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Drug Name Trade Name Synonyms Drug Classes Drug Description
Fluorouracil Adrucil 5-FU|5-Fluorouracil Chemotherapy - Antimetabolite 14 Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth and is FDA approved for colorectal, breast, stomach, and pancreatic cancer (FDA.gov).
Leucovorin Wellcovorin Calcium folinate|Calcium citrovorum factor|folinic acid Chemotherapy - Antimetabolite 14 Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554).
Oxaliplatin Eloxatin Diaminocyclohexane Oxalatoplatinum Chemotherapy - Platinum 7 Eloxatin (oxaliplatin) is comprised of a platinum complex, which causes DNA-platinum cross-links, inhibition of DNA replication and transcription, and cell toxicity, and is FDA approved for colorectal cancer (FDA.gov).
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
NCT05253651 Phase III Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03) Recruiting USA | SVK | POL | NOR | NLD | ITA | IRL | HUN | GRC | GBR | FRA | ESP | DEU | CHE | CAN | BRA | BEL | AUT | AUS | ARG 6
NCT05062889 Phase II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients (ERASE-CRC) Recruiting ITA 0
NCT04430738 Phase Ib/II Pembrolizumab + Trastuzumab + Tucatinib Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib Capecitabine + Oxaliplatin + Pembrolizumab + Trastuzumab + Tucatinib Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab + Trastuzumab + Tucatinib Capecitabine + Oxaliplatin + Trastuzumab + Tucatinib Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers Active, not recruiting USA 1


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