The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer (HER2CLIMB-04)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04539938
Recruitment Status : Active, not recruiting
First Posted : September 7, 2020
Last Update Posted : March 6, 2024
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

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.


Condition or disease Intervention/treatment Phase
HER2 Positive Breast Cancer Drug: tucatinib Drug: trastuzumab deruxtecan Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : October 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Single Arm
Tucatinib + trastuzumab deruxtecan
 Drug: tucatinib
300 mg orally twice daily
Other Name: TUKYSA, ARRY-380, ONT-380

Drug: trastuzumab deruxtecan
5.4 mg/kg via intravenous (into the vein; IV) infusion on Day 1 of each of 21-day cycle
Other Name: T-DXd, Enhertu, DS-8201


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Confirmed objective response rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 according to investigator assessment [ Time Frame: From start of treatment up to approximately 3 years ]
    ORR is defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR) per RECIST v1.1


Secondary Outcome Measures :
  1. Duration of response (DOR) per RECIST v1.1 according to investigator assessment [ Time Frame: From start of treatment up to approximately 3 years ]
    DOR is defined as the time from first documentation of objective response to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs earlier

  2. Progression-free survival (PFS) per RECIST v1.1 according to investigator assessment [ Time Frame: From start of treatment up to approximately 3 years ]
    PFS is defined as the time from start of study treatment to first documentation of tumor progression or to death due to any cause, whichever comes first

  3. Disease control rate (DCR) per RECIST v1.1 according to investigator assessment [ Time Frame: From start of treatment up to approximately 3 years ]
    DCR is defined as the proportion of subjects with confirmed CR, PR or stable disease according to RECIST v1.1

  4. Overall survival (OS) [ Time Frame: From start of treatment up to approximately 5 years ]
    OS is defined as the time from treatment initiation to death due to any cause

  5. Incidence of adverse events (AEs) [ Time Frame: From start of treatment up to approximately 3 years ]
    An AE is defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  6. Incidence of laboratory abnormalities [ Time Frame: From start of treatment up to approximately 3 years ]
  7. Incidence of dose modifications [ Time Frame: From start of treatment up to approximately 3 years ]
  8. Incidence of treatment discontinuations [ Time Frame: From start of treatment up to approximately 3 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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

  • 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

Exclusion Criteria

  • 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:

    • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539938


Locations
Show Show 33 study locations
Sponsors and Collaborators
Seagen Inc.
Investigators
Layout table for investigator information
Study Director: Jorge Ramos, DO Seagen Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT04539938    
Other Study ID Numbers: SGNTUC-025
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
HER2+ breast cancer
Metastatic breast cancer
Stage IV breast cancer
Seattle Genetics
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Tucatinib
Trastuzumab deruxtecan
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action