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Abemaciclib + Trastuzumab for Breast Cancer (monarcHER Trial)
monarcHER Trial Summary
This trial will compare abemaciclib+trastuzumab with or without fulvestrant to trastuzumab+ standard of care chemotherapy in women with HR+, HER2+ breast cancer.
monarcHER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowmonarcHER Trial Timeline
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 2 trial • 132 Patients • NCT02102490monarcHER Trial Design
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Who is running the clinical trial?
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- I have been treated with trastuzumab emtansine (T-DM1) before.I may have been treated with hormone therapy, but not fulvestrant.I am postmenopausal due to surgery, natural reasons, or medication.I am fully active or restricted in physically strenuous activity but can do light work.I have enough tumor tissue available for testing.My organs are working well.I am not pregnant and agree to use birth control during and after the study.You are allergic to trastuzumab, murine proteins, or fulvestrant.You have a type of cancer that can be measured using specific guidelines.Your heart's pumping ability (LVEF) is 50% or more before starting the study.I have brain metastases that are either untreated, causing symptoms, or need steroids for symptom control.I have not had major surgery in the last 14 days.I have been treated with CDK 4/6 inhibitors before.I haven't taken any unapproved drugs recently.I have not had heart failure, a heart attack, or severe chest pain in the last 6 months.In the past year, I haven't had any serious heart-related incidents.I do not have any active infections.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer or cervical carcinoma in-situ.I have not had a live virus vaccine in the last 28 days.I have HR+ and HER2+ breast cancer that cannot be surgically removed or has spread.I have had at least 2 treatments targeting HER2 for my advanced cancer.I stopped my targeted radiation therapy for pain relief or to prevent bone breaks at least 2 weeks ago and have recovered from its immediate effects.I stopped all cancer treatments except trastuzumab 3 weeks ago for strong drugs or 2 weeks for others, and have recovered from side effects.I have been treated with a taxane medication before.I can swallow pills.You have a serious condition affecting your internal organs.
- Group 1: 150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant
- Group 2: 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
- Group 3: 150 mg Abemaciclib + 8 mg/kg Trastuzumab
- 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 many participants are being enlisted in this research endeavor?
"At this time, no patients are being sought for the aforesaid trial which was first posted on May 23rd 2016. However, there is an abundance of other research opportunities; 2287 studies search for those with hormone receptor (hr)-positive breast cancer and 379 clinical trials seek out participants to test Abemaciclib."
Is Abemaciclib generally safe for consumption by people?
"According to our team at Power, Abemaciclib is relatively safe and thus deserving of a 2 rating as there is existing evidence that it meets safety standards but no efficacy data has yet been collected."
What are the conventional applications of Abemaciclib?
"Abemaciclib has established efficacy for preventing endocrine therapy, and can additionally be beneficial in managing disease, metastatic adenocarcinoma of the gastroesophageal junction, and post-surgical protocols."
What prior investigations have been conducted involving Abemaciclib?
"Abemaciclib was first investigated at Ospedale di Circolo e Fondazione Macchi in 1999. Presently, there are 470 completed studies of this medication and an additional 379 enrolling patients across the globe; a considerable portion is based in East Setauket, New york."
Is this research currently enrolling participants?
"This clinical trial is no longer accepting participants; it was last updated on August 8th, 2022. For those looking for alternative studies related to hormone receptor (hr)-positive breast cancer, there are 2287 trials now recruiting and 379 research initiatives that require Abemaciclib patients."
What is the geographical scope of this trial’s implementation?
"Currently, 34 different clinical trial centres are participating in the recruitment process. Examples of these locations include North Shore Hematology Oncology Associates in East Setauket, Tennessee Oncology PLLC in Nashville and Northwest Medical Specialties, PLLC in Puyallup amongst other sites."
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