TUKYSA 150 mg film-coated tablets
Sponsors
Institut Curie, Unicancer, Seagen Inc., Fundacion Grupo Espanol De Investigacion En Cancer De Mama, Fundacion Grupo Espanol De Investigacion En Cancer De Mama
Conditions
HER2+ metastatic breast cancer with isolated brain progressionHER3-mutant and HER2-not amplified metastatic breast cancerLA/mGC/GEJC (locally advanced unresectable or metastatic gastric cancer and gastroesophageal junction adenocarcinomaLocally-Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 AlterationsMetastatic HER2+ Breast cancerNon-resectable locally advanced or metastatic HER2-positive breast cancerPatients having a HER2-amplified metastatic breast cancer with evolutive leptomeningeal metastases (LM) requiring intrathecal therapyPreviously Treated
Phase 1
C5731004 - SGNDV-004 - A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination with Other Anticancer Therapies in Solid Tumors
RecruitingCTIS2023-507555-29-00
Start: 2024-08-16Target: 68Updated: 2025-10-03
Single arm phase II study of the efficacy and safety of the combination of Trastuzumab plus TUCAtinib plus viNorelbine in patients with HER2-positive non-resectable locally advanced or metastatic breast cancer “TrasTUCAN Study”
CompletedCTIS2024-512590-27-00
Start: 2023-03-08End: 2025-05-30Target: 49Updated: 2024-06-19
Phase 2
"TUC-TOC": Tucatinib in combination with Oral Etoposide (VP16) - Trastuzumab in Patients with metastatic HER2+ Breast cancer after progression under Tucatinib-Capecitabine-Trastuzumab or toxicity related to capecitabine: a multicenter Phase II
RecruitingCTIS2022-500743-20-00
Start: 2023-12-19Target: 66Updated: 2025-02-27
ETIC-LM_Multicentric single arm phase II study evaluating the Efficacy of association of Tucatinib, capecitabine and Intra-CSF trastuzumab in HER2 amplified breast cancer patients with Leptomeningeal Metastases.
RecruitingCTIS2022-502351-60-00
Start: 2024-02-22Target: 30Updated: 2025-04-17
InTTercePT : Treatment with Tucatinib in addition to Pertuzumab and Trastuzumab in patients with HER2-positive metastatic breast cancer after local therapy of isolated brain progression
Active, not recruitingCTIS2024-510703-11-00
Start: 2021-12-13Target: 55Updated: 2026-01-12
C4251003- A Phase 2 Basket Study of Tucatinib in Combination with Trastuzumab in Subjects with Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations.
Active, not recruitingCTIS2024-511481-37-00
Start: 2021-07-12Target: 29Updated: 2025-06-17
"H3RAKLES": Tucatinib and trastuzumab in HER3-mutant and HER2-not amplified metastatic breast cancer
Not yet recruitingCTIS2024-519624-24-00
Target: 20Updated: 2025-09-11
Phase 3
A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer (HER2CLIMB-05)
Active, not recruitingCTIS2023-503826-37-00
Start: 2022-02-11Target: 249Updated: 2026-01-08
C4251008 - An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer
RecruitingCTIS2024-514180-25-00
Start: 2022-11-21Target: 155Updated: 2025-12-05
Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer (HER2CLIMB-02)
Active, not recruitingCTIS2024-514733-38-00
Start: 2020-11-03Target: 101Updated: 2025-10-20