MedPath

Tucatinib

Generic Name
Tucatinib
Brand Names
Tukysa
Drug Type
Small Molecule
Chemical Formula
C26H24N8O2
CAS Number
937263-43-9
Unique Ingredient Identifier
234248D0HH
Background

Tucatinib is a kinase inhibitor drug used with trastuzumab and capecitabine in the treatment of unresectable or metastatic HER-2 positive breast cancer. It was developed by Seattle Genetics and approved by the FDA on April 17, 2020. Tucatinib is a promising new treatment for patients with metastatic breast cancer who have not responded adequately to other chemotherapy regimens.

Indication

本品与曲妥珠单抗和卡培他滨联用治疗人类表皮生长因子受体2(HER2)阳性且已出现转移(如脑转移)或无法进行乳房切除术的乳腺癌成人患者，患者应接受过一种或多种抗HER2乳腺癌药物治疗。

Associated Conditions
Breast Cancer, Unresectable Breast Cancer, Wild-type RAS Metastatic Colorectal Cancer, Unresectable RAS Wild Type Colorectal Cancer
Clinical Trials
Related News

A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

Phase 2
Completed
Conditions
Advanced Unresectable or Metastatic Solid Malignancy
Interventions
Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
Drug: Investigator's Choice of Chemotherapy
First Posted Date
2020-11-17
Last Posted Date
2025-01-08
Lead Sponsor
Genentech, Inc.
Target Recruit Count
252
Registration Number
NCT04632992
Locations
🇺🇸

Sarah Cannon Research Institute / Tennessee Oncology, Chattanooga, Tennessee, United States

🇺🇸

SCRI Oncology Partners, Nashville, Tennessee, United States

🇺🇸

Alaska Oncology and Hematology, Anchorage, Alaska, United States

and more 35 locations

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

Phase 2
Active, not recruiting
Conditions
Biliary Tract Neoplasms
Uterine Neoplasms
Urologic Neoplasms
Carcinoma, Non-Small-Cell Lung
HER2 Mutations Breast Neoplasms
Uterine Cervical Neoplasms
Interventions
First Posted Date
2020-10-08
Last Posted Date
2025-04-30
Lead Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Target Recruit Count
217
Registration Number
NCT04579380
Locations
🇺🇸

HealthPartners Institute, Saint Louis Park, Minnesota, United States

🇺🇸

Texas Oncology, P.A. - Dallas, Dallas, Texas, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 63 locations

A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

Phase 2
Active, not recruiting
Conditions
HER2 Positive Breast Cancer
Interventions
First Posted Date
2020-09-07
Last Posted Date
2025-05-15
Lead Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Target Recruit Count
70
Registration Number
NCT04539938
Locations
🇺🇸

UCLA Department of Medicine - Hematology & Oncology, Los Angeles, California, United States

🇺🇸

University of Texas Southwestern Medical Center, Dallas, Texas, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 30 locations

A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

Phase 1
Active, not recruiting
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2020-09-04
Last Posted Date
2025-02-14
Lead Sponsor
AstraZeneca
Target Recruit Count
245
Registration Number
NCT04538742
Locations
🇬🇧

Research Site, Buckhurst Hill, United Kingdom

TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases

Phase 1
Withdrawn
Conditions
Brain Metastases
HER2-positive Breast Cancer
Breast Cancer
CNS Disease
Interventions
First Posted Date
2020-08-13
Last Posted Date
2022-07-01
Lead Sponsor
Reva Basho
Registration Number
NCT04512261
Locations
🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer

Phase 2
Completed
Conditions
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Esophageal Adenocarcinoma
Interventions
Other: tucatinib placebo
Other: trastuzumab placebo
First Posted Date
2020-08-05
Last Posted Date
2025-01-22
Lead Sponsor
Seagen Inc.
Target Recruit Count
17
Registration Number
NCT04499924
Locations
🇺🇸

University of Chicago Medical Center, Chicago, Illinois, United States

🇺🇸

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States

🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

and more 45 locations

T-DM1 and Tucatinib Compared with T-DM1 Alone in Preventing Relapses in People with High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

Phase 3
Recruiting
Conditions
Anatomic Stage IA Breast Cancer AJCC V8
Anatomic Stage II Breast Cancer AJCC V8
Anatomic Stage IIA Breast Cancer AJCC V8
Anatomic Stage IIB Breast Cancer AJCC V8
Anatomic Stage III Breast Cancer AJCC V8
Anatomic Stage IIIA Breast Cancer AJCC V8
Anatomic Stage IIIB Breast Cancer AJCC V8
Anatomic Stage IIIC Breast Cancer AJCC V8
HER2 Positive Breast Carcinoma
Invasive Breast Carcinoma
Interventions
Drug: Placebo Administration
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
First Posted Date
2020-07-07
Last Posted Date
2025-01-13
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
1031
Registration Number
NCT04457596
Locations
🇺🇸

Hematology Oncology Associates of Central New York-Onondaga Hill, Syracuse, New York, United States

🇺🇸

Upstate Cancer Center at Verona, Verona, New York, United States

🇺🇸

Good Samaritan University Hospital, West Islip, New York, United States

and more 1166 locations

Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

Phase 2
Active, not recruiting
Conditions
GEJ Adenocarcinoma
Cholangiocarcinoma
Gallbladder Carcinoma
Colorectal Carcinoma
Esophageal Adenocarcinoma
Gastric Adenocarcinoma
Interventions
First Posted Date
2020-06-12
Last Posted Date
2025-05-13
Lead Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Target Recruit Count
41
Registration Number
NCT04430738
Locations
🇺🇸

Mayo Clinic Hospital, Phoenix, Arizona, United States

🇺🇸

Mayo Clinic, Scottsdale, Arizona, United States

🇺🇸

University of Colorado Denver CTO(CTRC), Aurora, Colorado, United States

and more 25 locations

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

Conditions
HER2-positive Breast Cancer
First Posted Date
2020-01-07
Last Posted Date
2020-05-07
Lead Sponsor
Seagen Inc.
Registration Number
NCT04220203

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

Phase 3
Active, not recruiting
Conditions
HER2-positive Breast Cancer
Interventions
Drug: placebo
First Posted Date
2019-06-05
Last Posted Date
2025-04-22
Lead Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Target Recruit Count
466
Registration Number
NCT03975647
Locations
🇺🇸

Texas Oncology - Medical City Dallas, Dallas, Texas, United States

🇺🇸

University of Texas Southwestern Medical Center, Dallas, Texas, United States

🇺🇸

Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States

and more 269 locations
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