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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05840211
Other study ID # GS-US-598-6168
Secondary ID 2022-502593-17-0
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 8, 2023
Est. completion date December 2028

Study information

Verified date June 2024
Source Gilead Sciences
Contact Gilead Clinical Study Information Center
Phone 1-833-445-3230 (GILEAD-0)
Email GileadClinicalTrials@gilead.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).


Recruitment information / eligibility

Status Recruiting
Enrollment 654
Est. completion date December 2028
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Able to understand and give written informed consent. - Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site. - Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably from a locally recurrent or metastatic site. - Documented evidence of HER2- status. - Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria. - Candidate for the first chemotherapy in the locally advanced or metastatic setting. - Eligible for capecitabine, nab-paclitaxel, or paclitaxel. - Individuals must have at least one of the following: - Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting. - Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting. - Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor (if ineligible or if unable to access a CDK 4/6 inhibitor) in the metastatic setting. - Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting. - Individuals may have received prior targeted therapies, including but not limited to PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations), phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations), or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies. - Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease. - Demonstrates adequate organ function. - Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Key Exclusion Criteria: - Progressive disease within 6 months of completing (neo)adjuvant chemotherapy. - Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment. - Current enrollment in another clinical study and use of any investigational device or drug (drugs not marketed for any indication) either within 5 half-lives or 28 days prior to randomization, whichever is longer. - Use of investigational drugs in the category of Selective Estrogen Receptor Degraders are acceptable if last dose was longer than 14 days prior to randomization. - Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I. - Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC. - Have an active second malignancy. - Have an active serious infection requiring antibiotics. - Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). - Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. - Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sacituzumab Govitecan-hziy
Administered intravenously
Paclitaxel
Administered intravenously
Nab-paclitaxel
Administered intravenously
Capecitabine
Administered orally

Locations

Country Name City State
Argentina Hospital Britanico de Buenos Aires Buenos Aires
Argentina Instituto de Investigaciones Clinicas de Mar del Plata Buenos Aires
Argentina Instituto Alexander Fleming C.a.b.a.
Argentina Hospital Alemán Caba
Argentina Centro Privado de RMI Rio Cuarto S.A. Cordoba
Argentina Instituto de Oncología de Rosario Rosario
Argentina CER San Juan Centro Polivalente de Asistencia e Investigación Clínica San Juan
Australia Icon Cancer Centre Wesley Auchenflower Queensland
Australia Flinders Medical Centre Bedford Park South Australia
Australia St Vincent's Hospital Sydney Darlinghurst New South Wales
Australia Icon Cancer Centre Hobart Hobart Tasmania
Australia Liverpool Hospital Liverpool New South Wales
Australia Austin Health Melbourne Victoria
Australia Breast Cancer Research Centre - WA Nedlands Western Australia
Australia Royal Brisbane and Women's Hospital Queensland ME
Australia Sunshine Hospital (Western Health) St Albans Victoria
Australia GenesisCare North Shore (Oncology) St Leonards New South Wales
Austria University Hospital Innsbruck Innsbruck
Austria Universitätsklinik für Innere Medizin 3 der PMU Salzburg
Austria Klinikum Wels-Grieskirchen Wels
Austria Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie Wien
Belgium GZA Ziekenhuizen - Campus Sint-Augustinus Antwerpen
Belgium AZ Klina Brasschaat
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium Universitaire Ziekenhuis Leuven Leuven
Belgium CHU UCL Namur-Site STE. Elisabeth Namur
Brazil Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará Fortaleza
Brazil Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias Goiânia
Brazil Oncosite - Centro de Pesquisa Clinica e Oncologia Ijui
Brazil Catarina Pesquisa Clinica Itajai
Brazil Oncoclinicas do Brasil Servicos Medicos AS Minas Gerais
Brazil Liga Norte-Rio-Grandense Contra o Câncer Natal
Brazil CIONC-Centro Integrado de Oncologia de Curitiba Paraana
Brazil Hospital Erasto Gaertner Paraná
