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Monoclonal Antibodies

Tucatinib + Trastuzumab Deruxtecan for Breast Cancer (HER2CLIMB-04 Trial)

Phase 2
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
CNS Inclusion - Based on medical history and screening contrast brain magnetic resonance imaging (MRI), participants with a history of brain metastases must have one of the following:
History of prior treatment with a taxane and trastuzumab in the LA/M setting OR progressed within 6 months after neoadjuvant or adjuvant treatment, including a taxane and trastuzumab
Must not have
Tucatinib or enrolled on a tucatinib clinical trial
Any investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) (eg, afatinib) at any time previously
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment up to approximately 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will see if tucatinib and T-DXd work better together than T-DXd alone to treat HER2+ breast cancer.

Who is the study for?
This trial is for people with HER2+ breast cancer that's spread or can't be fully removed by surgery. They should have had prior treatment with a taxane and trastuzumab, measurable disease, and treated brain metastases if present. Excluded are those who've recently used certain drugs like Lapatinib, have serious heart or lung conditions, active infections, liver diseases, or can't take pills.
What is being tested?
The study tests how well tucatinib works alongside trastuzumab deruxtecan (T-DXd) in treating HER2+ breast cancer. All participants will receive both medications to see their effectiveness and monitor any side effects when combined.
What are the potential side effects?
Possible side effects from tucatinib and T-DXd may include reactions at the infusion site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems. There might also be specific organ-related issues such as inflammation of the lungs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My brain scans show stable or treated brain metastases.
Select...
I was treated with taxane and trastuzumab for my cancer and it either didn't work or my cancer returned within 6 months.
Select...
I have had treatment for cancer that spread to my brain.
Select...
My breast cancer is HER2 positive, confirmed by a certified lab.
Select...
My breast cancer has worsened after the last treatment or I couldn't tolerate it.
Select...
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 currently taking tucatinib or am enrolled in a tucatinib trial.
Select...
I have never taken experimental drugs for HER2 or EGFR.
Select...
I cannot swallow pills or have a stomach condition that affects medication absorption.
Select...
I have not been treated with Trastuzumab deruxtecan or similar drugs.
Select...
I have a serious heart or lung condition, including a history of ILD/pneumonitis.
Select...
I do not have any serious infections that are uncontrolled.
Select...
I have a long-term liver condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment 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
Confirmed objective response rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 according to investigator assessment
Secondary study objectives
Disease control rate (DCR) per RECIST v1.1 according to investigator assessment
Duration of response (DOR) per RECIST v1.1 according to investigator assessment
Incidence of adverse events (AEs)
+2 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%
Muscle spasms
11%
Dyspepsia
11%
Upper respiratory tract infection
11%
Urinary tract infection
11%
Oedema peripheral
10%
Pruritus
10%
Insomnia
9%
Neutropenia
9%
Hypomagnesaemia
9%
Abdominal pain upper
8%
Myalgia
8%
Dehydration
8%
Asthenia
8%
Dysgeusia
8%
Oropharyngeal pain
8%
Skin hyperpigmentation
7%
Rash maculo-papular
7%
Thrombocytopenia
7%
Hypophosphataemia
7%
Blood alkaline phosphatase increased
7%
Abdominal distension
7%
Hyperbilirubinaemia
7%
Fall
7%
Rhinorrhoea
6%
Hyperglycaemia
6%
Paraesthesia
6%
Dry eye
6%
Gastrooesophageal reflux disease
6%
Influenza like illness
6%
Pyrexia
6%
Paronychia
6%
Alopecia
5%
Muscular weakness
5%
White blood cell count decreased
5%
Dry mouth
5%
Neutrophil count decreased
5%
Platelet count decreased
5%
Hypertension
5%
Nasopharyngitis
3%
Seizure
2%
Pneumonia
2%
Influenza
1%
Cholecystitis
1%
Sepsis
1%
Ejection fraction decreased
1%
Syncope
1%
Pleural effusion
1%
Pulmonary embolism
1%
Cardiac failure
1%
Gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tuc+Cap+Tra
Pbo+Cap+Tra

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 Interventions
Tucatinib + trastuzumab deruxtecan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tucatinib
2021
Completed Phase 3
~810

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,218 Total Patients Enrolled
5 Trials studying Breast Cancer
3,066 Patients Enrolled for Breast Cancer
Jorge Ramos, DOStudy DirectorSeagen Inc.
4 Previous Clinical Trials
1,346 Total Patients Enrolled

Media Library

Trastuzumab Deruxtecan (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04539938 — Phase 2
Breast Cancer Research Study Groups: Single Arm
Breast Cancer Clinical Trial 2023: Trastuzumab Deruxtecan Highlights & Side Effects. Trial Name: NCT04539938 — Phase 2
Trastuzumab Deruxtecan (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04539938 — Phase 2
~14 spots leftby Nov 2025
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