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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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%
Arthralgia
16%
Vomiting
16%
Back pain
16%
Cough
14%
Constipation
14%
Abdominal pain
14%
Dyspnoea
13%
Myalgia
10%
Anxiety
10%
Anaemia
9%
Headache
9%
Pruritus
9%
Dry skin
9%
Pain in extremity
8%
Rash maculo-papular
8%
Peripheral sensory neuropathy
8%
Insomnia
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%
Hypokalaemia
6%
Rhinitis allergic
6%
COVID-19
6%
Alanine aminotransferase increased
6%
Aspartate aminotransferase increased
5%
Dry mouth
5%
Oropharyngeal pain
5%
Dizziness
5%
Nephrolithiasis
5%
Rash
5%
Ejection fraction decreased
5%
Musculoskeletal chest pain
5%
Abdominal pain upper
5%
Haematuria
5%
Urinary tract infection
5%
Dysgeusia
5%
Flank pain
3%
Blood creatinine increased
3%
Pollakiuria
3%
Asthenia
3%
Gastrooesophageal reflux disease
3%
Vision Blurred
3%
Flatulence
3%
Non-cardiac chest pain
3%
Large intestinal obstruction
3%
Dyspepsia
3%
Fall
3%
Dysuria
3%
Small intestinal obstruction
3%
Hyponatraemia
3%
Rhinorrhoea
3%
Wheezing
3%
Hypercreatinaemia
2%
Herpes zoster
2%
Thrombocytopenia
2%
Abdominal discomfort
2%
Rectal haemorrhage
2%
Influenza
2%
Blood alkaline phosphatase increased
2%
Abdominal distension
2%
Blepharospasm
2%
Rhinitis
2%
Gastrointestinal pain
2%
Nail infection
2%
Pelvic pain
2%
Peripheral swelling
2%
COVID-19 pneumonia
2%
Onychomadesis
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%
Acute kidney injury
1%
Cholangitis
1%
Hypotension
1%
Sepsis
1%
Bile duct stone
1%
Cancer pain
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)
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?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,870 Total Patients Enrolled
203 Trials studying Breast Cancer
81,103 Patients Enrolled for Breast Cancer
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
74,200 Total Patients Enrolled
6 Trials studying Breast Cancer
3,308 Patients Enrolled for Breast Cancer
Andrew Seidman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
289 Total Patients Enrolled
2 Trials studying Breast Cancer
53 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are actively engaging in the research endeavor?
"Affirmative, clinicaltrials.gov has confirmed that enrollment for this medical trial is ongoing as of the date of May 26th 2023. The study was initially added to the website on May 9th and requires 28 participants from a single site."
Answered by AI
Is there still capacity to join this clinical exploration?
"Affirmative. As evidenced on clinicaltrials.gov, this medical study is still searching for participants to join the trial which was originally posted on May 9th 2023 and most recently updated on May 26th 2023. 28 individuals are needed from one site in total."
Answered by AI
Is the use of Tucatinib by existing patients validated by United States Food and Drug Administration?
"Our evaluation determined that the safety rating of tucatinib, based on its phase 2 trial status, is a score of 2. This means there is data to support the medication's safety but not yet any acceptance for efficacy."
Answered by AI
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