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| Overall Recruitment Status: Active, currently enrolling |
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| 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) |
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
KP IRB No. |
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1496836 |
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| Study Type |
Phase |
| Clinical Trial |
Phase III |
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| Study Population Description |
| Individuals with Histologically confirmed HER2+ metastatic breast carcinoma. |
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| Purpose |
| 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.
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| Detailed Description |
| This study is designed to evaluate the efficacy and safety of tucatinib in combination with T-DM1 in subjects 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. Subjects 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, subjects 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, subjects in both arms of the study will continue to be followed for survival until study closure or withdrawal of consent.
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| Gender |
Age Limit |
| Male & Female |
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- Histologically confirmed HER2+ metastatic breast carcinoma as determined by a sponsor-designated central laboratory
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History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination
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Have progression of unresectable LA/M breast cancer after last systemic therapy, or be intolerant of last systemic therapy
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Measurable or non-measurable disease assessable by RECIST v1.1
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Hormone receptor (estrogen receptor/progesterone receptor) status must be known prior to randomization
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ECOG performance status score of 0 or 1
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Life expectancy >/=6 months
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CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), subjects 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
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Please contact study team for more eligibility criteria
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- Prior treatment with tucatinib, neratinib, afatinib, trastuzumab deruxtecan (DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. Prior treatment with lapatinib within 12 months of starting study treatment (except in cases where lapatinib was given for
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Prior treatment with T-DM1
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Treatment with any systemic anti-cancer therapy (including hormonal therapy), non-CNS radiation, experimental agent or participation in another interventional clinical trial
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Any toxicity related to prior cancer therapies that has not resolved to
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Please contact study team for more eligibility criteria
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Ado-trastuzumab emtansine
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Molecular Mechanisms of Pharmacological Action
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Antineoplastic Agents, Immunological
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Antineoplastic Agents, Phytogenic
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