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| Overall Recruitment Status: Study terminated early |
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| Official Title |
| 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) |
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| Region |
Sponsors |
| Hawaii |
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| Acronym |
KP IRB No. |
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1799234 |
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| Study Type |
Phase |
| Clinical Trial |
Phase III |
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| Study Population Description |
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| Purpose |
| To test how the study drugs, tucatinib plus trastuzumab and pertuzumab, work to treat HER2 positive breast cancer and what the side effects are. |
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| Detailed Description |
| This is a randomized, double-blind, placebo-controlled, international, multicenter, phase 3 study designed to evaluate the efficacy and safety of tucatinib in combination with trastuzumab and pertuzumab as maintenance therapy in subjects with advanced HER2+ breast cancer who have had prior treatment with a taxane, trastuzumab, and pertuzumab. After signing informed consent and meeting all eligibility criteria, subjects will be randomized in a 1:1 ratio to receive 21-day cycles of either tucatinib or placebo in combination with trastuzumab and pertuzumab. Randomization will be stratified by diagnosis (de-novo versus recurrent), hormone receptor status (positive versus negative), and presence or history of brain metastases (yes versus no).
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| Gender |
Age Limit |
| Male & Female |
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- 1. Have centrally confirmed HER2+ breast carcinoma per 2018 American Society of Clinical Oncologists (ASCO)-College of American Pathologists (CAP) guidelines
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2. Have unresectable locally advanced or metastatic (hereafter referred to as “advanced”) disease
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- 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])
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- however, Exclusion Criterion 1 should be noted
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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)
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4. Known hormone receptor status (per local guidelines
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- may be hormone receptor positive [HR+] or negative [HR-])
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5. Be at least 18 years of age, and legally an adult at time of consent and = the age of majority per regional requirements
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- 1. Have previously been treated with any anti-HER2 and/or anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in the extended adjuvant setting and at least 12 months have elapsed from the last neratinib dose to the start of study drug) or are currently participating in another interventional clinical trial
2. Unable for any reason to undergo contrast MRI of the brain
3. History of allergic reactions to trastuzumab, pertuzumab, or compounds chemically or biologically similar to tucatinib, except for Grade 1 or 2 infusion-related reactions to trastuzumab or pertuzumab that were successfully managed, known allergy to one of the excipients in the study drugs, or hypersensitivity to murine proteins
4. Are positive for Hepatitis B by surface antigen expression, positive for Hepatitis C infection, or the presence of known chronic liver disease. Subjects who have been treated for Hepatitis C infection are permitted if they have documented sustained virologic response of at least 12 weeks. The latest localguidelines should be followed regarding the testing of Hepatitis B DNA levels by polymerase chain reaction (PCR). Subjects with Hepatitis B DNA levels by PCR that require nucleoside analogue or other therapies are not eligible for the trial.
5. Subjects known to be positive for human immunodeficiency virus (HIV) are excluded if they meet any of the following criteria:
a. CD4+ T-cell count of <350 cells/µL
b. Detectable HIV viral load
c. History of an opportunistic infection within the past 12 months
d. On stable antiretroviral therapy for <4 weeks
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