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Tyrosine Kinase Inhibitor
Bosutinib + Palbociclib + Fulvestrant for Advanced Breast Cancer
Phase 1
Waitlist Available
Led By Claudine Isaacs, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Biopsy proven diagnosis of ER and/or PR positive, HER2 negative, advanced breast cancer (locoregionally recurrent or metastatic disease), either from the primary or a metastatic site.
HER2-negative breast cancer:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is designed to study the safety of a new cancer drug and to see if it works. The drug will be given to patients 5 days a week, with 2 days off, and the dose will be increased gradually to ensure safety. The study will enroll patients in groups of 3, and will observe them for 28 days to see if there are any side effects. If the drug is found to be safe and effective, patients will be able to continue treatment.
Who is the study for?
This trial is for adults over 18 with advanced breast cancer that's ER/PR positive and HER2 negative, who've had no more than three chemo treatments and are resistant to certain inhibitors. Participants must not be pregnant, should agree to contraception if of childbearing potential, have good organ function, and an ECOG status of 0-1 (fully active or restricted in physically strenuous activity but ambulatory).Check my eligibility
What is being tested?
The study tests a combination of Bosutinib, Palbociclib, and Fulvestrant on patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer refractory to CDK4/6 inhibitors. It follows a '3+3' dose escalation design where doses increase until the maximum tolerated dose is found.See study design
What are the potential side effects?
Potential side effects include blood disorders like low neutrophil or platelet counts; liver issues reflected in elevated enzymes; digestive problems affecting absorption; hormonal changes due to fulvestrant injections; fatigue from bosutinib's intensive schedule; plus general risks associated with oral medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is ER/PR positive and HER2 negative, and it has spread.
Select...
My breast cancer is not HER2 positive.
Select...
I can swallow and keep down pills.
Select...
My breast cancer is hormone receptor-positive.
Select...
I am a woman who has not gone through menopause or has already gone through it.
Select...
I am 18 years old or older.
Select...
My kidney function is within the normal range.
Select...
I am fully active or can carry out light work.
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I've had up to 3 chemotherapy treatments for breast cancer and my cancer did not respond to specific hormone and targeted therapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Grade of adverse events of bosutinib when used in combination with palbociclib and fulvestrant in patients with advanced HR+MBC who are refractory to AI and CDK4/6 inhibitors
Incidence of adverse events of bosutinib when used in combination with palbociclib and fulvestrant in patients with advanced HR+MBC who are refractory to AI and CDK4/6 inhibitors
Maximum Tolerated Doses (MTD) of palbociclib and bosutinib when used in combination with fulvestrant in patients with advanced HR+MBC who are refractory to AI and CDK4/6 inhibitors
+2 moreSide effects data
From 2020 Phase 3 trial • 536 Patients • NCT0213055775%
Diarrhoea
37%
Nausea
36%
Thrombocytopenia
34%
Alanine aminotransferase increased
26%
Aspartate aminotransferase increased
23%
Abdominal pain
23%
Rash
22%
Headache
22%
Anaemia
21%
Lipase increased
21%
Vomiting
21%
Fatigue
18%
Arthralgia
16%
Pyrexia
13%
Constipation
13%
Nasopharyngitis
13%
Asthenia
13%
Upper respiratory tract infection
12%
Back pain
12%
Neutropenia
11%
Pruritus
11%
Dyspnoea
11%
Decreased appetite
11%
Cough
10%
Dyspepsia
10%
Urinary tract infection
10%
Pain in extremity
10%
Abdominal pain upper
10%
Hypertension
9%
Influenza
9%
Amylase increased
9%
Dizziness
7%
Oedema peripheral
7%
Insomnia
7%
Dry skin
7%
Bronchitis
7%
Blood creatinine increased
7%
Leukopenia
6%
Influenza like illness
6%
Blood alkaline phosphatase increased
6%
Alopecia
6%
Blood bilirubin increased
6%
Oropharyngeal pain
6%
Sinusitis
6%
Anxiety
6%
Lymphopenia
5%
Toothache
