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Antibody Drug Conjugate

Tucatinib + T-DM1 for Breast Cancer

Phase 3
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status score of 0 or 1
History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination
Must not have
CNS Exclusion - Based on screening contrast brain magnetic resonance imaging (MRI), subjects must not have any of the following: Any untreated brain lesions >2 cm in size. Ongoing use of corticosteroids for control of symptoms of brain metastases at a total daily dose of >2 mg of dexamethasone (or equivalent). Any brain lesion thought to require immediate local therapy. Known or concurrent leptomeningeal disease as documented by the investigator. Poorly controlled generalized or complex partial seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Pivotal Trial

Summary

This trial is being done to see if adding tucatinib to T-DM1 helps patients with HER2 positive breast carcinoma.

Who is the study for?
This trial is for adults with advanced or metastatic HER2+ breast cancer that has worsened after previous treatment or if they couldn't tolerate the last therapy. They should be relatively healthy (ECOG score of 0 or 1) and may have brain metastases if stable, treated, or not requiring immediate intervention. People can't join if they've had certain recent anti-HER2 treatments, large untreated brain lesions, need high-dose steroids for brain symptoms, have leptomeningeal disease, or uncontrolled seizures.
What is being tested?
The study tests whether adding tucatinib to T-DM1 (a standard drug for this cancer type) improves outcomes in patients with HER2+ breast carcinoma compared to T-DM1 alone. Participants will either receive tucatinib pills twice daily plus T-DM1 injections every three weeks or placebo pills with T-DM1 injections in a blinded setup where neither patient nor doctor knows which treatment is given.
What are the potential side effects?
Tucatinib may cause diarrhea, liver problems, fatigue, mouth sores and rash. The common side effects of T-DM1 include low blood cell counts leading to increased infection risk and bleeding issues; liver issues; heart problems; fatigue; nausea and muscle pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
Select...
I have been treated with both a taxane and trastuzumab before.
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My breast cancer is HER2 positive, confirmed by a specific lab.
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My breast cancer has worsened after the last treatment or I couldn't tolerate it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have large untreated brain lesions, uncontrolled seizures, or need high doses of steroids for brain symptoms.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment
Secondary study objectives
Clinical Benefit Rate (CBR) Per RECIST v1.1 Based on Investigator Assessment
Clinical Benefit Rate as Per RECIST v1.1 by BICR
Duration of Response (DOR) as Per RECIST v1.1 Based on Investigator Assessment
+9 more

Side effects data

From 2022 Phase 2 trial • 612 Patients • NCT02614794
82%
Diarrhoea
66%
Palmar-plantar erythrodysaesthesia syndrome
60%
Nausea
48%
Fatigue
38%
Vomiting
27%
Decreased appetite
26%
Stomatitis
24%
Headache
23%
Aspartate aminotransferase increased
22%
Anaemia
22%
Alanine aminotransferase increased
20%
Blood bilirubin increased
20%
Arthralgia
18%
Hypokalaemia
17%
Constipation
17%
Cough
16%
Abdominal pain
16%
Blood creatinine increased
15%
Weight decreased
14%
Back pain
13%
Epistaxis
13%
Pain in extremity
13%
Dizziness
13%
Peripheral sensory neuropathy
13%
Dyspnoea
11%
Dry skin
11%
Muscle spasms
11%
Dyspepsia
11%
Upper respiratory tract infection
11%
Urinary tract infection
11%
Oedema peripheral
10%
Pruritus
10%
Insomnia
9%
Neutropenia
9%
Hypomagnesaemia
9%
Abdominal pain upper
8%
Dehydration
8%
Myalgia
8%
Asthenia
8%
Dysgeusia
8%
Oropharyngeal pain
8%
Skin hyperpigmentation
7%
Thrombocytopenia
7%
Hypophosphataemia
7%
Rash maculo-papular
7%
Blood alkaline phosphatase increased
7%
Abdominal distension
7%
Hyperbilirubinaemia
7%
Fall
7%
Rhinorrhoea
6%
Paraesthesia
6%
Hyperglycaemia
6%
Dry eye
6%
Gastrooesophageal reflux disease
6%
Influenza like illness
6%
Pyrexia
6%
Paronychia
6%
Alopecia
5%
Muscular weakness
5%
White blood cell count decreased
5%
Dry mouth
5%
Neutrophil count decreased
5%
Platelet count decreased
5%
Hypertension
5%
Nasopharyngitis
3%
Seizure
2%
Pneumonia
2%
Influenza
1%
Cholecystitis
1%
Sepsis
1%
Ejection fraction decreased
1%
Syncope
1%
Pleural effusion
1%
Pulmonary embolism
1%
Cardiac failure
1%
Gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tuc+Cap+Tra
Pbo+Cap+Tra

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tucatinib + T-DM1Experimental Treatment2 Interventions
Tucatinib + T-DM1
Group II: Placebo + T-DM1Active Control2 Interventions
Placebo + T-DM1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
T-DM1
2014
Completed Phase 2
~450
tucatinib
2021
Completed Phase 3
~810

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
73,822 Total Patients Enrolled
5 Trials studying Breast Cancer
3,066 Patients Enrolled for Breast Cancer
Medical MonitorStudy DirectorSeagen Inc.
1,674 Previous Clinical Trials
987,993 Total Patients Enrolled
9 Trials studying Breast Cancer
699 Patients Enrolled for Breast Cancer
Mike Schmitt, MDStudy DirectorSeagen Inc.

Media Library

T-DM1 (Antibody Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03975647 — Phase 3
Breast Cancer Research Study Groups: Tucatinib + T-DM1, Placebo + T-DM1
Breast Cancer Clinical Trial 2023: T-DM1 Highlights & Side Effects. Trial Name: NCT03975647 — Phase 3
T-DM1 (Antibody Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03975647 — Phase 3
~77 spots leftby Nov 2025
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