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)
NCT ID: NCT04436744
Last Updated: 2023-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
221 participants
INTERVENTIONAL
2020-09-04
2021-11-24
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Giredestrant + Palbociclib
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.
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.
Anastrozole + 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed operable or inoperable invasive breast carcinoma
* Candidate for neoadjuvant treatment and considered appropriate for endocrine therapy
* Willingness to undergo breast surgery after neoadjuvant treatment and to provide three mandatory tumor samples
* Documented estrogen receptor (ER)-positive tumor in accordance to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Allison et al.2020), assessed locally and defined as ≥1% of tumor cells stained positive on the basis of the most recent tumor biopsy
* Documented progesterone receptor status (positive or negative) as per local assessment
* Documented human epidermal growth factor receptor-2 (HER2)-negative tumor in accordance to 2018 ASCO/CAP guidelines (Wolff et al. 2018), assessed locally on the most recent tumor biopsy
* Ki67 score ≥5% analyzed centrally or locally
* Eastern Cooperative Oncology Group Performance Status 0-1
* Adequate organ function
Exclusion Criteria
* Inflammatory breast cancer (cT4d)
* Bilateral invasive breast cancer
* History of invasive breast cancer, ductal carcinoma in situ or lobular carcinoma in situ and other malignancy within 5 years prior to screening
* Previous systemic or local treatment for the primary breast cancer currently under investigation
* History of any prior treatment with aromatase inhibitors (AIs), tamoxifen, selective estrogen receptor down regulator, or cyclin-dependent kinase 4 and 6 inhibitors
* Major surgery within 4 weeks prior to randomization
* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
* History of allergy to anastrozole, or palbociclib or any of its excipients
* Known issues with swallowing oral medication
* History of documented hemorrhagic diathesis, coagulopathy, or thromboembolism
* Active cardiac disease or history of cardiac dysfunction
* Current treatment with medications that are well known to prolong the QT interval
* Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery including gastric resection
* Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives prior to randomization
* Known HIV infection
* Serious infection requiring oral or IV antibiotics, or other clinically significant infection within 14 days prior to screening
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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, Pernambuco, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
São Paulo, São Paulo, 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
Kecskemét, , Hungary
Tolna Megyei Kórház, Onkológia
Szekszárd, , Hungary
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
Warsaw, , Poland
DOLNOSLASKIE CENTRUM ONKOLOGII; Oddzial Chirurgii Piersi
Wroclaw, , Poland
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, Russia
Private Healthcare Institution Clinical Hospital RZhD Medicine
Saint Petersburg, Sankt-Peterburg, Russia
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan', Tatarstan Republic, Russia
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
Nizhny Novgorod, , Russia
FSI "SRC of Oncology n. a. N.N.Petrov of Rosmedtekhnologiy"
Saint Petersburg, , Russia
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint Petersburg, , Russia
National Cancer Center; Medical Oncology
Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Severance Hospital; Internal Medicine
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
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 de Navarra; Servicio de Oncologia
Navarra, Navarre, Spain
Hospital Universitari Sant Joan de Reus; Planta baja, color lila
Reus, Tarragona, Spain
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal de 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 Universitario Virgen Macarena
Seville, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
National Cheng Kung Uni Hospital; Surgery
Tainan City, , 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
Countries
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References
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Hurvitz SA, Bardia A, Quiroga V, Park YH, Blancas I, Alonso-Romero JL, Vasiliev A, Adamchuk H, Salgado M, Yardley DA, Berzoy O, Zamora-Aunon P, Chan D, Spera G, Xue C, Ferreira E, Badovinac Crnjevic T, Perez-Moreno PD, Lopez-Valverde V, Steinseifer J, Fernando TM, Moore HM, Fasching PA; coopERA Breast Cancer study group. Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study. Lancet Oncol. 2023 Sep;24(9):1029-1041. doi: 10.1016/S1470-2045(23)00268-1.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020-001007-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WO42133
Identifier Type: -
Identifier Source: org_study_id
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