Clinical Trials

Phase 1/2 Active not recruiting

Breast Neoplasms

NCT05230810 2026-03-16

Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

40 enrolled

HER2-positive Metastatic Breast Cancer

NCT01042379 2026-03-13

I-SPY

Phase 1 Active not recruiting

5,000 enrolled

BreastSarcoma

Pathologic Complete Response, Breast Neoplasms, Hemangiosarcoma, Neoplasms, Triple Negative Breast Neoplasms

NCT05382364 2026-03-12

Safety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002)

25 enrolled

BreastGastrointestinal

Breast Neoplasms, Colorectal Neoplasms

NCT07413939 2026-03-10

BREnnA

Phase 2/3 Not yet recruiting

650 enrolled

HER2-positive Breast Cancer

NCT06016387 2026-02-23

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

30 enrolled

Breast Neoplasms, Meningeal Neoplasms

NCT07193394 2026-02-23

H3RAKLES

20 enrolled

Breast Neoplasms, Neoplasm Metastasis, Neoplasms

NCT06686394 2026-02-13

MK-1022-009

Phase 1/2 Recruiting

81 enrolled

Breast Neoplasms

NCT05458674 2026-01-12

Tucatinib+Trastuzumab+Eribulin in HER2+ MBC

30 enrolled

Phase 2 Active not recruiting

Breast Neoplasms

NCT04721977 2026-01-09

MK-7119-001

66 enrolled 7 charts

Breast Neoplasms

NCT06961331 2026-01-09

Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer.

Completed

86 enrolled

Phase 3 Active not recruiting

Breast Neoplasms

NCT03975647 2025-12-10

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

466 enrolled 17 charts

HER2-positive Breast Cancer

NCT05583110 2025-12-10

TrasTUCAN

Phase 2 Terminated

13 enrolled

Phase 1/2 Active not recruiting

Breast Neoplasms

NCT04538742 2025-12-08

DB-07

245 enrolled

Brain Neoplasms, Breast Neoplasms

NCT05253911 2025-12-04

TRACE

Completed

49 enrolled

Phase 2 Active not recruiting

HER2-positive Breast Cancer

NCT05041842 2025-11-17

InTTercePT

53 enrolled

Metastatic Breast Cancer With a Isolated Brain Progression

NCT04539938 2025-09-30

HER2CLIMB-04

Phase 2 Completed

70 enrolled 11 charts

Breast Neoplasms

NCT06239467 2025-09-09

PIKture-01

Phase 1 Recruiting

200 enrolled

Breast Neoplasms

NCT03501979 2025-08-29

Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD

Phase 2 Terminated

17 enrolled 16 charts

Breast Neoplasms, Meningeal Neoplasms

NCT04220203 2025-06-26

Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer

Approved for marketing

HER2-positive Breast Cancer

NCT06439693 2025-06-26

The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

72 enrolled

Breast Neoplasms

NCT05319873 2025-05-13

Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer

Phase 1/2 Recruiting

18 enrolled

Anatomic Stage II Breast Cancer AJCC v8

NCT05868226 2025-04-04

PRE-I-SPY-PI

Phase 1 Recruiting

124 enrolled

Breast Neoplasms, Neoplasm Metastasis, Triple Negative Breast Neoplasms

NCT05955170 2025-03-27

TUC-TOC

66 enrolled

HER2-positive Breast Cancer

NCT05748834 2025-01-31

Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

36 enrolled

BreastGastrointestinalGynecologicThoracic

Breast Neoplasms

NCT02892123 2024-11-27

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

Phase 1 Completed

279 enrolled

Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms, Ovarian Neoplasms, Stomach Neoplasms

NCT06162559 2024-01-11

TRAIN-4

Phase 1 Recruiting

30 enrolled

Breast Neoplasms

NCT03054363 2023-11-13

Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer

Phase 1/2 Completed

42 enrolled 16 charts

612 enrolled 30 charts 2 FDA

Breast Neoplasms

NCT02614794 2023-08-14

HER2CLIMB

Phase 2 Completed

Brain Neoplasms, Breast Neoplasms

NCT04896320 2023-06-22

2019-101826

Phase 1/2 Withdrawn

BreastGastrointestinalThoracic

Breast Neoplasms, Neoplasm Metastasis

NCT05091528 2022-08-18

A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers

Phase 1/2 Terminated

2 enrolled 9 charts

Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Colorectal Neoplasms

NCT05227131 2022-07-11

MARGARET

Phase 2 Withdrawn

Breast Neoplasms

NCT04512261 2022-07-01

TOPAZ

Phase 1/2 Withdrawn

Brain Neoplasms, Breast Neoplasms, Central Nervous System Diseases

NCT03846583 2020-10-23

Tucatinib + Abemaciclib + Herceptin for HER2+ MBC

Phase 1 Withdrawn

Breast Neoplasms

NCT01983501 2020-09-21

A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer

Phase 1 Completed

57 enrolled

Breast Neoplasms

NCT02025192 2020-06-04

A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer

Phase 1 Completed

60 enrolled

Breast Neoplasms

NCT03424473 2020-02-25

Expanded Access Use of Tucatinib for HER2+ Metastatic Breast Cancer

No longer available