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Endocrine Therapy + Abemaciclib for Breast Cancer
Study Summary
This trial will study the effects of a new cancer drug on the tumor and the patient's immune system.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My organs are functioning well.I do not have serious health issues that would stop me from joining this study.I am on blood thinners due to a history of blood clots or heart conditions.I have a tumor from breast cancer that can be biopsied.I have fully recovered from any side effects of my recent radiotherapy.I have a bleeding disorder that makes biopsies unsafe for me.My breast cancer is estrogen receptor positive.I am starting standard hormone therapy for my condition.My cancer is not HER2 positive.I can take pills by mouth.My condition cannot be checked with a biopsy.I've had a severe allergic reaction to the numbing medicine used in a biopsy.I haven't taken steroids or immunosuppressants in the last 30 days.I have not had any cancer except for skin cancer in the last 5 years.I am currently using hormonal birth control or estrogen replacement therapy.I have not taken medication for an autoimmune disease in the last 6 months.I am not using cancer treatments other than bisphosphonates.I am not pregnant or breastfeeding.I do not have any active infections.My breast cancer cannot be removed by surgery or has spread.I am willing and able to have biopsies before and 4 weeks into treatment.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.I am a woman aged 18 or older.I have recovered from the side effects of my last chemotherapy.
- Group 1: Cohort 1
- Group 2: Cohort 2
- 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 primary purpose of taking Cohort 1?
"The first cohort is typically used to treat patients with the pik3ca gene mutation. Additionally, this course of treatment can be taken by those struggling with advanced forms of hr+ her2- breast cancer and malignant neoplasms."
What is the risk profile for people in Cohort 1?
"Cohort 1's safety level was estimated to be a 2 by our team at Power. This is due to it being a Phase 2 trial, so while there is some data supporting safety, there is none for efficacy."
How many people are being enrolled in this clinical trial?
"That is accurate. According to the information available on clinicaltrials.gov, this study was posted on September 14th 2020 and updated June 7th 2022. They are looking for 30 participants at a single site."
Are people with the qualifying condition able to participate in this experiment currently?
"The study, which was originally posted on September 14th 2020, is currently looking for eligible participants. The listing was last edited on June 7th, 2022."
Are there other research projects that have studied Cohort 1?
"Across the globe, there are 216 active studies being conducted on Cohort 1 with 42 of those in Phase 3. Many of the trials related to Cohort 1 take place in Alicante and Pamplona/Iruña, but 9844 locations total are running similar investigations."
What is the primary purpose of this clinical trial?
"The primary outcome of this study is to compare changes in serum estrogen levels with changes in tumor immune cell repertoire and function in response to endocrine therapy and CDK 4/6 inhibition. The secondary outcomes include the number of participants with at least one serious adverse event, changes in tumor immune cell populations in response to fulvestrant and aromatase inhibitor therapy plus abemaciclib, and the best overall response rate of abemaciclib and endocrine therapy in both treatment arms."
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