SGNTUC-028: 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; Porter, Janice (Melinda)
IRB No: W21.126.08
Protocol Abbrev: HER2CLIMB-05
Principal Investigator: Rebecca L. Moroose, MD
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
ClinicalTrials.gov ID: NCT05132582
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.
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),