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Monoclonal Antibodies

T-DM1 + Tucatinib for Breast Cancer

Phase 3

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate excision of clinically evident disease in the breast and lymph nodes

An interval of no more than 12 weeks between the completion date of the last definitive treatment and the date of registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study Summary

This trial tests a combination of two drugs to see if they're better than one drug at preventing breast cancer from coming back in patients with high risk, HER2 positive breast cancer.

Who is the study for?

This trial is for patients with high risk, HER2 positive breast cancer who have had some treatment but still have invasive disease. They should not be pregnant or nursing and must not have metastatic (stage IV) breast cancer or a history of severe allergies to the drugs used in this study. Participants need good heart function and cannot have had another invasive breast cancer within the last 3 years.Check my eligibility

What is being tested?

The trial is testing if combining T-DM1 (a targeted therapy that delivers chemo directly to cancer cells) with tucatinib (which blocks enzymes needed for tumor growth) prevents relapse better than T-DM1 alone in those at high risk of their HER2 positive breast cancer returning.See study design

What are the potential side effects?

Possible side effects include allergic reactions to medication components, liver issues from hepatitis B/C or other chronic diseases, heart problems due to previous treatments, and potential nerve damage exceeding mild numbness or tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast and lymph node cancer has been fully removed.

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My last major treatment was within the last 3 months.

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My surgery report shows HR-negative, HER2 positive cancer in breast or lymph nodes.

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My biopsy shows my cancer is HER2-positive with a high score.

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My breast cancer is slightly estrogen receptor-positive.

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My cancer was at an early or advanced stage when found and still present after surgery.

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Both of my breast cancer lesions are HER2 positive.

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My cancer is either estrogen or progesterone receptor positive, or both are negative.

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My cancer's hormone receptor status is known.

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I received specific chemotherapy before surgery.

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My breast cancer was at stage T1-4, N0-3 at diagnosis and I still have invasive disease after surgery.

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I have received 1 or fewer cycles of T-DM1 for early-stage treatment.

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My cancer is HER2-positive based on a biopsy.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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

Modified invasive disease-free survival (iDFS)

Secondary outcome measures

Brain metastases-free survival

Breast cancer-free survival

Distant recurrence-free survival

+3 more

Other outcome measures

Quality of life

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

Headache

Pruritus

Dry skin

Pain in extremity

Rash maculo-papular

Peripheral sensory neuropathy

Insomnia

Influenza like illness

Dehydration

Oedema peripheral

Nasal congestion

Upper-airway cough syndrome

Productive cough

Weight decreased

Muscle spasms

Epistaxis

Hypokalaemia

Rhinitis allergic

COVID-19

Alanine aminotransferase increased

Aspartate aminotransferase increased

Dry mouth

Oropharyngeal pain

Dizziness

Nephrolithiasis

Rash

Ejection fraction decreased

Musculoskeletal chest pain

Abdominal pain upper

Haematuria

Urinary tract infection

Dysgeusia

Flank pain

Blood creatinine increased

Pollakiuria

Asthenia

Gastrooesophageal reflux disease

Vision Blurred

Dysuria

Flatulence

Non-cardiac chest pain

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

Hypotension

Sepsis

Cholangitis

Bile duct stone

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)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (trastuzumab emtansine, tucatinib)Experimental Treatment4 Interventions

Patients receive T-DM1 IV over 30-90 minutes on day 1 and tucatinib PO BID on days 1-21. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (trastuzumab emtansine, placebo)Active Control4 Interventions

Patients receive T-DM1 IV over 30-90 minutes on day 1 and placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tucatinib

2017

Completed Phase 2

~520

Trastuzumab Emtansine

2016

Completed Phase 3

~5630

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Industry Sponsor

208 Previous Clinical Trials

73,197 Total Patients Enrolled

6 Trials studying Breast Cancer

3,308 Patients Enrolled for Breast Cancer

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

216,607 Total Patients Enrolled

75 Trials studying Breast Cancer

40,143 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,924,874 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Media Library

Trastuzumab Emtansine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04457596 — Phase 3

Breast Cancer Research Study Groups: Arm II (trastuzumab emtansine, tucatinib), Arm I (trastuzumab emtansine, placebo)

Breast Cancer Clinical Trial 2023: Trastuzumab Emtansine Highlights & Side Effects. Trial Name: NCT04457596 — Phase 3

Trastuzumab Emtansine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04457596 — Phase 3

Breast Cancer Patient Testimony for trial: Trial Name: NCT04457596 — Phase 3

Frequently Asked Questions

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

Is there a high degree of risk when patients take Tucatinib?

"Tucatinib's safety is based on data from past Phase 3 trials, meaning that there is some evidence of the medication's efficacy and that it has undergone several rounds of testing for safety."

Answered by AI

Are there other drugs similar to Tucatinib that have been studied before?

"Tucatinib was first researched in 2008 at A.O. Universitaria Pisana; Oncologia. Now, 284 studies have been completed with 60 more actively recruiting. A majority of these active studies are based in Mineola, New york."

Answered by AI

Is this medical trial novel in any way?

"Tucatinib has a long history, with the very first clinical trials being conducted in 2008. Genentech, Inc. sponsored the initial study. Tucatinib received Phase 2 drug approval after the first study, which observed 720 patients. As of now, there are 60 active studies being conducted in 57 countries and 1549 cities."

Answered by AI

How is Tucatinib most often employed in medical care?

"Tucatinib is most often associated with its ability to treat breast cancer, however, it can also be used as a last-line of defence against metastasis in patients that have already received anti-her2 treatments."

Answered by AI

Are there any spots left in this research program for new participants?

"That is correct, the online information indicates that the study is currently looking for 1031 participants from 100 different locations. The original posting was on January 6th, 2021 with the most recent update being February 16th, 2022."

Answered by AI

How many individuals are being trialed with this medication?

"The pharmaceutical company sponsoring this trial, Seagen Inc., needs 1031 eligible patients to participate. Seagen will be administering the trial from several hospitals, including NYU Winthrop Hospital in Mineola, New york and Armes Family Cancer Center in Findlay, Ohio."

Answered by AI

In how many different places is this trial being run today?

"There are 4 primary locations for this trial: NYU Winthrop Hospital (Mineola, New york), Armes Family Cancer Center (Findlay, Ohio), UCHealth Highlands Ranch Hospital (Highlands Ranch, Colorado), and 100 other sites."

Answered by AI