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Monoclonal Antibodies
Tucatinib + Trastuzumab Deruxtecan for Breast Cancer (HER2CLIMB-04 Trial)
Houston, TX
Phase 2
Waitlist Available
Research Sponsored by Seagen, a wholly owned subsidiary of Pfizer
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.
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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.Check my eligibility
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.See study design
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 belowSelect...
My brain scans show stable or treated brain metastases.
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I was treated with taxane and trastuzumab for my cancer and it either didn't work or my cancer returned within 6 months.
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I have had treatment for cancer that spread to my brain.
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My breast cancer is HER2 positive, confirmed by a certified lab.
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My breast cancer has worsened after the last treatment or I couldn't tolerate it.
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I am fully active or can carry out light work.
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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.
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I have never taken experimental drugs for HER2 or EGFR.
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I cannot swallow pills or have a stomach condition that affects medication absorption.
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I have not been treated with Trastuzumab deruxtecan or similar drugs.
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I have a serious heart or lung condition, including a history of ILD/pneumonitis.
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I do not have any serious infections that are uncontrolled.
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I have a long-term liver condition.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment up to approximately 5 years
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 moreSide effects data
From 2024 Phase 2 & 3 trial • 17 Patients • NCT0449992450%
Diarrhoea
50%
Rash
38%
Alopecia
38%
Aspartate aminotransferase increased
38%
Constipation
38%
Pyrexia
25%
Stomatitis
25%
Dermatitis acneiform
25%
Weight decreased
25%
Abdominal pain
25%
Myalgia
25%
Epistaxis
25%
Hypertension
25%
Fatigue
25%
Nausea
25%
Alanine aminotransferase increased
25%
Anaemia
25%
Ejection fraction decreased
13%
Gastritis
13%
Dizziness
13%
Dyspepsia
13%
Dyspnoea
13%
Anal haemorrhage
13%
Rectal abscess
13%
Neck pain
13%
Night sweats
13%
Neutropenia
13%
Vomiting
13%
Chills
13%
Skin infection
13%
Hyphaema
13%
Infusion related reaction
13%
Temperature intolerance
13%
Arthralgia
13%
Thrombocytopenia
13%
Eye pruritus
13%
Fall
13%
Acute kidney injury
13%
Rhinorrhoea
13%
Decreased appetite
13%
Skin laceration
13%
Myofascial pain syndrome
13%
Chromaturia
13%
Palmar-plantar erythrodysaesthesia syndrome
13%
Enteritis
13%
Respiratory failure
13%
Gastrooesophageal reflux disease
13%
Haemorrhoids
13%
Odynophagia
13%
Hyperbilirubinaemia
13%
COVID-19
13%
Tympanic membrane perforation
13%
Peripheral swelling
13%
Peripheral sensory neuropathy
13%
Gastric haemorrhage
13%
Anal fissure
13%
Localised oedema
13%
Cough
13%
Hypotension
13%
Intestinal sepsis
13%
Pneumonia
13%
Pneumothorax
13%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paclitaxel 60 mg/m^2
Paclitaxel 80 mg/m^2
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
Closest Location:Memorial Sloan Kettering Cancer Center· New York, NY· 24 miles
Who is running the clinical trial?
Seagen, a wholly owned subsidiary of PfizerLead Sponsor
6 Previous Clinical Trials
1,585 Total Patients Enrolled
Seagen Inc.Lead Sponsor
211 Previous Clinical Trials
73,600 Total Patients Enrolled
5 Trials studying Breast Cancer
3,066 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,587 Previous Clinical Trials
47,967,898 Total Patients Enrolled
48 Trials studying Breast Cancer
18,752 Patients Enrolled for Breast Cancer
Jorge Ramos, DOStudy DirectorSeagen Inc.
4 Previous Clinical Trials
1,346 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain scans show stable or treated brain metastases.I am currently taking tucatinib or am enrolled in a tucatinib trial.I was treated with Lapatinib or neratinib less than a year ago, but not for disease progression or severe side effects.I was treated with taxane and trastuzumab for my cancer and it either didn't work or my cancer returned within 6 months.I have brain metastases that don't require immediate treatment.It's been over 2 weeks since my whole brain radiation, over a week since my radiosurgery, or over 4 weeks since any surgical resection.I have had treatment for cancer that spread to my brain.You have a disease that can be measured and assessed using a specific method called RECIST v1.1.I have never taken experimental drugs for HER2 or EGFR.I cannot swallow pills or have a stomach condition that affects medication absorption.I have not been treated with Trastuzumab deruxtecan or similar drugs.My brain cancer has been treated and is either stable or worse, but doesn't need immediate treatment.I can provide records of my brain treatment.I've had brain treatment for new or worsening lesions found during this study's screening.I haven't had a heart attack or unstable chest pain in the last 6 months.My breast cancer is HER2 positive, confirmed by a certified lab.My breast cancer has worsened after the last treatment or I couldn't tolerate it.I have not had major surgery within the last 4 weeks.You have other areas of the body with measurable disease according to specific guidelines.I haven't taken cancer treatment or been in a trial within the last 3 weeks, except for GnRH agonists.I have a serious heart or lung condition, including a history of ILD/pneumonitis.I have not had radiation treatment outside of the brain within the last week.I have hepatitis B or C, but if I had hepatitis C, I've been successfully treated.I do not have any serious infections that are uncontrolled.I have a long-term liver condition.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.