Therapy Detail

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Therapy Name Capecitabine + Trastuzumab + Tucatinib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Capecitabine Xeloda R340 Chemotherapy - Antimetabolite 11 Xeloda (capecitabine) is an antimetabolite that when activated to 5-FU ultimately inhibits DNA synthesis and cell division (NCI Drug Dictionary).
Trastuzumab Herceptin Anti HER2 HER2 (ERBB2) Antibody 47 Herceptin (trastuzumab) is a monoclonal antibody, which binds ERBB2 (HER2) to induce tumor cellular cytotoxicity (PMID: 17611206). Herceptin (trastuzumab) is FDA approved for HER2-overexpressing (or amplification) breast cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma (FDA.gov).
Tucatinib Tukysa ONT-380|ARRY-380|irbinitinib HER2 Inhibitor 25 Tukysa (tucatinib) selectivity inhibits ERBB2 (HER2), resulting in decreased proliferation and increased apoptosis in ERBB2 (HER2) expressing tumor cells (PMID: 28053022). Tukysa (tucatinib) in combination with Herceptin (trastuzumab) and Xeloda (capecitabine) is FDA approved for use in patients with advanced unresectable or metastatic ERBB2 (HER2)-positive breast cancer, including patients with brain metastasis, who have received prior anti-HER2 therapies (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 amp Her2-receptor positive breast cancer sensitive Capecitabine + Trastuzumab + Tucatinib Guideline Actionable Tukysa (tucatinib), Herceptin (trastuzumab), and Xeloda (capecitabine) combination therapy is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 amp Her2-receptor positive breast cancer sensitive Capecitabine + Trastuzumab + Tucatinib FDA approved Actionable In a Phase II trial (HER2CLIMB) that supported FDA approval, addition of Tukysa (tucatinib) to Herceptin (trastuzumab) and Xeloda (capecitabine) significantly improved progression-free survival at 1 year (PFS1) compared to placebo (33.1% vs 12.3%, HR=0.54, p<0.001) in patients with metastatic ERBB2 (HER2)-positive breast cancer who received prior HER2-targeted therapy, PFS1 was significantly improved (24.9% vs 0%, HR=0.48, p<0.001) in patients with brain metastasis (PMID: 31825569; NCT02614794). detail... 31825569
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive Capecitabine + Trastuzumab + Tucatinib Phase Ib/II Actionable In a Phase Ib trial, the combination of Tukysa (tucatinib), Herceptin (trastuzumab), and Capecitabine demonstrated clinical activity in CNS metastases in patients with ERBB2 (HER2)-positive metastatic breast cancer, with 50% (1/2) of evaluable patients achieving CNS partial response and 50% (1/2) achieving CNS stable disease (San Antonio Breast Cancer Symposium 2015, Abstract P4-14-19). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive Capecitabine + Trastuzumab + Tucatinib Guideline Actionable Tukysa (tucatinib), Herceptin (trastuzumab), and Xeloda (capecitabine) combination therapy is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive Capecitabine + Trastuzumab + Tucatinib FDA approved Actionable In a Phase II trial (HER2CLIMB) that supported FDA approval, addition of Tukysa (tucatinib) to Herceptin (trastuzumab) and Xeloda (capecitabine) significantly improved progression-free survival at 1 year (PFS1) compared to placebo (33.1% vs 12.3%, HR=0.54, p<0.001) in patients with metastatic ERBB2 (HER2)-positive breast cancer who received prior HER2-targeted therapy, PFS1 was significantly improved (24.9% vs 0%, HR=0.48, p<0.001) in patients with brain metastasis (PMID: 31825569; NCT02614794). detail... 31825569

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Clinical Trial Phase Therapies Title Recruitment Status
NCT02614794 Phase II Capecitabine + Trastuzumab + Tucatinib Capecitabine + Trastuzumab A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer (HER2CLIMB) Active, not recruiting
NCT02025192 Phase I Capecitabine + Trastuzumab + Tucatinib Trastuzumab + Tucatinib Capecitabine + Tucatinib A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer Completed
NCT03501979 Phase II Capecitabine + Trastuzumab + Tucatinib Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD Recruiting


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