Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Clinical Trial
Official title:
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
| Verified date | February 2024 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.
| Status | Active, not recruiting |
| Enrollment | 992 |
| Est. completion date | March 18, 2027 |
| Est. primary completion date | March 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment - Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent - Documented ER-positive tumor and HER2-negative tumor, assessed locally - Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry - No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease - Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months - Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed - Eastern Cooperative Oncology Group Performance Status 0-1 - Adequate organ function Exclusion Criteria: - Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor - Prior treatment with a selective estrogen receptor degrader (SERD) - Treatment with any investigational therapy within 28 days prior to study treatment - Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization - Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term - Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease - Active cardiac disease or history of cardiac dysfunction, as defined in the protocol - Pregnant or breastfeeding |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | |
| Argentina | Hospital Britanico | Ciudad Autonoma Bs As | |
| Argentina | Hospital de Onc Angel Roffo | Ciudad Autonoma Buenos Aires | |
| Argentina | Organización medica de Investi | Ciudad Autonoma Buenos Aires | |
| Argentina | Hospital Provincial del Centenario | Rosario | |
| Argentina | Instituto de Oncología de Rosario | Rosario | |
| Argentina | CEMER Centro Medico de Enfermedades Respiratorias | Vicente López | |
| Australia | Flinders Medical Centre; Medical Oncology | Bedford Park | South Australia |
| Australia | Peter MacCallum Cancer Centre-East Melbourne | Melbourne | Victoria |
| Australia | Fiona Stanley Hospital - Medical Oncology | Murdoch | Western Australia |
| Australia | Mater Hospital Brisbane | South Brisbane | Queensland |
| Australia | Sunshine Hospital | St Albans | Victoria |
| Australia | Calvary Mater Newcastle; Medical Oncology | Waratah | New South Wales |
| Australia | Princess Alexandra Hospital; Division of Cancer Services | Woolloongabba | Queensland |
| Austria | Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU | Salzburg | |
| Austria | A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie | Steyr | |
| Austria | Medizinische Universität Wien; Univ.Klinik für Innere Medizin I | Wien | |
| Belgium | Cliniques Universitaires St-Luc | Bruxelles | |
| Belgium | Jessa Zkh (Campus Virga Jesse) | Hasselt | |
| Brazil | Hospital Araujo Jorge; Departamento de Ginecologia E Mama | Goiania | GO |
| Brazil | Hospital Sao Lucas - PUCRS | Porto Alegre | RS |
| Brazil | Santa Casa de Misericordia de Porto Alegre | Porto Alegre | RS |
| Brazil | Hospital do Cancer de Pernambuco - HCP | Recife | PE |
| Brazil | Hospital Sao Rafael - HSR | Salvador | BA |
| Brazil | Hospital de Base de Sao Jose do Rio Preto | Sao Jose do Rio Preto | SP |
| Brazil | Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda | Sao Paulo | SP |
| Brazil | Beneficencia Portuguesa de Sao Paulo | São Paulo | SP |
| Canada | Royal Victoria Regional Health Centre | Barrie | Ontario |
| Canada | William Osler Health System Brampton Civic Hospital | Brampton | Ontario |
| Canada | Tom Baker Cancer Centre-Calgary | Calgary | Alberta |
| Canada | Centre Hospitalier de l?Université de Montréal (CHUM) | Montreal | Quebec |
| Canada | Jewish General Hospital | Montreal | Quebec |
| Canada | McGill University Health Center | Montreal | Quebec |
| Canada | Universite de Montreal - Hopital Maisonneuve-Rosemont | Montreal | Quebec |
| Canada | Ottawa Hospital Research Institute | Ottawa | Ontario |
| Canada | Hopital du Saint Sacrement | Quebec City | Quebec |
| Canada | BC Cancer ? Surrey | Surrey | British Columbia |
