Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 5, 2025

Primary Completion Date

December 7, 2028

Study Completion Date

June 8, 2029

Conditions
Metastatic Breast Cancer ( HER2 Negative)Unresectable Breast Cancer
Interventions
DRUG

Tucatinib (ONT-380)

Patients with a HER2-not amplified metastatic or unresectable breast cancer harboring an activating ERBB3 mutation will receive experimental treatment with tucatinib and trastuzumab combination

DRUG

Trastuzumab (Herceptin)

Patients with a HER2-not amplified metastatic or unresectable breast cancer harboring an activating ERBB3 mutation will receive experimental treatment with tucatinib and trastuzumab combination

Trial Locations (9)

13009

Institut Paoli-Calmettes, Marseille

33 300

Polyclinique Bordeaux Nord Aquitaine, Bordeaux

87 042

Chu Dupuytren- Limoges, Limoges

06 189

Centre Antoine Lacassagne, Nice

30 029

CHU de Nîmes, Nîmes

35 042

Centre Eugène Marquis, Rennes

92 210

Institut Curie_ Site Saint-Cloud, Saint-Cloud

31 059

Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole Claudius Regaud, Toulouse

54 519

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Eurofins

INDUSTRY

collaborator

UNICANCER

OTHER

lead

Institut Curie

OTHER