Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
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Trial Identification
Brief Title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
Official Title: A Randomized, Multicenter, Open-Label, Two-Arm, Phase II, Neoadjuvant Study Evaluating the Efficacy, Safety, and Pharmacokinetics of GDC-9545 Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer
Study ID: NCT04436744
Conditions
Study Description
Brief Summary: This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus palbociclib compared with anastrozole plus palbociclib (in the neoadjuvant phase) in postmenopausal women with untreated, estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, early breast cancer. The study consists of a screening period of up to 28 days, a window-of-opportunity phase for 14 days, followed by a neoadjuvant treatment phase for 16 weeks (four 28-day cycles), surgery, and an end of study visit (28 days after the final dose of study treatment).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
UCLA - Burbank, Burbank, California, United States
UCLA - Laguna Hills, Laguna Hills, California, United States
UCLA Hematology/Oncology-San Luis Obispo, San Luis Obispo, California, United States
UCLA Hematology Oncology-Santa Monica, Santa Monica, California, United States
Torrance Memorial Physician Network/Cancer Care, Torrance, California, United States
Orlando Health Inc., Orlando, Florida, United States
SCRI Florida Cancer Specialists East, West Palm Beach, Florida, United States
Saint Barnabas Medical Center Cancer Center, Livingston, New Jersey, United States
Tennessee Oncology; Sarah Cannon Research Institute, Nashville, Tennessee, United States
Univ of Wisconsin-Madison; Clinical Science Center, Madison, Wisconsin, United States
Macquarie University Hospital, Macquarie Park, New South Wales, Australia
Westmead Hospital; Medical Oncology and Pallative Care, Westmead, New South Wales, Australia
Hospital do Cancer de Pernambuco - HCP, Recife, PE, Brazil
Santa Casa de Misericordia de Porto Alegre, Porto Alegre, RS, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, Sao Paulo, SP, Brazil
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA, Sao Paulo, SP, Brazil
Universitätsklinikum Dresden, Dresden, , Germany
LUISENKRANKENHAUS; Senological Oncology, Düsseldorf, , Germany
UNIVERSITATSKLINIKUM ERLANGEN; Department of Gynecology and Obstetrics, Erlangen, , Germany
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont; Onkoradiologiai Kozpont, Kecskemet, , Hungary
Tolna Megyei Kórház, Onkológia, Szekszárd, , Hungary
National Cancer Center; Medical Oncology, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Severance Hospital; Internal Medicine, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Szpital Morski Im. Pck; Oncology & Radiotherapy Dept, Gdynia, , Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej, Lublin, , Poland
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology, Warszawa, , Poland
DOLNOSLASKIE CENTRUM ONKOLOGII; Oddzial Chirurgii Piersi, Wrocław, , Poland
Moscow City Oncology Hospital #62, Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation
Private Healthcare Institution Clinical Hospital RZhD Medicine, St. Petersburg, Sankt Petersburg, Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic, Kazan, Tatarstan, Russian Federation
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod, Nizhny Novgorod, , Russian Federation
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological), Saint-Petersburg, , Russian Federation
FSI "SRC of Oncology n. a. N.N.Petrov of Rosmedtekhnologiy", St. Petersburg, , Russian Federation
Institutio Catalan De Oncologia, Badalona, Barcelona, Spain
Complejo Hospitalario de Althaia; Servicio de Oncologia, Manresa, Barcelona, Spain
Hospital de Jerez de la Frontera; Servicio de Oncologia, Jerez de La Frontera, Cadiz, Spain
Hospital Universitari Arnau de Vilanova, Lleida, Lerida, Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain
Hospital Universitari Sant Joan de Reus; Planta baja, color lila, Reus, Tarragona, Spain
Hospital Universitario de Canarias;servicio de Oncologia, La Laguna, Tenerife, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Quirón Dexeus, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Virgen de las Nieves : Hospital General, Granada, , Spain
Hospital Clinico San Cecilio, Granada, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Fundación Jimenez Díaz, Madrid, , Spain
Hosp Univ Fundacion Alcorcon, Madrid, , Spain
Hospital Universitario Virgen de La Arrixaca, Murcia, , Spain
Hospital de Navarra; Servicio de Oncologia, Navarra, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
National Cheng Kung Uni Hospital; Surgery, Tainan, , Taiwan
National Taiwan Uni Hospital; General Surgery, Taipei, , Taiwan
Regional Oncology Center of Kharkiv Regional Council; Department of Soft Tissues and Breast Cancer, Kharkiv, Kharkiv Governorate, Ukraine
Odesa Regional Clinical Hospital; Department of Thoracic Surgery, Odesa, Kharkiv Governorate, Ukraine
Khmelnytsky Regional Antitumor Center; Department of Breast, Skin, Soft Tissues and Bones Tumors, Khmelnytskyi, Podolia Governorate, Ukraine
Municipal institution Dnipropetrovsk City Multifield Clinical Hospital #4; dept. of Chemotherapy, Dnipropetrovsk, , Ukraine
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department, Kryvyi Rih, , Ukraine
Kyiv Regional Oncological Dispensary, Kyiv, , Ukraine
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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