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Monoclonal Antibodies

Tucatinib + Trastuzumab + Pertuzumab for Breast Cancer (HER2CLIMB-05 Trial)

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
Have unresectable locally advanced or metastatic disease
Centrally confirmed HER2+ breast carcinoma according to the 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines prior to randomization (defined as a 3+ score on immunohistochemistry (IHC) and/or 2+ IHC and concurrent positive by ISH)
Must not have
Ongoing use of systemic corticosteroids at a total daily dose of >2 mg of dexamethasone (or equivalent)
Poorly controlled (>1/week) seizures, or other persistent neurologic symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing to see if adding tucatinib to trastuzumab and pertuzumab will help people with HER2-positive breast cancer live longer without their disease getting worse.

Who is the study for?
This trial is for individuals with HER2-positive breast cancer that's locally advanced, unresectable, or metastatic. Participants should have received specific induction therapy without disease progression and can't be undergoing certain treatments or have poorly controlled seizures. They must not need immediate treatment for brain metastases and should not have symptomatic brain lesions posing risk.
What is being tested?
The study tests if tucatinib plus trastuzumab and pertuzumab is more effective than a placebo combined with the same drugs in treating HER2-positive breast cancer. It's randomized and blinded, meaning participants won't know if they're receiving tucatinib or a placebo.
What are the potential side effects?
Potential side effects include reactions to the drug combination such as fatigue, nausea, allergic responses, potential heart issues due to trastuzumab and pertuzumab, as well as any unforeseen effects of tucatinib since it's being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer cannot be removed by surgery and has spread.
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My breast cancer is HER2 positive as per the latest guidelines.
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I have had brain metastases treatment and currently have no symptoms.
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I do not have cancer that has spread to my brain.
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I have brain metastases from cancer that don't need immediate treatment and haven't worsened since my last therapy.
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I've had 4-8 rounds of specific breast cancer treatment without the cancer getting worse.
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My brain cancer has not worsened after treatment.
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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:
Select...
I am taking more than 2 mg of dexamethasone daily.
Select...
I experience seizures more than once a week or have ongoing neurological symptoms.
Select...
I have or might have cancer spread to the lining of my brain and spinal cord.
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I still have symptoms from brain cancer after treatment aimed at my brain.
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My brain MRI and clinical assessment show I don't have CNS issues.
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My brain cancer has worsened despite treatment with trastuzumab, pertuzumab, and taxane.
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I have a brain lesion that has not been treated and could be risky.

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) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary study objectives
Central nervous system (CNS) PFS
Incidence of adverse events (AEs)
Incidence of laboratory abnormalities
+8 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Headache
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

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 + trastuzumab + pertuzumabExperimental Treatment4 Interventions
Tucatinib + trastuzumab + pertuzumab
Group II: Placebo + trastuzumab + pertuzumabActive Control4 Interventions
Placebo + trastuzumab + pertuzumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tucatinib
2017
Completed Phase 2
~520
Pertuzumab
2014
Completed Phase 3
~7500
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
73,634 Total Patients Enrolled
5 Trials studying Breast Cancer
3,066 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
4,001 Previous Clinical Trials
5,184,257 Total Patients Enrolled
60 Trials studying Breast Cancer
7,457 Patients Enrolled for Breast Cancer
Libero Santarpia, MD, PhDStudy DirectorSeagen Inc.

Media Library

Pertuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05132582 — Phase 3
Breast Cancer Research Study Groups: Placebo + trastuzumab + pertuzumab, Tucatinib + trastuzumab + pertuzumab
Breast Cancer Clinical Trial 2023: Pertuzumab Highlights & Side Effects. Trial Name: NCT05132582 — Phase 3
Pertuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05132582 — Phase 3
~103 spots leftby May 2025
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