than 2 seizures in the past 4 weeks before joining the study.You cannot have another type of cancer that is currently active. If you had cancer before, it must have been treated and not returned for at least 2 years, and your doctor must think it's unlikely to come back.You must have a brain lesion that can be accurately measured and is at least 10 millimeters in size.
- Group 1: ARRY-380 Twice Daily Dosage
- Group 2: ARRY-380 Once Daily
- 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 patient enrollment size of this trial?
"Unfortunately, this research is not currently recruiting. The trial was posted on the 1st of August 2013 and last updated on August 15th 2022. For those seeking to join other studies, there are 3101 trials for neoplasm metastasis and 199 clinical trials with ARRY-380 Twice Daily Dosage actively taking in patients."
Has the FDA given authorization to use ARRY-380 at two intervals per day?
"The safety of ARRY-380 Twice Daily Dosage is assessed as a '1' on the 1 to 3 scale, due to it being in its first phase trialing and having limited data supporting both efficacy and security."
What pathological conditions does ARRY-380 Twice Daily Dosage commonly address?
"ARRY-380 Twice Daily Dosage is generally administered to breast cancer patients, though its efficacy has also been observed when treating high risk of recurrence, first line treatment and surgery."
Are new participants being admitted to this research endeavor?
"At the present moment, this medical study is not actively seeking patients. The trial was originally posted on August 1st 2013 and last updated on August 15th 2022. However, there are 3100 studies recruiting for neoplasm metastasis and 199 trials looking for ARRY-380 Twice Daily Dosage participants."
Could you elaborate on other research which has explored the effectiveness of ARRY-380 Twice Daily Dosage?
"Currently, 199 clinical studies for the ARRY-380 Twice Daily Dosage are ongoing. Of those trials, 51 have reached Phase 3. Whilst many of these research projects are located in Phoenix, Arizona there exists 15774 sites offering this trial across the globe."
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