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Antibody Drug Conjugate

Tucatinib + T-DM1 for Breast Cancer

Phase 3

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

Study 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.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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator assessment

Secondary outcome measures

CBR per RECIST v1.1 by BICR

Clinical benefit rate (CBR) per RECIST v1.1 by investigator assessment

DOR per RECIST v1.1 by BICR

+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%

Dyspepsia

11%

Upper respiratory tract infection

11%

Urinary tract infection

11%

Muscle spasms

11%

Oedema peripheral

10%

Pruritus

10%

Insomnia

Hypomagnesaemia

Neutropenia

Abdominal pain upper

Dehydration

Asthenia

Myalgia

Dysgeusia

Oropharyngeal pain

Skin hyperpigmentation

Hypophosphataemia

Rash maculo-papular

Blood alkaline phosphatase increased

Thrombocytopenia

Abdominal distension

Hyperbilirubinaemia

Fall

Rhinorrhoea

Paraesthesia

Dry eye

Hyperglycaemia

Gastrooesophageal reflux disease

Influenza like illness

Pyrexia

Paronychia

Alopecia

White blood cell count decreased

Dry mouth

Neutrophil count decreased

Platelet count decreased

Muscular weakness

Hypertension

Nasopharyngitis

Seizure

Pneumonia

Influenza

Cholecystitis

Sepsis

Ejection fraction decreased

Syncope

Pleural effusion

Pulmonary embolism

Cardiac failure

Gastroenteritis

100%

80%

60%

40%

20%

Study treatment Arm

Tuc+Cap+Tra

Pbo+Cap+Tra

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

2018

Completed Phase 2

~800

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

208 Previous Clinical Trials

73,663 Total Patients Enrolled

6 Trials studying Breast Cancer

3,308 Patients Enrolled for Breast Cancer

Mike Schmitt, MDStudy DirectorSeagen Inc.

Evelyn Rustia, MDStudy DirectorSeagen Inc.

1 Previous Clinical Trials

225 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

Frequently Asked Questions

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

Have other research groups looked into this treatment before?

"Tucatinib has been the focus of 61 medical studies over the last 13 years. The first study occurred in 2008 and was sponsored by Hoffmann-La Roche. After this initial trial, which 720 people participated in, tucatinib received Phase 2 drug approval. Currently there are 61 live trials for tucatinib happening across 1555 cities and 57 countries."

Answered by AI

What disease does tucatinib target?

"breast cancer patients who have received one or more anti-her2-based regimens in the metastatic setting can be treated with tucatinib."

Answered by AI

What other investigations have been carried out with tucatinib?

"Tucatinib is being studied in 61 active clinical trials, 11 of which are Phase 3. The majority of these research sites are based in Koto-ku, but there are 6763 total locations running tucatinib trials."

Answered by AI

Are new participants still being accepted into this research program?

"Yes, this research is still open and recruiting patients as of today. The trial was first announced on October 2nd, 2019 with the most recent update taking place on October 31st, 2020."

Answered by AI

When will tucatinib be cleared by the FDA for public use?

"Tucatinib received a safety estimate of 3 because it is in Phase 3 clinical trials. This means that while there is data supporting the efficacy of tucatinib, there are multiple rounds of data affirming its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

2019. "A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03975647.

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