Brazil IMIP - Instituto de Medicina Integral Professor Fernando Figueira Pernambuco
Brazil HGB - Hospital Giovanni Battista/Mãe de Deus Center Porto Alegre
Brazil Hospital de Clínicas de Porto Alegre - HCPA Porto Alegre
Brazil Hospital São Lucas da PUCRS Porto Alegre
Brazil Irmandade da Santa Casa de Misericórdia de Porto Alegre Porto Alegre
Brazil Instituto Americas Rio de Janeiro
Brazil Clínica de Oncologia de Porto Alegre Ltda - CLINIONCO Rio Grande Do Sul
Brazil Instituto do Câncer - Hospital São Vicente de Paulo Rio Grande Do Sul
Brazil Unidade de PesquisasClinicas em Oncologia - UPCO Rio Grande Do Sul
Brazil CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia Santo Andre
Brazil Clinica de pesquisa e centro de estudos em oncologia ginecológica e mamaria São Paulo
Brazil Instituto Hemomed Oncologia e Hematologia São Paulo
Canada BC Cancer - Kelowna Kelowna
Canada The Ottawa Hospital Cancer Centre Ottawa
Canada CHU de Québec-Université Laval, Hôpital du Saint-Sacrement Quebec
Canada Humber River Hospital Toronto
Canada BC Cancer-Victoria Victoria
Chile Centro de Investigacion Clinica Bradford Hill Recoleta
Chile Centro del Cancer UC Region Metropolitana
Chile Centro de Oncología de Precisión (COP) Santiago Region
Chile James Lind Centro de Investigacion del Cancer Temuco
Chile Oncocentro APYS Vina del Mar
China The First Affiliated Hospital of USTC (Anhui Provincial Hospital) Anhui
China Peking University People's Hospital Beijing
China The First Hospital of Jilin University Changchun
China Xiangya Hospital Central South University Changsha
China West China Hospital Sichuan University Chengdu
China Chongqing University Cancer Hospital Chongqing
China Fujian Cancer Hospital Fujian
China Fujian Medical University Union Hospital Fuzhou
China Sun Yat-Sen University Cancer Center Guangdong
China Guangdong Provincial People's Hospital Guangzhou
China Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Guangzhou
China The First Affiliated Hospital of Sun Yat-sen University Guangzhou
China Sir Run Run Shaw Hospital,Zhejiang University School of Medicine Hangzhou
China Zhejiang Cancer Hospital Hangzhou
China Harbin Medical University Cancer Hospital Heilongjiang
China Jiangsu Province Hospital Jiangsu
China The First Affiliated Hospital of Soochow University Jiangsu
China The Nanchang Third Hospital Jiangxi
China The Second Hospital of Jilin University Jilin Sheng
China Affiliated Cancer Hospital of Shandong First Medical University Jinan
China The First Affiliated Hospital of Nanchang University Nanchang
China General Hospital of Ningxia Medical University Ningxia Hui
China The Affiliated Hospital Of Qingdao University Qingdao
China Fudan University Shanghai Cancer Center Shanghai
China Tianjin Medical University Cancer Institute & Hospital Tianjin
China Hubei Cancer Hospital Wuhan
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an
China The Second Affiliated Hospital of Zhejiang University School of Medicine Zhejiang
China Henan Cancer Hospital Zhengzhou
Czechia Fakultni Nemocnice Brno Brno
Czechia Masaryk Memorial Cancer Institute Brno
Czechia University Hospital Olomouc Olomouc
Czechia Multiscan s.r.o Pardubice
Czechia Charles General University Hospital, Prague Prague
Czechia Fakultni nemocnice v Motole Prague 4
Czechia Krajska nemocnice Tomase Bati Zlin Zlin
France CHU Jean Minjoz Besancon
France Institut Bergonié Bordeaux
France Centre Georges François Leclerc Dijon
France Centre Oscar Lambret Lille
France Ico René Gauducheau Loire Atlantique
France Centre Leon Berard Lyon
France Institut Paoli Calmettes Marseille
France Institut Regional du Cancer de Montpellier Montpellier Cedex 5
France Institut Curie Paris
France Centre Hospitalier Lyon-Sud Pierre-benite
France Hopital Privé des Cotes d'Armor Plerin
France Centre Jean Bernard Service d'Oncologie Médicale Rennes Cedex
France Centre Henri Becquerel Rouen
France Institut Universitaire du Cancer de Toulouse Oncopole Toulouse Cedex 9
France Institut Gustave Roussy Villejuif
Germany University Hospital rechts der Isar Technical University of Munich Bayern
Germany HELIOS Klinikum Berlin-Buch Berlin
Germany Vivantes Klinikum am Urban Berlin
Germany Marienhospital Bottrop Bottrop
Germany Universitätsklinik Erlangen Erlangen
Germany SRH Wald-Klinikum Gera GmbH Gera
Germany Universitatsklinikum Hamburg-Eppendorf Hamburg
Germany Medizinische Hochschule Hannover Hannover
Germany Nationales Centrum für Tumorerkrankungen Heidelberg Heidelberg
Germany Universitätsklinikum Mannheim Mannheim
Germany LMU Klinikum der Universitat München München
Germany Universitatsklinikum Munster Munster
Germany Universitäts - Frauenklinik Tübingen
Greece Alexandra General Hospital Athens
Greece Attikon Hospital Athens
Greece University Hospital of Heraklion Heraklion
Greece University Hospital of Larissa Larissa
Greece University Hospital of Patras Patras
Greece Bioclinic of Thessaloniki Thessaloniki
Greece Euromedica General Clinic of Thessaloniki Thessaloniki
Hong Kong Hong Kong Integrated Oncology Centre Hong Kong
