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AzTrials

HER2 Positive Breast CancerPhase 2HER2CLIMB-04NCT04539938

A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

A Phase 2 study testing tucatinib and trastuzumab deruxtecan in people with HER2 Positive Breast Cancer, run by Seagen, a wholly owned subsidiary of Pfizer at 140 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2 Positive Breast Cancer
What is being tested?
tucatinib and trastuzumab deruxtecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
140 sitesUnited States
Study dates
1 Dec 2020to 7 Mar 2025
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have confirmed HER2+ breast cancer, as defined by the current American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines, previously determined at a Clinical Laboratory Improvements Amendments (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory.
  • 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.
  • Have progression of unresectable LA/M breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy
  • Have measurable disease assessable by RECIST v1.1
  • Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
  • Have a life expectancy of at least 6 months, in the opinion of the investigator
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  • 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:
  • Untreated brain metastases not needing immediate local therapy. For participants with untreated central nervous system (CNS) lesions >2.0 cm on screening contrast brain MRI, discussion with and approval from the medical monitor is required prior to enrollment
  • Previously treated brain metastases
  • Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator
  • Participants treated with CNS local therapy for newly identified or previously treated progressing lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if all of the following criteria are met:
  • Time since whole brain radiation therapy (WBRT) is ≥14 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥7 days prior to first dose of study treatment, or time since surgical resection is ≥28 days
  • Other sites of measurable disease by RECIST v1.1 are present
  • Relevant records of any CNS treatment must be available

Who cannot join

  • Have previously been treated with:
  • Lapatinib or neratinib within 12 months of starting study treatment (except in cases where lapatinib or neratinib was given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity)
  • 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
  • Trastuzumab deruxtecan or another antibody-drug conjugate (ADC) consisting of an exatecan derivative
  • Have received treatment with:
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  • Any systemic anti-cancer therapy (including hormonal therapy) or experimental agent ≤21 days of first dose of study treatment or are currently participating in another interventional clinical trial. An exception for the washout of hormonal therapies is gonadotropin releasing hormone (GnRH) agonists used for ovarian suppression in premenopausal women, which are permitted concomitant medications
  • Treatment with non-CNS radiation ≤7 days prior to first dose of study treatment
  • Major surgery <28 days of first dose of study treatment
  • Have clinically significant cardiopulmonary disease (such as history of iterstitial lung disease (ILD)/pneumonitis that required systemic corticosteroids, or have current ILD/pneumonitis, or where suspected ILD /pneumonitis cannot be ruled out be imaging at screening)
  • Have known myocardial infarction or unstable angina within 6 months prior to first dose of study treatment
  • Known to be positive for hepatitis B by surface antigen expression. Known to be positive for hepatitis C infection. Participants who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of 12 weeks
  • Presence of known chronic liver disease
  • Active or uncontrolled clinically serious infection
  • Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications

Trial locations and contacts

140 sites in 1 country.

140 sites in 1 country

United States140 sites

  • UCLA Hematology/Oncology - Alhambra

    Alhambra, California, 91801

  • Florida Cancer Specialists

    Altamonte Springs, Florida, 32701

  • Northside Hospital, Inc - GCS/Athens

    Athens, Georgia, 30606

  • Winship Cancer Institute @ Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • Winship Cancer Institute / Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Atlanta Cancer Care - Atlanta

    Atlanta, Georgia, 30342

  • Northside Hospital, Inc. - Central Research Department

    Atlanta, Georgia, 30342

  • Northside Hospital, Inc. - GCS/Center Pointe

    Atlanta, Georgia, 30342

  • University of Colorado Denver CTO/CTRC - Outpatient.

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

    Aurora, Colorado, 80045

  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square

    Baltimore, Maryland, 21237

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920

  • University Of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham, IDS Pharmacy

    Birmingham, Alabama, 35249

  • University Of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

    Blacksburg, Virginia, 24060

  • Northside Hospital, Inc - GCS/Blairsville

    Blairsville, Georgia, 30512

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Florida Cancer Specialists

    Brandon, Florida, 33511

  • UCLA Hematology/Oncology - Burbank

    Burbank, California, 91505

  • Northside Hospital, Inc - GCS/Canton

    Canton, Georgia, 30114

  • Tennessee Oncology, PLLC

    Chattanooga, Tennessee, 37403

  • Sarah Cannon Research Institute

    Chattanooga, Tennessee, 37404

  • Tennessee Oncology, PLLC

    Chattanooga, Tennessee, 37404

  • Florida Cancer Specialists

    Clearwater, Florida, 33761

  • Tennessee Oncology, PLLC

    Cleveland, Tennessee, 37311

  • MSK Commack

    Commack, New York, 11725

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Minnesota Oncology Hematology, PA

