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Kinase Inhibitor
Tucatinib for Metastatic Breast Cancer
Phase 2
Recruiting
Led By Andrew Seidman, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days after treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial studies tucatinib in people with HER2+ cancer that has spread to the brain, to learn more about how cancer cells can develop resistance to treatment.
Who is the study for?
Adults with HER2+ cancers that have spread to the brain, able to swallow pills, and expected to live more than 12 weeks. They should not have decision-making impairments or significant other illnesses as judged by a doctor. Women must test negative for pregnancy and agree to use contraception.
What is being tested?
The trial is testing how tucatinib behaves in the brain when treating HER2+ cancers that have metastasized there. It aims to understand drug distribution, elimination, and resistance development in patients undergoing surgery for these tumors.
What are the potential side effects?
Tucatinib may cause side effects related to liver function changes (elevated bilirubin), digestive issues (since it's an oral medication), potential allergic reactions if sensitive to its components, and interactions with certain drugs affecting liver enzymes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 days after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days after treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum observed plasma concentration (Cmax) of Tucatinib
Side effects data
From 2023 Phase 2 trial • 117 Patients • NCT0304331364%
Diarrhoea
43%
Fatigue
34%
Nausea
21%
Infusion related reaction
20%
Pyrexia
19%
Chills
19%
Decreased appetite
19%
Dermatitis acneiform
17%
Hypertension
16%
Vomiting
16%
Arthralgia
16%
Back pain
16%
Cough
14%
Constipation
14%
Abdominal pain
14%
Dyspnoea
13%
Myalgia
10%
Anaemia
10%
Anxiety
9%
Pruritus
9%
Headache
9%
Pain in extremity
9%
Dry skin
8%
Rash maculo-papular
8%
Insomnia
8%
Peripheral sensory neuropathy
8%
Influenza like illness
8%
Dehydration
8%
Oedema peripheral
8%
Nasal congestion
7%
Productive cough
7%
Upper-airway cough syndrome
7%
Weight decreased
7%
Muscle spasms
7%
Epistaxis
6%
Rhinitis allergic
6%
Hypokalaemia
6%
COVID-19
6%
Alanine aminotransferase increased
6%
Aspartate aminotransferase increased
5%
Dizziness
5%
Musculoskeletal chest pain
5%
Ejection fraction decreased
5%
Nephrolithiasis
5%
Abdominal pain upper
5%
Dry mouth
5%
Oropharyngeal pain
5%
Rash
5%
Haematuria
5%
Urinary tract infection
5%
Dysgeusia
5%
Flank pain
3%
Vision Blurred
3%
Non-cardiac chest pain
3%
Pollakiuria
3%
Asthenia
3%
Flatulence
3%
Dysuria
3%
Gastrooesophageal reflux disease
3%
Fall
3%
Blood creatinine increased
3%
Dyspepsia
3%
Large intestinal obstruction
3%
Small intestinal obstruction
3%
Hyponatraemia
3%
Rhinorrhoea
3%
Wheezing
3%
Hypercreatinaemia
2%
Influenza
2%
Blood alkaline phosphatase increased
2%
Peripheral swelling
2%
Herpes zoster
2%
COVID-19 pneumonia
2%
Blepharospasm
2%
Rhinitis
2%
Rectal haemorrhage
2%
Thrombocytopenia
2%
Nail infection
2%
Abdominal distension
2%
Abdominal discomfort
2%
Gastrointestinal pain
2%
Onychomadesis
2%
Pelvic pain
2%
Rectal perforation
2%
Muscular weakness
2%
Weight increased
2%
Dysphonia
2%
Erythema
2%
Nail disorder
2%
Urticaria
2%
Hypoalbuminaemia
2%
Dyspnoea exertional
2%
Pulmonary embolism
2%
Sinus pain
1%
Cancer pain
1%
Hypotension
1%
Sepsis
1%
Acute kidney injury
1%
Bile duct stone
1%
Cholangitis
1%
Angina unstable
1%
Colitis
1%
Gastrointestinal obstruction
1%
Kidney infection
1%
Renal colic
1%
Acute respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tucatinib+Trastuzumab (Cohorts A+B)
Cohort C (Pre-Crossover)
Cohort C (Post-Crossover)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Patients with documented radiological and/or clinical CNS progression with no prior tucatinibExperimental Treatment1 Intervention
Cohort B: Is to administer Tucatinib at standard dose of 300mg orally twice daily for 4 days prior to surgery (day -4 to 0).
Group II: Patients already on TucatinibExperimental Treatment1 Intervention
Cohort A: This is a non-interventional study patients who will enter while already on Tucatinib . Patients in cohort A who are already on Tucatinib at a dose reduction (i.e., for toxicity) will continue the same dose.
Group III: HER2+ esophagogastric, lung, or colon cancer brain metastases and HER2 mutant breast cancerExperimental Treatment1 Intervention
Cohort C: Is to administer Tucatinib at standard dose of 300mg orally twice daily for 4 days prior to surgery (day -4 to 0).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tucatinib
2017
Completed Phase 2
~520
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,655 Previous Clinical Trials
17,746,230 Total Patients Enrolled
114 Trials studying Breast Cancer
41,346 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,295 Total Patients Enrolled
207 Trials studying Breast Cancer
82,323 Patients Enrolled for Breast Cancer
Seagen Inc.Industry Sponsor
210 Previous Clinical Trials
74,260 Total Patients Enrolled
5 Trials studying Breast Cancer
3,066 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had multiple treatments for my condition.I am taking medication that interacts with certain enzymes and could cause serious side effects.I am not allergic to tucatinib or its ingredients.I took lapatinib or neratinib over 6 months ago.I have recently used specific strong or moderate drugs that affect how my body processes medications.My cancer has spread to my brain.I am 18 or older and can make my own decisions.I have brain metastases needing surgery and may also have cancer in the lining of my brain.My recent tests show my bone marrow, liver, kidneys, and blood clotting are functioning well.My cancer is HER2 positive and has spread to my brain, requiring surgery.I can take care of myself and am up and about more than half of my waking hours.My breast cancer has spread to my brain and I haven't taken tucatinib.My last treatment for breast cancer, which is HER2 positive, was tucatinib and it did not stop the cancer from growing in my brain.I can swallow and keep down pills.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with documented radiological and/or clinical CNS progression with no prior tucatinib
- Group 2: Patients already on Tucatinib
- Group 3: HER2+ esophagogastric, lung, or colon cancer brain metastases and HER2 mutant breast cancer
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.
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