| Canada | Princess Margaret Cancer Center | Toronto | Ontario |
| China | Anyang Tumor Hosptial | Anyang City | |
| China | Affiliated Hospital of Hebei University; Department of medical oncology | Baoding | |
| China | Beijing Cancer Hospital | Beijing | |
| China | Peking University People's Hospital | Beijing | |
| China | the First Affiliated Hospital of Bengbu Medical College | Bengbu City | |
| China | The First Hospital of Jilin University | Changchun City | |
| China | Hunan Cancer Hospital | Changsha CITY | |
| China | Fujian Medical University Union Hospital | Fuzhou City | |
| China | Sun Yat-sen Memorial Hospital | Guangzhou | |
| China | Sun Yet-sen University Cancer Center | Guangzhou City | |
| China | Sir Run Run Shaw Hospital Zhejiang University | Hangzhou City | |
| China | Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department | Hangzhou City | |
| China | Harbin Medical University Cancer Hospital | Harbin | |
| China | Shandong Cancer Hospital | Jinan | |
| China | The Third Hospital of Nanchang | Nanchang City | |
| China | Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) | Nanjing City | |
| China | Guangxi Cancer Hospital of Guangxi Medical University | Nanning City | |
| China | Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai City | |
| China | Cancer Hospital of Shantou University Medical College | Shantou | |
| China | Liaoning cancer Hospital & Institute | Shenyang | |
| China | Shengjing Hospital of China Medical University | ShenYang | |
| China | Hubei Cancer Hospital | Wuhan | |
| China | Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan City | |
| China | The First Affiliated Hospital of Xian Jiao Tong University | Xi'an City | |
| Denmark | Herlev Hospital; Afdeling for Kræftbehandling | Herlev | |
| Denmark | Sjællands Universitetshospital, Næstved; Onkologisk Afdeling | Naestved | |
| Denmark | Odense Universitetshospital, Onkologisk Afdeling R | Odense C | |
| France | ICO Paul Papin; Oncologie Medicale. | Angers | |
| France | Centre Hospitalier de La Cote Basque; Oncologie | Bayonne | |
| France | CHD DE VENDEE; Unité de Recherche Clinique Onco-Hematologie | La Roche Sur Yon | |
| France | Institut régional du Cancer Montpellier | Montpellier | |
| France | Chu La Miletrie; Oncologie Medicale | Poitiers | |
| France | Institut Jean Godinot; Oncologie Medicale | Reims CEDEX | |
| France | Centre Eugene Marquis; Service d'oncologie | Rennes | |
| France | ICL; Hematologie | Saint-Priest en Jarez | |
| France | Centre Alexis Vautrin; Oncologie Medicale | Vandoeuvre-les-nancy | |
| Germany | Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters | Berlin | |
| Germany | Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik | Chemnitz | |
| Germany | Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden | Dresden | |
| Germany | Universitätsklinikum Essen; Zentrum Für Frauenheilkunde | Essen | |
| Germany | Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH | Georgsmarienhütte | |
| Germany | Dres.Andreas Ammon und Dirk Meyer | Göttingen | |
| Germany | Facharztzentrum Eppendorf, Studien GbR | Hamburg | |
| Germany | Universitätsklinikum Hamburg-Eppendorf; Frauenklinik | Hamburg | |
| Germany | Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie | Hannover | |
| Germany | Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg | Heidelberg | |
| Germany | Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin | Koblenz | |
| Germany | Dres. Andreas Köhler und Roswitha Fuchs | Langen | |
| Germany | St. Elisabeth-Krankenhaus, Senologie/Brustzentrum | Leipzig | |
| Germany | Universitätsklinikum Mannheim; Frauenklinik | Mannheim | |
| Germany | Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt | München | |
| Germany | Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg | Ravensburg | |
| Germany | Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie | Trier | |
| Germany | Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis | Troisdorf | |
| Germany | Universitätsklinik Tübingen; Frauenklinik | Tübingen | |
| Greece | Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine | Athens | |