    Coon Rapids, Minnesota, 55433

  • UPMC Hillman Cancer Center Passavant North

    Cranberry Township, Pennsylvania, 16066

  • Atlanta Cancer Care - Cumming

    Cumming, Georgia, 30041

  • Northside Hospital, Inc. - GCS/Decatur

    Decatur, Georgia, 30033

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055

  • City of Hope (City of Hope National Medical Center, City of Hope Medical center)

    Duarte, California, 91010

  • City of Hope Investigational Drug Services (IDS)

    Duarte, California, 91010

  • NHCI Suburban Hematology-oncology Associates - Duluth

    Duluth, Georgia, 30096

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Mercy Hospital - Unity Campus

    Fridley, Minnesota, 55432

  • Minnesota Oncology Hematology, PA

    Fridley, Minnesota, 55433

  • Florida Cancer Specialists

    Gainesville, Florida, 32605

  • Virginia Cancer Specialists, PC

    Gainesville, Virginia, 20155

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • UPMC Hillman Cancer Center Mountainview

    Greensburg, Pennsylvania, 15601

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MSK Westchester

    Harrison, New York, 10604

  • Tennessee Oncology, PLLC

    Hendersonville, Tennessee, 37075

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • U.T. MD Anderson Cancer Center

    Houston, Texas, 77030

  • US Oncology Investigational Product Center (IPC)

    Irving, Texas, 75063

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063

  • US Oncology lnvestigational Products Center (IPC)

    Irving, Texas, 75063

  • UCLA Hematology/Oncology - Laguna Hills

    Laguna Hills, California, 92653

  • Florida Cancer Specialists

    Largo, Florida, 33770

  • NHCI Suburban Hematology-oncology Associates - lawrenceville

    Lawrenceville, Georgia, 30046

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37909

  • Florida Cancer Specialists

    Lecanto, Florida, 34461

  • Virginia Cancer Specialists, PC

    Leesburg, Virginia, 20176

  • UC Health Lone Tree Medical Center

    Lone Tree, Colorado, 80124

  • Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

    Long Island City, New York, 11101

  • (IRB# 20-001502) Ronald Reagan UCLA Medical Center, Drug Information Center

    Los Angeles, California, 90095

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

  • Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

    Low Moor, Virginia, 24457

  • Northside Hospital, Inc - GCS/Macon

    Macon, Georgia, 31217

  • UW Health Oncology - One South Park

    Madison, Wisconsin, 53715

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792

  • Northside Hospital, Inc. - GCS/Marietta

    Marietta, Georgia, 30060

  • MSK Monmouth

    Middletown, New Jersey, 07748

  • Minnesota Oncology Hematology, PA

    Minneapolis, Minnesota, 55404

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Allina Health Cancer institute

    Minneapolis, Minnesota, 55407

  • UPMC Hillman Cancer Center UPMC East

    Monroeville, Pennsylvania, 15146

  • MSK Bergen

    Montvale, New Jersey, 07645

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37129

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211

  • Evelyn H. Lauder Breast and Imaging Center (BAIC).

    New York, New York, 10065

  • Dana Farber Cancer Institute- Chestnut Hill

    Newton, Massachusetts, 02459

  • Florida Cancer Specialists

    Ocala, Florida, 34474

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68114

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68124

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Florida Cancer Specialists

    Orange City, Florida, 32763

  • Florida Cancer Specialists

    Orlando, Florida, 32806

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Papillion, Nebraska, 68046

  • UCLA Hematology/Oncology - Pasadena

    Pasadena, California, 91105

  • UPMC Hillman Cancer Center Upper Saint Clair

    Pittsburgh, Pennsylvania, 15102

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • University of Pittsburgh Cancer Institute Investigational Drug Service UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC Cancer Centers William M. Cooper Ambulatory Care Pavilion of the Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC Hillman Cancer Center UPMC Passavant

