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Antibody Drug Conjugate

Tucatinib + T-DM1 for Breast Cancer

Miami, FL
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.

See full description
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.Check my eligibility
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.See study design
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.
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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.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have large untreated brain lesions, uncontrolled seizures, or need high doses of steroids for brain symptoms.
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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 2024 Phase 2 & 3 trial • 17 Patients • NCT04499924
50%
Diarrhoea
50%
Rash
38%
Constipation
38%
Pyrexia
38%
Aspartate aminotransferase increased
38%
Alopecia
25%
Anaemia
25%
Abdominal pain
25%
Nausea
25%
Stomatitis
25%
Fatigue
25%
Alanine aminotransferase increased
25%
Ejection fraction decreased
25%
Weight decreased
25%
Myalgia
25%
Epistaxis
25%
Dermatitis acneiform
25%
Hypertension
13%
Enteritis
13%
Gastric haemorrhage
13%
Intestinal sepsis
13%
Pneumonia
13%
Respiratory failure
13%
Neutropenia
13%
Thrombocytopenia
13%
Tympanic membrane perforation
13%
Eye pruritus
13%
Anal fissure
13%
Anal haemorrhage
13%
Dyspepsia
13%
Gastritis
13%
Gastrooesophageal reflux disease
13%
Haemorrhoids
13%
Odynophagia
13%
Vomiting
13%
Chills
13%
Localised oedema
13%
Peripheral swelling
13%
Temperature intolerance
13%
Hyperbilirubinaemia
13%
COVID-19
13%
Rectal abscess
13%
Skin infection
13%
Fall
13%
Hyphaema
13%
Infusion related reaction
13%
Skin laceration
13%
Decreased appetite
13%
Arthralgia
13%
Myofascial pain syndrome
13%
Neck pain
13%
Dizziness
13%
Peripheral sensory neuropathy
13%
Acute kidney injury
13%
Chromaturia
13%
Cough
13%
Dyspnoea
13%
Pneumothorax
13%
Rhinorrhoea
13%
Night sweats
13%
Palmar-plantar erythrodysaesthesia syndrome
13%
Pruritus
13%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paclitaxel 60 mg/m^2
Paclitaxel 80 mg/m^2

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
~850
tucatinib
2021
Completed Phase 3
~810

Find a Location

Closest Location:Ft Wayne Medical Oncology and Hematology, Inc TRIO· Fort Wayne, IN· 138 miles

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
211 Previous Clinical Trials
73,204 Total Patients Enrolled
5 Trials studying Breast Cancer
3,066 Patients Enrolled for Breast Cancer
Seagen, a wholly owned subsidiary of PfizerLead Sponsor
8 Previous Clinical Trials
2,056 Total Patients Enrolled
Medical MonitorStudy DirectorSeagen Inc.
1,679 Previous Clinical Trials
988,448 Total Patients Enrolled
9 Trials studying Breast Cancer
699 Patients Enrolled for Breast Cancer
Mike Schmitt, MDStudy DirectorSeagen Inc.
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,589 Previous Clinical Trials
47,968,101 Total Patients Enrolled
48 Trials studying Breast Cancer
18,752 Patients Enrolled for Breast Cancer
Evelyn Rustia, MDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
225 Total Patients Enrolled
Kit Wong, MDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
10 Total Patients Enrolled

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
~73 spots leftby Mar 2026
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