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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment up to approximately 5 years
Awards & highlights
HER2CLIMB-04 Trial 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.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.
HER2CLIMB-04 Trial 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.
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.
HER2CLIMB-04 Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed objective response rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 according to investigator assessment
Secondary outcome measures
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)
+5 moreSide effects data
From 2022 Phase 2 trial • 612 Patients • NCT0261479482%
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%
Dyspepsia
11%
Upper respiratory tract infection
11%
Urinary tract infection
11%
Muscle spasms
11%
Oedema peripheral
10%
Pruritus
10%
Insomnia
9%
Hypomagnesaemia
9%
Neutropenia
9%
Abdominal pain upper
8%
Dehydration
8%
Asthenia
8%
Myalgia
8%
Dysgeusia
8%
Oropharyngeal pain
8%
Skin hyperpigmentation
7%
Hypophosphataemia
7%
Blood alkaline phosphatase increased
7%
Rash maculo-papular
7%
Thrombocytopenia
7%
Abdominal distension
7%
Hyperbilirubinaemia
7%
Fall
7%
Rhinorrhoea
6%
Paraesthesia
6%
Dry eye
6%
Hyperglycaemia
6%
Gastrooesophageal reflux disease
6%
Influenza like illness
6%
Pyrexia
6%
Paronychia
6%
Alopecia
5%
White blood cell count decreased
5%
Dry mouth
5%
Neutrophil count decreased
5%
Platelet count decreased
5%
Muscular weakness
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
HER2CLIMB-04 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
2018
Completed Phase 2
~800
Find a Location
Who is running the clinical trial?
Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
69,087 Total Patients Enrolled
6 Trials studying Breast Cancer
3,308 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any other experiments explored the effects of tucatinib?
"Tucatinib first entered the research sphere in 2010, when City of Hope initiated its own clinical trials. Subsequently, 15 completed studies have been conducted and 56 additional active investigations are being carried out across Pittsburgh, Pennsylvania."
Answered by AI
Has the federal government authorized tucatinib for general use?
"The safety of tucatinib has been estimated to be a 2 on the 1-3 scale due to Phase 2 trial results, which demonstrate some evidence of its security but no indication yet of efficacy."
Answered by AI
Is tucatinib typically employed to address various medical conditions?
"Those affected with metastatic HER2-positive breast cancer, who have had two or more prior anti-HER2 regimens in the setting of metastasis and at least one such regimen for treating said metastasis can be treated using tucatinib."
Answered by AI
What is the geographic scope of this experiment?
"Currently, this trial is occurring in a total of 32 medical centres throughout the United States. These locations include Pittsburgh, Houston and Fairfax among others. Participants can choose to attend their closest site for convenience and to reduce travel requirements."
Answered by AI
Is this experiment currently accepting new participants?
"Clinicaltrials.gov registers that patient recruitment for this trial is still ongoing, with the study being first advertised on December 1st 2020 and edited as recently as October 26th 2022."
Answered by AI
What is the current size of the cohort participating in this experiment?
"Affirmative. Clinicaltrials.gov demonstrates that this particular trial, initially published on December 1st 2020, is presently searching for volunteers. Approximately 70 participants are required from 32 different clinical sites."
Answered by AI
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