    Pittsburgh, Pennsylvania, 15237

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Virginia Cancer Specialists, PC

    Reston, Virginia, 20190

  • Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Allina Health Cancer Institute

    Saint Paul, Minnesota, 55102

  • Minnesota Oncology Hematology PA

    Saint Paul, Minnesota, 55102

  • Minnesota Oncology Hematology, PA

    Saint Paul, Minnesota, 55102

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

    Salem, Virginia, 24153

  • Zuckerberg San Francisco General Hospital- Breast Clinic

    San Francisco, California, 94110

  • Zuckerberg San Francisco General Hospital- Oncology Clinic

    San Francisco, California, 94110

  • University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

  • UCLA Hematology/Oncology - San Luis Obispo

    San Luis Obispo, California, 93401

  • UCLA Hematology/Oncology - Santa Barbara

    Santa Barbara, California, 93105

  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California, 90404

  • UCLA Hematology/Oncology Parkside

    Santa Monica, California, 90404

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee, 37160

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Atlanta Cancer Care - Stockbridge

    Stockbridge, Georgia, 30281

  • Florida Cancer Specialists

    Tampa, Florida, 33607

  • Florida Cancer Specialists

    Tavares, Florida, 32778

  • Florida Cancer Specialists

    The Villages, Florida, 32159

  • Florida Cancer Specialists

    Trinity, Florida, 34655

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85704

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85711

  • MSK Nassau

    Uniondale, New York, 11553

  • UPMC Hillman Cancer Center Uniontown

    Uniontown, Pennsylvania, 15401

  • UCLA Hematology/Oncology - Ventura

    Ventura, California, 93003

  • UPMC Hillman Cancer Center Washington

    Washington, Pennsylvania, 15301

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Washington Cancer Institute at MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • UCLA Hematology/Oncology - Westlake

    Westlake Village, California, 91361

  • Florida Cancer Specialists

    Winter Park, Florida, 32789

  • Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

    Wytheville, Virginia, 24382

Other trials in United States

About this study

Official title: A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination With Trastuzumab Deruxtecan in Subjects With Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer

This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer.

Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.

Being tested
tucatinib, trastuzumab deruxtecan
Keywords
HER2+ breast cancer, Metastatic breast cancer, Stage IV breast cancer, Seattle Genetics
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tucatinibDrug

    Also called TUKYSA, ARRY-380, ONT-380, PF-07265792

    300 mg orally twice daily

  • trastuzumab deruxtecanDrug

    Also called T-DXd, Enhertu, DS-8201

    5.4 mg/kg via intravenous (into the vein; IV) infusion on Day 1 of each of 21-day cycle

Study groups in NCT04539938
Study groupRoleWhat they receive
Single ArmExperimentalTucatinib + trastuzumab deruxtecan
Receives: Drug: tucatinib; Drug: trastuzumab deruxtecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed Objective Response Rate (cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 According to Investigator (INV) Assessment

    Confirmed objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per investigator according to RECIST v1.1. For a response to be considered confirmed, the subsequent response had to be at least 4 weeks after the initial response. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR: a greater than equal to (>=) 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. 95% exact confidence interval (CI) was based on Clopper-Pearson method.

    Measured: From the first dose of study treatment until the first documented PD or before start of any new anti-cancer therapy (up to 43 months)

Secondary outcomes (13)

  1. Progression-Free Survival (PFS) Per RECIST v1.1 According to INV

    PFS as per INV was defined as the time from the start of the study treatment to the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Kaplan-Meier methods was used for analysis.

    Measured: From the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first (approximately 46.2 months of treatment exposure)

  2. Duration of Response (DOR) Per RECIST v1.1 According to INV

    DOR was defined as the time from the date of first documented objective response (CR or PR that was subsequently confirmed) to the date of first documented PD per RECIST v1.1 or death due to any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: a >= 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Kaplan-Meier methods was used for analysis.

    Measured: From the first documented objective response until the first documentation of PD or death, whichever occurred first (approximately 46.2 months)

  3. Disease Control Rate (DCR) Per RECIST v1.1

    DCR was defined as percentage of participants with confirmed CR, PR or stable disease ([SD] or non-CR/non-PD) per RECIST v1.1. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: a >= 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. 95% CI was computed using Clopper-Pearson method.

