17 active not recruiting, 17 completed, 17 recruiting, 5 terminated. 43 Phase 2, 25 Phase 1, 6 Phase 3, 1 Early Phase 1, 1 Phase 4.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Tucatinib Continuation Study tucatinib - HER2-positive Breast Cancer, Cervical Cancer | Phase 4 | Not yet recruiting | Pfizer | 175 | 2026-11-06 | 2026-08-28 |
| Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer Zanidatamab, Tucatinib, Capecitabine - HER 2 Positive Advanced Breast Cancer, Breast Cancer | Phase 1 / Phase 2 | Not yet recruiting | MedSIR | 24 | 2026-07-01 | 2026-04-23 |
| RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive RO7771950, Tucatinib, Trastuzumab - HER2-positive Breast Cancer | Phase 2 / Phase 3 | Recruiting | Hoffmann-La Roche | 650 | 2026-05-21 | 2026-10-06 |
| ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer SOC (Standard of care), Bevacizumab, Cetuximab - Dynamic Tumor Resistance, Metastatic Colorectal Cancer | Early Phase 1 | Recruiting | M.D. Anderson Cancer Center | 100 | 2026-04-22 | 2026-10-14 |
| Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer Tucatinib (ONT-380), Trastuzumab (Herceptin) - Metastatic Breast Cancer ( HER2 Negative), Unresectable Breast Cancer | Phase 2 | Recruiting | Institut Curie | 20 | 2026-01-31 | 2026-02-23 |
| Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer. Tucatinib, Trastuzumab, Capecitabine - Metastatic HER2+ Advanced Breast Cancer | Completed | Pfizer | 86 | 2025-05-07 | 2026-01-09 | |
| Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) Patritumab deruxtecan, Trastuzumab, Trastuzumab Biosimilar - Breast Neoplasms, Breast Cancer | Phase 1 / Phase 2 | Recruiting | Merck Sharp & Dohme LLC | 181 | 2025-02-26 | 2026-10-21 |
| The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer Nab-Paclitaxel, Paclitaxel, Docetaxel - Breast Cancer Female, Breast Cancer | Phase 2 | Recruiting | Dana-Farber Cancer Institute | 72 | 2024-08-08 | 2026-08-06 |
| A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors disitamab vedotin, tucatinib - Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma | Phase 2 | Active not recruiting | Seagen, a wholly owned subsidiary of Pfizer | 54 | 2024-05-20 | 2026-07-22 |
| First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer OKI-219, Fulvestrant, Trastuzumab - Advanced Cancer, Breast Cancer | Phase 1 | Active not recruiting | OnKure, Inc. | 200 | 2024-02-26 | 2026-07-06 |
| Tucatinib+Trastuzumab+Eribulin in HER2+ MBC Tucatinib, Eribulin, Trastuzumab - Breast Cancer, Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer | Phase 2 | Active not recruiting | Criterium, Inc. | 17 | 2024-01-30 | 2026-07-10 |
| Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer Combined use of SRS with Tucatinib, Trastuzumab, and Capecitabine - Brain Metastases, HER2-positive Breast Cancer | Phase 1 | Terminated | Baptist Health South Florida | 1 | 2024-01-29 | 2025-12-31 |
| Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer Cetuximab, Osimertinib, Tucatinib - Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma | Phase 1 | Not yet recruiting | Jonathan Riess | 36 | 2024-01-01 | 2023-10-05 |
| Tucatinib in Combination With Oral Etoposide andTrastuzumab in Patients With Metastatic HER2+ Breast Cancer Tucatinib in Combination of Oral VP16 and trastuzumab - HER2-positive Breast Cancer | Phase 2 | Recruiting | Institut Curie | 66 | 2023-12-19 | 2025-03-27 |
| Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease Tucatinib Oral Tablet, Capecitabine tablets, Trastuzumab Injection - Leptomeningeal Metastasis, Leptomeningeal Disease | Phase 2 | Recruiting | UNICANCER | 30 | 2023-12-18 | 2025-11-18 |
| Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study Tucatinib, Trastuzumab, Pertuzumab - Breast Cancer | Phase 1 | Recruiting | The Netherlands Cancer Institute | 30 | 2023-12-18 | 2024-01-11 |
| Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study Tucatinib 150 MG, Trastuzumab, Capecitabine - HER2-positive Breast Cancer, LMD | Phase 2 | Recruiting | Sunnybrook Health Sciences Centre | 30 | 2023-11-25 | 2026-02-23 |
| Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study Trastuzumab, Trifluridine and Tipiracil Hydrochloride, Tucatinib - Metastatic Colon Adenocarcinoma, Metastatic Colorectal Adenocarcinoma | Phase 2 | Withdrawn | Academic and Community Cancer Research United | 2023-10-31 | 2024-09-19 | |
| Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer Tucatinib, Doxil - Breast Cancer | Phase 2 | Recruiting | SCRI Development Innovations, LLC | 36 | 2023-07-24 | 2026-03-20 |
| Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients 5-Fluorouracil continuous infusion FOLFOXIRI schedule, 5-Fluorouracil bolus FOLFOX schedule, 5-Fluorouracil continuous infusion FOLFOX schedule - Stage II Colon Cancer, Stage III Colon Cancer | Phase 2 | Suspended | Gruppo Oncologico del Nord-Ovest | 477 | 2023-05-17 | 2026-02-03 |
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Breast Neoplasms (34) · Colorectal Neoplasms (10) · Brain Neoplasms (8) · Neoplasms (5) · Carcinoma, Non-Small-Cell Lung (4) · Neoplasm Metastasis (4) · Stomach Neoplasms (4) · Colonic Neoplasms (3) · Meningeal Neoplasms (3) · Rectal Neoplasms (3) · Triple Negative Breast Neoplasms (3) · Adenocarcinoma (2) · Adenocarcinoma Of Esophagus (2) · Biliary Tract Neoplasms (2) · Lymphoma, Non-Hodgkin (2)
Seagen Inc. (11) · Seagen, a wholly owned subsidiary of Pfizer (8) · Pfizer (4) · Criterium, Inc. (2) · Dana-Farber Cancer Institute (2) · Institut Curie (2) · M.D. Anderson Cancer Center (2) · MedSIR (2) · Memorial Sloan Kettering Cancer Center (2) · QuantumLeap Healthcare Collaborative (2) · UNICANCER (2) · Academic and Community Cancer Research United (1) · Alliance for Clinical Trials in Oncology (1) · American Society of Clinical Oncology (1) · AstraZeneca (1)
United States (48) · Canada (14) · South Korea (13) · France (12) · Italy (11) · Spain (11) · United Kingdom (10) · Australia (9) · Germany (9) · Belgium (8) · Japan (8) · Taiwan (8) · Austria (6) · China (6) · Brazil (4)
JoAl Mayor, PharmD, BCOP (4) · Corinna Palanca-Wessels, MD, PhD (3) · Joseph Woolery, PharmD, BCOP (3) · Alex Vo, PhD (2) · John H Strickler (2) · Jorge Ramos, DO (2) · Alison Conlin, MD (1) · Andrea Cercek, MD (1) · Andrew Seidman, MD (1) · Anja Welt, PD Dr. (1) · Anne-Claire Hardy-Bessard, MD (1) · Barbara J O'Brien, MD (1) · Carey Anders, MD (1)
PMID 39368039, PMID 29804905, PMID 21796368, PMID 22198468, PMID 22623692, PMID 22649152, PMID 27406346, PMID 27406347, PMID 28851423, PMID 29955792, PMID 31825569, PMID 32031889, PMID 32053137, PMID 32450725, PMID 32468955, PMID 32701140, PMID 33068284, PMID 33090333, PMID 33844595, PMID 34214937, PMID 34529000, PMID 34636255, PMID 34728571, PMID 34741021, PMID 35623341, PMID 35931943, PMID 35993306, PMID 36069821, PMID 36315917, PMID 36400106, PMID 36454580, PMID 36456573, PMID 36471222, PMID 36753688, PMID 37027810, PMID 37029329, PMID 37142372, PMID 37315265, PMID 37318379, PMID 37325931, PMID 37363965, PMID 37489819, PMID 37505107, PMID 37561967, PMID 37751113, PMID 37751561, PMID 37941353, PMID 38039429, PMID 38086377, PMID 38096472
2023 (3), 2025 (3), P30CA015083 (2), 2015 (1), 2019 (1), P30CA093373 (1), U10CA180821 (1)