Stage IV Breast Cancer Clinical Trial
— ASCENT-07Official title:
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
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).
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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Britanico de Buenos Aires | Buenos Aires | |
Australia | Icon Cancer Centre Wesley | Auchenflower | Queensland |
Australia | St Vincent's Hospital Sydney | Darlinghurst | New South Wales |
Australia | Icon Cancer Centre Hobart | Hobart | Tasmania |
Australia | Austin Health | Melbourne | Victoria |
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 | 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 | HGB - Hospital Giovanni Battista/Mãe de Deus Center | Porto Alegre | |
Brazil | CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia | Santo Andre | |
Canada | BC Cancer - Kelowna | Kelowna | |
Canada | The Ottawa Hospital Cancer Centre | Ottawa | |
Canada | CHU de Québec-Université Laval, Hôpital du Saint-Sacrement | Quebec | |
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, Universidad Mayor | Santiago Region | |
Chile | James Lind Centro de Investigacion del Cancer | Temuco | |
Chile | Oncocentro APYS | Vina del Mar | |
China | West China Hospital Sichuan University | Chengdu | |
China | Sun Yat-Sen University Cancer Center | Guangdong | |
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 | The Nanchang Third Hospital | Jiangxi | |
China | The Second Hospital of Jilin University | Jilin Sheng | |
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 | |
Czechia | Masaryk Memorial Cancer Institute | Brno | |
Czechia | University Hospital Olomouc | Olomouc | |
Czechia | Multiscan s.r.o | Pardubice | |
Czechia | Krajska nemocnice Tomase Bati Zlin | Zlin | |
France | CHU Jean Minjoz | Besancon | |
France | Centre Georges François Leclerc | Dijon | |
France | Ico René Gauducheau | Loire Atlantique | |
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 | |
Germany | Universitäts - Frauenklinik | Tübingen | |
Greece | Alexandra General Hospital | Athens | |
Greece | Attikon Hospital | Athens | |
Greece | University Hospital of Heraklion | Heraklion | |
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 | Debreceni Egyetem Klinikai Központ | Debrecen | |
Israel | Oncology Institute Rambam Health Care Campus | Haifa | |
Israel | Hadassah Medical Center | Jerusalem | |
Israel | Shaare Zedek Medical Center | Jerusalem | |
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 | Humanitas Gavazzeni | Bergamo | |
Italy | Humanitas Istituto Clinico Catanese | Catania | |
Italy | Azienda Ospedaliera Mater Domini | Catanzaro | |
Italy | Istituto Europeo di Oncologia | Milan | |
Italy | Istituto Nazionale Tumori IRCCS Fondazione G. Pascale | Napoli | |
Italy | Irccs Crob | Rionero in Vulture | |
Italy | Azienda Ospedaliero-Universitaria Policlinico Umberto I | Roma | |
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 | |
Poland | Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o | Krakow | |
Poland | Instytut MSF Sp. z o.o. | Lodz | |
Poland | Maria Sklodowska - Curie Institute of Oncology | Warszawa | |
Portugal | Centro Clinico Academico - Hospital de Braga | Braga | |
Singapore | National Cancer Centre Singapore | Singapore | |
Singapore | Tan Tock Seng Hospital | Singapore | |
South Africa | The Medical Oncology Centre of Rosebank | Johannesburg | |
Spain | Hospital Clinic de Barcelona | Barcelona | |
Spain | Hospital Universitari Vall D'Hebron | Barcelona | |
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 Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
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 | The Royal Marsden NHS Foundation Trust | London | |
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 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Yale-New Haven Hospital-Yale Cancer Center | New Haven | Connecticut |
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 |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Poland, Portugal, Singapore, South Africa, Spain, Taiwan, United Kingdom,
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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