HER2CLIMB-05/SGNTUC-028: Treating HER2 Positive Breast Cancer with Tucatinib

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)

  • Clinical Trial Information

    Trial Contact: Durand, Jennifer; Ribacchi, Stephanie

    Trial Phone: 321.843.2026 ; 321-841-1077

  • IRB No: W21.126.08

    Protocol Abbrev: HER2CLIMB-05

    Principal Investigator:

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: SGNTUC-028

    Treatment: Arm 1: Tucatinib in combination with trastuzumab and Pertuzumab as maintenance therapy Arm 2: Placebo in combination with trastuzumab and Pertuzumab as maintenance therapy

    Therapies Involved: Medication ID: NCT05132582

  • Objective

    This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of tucatinib in combination with trastuzumab and pertuzumab as maintenance therapy in subjects with advanced HER2+ breast cancer.

  • Key Eligibility

    1. Have centrally confirmed HER2+ breast carcinoma per 2018 American Society of Clinical Oncologists (ASCO)-College of American Pathologists (CAP) guidelines.
    a. Tissue blocks or slides must be submitted and confirmed as HER2+ by a sponsor-designated central laboratory prior to randomization

    2. Have unresectable locally advanced or metastatic (hereafter referred to as “advanced”) disease; if recurrent (after [neo]adjuvant therapy), there must be a minimum 6-month treatment-free interval from any trastuzumab or pertuzumab received in the early breast cancer setting to the diagnosis of advanced HER2+ disease. Prior standard of care therapy for early breast cancer is permitted (eg, prior ado-trastuzumab emtansine [T-DM1]); however, Exclusion Criterion 1 should be noted.

    3. Have received 4-8 cycles (21-day cycles) of previous treatment with trastuzumab, pertuzumab, and taxane as first-line therapy for advanced HER2+ breast cancer with no evidence of disease progression (per investigator judgement)

    4. Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-])

    5. Be at least 18 years of age, and legally an adult at time of consent

    6. Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

    7. Have adequate hepatic function

    8. Have adequate baseline hematologic parameters

    9. Have a serum or plasma creatinine ≤1.5 X institutional ULN.

    10. Have left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 4 weeks prior to first dose of study treatment.

    11. For subjects of childbearing potential, the following stipulations apply

    13. Provide signed informed consent per a consent document that has been approved by an institutional review board or independent ethics committee (IRB/IEC) prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the subject’s disease

    14. Be willing and able to comply with study procedures

    15. CNS Inclusion – Based on screening contrast brain magnetic resonance imaging (MRI),