| Greece | Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine | Athens | |
| Greece | University Hospital of Larissa;Department of Medical Oncology | Larissa | |
| Greece | Euromedical General Clinic of Thessaloniki; Oncology Department | Thessaloniki | |
| Hong Kong | Pamela Youde Nethersole Eastern Hospital; Clinical Oncology | Hong Kong | |
| Hong Kong | Princess Margaret Hospital; Oncology | Hong Kong | |
| Hong Kong | Queen Mary Hospital; Dept of Medicine | Hong Kong | |
| Hungary | Budapesti Uzsoki Utcai Kórház; Onkoradiológiai Osztály | Budapest | |
| Hungary | Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department | Budapest | |
| Israel | Davidof Center - Rabin Medical Center | Petah Tiqwa | |
| Israel | Chaim Sheba Medical Center; Oncology Dept | Ramat Gan | |
| Israel | Tel Aviv Sourasky Medical Ctr; Oncology | Tel Aviv | |
| Italy | Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina | Brescia | Lombardia |
| Italy | Fondazione del Piemonte per l?Oncologia (IRCCS) | Candiolo | Piemonte |
| Italy | Ospedale Civile - Livorno | Livorno | Toscana |
| Italy | IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna |
| Italy | Istituto Europeo Di Oncologia | Milano | Lombardia |
| Italy | Humanitas Centro Catanese Di Oncologia; Oncologia Medica | Misterbianco (CT) | Sicilia |
| Italy | ASST DI MONZA; Oncologia Medica | Monza | Lombardia |
| Italy | Ospedale Sacro Cuore Don Calabria | Negrar | Veneto |
| Italy | IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II | Padova | Veneto |
| Italy | IRCCS Istituto Regina Elena (IFO); Oncologia Medica B | Roma | Lazio |
| Italy | Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza | Vicenza | Veneto |
| Japan | Nagoya University Hospital | Aichi | |
| Japan | Chiba Cancer Center | Chiba | |
| Japan | National Cancer Center Hospital East | Chiba | |
| Japan | National Hospital Organization Kyushu Cancer Center | Fukuoka | |
| Japan | Fukushima Medical University Hospital | Fukushima | |
| Japan | Hiroshima City Hiroshima Citizens Hospital | Hiroshima | |
| Japan | Hiroshima University Hospital | Hiroshima | |
| Japan | National Hospital Organization Hokkaido Cancer Center | Hokkaido | |
| Japan | Hyogo Cancer Center | Hyogo | |
| Japan | University of Tsukuba Hospital | Ibaraki | |
| Japan | Sagara Hospital | Kagoshima | |
| Japan | Kanagawa Cancer Center | Kanagawa | |
| Japan | St. Marianna University Hospital | Kanagawa | |
| Japan | Tokai University Hospital | Kanagawa | |
| Japan | Kumamoto University Hospital | Kumamoto | |
| Japan | Niigata Cancer Center Hospital | Niigata | |
| Japan | Naha-nishi Clinic | Okinawa | |
| Japan | National Hospital Organization Osaka National Hospital | Osaka | |
| Japan | Osaka International Cancer Institute | Osaka | |
| Japan | Saitama Cancer Center | Saitama | |
| Japan | Juntendo University Hospital | Tokyo | |
| Japan | National Cancer Center Hospital | Tokyo | |
| Japan | Showa University Hospital | Tokyo | |
| Japan | St. Luke's Internat. Hospital, Breast Surgical Oncology | Tokyo | |
| Japan | The Cancer Institute Hospital of JFCR | Tokyo | |
| Korea, Republic of | Chungbuk National University Hospital | Cheongju-si | |
| Korea, Republic of | Kyungpook National University Medical Center | Daegu | |
| Korea, Republic of | National Cancer Center | Goyang-si | |
| Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Gangnam Severance Hospital | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
| Korea, Republic of | Ulsan University Hosiptal | Ulsan | |
| Mexico | Centro Medico Dalinde | Cdmx | Mexico CITY (federal District) |
| Mexico | Health Pharma Professional Research | Cdmx | Mexico CITY (federal District) |
| Mexico | Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | Jalisco |
| Mexico | Filios Alta Medicina | Monterrey | Nuevo LEON |
| Mexico | Centro de Investigacion Clinica de Oaxaca | Oaxaca de Juárez | Oaxaca |
| Mexico | Oncologico Potosino | San Luis Potosí | SAN LUIS Potosi |
| Mexico | Sociedad de Metabolismo y Corazón (SOMECO) | Veracruz | |
| New Zealand | Auckland City Hospital; Clinical Oncology | Auckland | |
