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Ribociclib + Bicalutamide for Breast Cancer
Study Summary
This trial is testing a new drug to see if it works well with another existing drug to treat a certain kind of breast cancer.
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 2020 Phase 3 trial • 502 Patients • NCT03096847Trial Design
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Who is running the clinical trial?
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- I am a woman who can have children and I have a recent negative pregnancy test.I've been mostly active and able to care for myself in the last 28 days.I can swallow pills.I have not used CDK 4/6 inhibitors, except in a study for early-stage breast cancer.I am taking medication that affects my heart's rhythm and cannot stop.I have cirrhosis with a moderate to severe liver function impairment.You have eaten certain fruits within a week before joining the study.I am 18 years old or older.I have not had a stroke or mini-stroke in the last year.My organs and bone marrow are working well.I have not had major surgery or recovered from its major side effects within the last 14 days.I have been diagnosed with HIV.I had radiotherapy less than 2 weeks ago and still have side effects.I have a digestive condition that affects how my body absorbs medication.I have Long QT syndrome or a family history of sudden death.I have severe heart failure or my heart's pumping ability is reduced (LVEF <50%).I haven't had serious heart rhythm problems in the last year.I am currently taking warfarin or a similar blood thinner.I have another cancer that is growing and needs treatment.I do not have any serious wounds, ulcers, or unhealed bone fractures.You have a detectable disease according to specific medical guidelines within the last 28 days before joining the study.My breast cancer is triple-negative and cannot be surgically removed, but tests show it is AR positive.I have had a heart attack or other heart issues in the last 6 months.I finished my last cancer treatment over 2 weeks ago and have recovered from its immediate side effects.We want to include people from different backgrounds and places in the study.I do not have any severe health issues that would make it unsafe for me to join the study.Your doctor thinks you will live for more than 12 weeks.I have taken steroids less than 14 days before starting the study drugs.I have previously been treated with hormone therapies for cancer.I have had up to 3 treatments for my cancer that has spread.I do not have cancer that has spread to my brain or spinal cord.I will stop taking herbal supplements 14 days before joining the study.I have not had a blood clot or pulmonary embolism in the last year.I haven't taken any experimental drugs recently.You are allergic to any of the ingredients in ribociclib or bicalutamide.I am currently on medication for an infection.I am not taking strong drugs affecting liver enzymes that can't be stopped a week before starting the study drug.Your blood pressure is too high (above 160) or too low (below 90) when checked at the beginning of the study.I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last 28 days.My heart's electrical activity is normal, with a safe QT interval and resting rate.I can follow the study's procedures for its duration.
- Group 1: Arm A - Phase I
- 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 symptoms is ribociclib commonly prescribed to treat?
"Ribociclib has been known to be effective against postmenopausal malignancies, stage d2 prostatic carcinomas and other neoplasms."
Has this type of medical experiment ever been attempted before?
"As of now, there are 81 ongoing research efforts for ribociclib in 1147 cities and 50 countries. The initial clinical trial occurred in 2000, sponsored by AstraZeneca with 600 participants who finished the Phase 3 approval period. In total, since then 101 tests have been done."
Has ribociclib been studied in other contexts?
"As of now, 81 clinical trials related to ribociclib are underway; 21 of which have reached phase 3. Even though the majority are found in Duarte, California - 5128 sites across the globe offer this medication."
How many participants are being recruited for this experiment?
"This trial necessitates 37 individuals who meet the prerequisites to join. Participating patients may attend clinical sites including University of Illinois Cancer Center in Chicago, Illinois and University of Wisconsin in Madison, Wisconsin."
Are there still opportunities for patients to join this research endeavor?
"Clinicaltrials.gov reports that this trial is actively seeking participants as of October 31, 2022; the study was first posted on May 7th 2018."
What key goals is the research team aiming to accomplish?
"The primary metric for this trial, measured during the first 16 weeks of treatment, is to identify a Maximum Tolerated Dose. Secondary outcomes include gauging Duration of Response (measured from time when criteria are met until disease progression), assessing Safety and Tolerability via NCI CTCAE Version 4-defined Grade 3-5 adverse events, and analyzing Ribociclib pharmacokinetics with Peak Plasma Concentration pre dose and post 2 hours samples on Cycle 1 Day 1, 15; Cycle 2 Day 1 & 15 respectively."
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