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Antiandrogen
Ribociclib + Bicalutamide for Breast Cancer
Phase 1 & 2
Recruiting
Led By Kari Wisinski, MD
Research Sponsored by Ruth O'Regan, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to swallow bicalutamide and ribociclib capsules/tablets
Age ≥ 18 years at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with advanced AR+ triple-negative breast cancer who haven't had certain treatments, have no active brain metastases, and whose major organs function well. They must not be pregnant or breastfeeding, agree to use contraception, and can swallow pills. Excluded are those with recent heart issues, strokes, uncontrolled conditions that could affect safety or compliance, known HIV infection or other active cancers needing treatment.Check my eligibility
What is being tested?
The study tests ribociclib in combination with bicalutamide on patients with a specific type of breast cancer (AR+ TNBC). It's an open-label phase II trial without randomization or blinding. Participants will receive both drugs to see how effective this combo is against their cancer.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems; liver issues; potential heart rhythm problems; allergic reactions; and possible interactions with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills.
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I am 18 years old or older.
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My breast cancer is triple-negative and cannot be surgically removed, but tests show it is AR positive.
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I do not have cancer that has spread to my brain or spinal cord.
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My heart's electrical activity is normal, with a safe QT interval and resting rate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Maximum Tolerated Dose
Phase II: Clinical benefit rate (CBR) of treatment combination
Secondary outcome measures
Phase I: Assess Safety and Tolerability By summarizing counts and percentages grade 3-5 adverse events (NCI CTCAE Version 4)
Phase I: Duration of Response
Phase I: Objective Response Rate (ORR)
+6 moreSide effects data
From 2020 Phase 3 trial • 502 Patients • NCT0309684746%
NEUTROPENIA
43%
NAUSEA
38%
FATIGUE
33%
ALOPECIA
25%
NASOPHARYNGITIS
20%
LEUKOPENIA
20%
DIARRHOEA
20%
ASPARTATE AMINOTRANSFERASE INCREASED
19%
ARTHRALGIA
19%
ALANINE AMINOTRANSFERASE INCREASED
18%
CONSTIPATION
18%
ANAEMIA
17%
HEADACHE
17%
VOMITING
15%
NEUTROPHIL COUNT DECREASED
15%
STOMATITIS
14%
INSOMNIA
13%
PAIN IN EXTREMITY
13%
BACK PAIN
13%
DYSPNOEA
12%
HOT FLUSH
11%
THROMBOCYTOPENIA
11%
RASH
11%
OEDEMA PERIPHERAL
11%
DECREASED APPETITE
10%
URINARY TRACT INFECTION
10%
WHITE BLOOD CELL COUNT DECREASED
10%
COUGH
10%
PRURITUS
8%
ELECTROCARDIOGRAM QT PROLONGED
8%
DYSPEPSIA
8%
VERTIGO
8%
MUSCULOSKELETAL PAIN
8%
DRY SKIN
8%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
6%
LACRIMATION INCREASED
6%
ABDOMINAL PAIN UPPER
6%
WEIGHT DECREASED
6%
ABDOMINAL PAIN
6%
PYREXIA
6%
BLOOD CREATININE INCREASED
6%
BONE PAIN
6%
DRY MOUTH
6%
ERYTHEMA
5%
DRY EYE
5%
DIZZINESS
4%
HYPERTENSION
4%
MYALGIA
4%
CYSTITIS
4%
DYSGEUSIA
4%
DEPRESSION
4%
SLEEP DISORDER
3%
GENERAL PHYSICAL HEALTH DETERIORATION
3%
BRONCHITIS
3%
MUSCULOSKELETAL CHEST PAIN
3%
POLYNEUROPATHY
2%
SEASONAL ALLERGY
2%
PLEURAL EFFUSION
2%
HYPOCALCAEMIA
1%
OROPHARYNGEAL PAIN
1%
INFLUENZA
1%
METASTASES TO SPINE
1%
SKIN ULCER
1%
GASTROINTESTINAL INFECTION
1%
URETEROLITHIASIS
1%
DEVICE RELATED INFECTION
1%
ARTHROPOD BITE
1%
CHEST PAIN
1%
CYSTITIS ESCHERICHIA
1%
SEPSIS
1%
INCISIONAL HERNIA
1%
COLON CANCER
1%
METASTASES TO BONE
1%
PULMONARY EMBOLISM
1%
ATRIAL FIBRILLATION
1%
ANAL HAEMORRHAGE
1%
HELICOBACTER GASTRITIS
1%
TUMOUR LYSIS SYNDROME
1%
TUMOUR PAIN
1%
WEIGHT INCREASED
1%
PANIC ATTACK
1%
FLANK PAIN
1%
SPINAL PAIN
1%
FEBRILE NEUTROPENIA
1%
CARDIAC FAILURE
1%
ILEUS
1%
INTESTINAL STRANGULATION
1%
COMPLICATION OF DEVICE INSERTION
1%
IMPAIRED HEALING
1%
PAIN
1%
HEPATIC CIRRHOSIS
1%
ABSCESS JAW
1%
APPENDICITIS
1%
MASTITIS
1%
PNEUMONIA
1%
HIP FRACTURE
1%
JAW FRACTURE
1%
RADIUS FRACTURE
1%
BLOOD BILIRUBIN INCREASED
1%
HYPERCALCAEMIA
1%
HYPERKALAEMIA
1%
DEVICE LOOSENING
1%
RENAL FAILURE
1%
RENAL IMPAIRMENT
1%
CIRCULATORY COLLAPSE
1%
TOOTHACHE
1%
BLOOD LACTATE DEHYDROGENASE INCREASED
1%
HYPOAESTHESIA
1%
HYPERFIBRINOLYSIS
1%
DRUG-INDUCED LIVER INJURY
1%
ABDOMINAL PAIN LOWER
1%
DEHYDRATION
1%
OSTEITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ribociclib + Letrozole Cohort B2
Ribociclib + Letrozole Cohort A
Ribociclib + Letrozole Cohort B1
Total
Ribociclib + Letrozole Cohort B
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm A - Phase IExperimental Treatment2 Interventions
Dose Escalation Cohort 1 will consist of 3-6 patients who will receive bicalutamide 150mg PO daily on days 1-28 of a 28 day cycle and ribociclib 400mg PO daily on days 1-21 of a 28 day cycle.
Cohort 2 will consist of 3-6 patients who will receive bicalutamide 150mg PO daily on days 1-28 of a 28 day cycle and ribociclib 400mg PO daily on days 1-28 of a 28 day cycle.
Cohort 3 will consist of 3-6 patients who will receive bicalutamide 150mg PO daily on days 1-28 of a 28 day cycle and ribociclib 600mg PO daily on days 1-21 of a 28 day cycle.
Experimental: Arm B - Phase II Investigational Treatment The maximum safe dose of ribociclib in combination with bicalutamide will be given to up to 25 patients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bicalutamide
2003
Completed Phase 3
~5330
ribociclib
2016
Completed Phase 3
~560
Find a Location
Who is running the clinical trial?
Ruth O'Regan, M.D.Lead Sponsor
University of Wisconsin, MadisonOTHER
1,183 Previous Clinical Trials
3,167,550 Total Patients Enrolled
36 Trials studying Breast Cancer
38,519 Patients Enrolled for Breast Cancer
Kari WisinskiLead Sponsor
2 Previous Clinical Trials
81 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A - Phase I
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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