| Peru | Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel | Lima | |
| Peru | Instituto Nacional de Enfermedades Neoplasicas | Lima | |
| Peru | Instituto Peruano de Oncología y Radioterapia | Lima | |
| Peru | Oncosalud Sac; Oncología | Lima | |
| Peru | Clinica Ricardo Palma | San Isidro | |
| Peru | Instituto Regional de Enfermedades Neoplasicas - IREN Norte | Trujillo | |
| Poland | Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii | Gdansk | |
| Poland | Szpital Morski im. PCK; Poradnia Onkologiczna | Gdynia | |
| Poland | Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr | Warszawa | |
| Portugal | IPO de Coimbra; Servico de Oncologia Medica | Coimbra | |
| Portugal | Centro Hospitalar Lisboa Norte | Lisboa | |
| Portugal | Hospital da Luz; Departamento de Oncologia Medica | Lisboa | |
| Portugal | IPO do Porto; Servico de Oncologia Medica | Porto | |
| Russian Federation | Chelyabinsk region oncology dispensary | Chelyabinsk | |
| Russian Federation | SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM" | Moskva | Moskovskaja Oblast |
| Russian Federation | Podolsk City Clinical Hospital; Hematology | Podolsk | Moskovskaja Oblast |
| Russian Federation | Ryazan Regional clinical oncology dispensary | Ryazan | Rjazan |
| Russian Federation | GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology) | Saint Petersburg | Sankt Petersburg |
| Russian Federation | Multidisciplinary clinic Reaviz | Samara | |
| Russian Federation | Respublikanskiy Onkologicheskiy Dispanser | Saransk | Mordovija |
| Russian Federation | Regional Clinical Oncology Hospital | Yaroslavl | |
| Spain | Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia | A Coruña | LA Coruña |
| Spain | Hospital del Mar; Servicio de Oncologia | Barcelona | |
| Spain | Hospital Duran i Reynals; Oncologia | Barcelona | |
| Spain | Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica | Barcelona | |
| Spain | Vall d?Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | |
| Spain | Hospital Lucus Augusti; Servicio de Oncologia | Lugo | |
| Spain | Centro Oncologico MD Anderson Internacional; Servicio de Oncologia | Madrid | |
| Spain | HM Sanchinarro ? CIOCC; Servicio de Oncologia | Madrid | |
| Spain | Hospital Clinico San Carlos; Servicio de Oncologia | Madrid | |
| Spain | Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | |
| Spain | Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | |
| Spain | Hospital Quiron de Madrid; Servicio de Oncologia | Pozuelo de Alarcon | Madrid |
| Spain | Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona |
| Spain | Hospital de Donostia; Servicio de Oncologia Medica | San Sebastian | Guipuzcoa |
| Spain | Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Sevilla | |
| Spain | Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | |
| Taiwan | China Medical University Hospital; Surgery | Taichung | |
| Taiwan | National Cheng Kung Uni Hospital; Dept of Hematology and Oncology | Tainan | |
| Taiwan | Mackay Memorial Hospital; Dept of Surgery | Taipei | |
| Taiwan | National Taiwan Uni Hospital; Dept of Oncology | Taipei | |
| Taiwan | VETERANS GENERAL HOSPITAL; Department of General Surgery | Taipei | |
| Taiwan | Chang Gung Memorial Hosipital at Linkou | Taoyuan City | |
| Thailand | Chulalongkorn Hospital, Faculty of Medicine; Dept. of Medicine | Bangkok | |
| Thailand | Rajavithi Hospital; Division of Medical Oncology | Bangkok | |
| Thailand | Ramathibodi Hospital; Medicine/Oncology | Bangkok | |
| Thailand | Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology | Chang Mai | |
| Thailand | Songklanagarind Hospital; Department of Oncology | Songkhla | |
| Turkey | Adana Baskent University Hospital; Medical Oncology | Adana | |
| Turkey | Ankara Bilkent City Hospital | Ankara | |
| Turkey | Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi | Edirne | |
| Turkey | Medipol University Medical Faculty; Oncology Department | Istanbul | |
| Turkey | Katip Celebi University Ataturk Training and Research Hospital; Oncology | Izmir | |
| Turkey | Kocaeli University Faculty of Medicine; Medical oncology | Izmit | |
