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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 that interferes with DNA and RNA synthesis, thereby preventing cancer cell growth (PMID: 28520376). Adrucil (fluorouracil) is FDA-approved for use in patients with adenocarcinoma of the colon, rectum, breast, stomach, and pancreas (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 80 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 45 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
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) Suspended ITA 0
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 | GRC | GBR | FRA | ESP | DEU | CHE | CAN | BRA | BEL | AUT | AUS | ARG 6
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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