377
Participants
Start Date
June 26, 2017
Primary Completion Date
November 1, 2023
Study Completion Date
November 1, 2026
Perjeta
All patients will receive Perjeta® as an IV infusion on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent 3-week cycle. Perjeta® IV should be administered 60 minutes after the end of Herceptin® SC (subcutaneous) administration. An observation period of 30-60 minutes is recommended after each Perjeta® infusion.
Herceptin
All patients will receive a fixed dose of 600 mg, irrespective of the patient's weight, will be administered throughout the treatment phase. All doses of Herceptin® SC will be administered as an SC injection into the thigh by a trained health care professional over a period of 2-5 minutes. No loading dose is required with Herceptin® SC.
Docetaxel
Docetaxel will be administered in line with the respective product information and/or recognized clinical practice guidelines. It will be administered after Herceptin® SC, Perjeta® IV, and carboplatin
Carboplatin
Carboplatin will be administered in line with the respective product information and/or recognized clinical practice guidelines. It will be administered after Herceptin® SC and Perjeta® IV.
Letrozole
Postmenopausal women will receive letrozole 2.5 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.
Tamoxifen
"Premenopausal women will receive tamoxifen 20 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.~Male patients will receive tamoxifen 20 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy."
Hospital Lozano Blesa, Zaragoza
Institute Jules Bordet, Brussels
CLCC d'Auvergne. Centre Jean Perrin., Clermont-Ferrand
Institute de Cancerologie de Laurraine, Nancy
Groupe Hospitalier Diaconesses, Paris
Hopital Tenon, Paris
Hospital Georges Pompidou, Paris
Centre Paul Strauss, Strasbourg
Institut Claudius Régaud, Toulouse
Kliniken Essen Mitte, Essen
Klinikum der Med. Fakultät Halle, Halle
National center for tumor disease NCT, Heidelberg
"Städtisches Klinikum St. Georg Leipzig", Leipzig
Clinical of Nuclear Medicine Technical University Munich, Munich
Hämatologisch-Onkologische Schwerpunktpraxis, München
Ospedale Maggiore Bologna, Bologna
Ospedale Antonio Perrino, Brindisi
Istituto Ospedalieri di Cremona, Cremona
Ospedale Mantova, Mantova
Istituto Europeo di Oncologia, Milan
Ospedale San Gerardo, Monza
Ospedale Guglielmo de Saliceto, Piacenza
Hospital Senhora da Oliveira, Guimarães
Hospital Beatriz Angelo, Lisbon
Hospital da Luz, Lisbon
Hospital Fernando Fonseca, Lisbon
Centro Hospitalar Sao Joao, Porto
Hospital do Santo Antonio, Porto
Centro Hospitalaer de Tras-os-Montes e Alto Douro, Vila Real
ICO Badalona, Badalona
Hospital Provincial de Castellón, Castelló
Hospital de Jaén, Jaén
Hospital Universitario Virgen de la Victoria, Málaga
Hospital San Joan de Reus, Reus
Hospital Universitario A Coruña, A Coruña
Hospital Clínic i Provincial de Barcelona, Barcelona
Hospital Universitario de Burgos, Burgos
Hospital Reina Sofía, Córdoba
ICO Girona, Girona
Hospital Arnau de Vilanova, Lleida
Hospital La Paz, Madrid
Hospital Ramón y Cajal, Madrid
CHUS Santiago de Compostela, Santiago de Compostela
Hospital Universitario Virgen del Rocío, Seville
Hospital Arnau de Vilanova, Valencia
Hospital Clínic Universitari de Valencia, Valencia
Hospital Dr Peset, Valencia
Hospital General Universitari de Valencia, Valencia
Hospital Universitari i Politecnic La Fe, Valencia
Instituto Valenciano de Oncologia, Valencia
Hospital Universitario Miquel Servet, Zaragoza
Barts Cancer Institute, London
The Christie NHS Foundation Trust, Manchester
Royal Cornwall Hospital, Truro
ICO l'Hospitalet, L'Hospitalet de Llobregat
Hospital Vall D'Hebrón, Barcelona
MedSIR
OTHER