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Small Molecule Kinase Inhibitor

Tucatinib for Breast Cancer (2019-101826 Trial)

Phase 1 & 2
Waitlist Available
Led By Alison Conlin, MD
Research Sponsored by Providence Health & Services
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 up to 5 years
Awards & highlights

2019-101826 Trial Summary

This trial is testing a new drug, tucatinib, to see if it can help treat metastatic HER2+ breast cancer when used with either vinorelbine or gemcitabine and trastuzumab.

Eligible Conditions
  • Breast Cancer Stage IV

2019-101826 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the maximum tolerated dose and recommended dosing of tucatinib to be given in combination with either vinorelbine or gemcitabine and trastuzumab.
Secondary outcome measures
Overall Response Rate
Progression Free Survival
Study Treatment-Related Adverse Events

Side effects data

From 2023 Phase 2 trial • 117 Patients • NCT03043313
64%
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%
Pruritus
9%
Headache
9%
Dry skin
9%
Pain in extremity
8%
Peripheral sensory neuropathy
8%
Insomnia
8%
Rash maculo-papular
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%
Dizziness
5%
Nephrolithiasis
5%
Dry mouth
5%
Oropharyngeal pain
5%
Rash
5%
Musculoskeletal chest pain
5%
Ejection fraction decreased
5%
Abdominal pain upper
5%
Haematuria
5%
Urinary tract infection
5%
Dysgeusia
5%
Flank pain
3%
Blood creatinine increased
3%
Pollakiuria
3%
Flatulence
3%
Dyspepsia
3%
Asthenia
3%
Vision Blurred
3%
Non-cardiac chest pain
3%
Large intestinal obstruction
3%
Fall
3%
Dysuria
3%
Gastrooesophageal reflux disease
3%
Small intestinal obstruction
3%
Hyponatraemia
3%
Rhinorrhoea
3%
Wheezing
3%
Hypercreatinaemia
2%
Blood alkaline phosphatase increased
2%
Abdominal distension
2%
Rectal haemorrhage
2%
Influenza
2%
Herpes zoster
2%
Rhinitis
2%
Gastrointestinal pain
2%
Nail infection
2%
Pelvic pain
2%
Peripheral swelling
2%
COVID-19 pneumonia
2%
Thrombocytopenia
2%
Abdominal discomfort
2%
Onychomadesis
2%
Blepharospasm
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%
Bile duct stone
1%
Acute kidney injury
1%
Sepsis
1%
Hypotension
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)

2019-101826 Trial Design

2Treatment groups
Experimental Treatment
Group I: Vinorelbine + Tucatinib + TrastuzumabExperimental Treatment1 Intervention
Vinorelbine (25 mg/m2) will be administered intravenously on Days 1 and 8 of each 21-day cycle. The investigational study drug (tucatinib) will be administered as 300mg by mouth taken twice a day of every day in each cycle. Trastuzumab will be administered per package insert on Day 1 of each cycle.
Group II: Gemcitabine + Tucatinib + TrastuzumabExperimental Treatment1 Intervention
Gemcitabine (1000 mg/m2) will be administered intravenously on Days 1 and 8 of each 21-day cycle. The investigational study drug (tucatinib) will be administered as 300mg by mouth taken twice a day of every day in each cycle. Trastuzumab will be administered per package insert on Day 1 of each cycle.
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?

Providence Health & ServicesLead Sponsor
118 Previous Clinical Trials
822,567 Total Patients Enrolled
7 Trials studying Breast Cancer
4,608 Patients Enrolled for Breast Cancer
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
73,998 Total Patients Enrolled
6 Trials studying Breast Cancer
3,308 Patients Enrolled for Breast Cancer
Alison Conlin, MDPrincipal InvestigatorProvidence Health & Services
1 Previous Clinical Trials
14 Total Patients Enrolled
~0 spots leftby Jun 2025
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