for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
completion around



This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery.

Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer.

Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

Official Title

Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)


This study is designed to evaluate the efficacy and safety of tucatinib in combination with T-DM1 in participants with unresectable locally-advanced or metastatic HER2+ breast cancer who have had prior treatment with a taxane and trastuzumab in any setting. Prior pertuzumab treatment is permitted, but not required. Participants will be randomized in a 1:1 manner to receive 21-day cycles of either tucatinib or placebo in combination with T-DM1.

While on study treatment, participants will be assessed for progression every 6 weeks for the first 24 weeks, and every 9 weeks thereafter, irrespective of dose holds or interruptions. Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. After completion of study treatment and after occurrence of disease progression, participants in both arms of the study will continue to be followed for survival until study closure or withdrawal of consent.


HER2-positive Breast Cancer, Seattle Genetics, Breast Neoplasms, Tucatinib, Tucatinib + T-DM1


You can join if…

Open to people ages 18 years and up

  • Histologically confirmed HER2+ breast carcinoma as determined by a sponsor-designated central laboratory
  • History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination
  • Have progression of unresectable locally advanced/metastatic breast cancer after last systemic therapy, or be intolerant of last systemic therapy
  • Measurable or non-measurable disease assessable by RECIST v1.1
  • ECOG performance status score of 0 or 1
  • CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must have at least one of the following:

    (a) No evidence of brain metastases

    (b) Untreated brain metastases not needing immediate local therapy

    (c) Previously treated brain metastases

    1. 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
    2. Participants treated with CNS local therapy for newly identified lesions or previously treated and progressing lesions may be eligible to enroll if all of the following criteria are met:

      (i) Time since SRS is at least 7 days prior to first dose of study treatment, time since WBRT is at least 14 days prior to first dose, or time since surgical resection is at least 28 days.

      (ii) Other sites of evaluable disease are present

    3. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions

You CAN'T join if...

  • Prior treatment with tucatinib, afatinib, trastuzumab deruxtecan (DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. Prior treatment with lapatinib or neratinib within 12 months of starting study treatment (except in cases where they were given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity). Prior treatment with pyrotinib for recurrent of mBC (except in cases where pyrotinib was given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity).
  • CNS Exclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must not have any of the following:
    1. Any untreated brain lesions >2 cm in size
    2. Ongoing use of corticosteroids for control of symptoms of brain metastases at a total daily dose of >2 mg of dexamethasone (or equivalent).
    3. Any brain lesion thought to require immediate local therapy
    4. Known or concurrent leptomeningeal disease as documented by the investigator
    5. Poorly controlled generalized or complex partial seizures


  • Chao Family Comprehensive Cancer Center University of California Irvine in progress, not accepting new patients
    Orange California 92868 United States
  • University of California Irvine - Newport in progress, not accepting new patients
    Orange California 92868 United States
  • St. Joseph Heritage Healthcare TRIO completed
    Fullerton California 92835 United States
  • Cancer Hospital Chinese Academy of Medical Sciences accepting new patients
    Beijing City Other 100021 China
  • Peking University People's Hospital accepting new patients
    Beijing Other 100044 China
  • Jilin Province Cancer Hospital accepting new patients
    Changghun Other 130012 China
  • Hunan Cancer Hospital accepting new patients
    Changsha Other 410013 China
  • Sun Yat-sen University Cancer Center accepting new patients
    Guangzhou City Other 510060 China
  • Guangdong Provincial People's Hospital accepting new patients
    Guangzhou Other 510080 China
  • Zhejiang Cancer Hospital accepting new patients
    Hangzhou City Other 310022 China


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
Seagen Inc.
Phase 3 research study
Study Type
Expecting 565 study participants
Last Updated