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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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%

Abdominal pain

14%

Constipation

14%

Dyspnoea

13%

Myalgia

10%

Anxiety

10%

Anaemia

Headache

Pruritus

Dry skin

Pain in extremity

Rash maculo-papular

Peripheral sensory neuropathy

Insomnia

Influenza like illness

Dehydration

Oedema peripheral

Nasal congestion

Productive cough

Upper-airway cough syndrome

Weight decreased

Muscle spasms

Epistaxis

Hypokalaemia

Rhinitis allergic

COVID-19

Alanine aminotransferase increased

Aspartate aminotransferase increased

Dry mouth

Oropharyngeal pain

Ejection fraction decreased

Dizziness

Nephrolithiasis

Rash

Abdominal pain upper

Musculoskeletal chest pain

Haematuria

Urinary tract infection

Dysgeusia

Flank pain

Blood creatinine increased

Pollakiuria

Asthenia

Vision Blurred

Dysuria

Flatulence

Non-cardiac chest pain

Gastrooesophageal reflux disease

Large intestinal obstruction

Dyspepsia

Fall

Small intestinal obstruction

Hyponatraemia

Rhinorrhoea

Wheezing

Hypercreatinaemia

Herpes zoster

Abdominal distension

Thrombocytopenia

Abdominal discomfort

Rectal haemorrhage

Influenza

Blood alkaline phosphatase increased

Blepharospasm

Rhinitis

Gastrointestinal pain

Nail infection

Pelvic pain

Peripheral swelling

COVID-19 pneumonia

Onychomadesis

Rectal perforation

Muscular weakness

Weight increased

Dysphonia

Erythema

Nail disorder

Urticaria

Hypoalbuminaemia

Dyspnoea exertional

Pulmonary embolism

Sinus pain

Acute kidney injury

Cholangitis

Bile duct stone

Hypotension

Sepsis

Cancer pain

Angina unstable

Colitis

Gastrointestinal obstruction

Kidney infection

Renal colic

Acute respiratory failure

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor

117 Previous Clinical Trials

822,535 Total Patients Enrolled

7 Trials studying Breast Cancer

4,608 Patients Enrolled for Breast Cancer

Seagen Inc.Industry Sponsor

207 Previous Clinical Trials

69,157 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what purpose is Tucatinib most commonly prescribed?

"Tucatinib can be used to treat breast cancer metastasis in patients that have received one or more anti-her2-based regimens."

Answered by AI

Are there any other ongoing or completed clinical trials that Tucatinib is a part of?

"Tucatinib is being trialed in 22 clinical studies, 4 of which are in Phase 3. Kashiwa-shi and Other are research sites for Tucatinib, but there are 1914 total locations running trials for the medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tucatinib With Chemotherapy and Trastuzumab in Advanced Her-2-neu Overexpressing, Previously Treated Breast Cancer.

2021. "Tucatinib With Chemotherapy and Trastuzumab in Advanced Her-2-neu Overexpressing, Previously Treated Breast Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04896320.