Hong Kong Prince of Wales Hospital New Territories
Hong Kong Queen Mary Hospital Pok Fu Lam
Hungary Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika Budapest
Hungary Debreceni Egyetem Klinikai Központ Debrecen
Hungary Bács-Kiskun Varmegyei Oktatokorhaz, Onkaradiologiai Kozpont Kecskemét
Hungary Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Onkoradiologia Nyiregyhaza
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szeged
Israel Oncology Institute Rambam Health Care Campus Haifa
Israel Hadassah Medical Center Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Rabin Medical Center Petah Tikva
Israel Sheba Medical Center Ramat Gan
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Italy Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona Ancona AN
Italy Centro di Riferimento Oncologico - IRCCS Aviano
Italy ASST Papa Giovanni XXIII Bergamo
Italy Humanitas Gavazzeni Bergamo
Italy IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola Bologna
Italy Humanitas Istituto Clinico Catanese Catania
Italy Azienda Ospedaliera Mater Domini Catanzaro
Italy IRCCS Ospedale Policlinico San Martino Genova GE
Italy Istituto Europeo di Oncologia Milan
Italy Fondazione IRCCS San Raffaele del Monte Tabor Milano
Italy Azienda Ospedaliera San Gerardo Monza
Italy Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Napoli
Italy Istituto Oncologico Veneto IOV Padova
Italy Irccs Crob Rionero in Vulture
Italy Azienda Ospedaliero-Universitaria Policlinico Umberto I Roma
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma
Italy Istituto Clinico Humanitas Rozzano
Japan Aichi Cancer Center Hospital Aichi
Japan Tohoku University Hospital Aoba-ku
Japan Juntendo University Hospital Bunkyo-ku
Japan Chiba Cancer Center Chiba
Japan National Cancer Center Hospital Chuo-ku
Japan Osaka Prefectural Hospital Organization Osaka International Cancer Institute Chuo-ku
Japan National Hospital Organization Shikoku Cancer Center Ehime
Japan Fukushima Medical University Hospital Fukushima
Japan Social Medical Corporation Hakuaikai Sagara Hospital Kagoshima-shi
Japan Tokai University Hospital Kanagawa
Japan National Cancer Center Hospital East Kashiwa
Japan Saitama Cancer Center Kitaadachi-gun
Japan Cancer Institute Hospital of JFCR Koto-Ku
Japan Kumamoto University Hospital Kumamoto- shi
Japan Kyoto University Hospital Kyoto-shi
Japan National Hospital Organization Kyushu Cancer Center Minami-ku
Japan Nagoya University Hospital Nagoya
Japan Hiroshima City Hiroshima Citizens Hospital Naka-ku
Japan Hyogo Medical University Hospital Nishinomiya-shi
Japan Okayama University Hospital Okayama
Japan Gunma Prefectural Cancer Center Ota
Japan National Hospital Organization Hokkaido Cancer Center Sapporo
Japan Center Hospital of the National Center for Global Health and Medicine Shinjuku-ku
Japan Showa University Hospital Tokyo
Japan Kanagawa Cancer Center Yokohama
Korea, Republic of Samsung Medical Center Gangnam-Gu
Korea, Republic of National Cancer Center Goyang-si Gyeonggi-do
Korea, Republic of Kyungpook National University Chilgok Hospital Gyeongsangbuk-do
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Malaysia Hospital Kuala Lumpur Kuala Lumpur
Malaysia University Malaya Medical Centre Kuala Lumpur
Malaysia Sarawak General Hospital Kuching
Malaysia Institut Kanser Negara Putrajaya
Mexico Centro de Investigacion y Avances Medicos Especializados Cancún
Mexico FUCAM México
Mexico COI Centro Oncologico Internacional S.A.P.I. de C.V. Mexico City
Mexico Clinica Integral Internacional de Oncologia S de RL de CV Puebla
Mexico Centro Medico Zambrano Hellion San Pedro Garza García
Mexico Centro de Atención e Investigación Clínica en Oncología Yucatán
Poland Copemicus Podmiot Leczniczy Wojewodzkie Centrum Okologii w Gdansku Gdansk
Poland Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o Krakow
Poland Instytut MSF Sp. z o.o. Lodz
Poland Wojewodzki Szpital Specjalistyczny lm. Stefana Kardynala Wyszynsklego SPZOZ w Lublinie Lublin
Poland LUX MED Onkologia Sp. Zo.o. Warszawa
Poland Maria Sklodowska - Curie Institute of Oncology Warszawa
Portugal Centro Clinico Academico - Hospital de Braga Braga
Portugal Hospital da Senhora da Oliveira Guimaraes Guimarães
Portugal Centro Hospitalar de Lisboa Central, E.P.E . - Hospital de Santo Antonio dos Capuchos Lisbon
Portugal Centro Hospitalar Lisboa Norte, EPE Lisbon
Portugal Fundacao Champalimaud Lisbon
Portugal Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano Matosinhos
Singapore National Cancer Centre Singapore Singapore
Singapore National University Hospital Singapore
Singapore Tan Tock Seng Hospital Singapore
South Africa Wilgers Oncology Centre Gauteng
South Africa The Medical Oncology Centre of Rosebank Johannesburg
South Africa Cape Town Oncology Trials Kraaifontein
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitari Dexeus Barcelona
Spain Hospital Universitari Vall D'Hebron Barcelona
Spain Hospital de Basurto Bilbo
Spain Hospital Universitario Reina Sofia Córdoba
