221
Participants
Start Date
September 4, 2020
Primary Completion Date
July 6, 2021
Study Completion Date
November 24, 2021
Giredestrant
During the window-of-opportunity phase (first 2 weeks) giredestrant will be taken orally once per day (QD) as a single agent. During the neoadjuvant treatment phase, giredestrant will be taken orally QD on Days 1-28 of each 28-day cycle for a total of 4 cycles, in combination with palbociclib.
Anastrozole
During the window-of-opportunity phase (first 2 weeks), anastrozole 1 mg will be taken orally QD as a single agent. During the neoadjuvant treatment phase, anastrozole 1 mg will be taken orally QD on Days 1-28 of each 28-day cycle for a total of 4 cycles, in combination with palbociclib.
Palbociclib
During the neoadjuvant treatment phase, palbociclib 125 mg will be taken orally QD on Days 1-21 of a 28-day cycle for a total of 4 cycles.
Surgery
Surgery must be performed within a maximum of 14 days after the final cycle in the neoadjuvant treatment phase and ideally should occur as soon as possible after the last dose of study treatment.
National Taiwan Uni Hospital; General Surgery, Taipei
National Cheng Kung Uni Hospital; Surgery, Tainan City
Macquarie University Hospital, Macquarie Park
Westmead Hospital; Medical Oncology and Pallative Care, Westmead
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont; Onkoradiologiai Kozpont, Kecskemét
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul
Tolna Megyei Kórház, Onkológia, Szekszárd
Hospital de Jerez de la Frontera; Servicio de Oncologia, Jerez de la Frontera
Hospital Universitario Virgen de las Nieves : Hospital General, Granada
Hospital Clinico San Cecilio, Granada
Hospital Universitari Arnau de Vilanova, Lleida
Hospital Universitario Lucus Augusti, Lugo
Fundación Jimenez Díaz, Madrid
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda
Hosp Univ Fundacion Alcorcon, Madrid
Khmelnytsky Regional Antitumor Center; Department of Breast, Skin, Soft Tissues and Bones Tumors, Khmelnytskyi
Hospital Universitario Virgen de La Arrixaca, Murcia
Hospital de Navarra; Servicio de Oncologia, Navarra
Orlando Health Inc., Orlando
SCRI Florida Cancer Specialists East, West Palm Beach
Tennessee Oncology; Sarah Cannon Research Institute, Nashville
Hospital Universitario de Canarias;servicio de Oncologia, San Cristóbal de La Laguna
LUISENKRANKENHAUS; Senological Oncology, Düsseldorf
Hospital Universitario Virgen Macarena, Seville
Hospital Universitari Sant Joan de Reus; Planta baja, color lila, Reus
Hospital General Universitario de Valencia, Valencia
Municipal institution Dnipropetrovsk City Multifield Clinical Hospital #4; dept. of Chemotherapy, Dnipropetrovsk
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department, Kryvyi Rih
Univ of Wisconsin-Madison; Clinical Science Center, Madison
Regional Oncology Center of Kharkiv Regional Council; Department of Soft Tissues and Breast Cancer, Kharkiv
Odesa Regional Clinical Hospital; Department of Thoracic Surgery, Odesa
UCLA Hematology Oncology-Santa Monica, Santa Monica
Torrance Memorial Physician Network/Cancer Care, Torrance
UNIVERSITATSKLINIKUM ERLANGEN; Department of Gynecology and Obstetrics, Erlangen
UCLA - Burbank, Burbank
UCLA - Laguna Hills, Laguna Hills
UCLA Hematology/Oncology-San Luis Obispo, San Luis Obispo
Moscow City Oncology Hospital #62, Moscovskaya Oblast
Private Healthcare Institution Clinical Hospital RZhD Medicine, Saint Petersburg
"FSI SRC of Oncology n. a. N.N.Petrov of Rosmedtekhnologiy", Saint Petersburg
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological), Saint Petersburg
Hospital Universitario La Paz, Madrid
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic, Kazan'
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod, Nizhny Novgorod
Saint Barnabas Medical Center Cancer Center, Livingston
Hospital do Cancer de Pernambuco - HCP, Recife
Santa Casa de Misericordia de Porto Alegre, Porto Alegre
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA, São Paulo
Universitätsklinikum Dresden, Dresden
Szpital Morski Im. Pck; Oncology & Radiotherapy Dept, Gdynia
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej, Lublin
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology, Warsaw
DOLNOSLASKIE CENTRUM ONKOLOGII; Oddzial Chirurgii Piersi, Wroclaw
National Cancer Center; Medical Oncology, Gyeonggi-do
Seoul National University Hospital, Seoul
Asan Medical Center, Seoul
Severance Hospital; Internal Medicine, Seoul
Samsung Medical Center, Seoul
Institutio Catalan De Oncologia, Badalona
Complejo Hospitalario de Althaia; Servicio de Oncologia, Manresa
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital Universitario Quirón Dexeus, Barcelona
Hospital Universitari Vall d'Hebron, Barcelona
Kyiv Regional Oncological Dispensary, Kyiv
Hoffmann-La Roche
INDUSTRY