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Clinical Trials List

Protocol NumberSGNTUC-028
NCT Number(ClinicalTrials.gov Identfier)NCT05132582
Active

2022-03-01 - 2027-08-31

Phase III

Recruiting14

ICD-10D05.00

Lobular carcinoma in situ of unspecified breast

ICD-10D05.01

Lobular carcinoma in situ of right breast

ICD-10D05.02

Lobular carcinoma in situ of left breast

ICD-10D05.10

Intraductal carcinoma in situ of unspecified breast

ICD-10D05.11

Intraductal carcinoma in situ of right breast

ICD-10D05.12

Intraductal carcinoma in situ of left breast

ICD-10D05.80

Other specified type of carcinoma in situ of unspecified breast

ICD-10D05.81

Other specified type of carcinoma in situ of right breast

ICD-10D05.82

Other specified type of carcinoma in situ of left breast

ICD-10D05.90

Unspecified type of carcinoma in situ of unspecified breast

ICD-10D05.91

Unspecified type of carcinoma in situ of right breast

ICD-10D05.92

Unspecified type of carcinoma in situ of left breast

ICD-9233.0

Carcinoma in situ of breast

A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 郭雨萱 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shin-Cheh Chen Division of General Surgery
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳守棟 Division of General Surgery
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Feng Hou Division of General Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HWEI-CHUNG WANG Division of General Surgery
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 戴明燊 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鍾奇峰 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chiun-Sheng Huang Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張源清 Division of General Surgery
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSU-YI CHAO Division of Hematology & Oncology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Pang Chung
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭雨萱 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

HER2 Positive Breast Cancer

Objectives

Primary objective: To compare progression-free survival (PFS) as determined by the trial administrator according to the Responsive Criteria in Solid Tumor Response (RECIST) version 1.1 between treatment groups. Key secondary objective: To compare overall survival (OS) between treatment groups.

Test Drug

錠劑

Active Ingredient

Tucatinib

Dosage Form

110

Dosage

50mg, 150mg

Endpoints

Primary endpoint: Progression-free survival (PFS), defined as the time elapsed from randomization to the occurrence of documented disease progression or death from any cause, as assessed by the trial administrator according to the Solid Cancer Response Assessment Criteria, version 1.1, whichever occurs first.

Key secondary endpoint: Overall survival (OS), defined as the time elapsed from randomization to death from any cause.

Inclution Criteria

Inclusion Criteria:

Centrally confirmed HER2+ breast carcinoma according to the 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines prior to randomization (defined as a 3+ score on immunohistochemistry (IHC) and/or 2+ IHC and concurrent positive by ISH).
Have unresectable locally advanced or metastatic disease.

If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.
Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.
Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-])
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance imaging (MRI), participants may have any of the following:

No evidence of brain metastases
Untreated brain metastases which are asymptomatic not needing immediate local treatment and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane
Previously treated brain metastases which are asymptomatic

Brain metastases previously treated with local therapy must not have progressed since treatment

Exclusion Criteria

Exclusion Criteria:

Prior treatment with any tyrosine kinase inhibitor targeting HER2 and/or epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months have elapsed since last neratinib dose prior to start of study drug)
Unable to undergo contrast-enhanced MRI of the brain
CNS Exclusion - Based on screening brain MRI and clinical assessment

Symptomatic brain metastasis after CNS-directed local therapy
Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane
Ongoing use of systemic corticosteroids at a total daily dose of >2 mg of dexamethasone (or equivalent)
Any untreated brain lesion in an anatomic site which may pose risk to participant
Known or suspected leptomeningeal disease (LMD)
Poorly controlled (>1/week) seizures, or other persistent neurologic symptoms

The Estimated Number of Participants

  • Taiwan

    31 participants

  • Global

    650 participants

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