Neoadjuvant Phase II Trial in Patients With T1c Operable, HER2-positive Breast Cancer According to TOP2A Status

PHASE2CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

October 7, 2019

Study Completion Date

July 8, 2024

Conditions
Breast Cancer
Interventions
DRUG

FEC100

"3 cycles of FEC 100 administered IV q3w~* 5-Fluorouracil (5-FU) 500 mg/m²~* Epirubicin 100 mg/m²~* Cyclophosphamide 500 mg/m²"

DRUG

Docetaxel

TOP2A amplified : DOCETAXEL 75 mg/m² IV escalating at 100 mg/m² IV as tolerated q3w TOP2A not amplified : DOCETAXEL 75 mg/m² IV

DRUG

Trastuzumab

Trastuzumab 8 mg/kg loading dose administered intravenously (IV) followed by 6 mg/kg IV q3w in subsequent cycles.

DRUG

Pertuzumab

Pertuzumab 840 mg loading dose administered IV followed by 420 mg IV q3w in subsequent cycles.

DRUG

Carboplatin

CARBOPLATIN AUC 6 IV q3w

Trial Locations (12)

Unknown

Institut de Cancerologie de L'Ouest - Site Paul Papin, Angers

Centre Hospitalier Regional Universitaire de Brest - Hôpital Morvan, Brest

Centre Francois Baclesse, Caen

Centre Jean Perrin, Clermont-Ferrand

Chu de Grenoble - Hopital Michallon, Grenoble

Chu de Limoges - Hôpital Dupuytren, Limoges

Centre Leon Berard, Lyon

Institut Regional Du Cancer Montpellier Val D'Aurelle, Montpellier

Institut de Cancerologie de L'Ouest - Site Rene Gauducheau, Saint-Herblain

Hopital D'Instructions Des Armees, Saint-Mandé

Centre Paul Strauss, Strasbourg

Institut de Cancerologie de Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy

All Listed Sponsors
lead

UNICANCER

OTHER

NCT02339532 - Neoadjuvant Phase II Trial in Patients With T1c Operable, HER2-positive Breast Cancer According to TOP2A Status | Biotech Hunter | Biotech Hunter