PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

July 22, 2024

Primary Completion Date

November 30, 2026

Study Completion Date

May 31, 2029

Conditions
HER2-positive Breast Cancer
Interventions
DRUG

Trastuzumab deruxtecan

10 mL type 1 amber borosilicate glass vial sealed with a fluoro-resin laminated butyl rubber stopper, and a polypropylene/aluminium yellow flip-off crimp cap. One vial of powder for concentrate for solution for IV infusion contains 100 mg of T-DXd. The drug product also contains L-histidine, L-histidine hydrochloride monohydrate, Sucrose, and Polysorbate 80.

DRUG

Phesgo 1,200 MG / 600 MG / 30,000 UNT Per 15 ML Injection

20 mL type I borosilicate glass vial tapered with fluororesin-laminated rubber stopper sealed with aluminum and covered by a cool green plastic flip-off cap, containing 15 mL solution of 1200 mg of pertuzumab and 600 mg of trastuzumab.

DRUG

Phesgo 600 MG / 600 MG / 20,000 UNT in 10 mL Injection

15 mL type I borosilicate glass vial tapered with fluororesin-laminated rubber stopper sealed with aluminum and covered by a cool green plastic flip-off cap, containing 10 mL solution of 600 mg of pertuzumab and 600 mg of trastuzumab.

Trial Locations (36)

11040

RECRUITING

Northwell Health, New York

20357

RECRUITING

Mammazentrum HH, Hamburg

46236

RECRUITING

Marienhospital Bottrop GmbH Klinik für Gynäkologie und Geburtshilfe, Bottrop

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

Unknown

RECRUITING

Institute Paoli Calmettes, Marseille

RECRUITING

Hopital Europeen Georges Pompidou, Paris

RECRUITING

Hôpital Tenon AP-HP, Paris

RECRUITING

Kliniken Essen Mitte, Essen

RECRUITING

Klinikum der Universität München, München

RECRUITING

Humanitas Gavazzeni, Bergamo

RECRUITING

Instituto Europeo di Oncologia, Milan

RECRUITING

University Hospital Maggiore della Carita, Novara

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli, Roma

RECRUITING

Hospital del Vinalopó, Alicante

RECRUITING

Hospital General Universitario Dr. Balmis (Alicante), Alicante

RECRUITING

Hospital Clínic i Provincial de Barcelona, Barcelona

RECRUITING

Hospital Universitari Dexeus, Barcelona

RECRUITING

Institut Català d' Oncologia L'Hospitalet (ICO), Barcelona

RECRUITING

Hospital Universitario de Basurto, Bilbao

RECRUITING

Hospital Provincial de Castellón, Castellon

RECRUITING

Hospital Universitario Reina Sofía, Córdoba

RECRUITING

Hospital Universitario Clínico San Cecilio de Granada, Granada

RECRUITING

Hospital Universitario de León, León

RECRUITING

Hospital Beata María Ana, Madrid

RECRUITING

Hospital Clínico San Carlos, Madrid

RECRUITING

Hospital Universitario La Paz, Madrid

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

RECRUITING

MD Anderson Cancer Center Madrid, Madrid

RECRUITING

Hospital Universitario Virgen de la Victoria, Málaga

RECRUITING

Hospital Quirónsalud Sagrado Corazón, Seville

RECRUITING

Hospital Universitario Virgen del Rocío, Seville

RECRUITING

Hospital Universitario Virgen Macarena, Seville

RECRUITING

Consorci Hospital General Universitari de València, Valencia

RECRUITING

Hospital Arnau de Vilanova de Valencia, Valencia

RECRUITING

Hospital Clínico Universitario de Valencia, Valencia

RECRUITING

Instituto Valenciano de Oncología (IVO), Valencia

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

MedSIR

OTHER