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 14 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 76 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 42 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, and in combination with Herceptin (trastuzumab) for patients with RAS wild-type ERBB2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05800275 Phase II Capecitabine + Trastuzumab + Tucatinib Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease (ETIC-LM) Recruiting FRA 0
NCT05553522 Phase I Capecitabine + Trastuzumab + Tucatinib Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer Recruiting USA 0
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) Completed USA | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BEL | AUT | AUS 1
NCT04896320 Phase Ib/II Trastuzumab + Tucatinib + Vinorelbine Capecitabine + Trastuzumab + Tucatinib Tucatinib With Chemotherapy and Trastuzumab in Advanced Her-2-neu Overexpressing, Previously Treated Breast Cancer. (2019-101826) Withdrawn USA 0
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 USA 0
NCT03501979 Phase II Capecitabine + Trastuzumab + Tucatinib Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD Active, not recruiting USA 0
NCT06016387 Phase II Capecitabine + Trastuzumab + Tucatinib Tucatinib With Brain and/or Spinal XRT in Patients With HER2+ Metastatic Breast Cancer and LMD Recruiting CAN 0


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