    Measured: From first dose of study treatment until PD or death, whichever occurred first (approximately 46.2 months)

  4. Overall Survival (OS)

    OS was defined as the time from the start of study treatment to the date of death due to any cause. Participants who were not known to have died at the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). For participants without data beyond the day of treatment initiation, OS was censored on the date of treatment initiation. Kaplan-Meier methods was used for analysis.

    Measured: From date of start of study treatment until date of death or censoring date (approximately 46.2 months)

  5. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product which did not necessarily have a causal relationship with this treatment. AEs included all non-serious adverse events (non-SAEs) and SAEs. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment.

    Measured: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)

  6. Number of Participants With Serious Adverse Events (SAEs)

    An SAE was an AE that at any dose, met any of the following criteria: resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or disability (substantial disruption of the participant's ability to conduct normal life functions), congenital anomaly/birth defect or considered medically significant.

    Measured: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)

  7. Number of Participants With Treatment Emergent Adverse Events Based on Severity

    An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. AEs were graded based on National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0 where, grade 1= mild; grade 2= moderate; grade 3= severe; grade 4= life-threatening; grade 5= death.

    Measured: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)

  8. Number of Participants With Treatment Related TEAEs

    An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. Relatedness of AEs to study treatment was determined by the investigator.

    Measured: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)

  9. Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities

    Laboratory abnormalities included: hematology; hemoglobin increased and decreased, leukocytes decreased, lymphocytes increased and decreased, neutrophils decreased and platelets decreased. Chemistry: alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatinine, magnesium, potassium, sodium and total bilirubin increased and glucose, magnesium, potassium and sodium decreased. Treatment-emergent laboratory abnormalities were defined as abnormalities that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. Laboratory test results were graded according to NCI CTCAE version 4.03, where Grade 0: no AE, Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Number of participants with any grade are reported in this outcome measure.

    Measured: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)

  10. Number of Participants With TEAEs Leading to Dose Modification

    An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. Dose modification included dose reduction, dose delay, dose hold and dose interruption. Number of participants with TEAEs leading to any type of dose modification for tucatinib and T-DXd are reported in this outcome measure.

    Measured: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)

  11. Number of Participants With TEAEs Leading to Treatment Discontinuation

    An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. In this outcome measure, participants with TEAEs leading to discontinuation of tucatinib and T-DXd treatment is reported.

    Measured: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)

  12. Number of Participants According to Change From Baseline Categories in Ejection Fraction

    Cardiac ejection fraction was assessed using multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO). Baseline was defined as most recent non-missing assessment on or before first dose date. Number of participants according to change from baseline in ejection fraction categories (i.e., no decrease, decrease <10%, decrease 10-<20% and decrease >=20%) is reported in this outcome measure.

    Measured: Baseline up to 30 days after last dose of study treatment (approximately 47.2 months)

  13. Number of Participants With Clinically Significant Vital Signs

    Vital signs included body temperature, respiratory rate, heart rate, oxygen saturation, and systolic blood pressure (SBP) and diastolic blood pressure (DBP). The clinically significant vital signs were defined as: heart rate > 100 beats per minute (bpm), temperature >=38.0 degrees Celsius (C), respiratory rate > 20 breaths per minute and oxygen saturation < 88%; SBP >=120 millimeters of mercury (mmHg) or DBP >=80 mmHg; SBP >=140 mmHg or DBP >=90 mmHg and SBP >=160 mmHg or DBP>=100 mmHg.

    Measured: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2020
  2. Study start1 Dec 2020
  3. Primary completion15 Jul 2024
  4. Study completion7 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04539938
Sponsor's protocol ID
SGNTUC-025
Other IDs
C4251006
Acronym
HER2CLIMB-04
Status last verified
Mar 2026
First submitted
31 Aug 2020
Last updated
23 Mar 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Modi S, Murthy RK, Chien AJ, Lin NU, McAndrew NP, Specht JM, Zelnak AB, Ramos J, Xie D, Ho J, Inoue JK, Carey LA, Hamilton EP. Tucatinib in Combination With Trastuzumab Deruxtecan in Patients With Previously Treated HER2+ Unresectable Locally Advanced or Metastatic Breast Cancer: An Open-Label Phase 2 Study. Clin Breast Cancer. 2026 Aug;26(8):21-30. doi: 10.1016/j.clbc.2026.05.010. Epub 2026 Jul 10.

    PubMed 42431148

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