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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
Must not have
Peripheral neuropathy of any etiology that exceeds grade 1
Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Pivotal Trial

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My nerve damage does not severely affect my daily activities.
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My cancer is ER+ and HER2+, has spread but not to my lymph nodes.
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My breast cancer has spread to other parts of my body.
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I haven't taken any experimental cancer drugs in the last 28 days.
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I do not have any severe, uncontrolled diseases.
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I do not have active or untreated hepatitis B, C, or chronic liver disease.
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My cancer has come back after initial treatment and surgery.
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I haven't had major surgery or serious injuries in the last 28 days.
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I cannot undergo radiotherapy due to health reasons.
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My heart and lung function is normal.
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I have not had invasive breast cancer in the last 3 years.
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I have been treated with a specific amount of anthracycline drugs.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Modified invasive disease-free survival (iDFS)
Secondary study objectives
Brain metastases-free survival
Breast cancer-free survival
Distant recurrence-free survival
+3 more
Other study objectives
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%
Vomiting
16%
Arthralgia
16%
Back pain
16%
Cough
14%
Constipation
14%
Abdominal pain
14%
Dyspnoea
13%
Myalgia
10%
Anxiety
10%
Anaemia
9%
Pruritus
9%
Headache
9%
Pain in extremity
9%
Dry skin
8%
Rash maculo-papular
8%
Peripheral sensory neuropathy
8%
Insomnia
8%
Influenza like illness
8%
Dehydration
8%
Oedema peripheral
8%
Nasal congestion
7%
Productive cough
7%
Upper-airway cough syndrome
7%
Weight decreased
7%
Muscle spasms
7%
Epistaxis
6%
Hypokalaemia
6%
Rhinitis allergic
6%
COVID-19
6%
Alanine aminotransferase increased
6%
Aspartate aminotransferase increased
5%
Nephrolithiasis
5%
Dizziness
5%
Musculoskeletal chest pain
5%
Ejection fraction decreased
5%
Abdominal pain upper
5%
Dry mouth
5%
Oropharyngeal pain
5%
Rash
5%
Haematuria
5%
Urinary tract infection
5%
Dysgeusia
5%
Flank pain
3%
Vision Blurred
3%
Blood creatinine increased
3%
Non-cardiac chest pain
3%
Pollakiuria
3%
Asthenia
3%
Flatulence
3%
Fall
3%
Dysuria
3%
Gastrooesophageal reflux disease
3%
Dyspepsia
3%
Large intestinal obstruction
3%
Small intestinal obstruction
3%
Hyponatraemia
3%
Rhinorrhoea
3%
Wheezing
3%
Hypercreatinaemia
2%
Influenza
2%
Abdominal distension
2%
Peripheral swelling
2%
Herpes zoster
2%
COVID-19 pneumonia
2%
Blepharospasm
2%
Blood alkaline phosphatase increased
2%
Rhinitis
2%
Rectal haemorrhage
2%
Thrombocytopenia
2%
Nail infection
2%
Abdominal discomfort
2%
Gastrointestinal pain
2%
Onychomadesis
2%
Pelvic pain
2%
Rectal perforation
2%
Muscular weakness
2%
Weight increased
2%
Dysphonia
2%
Erythema
2%
Nail disorder
2%
Urticaria
2%
Hypoalbuminaemia
2%
Dyspnoea exertional
2%
Pulmonary embolism
2%
Sinus pain
1%
Hypotension
1%
Sepsis
1%
Acute kidney injury
1%
Cancer pain
1%
Bile duct stone
1%
Cholangitis
1%
Angina unstable
1%
Colitis
1%
Gastrointestinal obstruction
1%
Kidney infection
1%
Renal colic
1%
Acute respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tucatinib+Trastuzumab (Cohorts A+B)
Cohort C (Pre-Crossover)
Cohort C (Post-Crossover)

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: 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
Trastuzumab Emtansine
2016
Completed Phase 3
~5730
Tucatinib
2017
Completed Phase 2
~520

Find a Location

Who is running the clinical trial?

Seagen Inc.Industry Sponsor
210 Previous Clinical Trials
73,257 Total Patients Enrolled
5 Trials studying Breast Cancer
3,066 Patients Enrolled for Breast Cancer
Alliance for Clinical Trials in OncologyLead Sponsor
515 Previous Clinical Trials
218,845 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,898 Previous Clinical Trials
41,011,682 Total Patients Enrolled
947 Trials studying Breast Cancer
1,545,598 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
~472 spots leftby Jan 2028
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