| Turkey | Medeniyet University Goztepe Training and Research Hospital. | Kadiköy | |
| Turkey | Antalya Memorial Hastanesi; Onkoloji | Kepez | |
| Turkey | Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department | Malatya | |
| Turkey | 19 Mayis University Medical Faculty; Medical Oncology Department | Samsun | |
| Turkey | Hacettepe Uni Medical Faculty Hospital; Oncology Dept | Sihhiye/Ankara | |
| Ukraine | Municipal Institution City Clinical Hospital #4 of Dnipro City Council | Dnipropetrovsk | Katerynoslav Governorate |
| Ukraine | Ivano-Frankivsk Regional Oncology Center | Ivano-Frankivsk | |
| Ukraine | SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU | Kharkiv | Kharkiv Governorate |
| Ukraine | ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department | Kryvyi Rih | |
| Ukraine | Sumy Regional Clinical Onc Ctr | Sumy | |
| Ukraine | Uzhgorod Central City Clinical Hospital | Uzhhorod | Katerynoslav Governorate |
| United Kingdom | Royal Sussex County Hospital | Brighton | |
| United Kingdom | Velindre Cancer Centre; Clinical Trials Unit | Cardiff | |
| United Kingdom | Leicester Royal Infirmary; Infectious Disease Unit | Leicester | |
| United Kingdom | Guys & St Thomas Hospital; Department of Oncology | London | |
| United Kingdom | Royal Free Hospital | London | |
| United Kingdom | Royal Marsden Hosp NHS Fnd; Breast Unit | London | |
| United Kingdom | University College London Hospital | London | |
| United Kingdom | Maidstone Hospital; Kent Oncology Centre | Maidstone | |
| United Kingdom | Nottingham City Hospital | Nottingham | |
| United Kingdom | Peterborough City Hospital; Oncology Research Department 018 | Peterborough | |
| United Kingdom | Derriford Hospital | Plymouth | |
| United Kingdom | Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit | Sutton | |
| United Kingdom | Royal Cornwall Hospital | Truro | |
| United States | Harrington Cancer Center | Amarillo | Texas |
| United States | University of Colorado | Aurora | Colorado |
| United States | Mercy Medical Center | Baltimore | Maryland |
| United States | Memorial Sloan Kettering Cancer Center Basking Ridge | Basking Ridge | New Jersey |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Roper St. Francis Healthcare | Charleston | South Carolina |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | MSKCC @ Commack | Commack | New York |
| United States | Texas Oncology - DFW | Dallas | Texas |
| United States | Rocky Mountain Cancer Center | Denver | Colorado |
| United States | Astera Cancer Care East Brunswick | East Brunswick | New Jersey |
| United States | Inova Fairfax Hospital | Falls Church | Virginia |
| United States | San Juan Oncology Associates | Farmington | New Mexico |
| United States | Florida Cancer Specialists - Fort Myers (Broadway) | Fort Myers | Florida |
| United States | Texas Oncology, P.A. - Fort Worth | Fort Worth | Texas |
| United States | The Center for Cancer and Blood Disorders - Fort Worth | Fort Worth | Texas |
| United States | Long Beach Memorial Medical Center | Fountain Valley | California |
| United States | Orange Coast Memorial Medical Center | Fountain Valley | California |
| United States | West Cancer Center | Germantown | Tennessee |
| United States | Memorial Sloan Kettering Cancer Center at Westchester | Harrison | New York |
| United States | Memorial Regional Cancer Ctr | Hollywood | Florida |
| United States | Kaiser Permanente - Moanalua Medical Center | Honolulu | Hawaii |
| United States | Baylor St. Luke's Medical Center | Houston | Texas |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | HCA Midwest Division | Kansas City | Missouri |
| United States | University of Wisconsin | Madison | Wisconsin |
| United States | University of Miami; Dept Sylvester Cancer Center | Miami | Florida |
| United States | Memorial Sloan Kettering - Monmouth | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center at Bergen | Montvale | New Jersey |
| United States | Sarah Cannon Research Inst. | Nashville | Tennessee |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | Providence Portland Medical Ctr | Portland | Oregon |