5%
Abdominal distension
5%
Rash maculo-papular
5%
Myalgia
5%
Blood creatine phosphokinase increased
4%
Gastroenteritis
4%
Muscle spasms
3%
Face oedema
3%
Pneumonia
3%
Depression
3%
Gastrooesophageal reflux disease
3%
Bone pain
3%
Hypophosphataemia
3%
Weight increased
2%
Night sweats
2%
Hypokalaemia
2%
Vision blurred
1%
Coronary artery disease
1%
Cardiac failure acute
1%
Myocardial ischaemia
1%
Hypertensive crisis
1%
Pleural effusion
1%
Pericarditis
1%
Cholecystitis acute
1%
Cellulitis
1%
Femoral neck fracture
1%
Atrial fibrillation
1%
Hepatitis
1%
Hepatotoxicity
1%
Pregnancy of partner
1%
Unintended pregnancy
1%
Chronic kidney disease
1%
Acute kidney injury
1%
Respiratory failure
1%
Musculoskeletal chest pain
1%
Rectal cancer
1%
Haematuria
1%
Periorbital oedema
1%
Eyelid oedema
1%
Conjunctival haemorrhage
1%
Dry eye
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bosutinib
Imatinib
Trial Design
4Treatment groups
Experimental Treatment
Group I: Dose Level B2Experimental Treatment3 Interventions
Palbociclib: 100mg daily for 21 days of each 28 day cycle
Bosutinib: 500mg on days 1-5 of each week of the 28 day cycle
Fulvestrant: 500mg on days day 1, 5, and 28 of each 28 day cycle
Group II: Dose Level B1Experimental Treatment3 Interventions
Palbociclib: 100mg daily for 21 days of each 28 day cycle
Bosutinib: 300mg on days 1-5 of each week of the 28 day cycle
Fulvestrant: 500mg on days day 1, 5, and 28 of each 28 day cycle
Group III: Dose Level A2Experimental Treatment2 Interventions
Palbociclib: 75mg daily for the first 21 days of each 28 day cycle
Bosutinib: 300mg on days 1-5 of each week of the 28 day cycle
Group IV: Dose Level A1Experimental Treatment3 Interventions
Palbociclib: 75mg daily for 21 days of each 28 day cycle
Bosutinib: 300mg on days 1-5 of each week of the 28 day cycle
Fulvestrant: 500mg on days day 1, 5, and 28 of each 28 day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3760
Fulvestrant
2011
Completed Phase 3
~3690
Bosutinib
2015
Completed Phase 3
~2390
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,483 Total Patients Enrolled
34 Trials studying Breast Cancer
13,085 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,910,459 Total Patients Enrolled
111 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer
Paula R Pohlmann, MD, MSc, PhDStudy ChairGeorgetown University
2 Previous Clinical Trials
54 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either over 60, had both ovaries removed, haven't had periods for 12 months before treatment, or have menopause-level hormone tests.I am considered postmenopausal.I have recovered from previous cancer treatments with minimal side effects.My breast cancer is ER/PR positive and HER2 negative, and it has spread.My breast cancer is not HER2 positive.I agree to use birth control during and for 3 months after my treatment.I am willing and able to follow the study's schedule and procedures.My biopsy sample has been sent and confirmed received by MedStar Georgetown University Hospital.I can swallow and keep down pills.My breast cancer is hormone receptor-positive.I am a woman who has not gone through menopause or has already gone through it.I am on long-term blood thinners.I do not have any conditions that affect how my body absorbs medication.I am HIV-positive and on combination antiretroviral therapy.I am 18 years old or older.You are allergic to fulvestrant, palbociclib, or bosutinib, or any of the ingredients in these medications.I am currently using medications or foods known to strongly affect liver enzymes.I do not have any severe illnesses that could interfere with the study.My kidney function is within the normal range.My brain metastases are treated and stable.I am fully active or can carry out light work.I do not have a significant history of liver disease.I've had up to 3 chemotherapy treatments for breast cancer and my cancer did not respond to specific hormone and targeted therapies.My cancer's ER, PR, and HER2 levels were tested in a certified lab.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level B2
- Group 2: Dose Level A1
- Group 3: Dose Level A2
- Group 4: Dose Level B1
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.
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