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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 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

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

66%

Diarrhoea

43%

Fatigue

34%

Nausea

21%

Pyrexia

21%

Infusion related reaction

20%

Decreased appetite

20%

Dermatitis acneiform

19%

Arthralgia

19%

Chills

19%

Back pain

17%

Hypertension

17%

Cough

16%

Vomiting

14%

Constipation

14%

Dyspnoea

13%

Myalgia

13%

Abdominal pain

10%

Pruritus

10%

Anxiety

10%

Headache

10%

Anaemia

Pain in extremity

Dry skin

Weight decreased

Nasal congestion

Insomnia

Rash maculo-papular

Peripheral sensory neuropathy

Influenza like illness

Dehydration

Oedema peripheral

Muscle spasms

Epistaxis

Abdominal pain upper

Upper-airway cough syndrome

Productive cough

COVID-19

Rhinitis allergic

Dizziness

Ejection fraction decreased

Hypokalaemia

Musculoskeletal chest pain

Alanine aminotransferase increased

Aspartate aminotransferase increased

Pollakiuria

Blood creatinine increased

Nephrolithiasis

Fall

Dyspepsia

Dry mouth

Oropharyngeal pain

Rash

Haematuria

Rhinorrhoea

Urinary tract infection

Dysgeusia

Flank pain

Vision Blurred

Blood alkaline phosphatase increased

Flatulence

Dysuria

Gastrooesophageal reflux disease

Nail infection

Asthenia

Non-cardiac chest pain

Vision blurred

Large intestinal obstruction

Small intestinal obstruction

Weight increased

Hyponatraemia

Wheezing

Hypercreatinaemia

Herpes zoster

Peripheral swelling

Pain

COVID-19 pneumonia

Blepharospasm

Influenza

Rectal haemorrhage

Thrombocytopenia

Abdominal distension

Rhinitis

Abdominal discomfort

Gastrointestinal pain

Onychomadesis

Pelvic pain

Otitis media

Pneumonia

Restless legs syndrome

Ecchymosis

Rectal perforation

Muscular weakness

Dysphonia

Erythema

Nail disorder

Urticaria

Upper respiratory tract infection

Syncope

Hypoalbuminaemia

Dyspnoea exertional

Pulmonary embolism

Sinus pain

Procedural pain

Onychoclasis

Vertigo

Proctalgia

Hypotension

Urinary tract infection bacterial

Stomatitis

Sepsis

Acute kidney injury

Cerebellar haemorrhage

Lymphoedema

Cancer pain

Malaise

Anorectal infection

Neck pain

Bile duct stone

Cholangitis

Angina unstable

Lacrimation increased

Hordeolum

Rash pustular

Colitis

Gastrointestinal obstruction

Kidney infection

Renal colic

Acute respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Tucatinib+Trastuzumab (Cohorts A+B)

Tucatinib Pre-Crossover (Cohort C)

Tucatinib Post-Crossover (Cohort C)

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

~5630

Tucatinib

2017

Completed Phase 2

~800