| United States | SCRI Florida Cancer Specialists North; Research Office North Region. | Saint Petersburg | Florida |
| United States | Kaiser Permanente - San Leandro Medical Center | San Leandro | California |
| United States | Maryland Oncology Hematology; Maryland Oncology Hematology, PA | Silver Spring | Maryland |
| United States | Stanford Univ Medical Center | Stanford | California |
| United States | Northwest Medical Specialties | Tacoma | Washington |
| United States | SCRI Florida Cancer Specialists PAN | Tallahassee | Florida |
| United States | Memorial Sloan Kettering Cancer Center at Nassau | Uniondale | New York |
| United States | Kaiser Permanente - Vallejo | Vallejo | California |
| United States | Kaiser Permanente - Walnut Creek | Walnut Creek | California |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Peru, Poland, Portugal, Russian Federation, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months) | ||
| Secondary | Overall Survival | From randomization to death from any cause (up to 78 months) | ||
| Secondary | Objective Response Rate, as Determined by the Investigator According to RECIST v1.1 | The objective response rate is defined as the percentage of participants with a complete response or partial response on two consecutive occasions at least (=)4 weeks apart. | From randomization until disease progression or death (up to 78 months) | |
| Secondary | Duration of Response, as Determined by the Investigator According to RECIST v1.1 | From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 78 months) | ||
| Secondary | Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1 | The clinical benefit rate is defined as the percentage of participants with stable disease for =24 weeks or a complete response or partial response. | From randomization until disease progression or death (up to 78 months) | |
| Secondary | Time to Confirmed Deterioration in Pain Level, Defined as the Time to First Documented =2-Point Increase from Baseline in the 'Worst Pain' Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire | From Baseline until treatment discontinuation (up to 78 months) | ||
| Secondary | Time to Confirmed Deterioration in Pain Presence and Interference, Defined as the Time to First Documented =10-Point Increase from Baseline in the EORTC QLQ-C30 Linearly Transformed Pain Scale Score | EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire | From Baseline until treatment discontinuation (up to 78 months) | |
| Secondary | Time to Confirmed Deterioration in Physical Functioning, Defined as the Time to First Documented =10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Physical Functioning Scale Score | From Baseline until treatment discontinuation (up to 78 months) | ||
| Secondary | Time to Confirmed Deterioration in Role Functioning, Defined as the Time to First Documented =10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Role Functioning Scale Score | From Baseline until treatment discontinuation (up to 78 months) | ||
| Secondary | Time to Confirmed Deterioration in Global Health Status and Quality of Life (GHS/QoL), Defined as the Time to First Documented =10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed GHS/QoL Scale Score | From Baseline until treatment discontinuation (up to 78 months) | ||
| Secondary | Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | From treatment initiation until 30 days after the final dose of study treatment (up to 78 months) | ||
| Secondary | Number of Participants with Vital Sign Abnormalities Over the Course of the Study | Vital signs include respiratory rate, pulse rate, and systolic and diastolic blood pressure while the participant is in a seated position, and temperature. | Baseline, Days 1 and 15 of Cycles 1 and 2, and Day 1 of each cycle thereafter until treatment discontinuation (1 cycle is 28 days) | |
| Secondary | Plasma Concentration of Giredestrant at Specified Timepoints | Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (1 cycle is 28 days) | ||
| Secondary | Plasma Concentration of Palbociclib at Specified Timepoints | Days 1 and 15 of Cycle 1 (1 cycle is 28 days) |