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Abemaciclib + Bicalutamide for Breast Cancer
Study Summary
This trial is testing a new drug, abemaciclib, in combination with bicalutamide for treating metastatic breast cancer that is positive for the androgen receptor and negative for HER2.
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.Side effects data
From 2018 Phase 2 trial • 132 Patients • NCT02102490Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- My breast cancer is AR+ with at least 1% staining.My breast cancer is HER2 negative, cannot be surgically removed, and has spread.I haven't taken any cancer treatments in the last 21 days.I agree to use a condom and not father a child or donate sperm during and for 90 days after the study.I am not pregnant, breastfeeding, and if capable of having children, I am using effective non-hormonal birth control.I have severe nausea, vomiting, or gut issues that prevent me from taking pills properly.I am a woman aged 18 or older.I've recovered from chemotherapy side effects, except for hair loss or mild nerve pain.You have evidence of the disease in your chest, abdomen, and pelvis from a recent scan.I am post-menopausal or receiving treatment to stop my ovaries from working.You need to have a negative pregnancy test within a week before starting the treatment.I have triple-negative breast cancer and have had 1 to 4 chemotherapy treatments for it.I can care for myself, haven't gotten worse in the past 2 weeks, and am expected to live at least 3 more months.My lung function is severely impaired.I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.I can choose not to participate in optional research without losing benefits.I have been treated with anti-androgen therapy before.I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.My blood tests show my bone marrow or organs are not working well.I have had 2 or fewer chemotherapy treatments for my cancer after it spread.I haven't had major surgery in the last 4 weeks.Your diabetes is not well controlled, as shown by high fasting blood sugar levels.I am currently taking hormone therapy for my condition.My brain-related cancer symptoms are stable, treated, and I haven't needed steroids for 2 weeks.I have liver disease but am on daily medication for hepatitis B.I have ER+ or PR+ breast cancer and received one endocrine therapy for it.My heart health meets the study's requirements.I haven't taken any experimental drugs in the last 28 days.I am allergic to abemaciclib, bicalutamide, or similar drugs.I have a condition that causes me to bleed easily.I have been treated with a CDK4/6 inhibitor before.My cancer's spread was confirmed by a biopsy and tested for hormone receptors.I am taking medications that can be combined with the trial drugs.You have a serious uncontrolled health condition, such as severe infections or bleeding disorders.I haven't had any cancer except for treated skin cancer or cervical cancer in the last 3 years.
- Group 1: Participants with Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
- 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 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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
Are minors eligible to participate in this scientific experiment?
"According to the terms of this clinical trial, individuals aged 18 and up until 90 years old are eligible for recruitment."
Has this clinical trial been previously tested in a similar fashion?
"Currently, there are 124 ongoing Abemaciclib trials spanning 1615 cities and 43 nations. AstraZeneca's 2000 trial in Phase 3 drug approval is the oldest known; it had 600 participants and has since been concluded along with 102 other studies."
Is the enrollment period still open for this research program?
"Affirmative. Clinicaltrials.gov displays that this clinical experiment, which was first released on September 29th 2021, is presently recruiting patients. A total of 60 participants need to be accepted from 3 distinct medical centers."
Are there other investigations that focus on the efficacy of Abemaciclib?
"Currently, 124 clinical studies are in progress for Abemaciclib. 30 of those active trials have moved into the third and final phase. Most of these trials can be found in Alicante or Pamplona/Iruña, though 8665 locations worldwide offer this treatment to patients."
Is my profile compatible with the selection criteria for this trial?
"This clinical trial is in search of 60 participants with a diagnosis of breast cancer, aged between 18 and 90. Criteria for eligibility include an Eastern Cooperatvie Oncology Group (ECOG) performance score between 0-2 without any degradation within the last two weeks, life expectancy of 12 or more weeks, one prior line of endocrine therapy administered to their metastatic disease state, no more than two prior lines cytotoxic chemotherapy against their metastasis condition as well being at least 18 years old. Furthermore, declining participation in voluntary exploratory research and/or genetic components will neither incur penalties nor disqualify them from other aspects"
For what medical conditions is Abemaciclib routinely prescribed?
"In order to reduce high risk of recurrence, abemaciclib is frequently employed. Abemaciclib can also be beneficial for treating advanced stage d2 prostatic carcinoma, endocrine therapy and hr + her 2- breast cancer."
What is the maximum number of participants accepted into this clinical research?
"Affirmative. On clinicaltrials.gov, the information indicates that this medical experiment is recruiting participants at present. It was initially published on September 29th 2021 and recently updated on November 8th 2022; 60 patients are needed from 3 distinct sites for enrolment in total."
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