Spain Hospital General Universitario De Elche Elche
Spain Hospital Universitario de Jaen Jaen
Spain Hospital Clinico San Carlos Madrid
Spain Hospital General Universitario Gregorio Marañón Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Spain MD Anderson Cancer Center Madrid
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital Clínico Universitario de Santiago de Compostela - CHUS Santiago de Compostela
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Universitario Virgen del Rocio Seville
Spain Hospital Clínico Universitario de Valencia Valencia
Spain Instituto Valenciano De Oncologia (IVO) Valencia
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung City
Taiwan Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare New Taipei City
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Chi Mei Hospital, Liouying Tainan City
Taiwan Koo Foundation Sun Yat-Sen Cancer Center Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Tri-Service General Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei City
Taiwan Chang Gung Memorial Hospital, Linkou Taoyuan City
United Kingdom Barts Cancer Institute London
United Kingdom The Royal Marsden NHS Foundation Trust London
United Kingdom University College London Hospitals London
United Kingdom The Christie NHS Foundation Trust Manchester
United Kingdom Nottingham University Hospitals NHS Trust Nottingham
United States Investigational Drug Services, AdventHealth Orlando Altamonte Springs Florida
United States Georgia Cancer Specialist - Annex Atlanta Georgia
United States Piedmont Cancer Institute Atlanta Georgia
United States MultiCare Regional Cancer Center - Auburn Auburn Washington
United States Hematology Oncology Clinic Baton Rouge Louisiana
United States Florida Cancer Specialists Brooksville Florida
United States Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Chandler Arizona
United States Cleveland Clinic Cleveland Ohio
United States Astera Cancer Care East Brunswick New Jersey
United States US Oncology Investigational Products Center (IPC) Fairfax Virginia
United States Prisma Health - Upstate Greenville South Carolina
United States Penn State Cancer Institute Hershey Pennsylvania
United States Saint Luke's Cancer Institute Kansas City Missouri
United States The University of Kansas Hospital Kansas City Kansas
United States Florida Cancer Specialist Leesburg Florida
United States Rocky Mountain Cancer Centers, LLP Littleton Colorado
United States Los Angeles Hematology Oncology Medical Group Los Angeles California
United States Northwest Georgia Oncology Centers Marietta Georgia
United States Tennessee Oncology, PLLC Nashville Tennessee
United States Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Yale-New Haven Hospital-Yale Cancer Center New Haven Connecticut
United States Memorial Sloan-Kettering Cancer Center (MSKCC) - New York New York New York
United States US Oncology Investigational Products Center (IPC) Norfolk Virginia
United States Stanford Cancer Institute Palo Alto California
United States Magee-Womens of UPMC Pittsburgh Pennsylvania
United States David C. Pratt Cancer Center Saint Louis Missouri
United States Florida Cancer Specialist Saint Petersburg Florida
United States University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Czechia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Poland,  Portugal,  Singapore,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first. Up to approximately 29 months
Secondary Overall Survival (OS) OS is defined as the time from randomization until the date of death from any cause. Until death, up to approximately 60 months
Secondary Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1 ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response. Until progression, up to approximately 60 months
Secondary Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16 The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
The Physical Functioning domain includes 5 questions in which participants will be asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 4 (excellent), with a higher score representing a high QoL.
Baseline, Week 16
Secondary Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden. Up to approximately 60 months
Secondary Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first. Until progression or death, up to approximately 60 months
Secondary Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1 ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response. Up to approximately 60 months
Secondary Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1 DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first). Until progression or death, up to approximately 60 months
Secondary Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) First dose date up to 30 days post last dose, up to approximately 60 months
Secondary Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities First dose date up to 30 days post last dose, up to approximately 60 months
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