Metastatic Breast Cancer Clinical Trial
Official title:
A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer
Verified date | February 2023 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P.
Status | Completed |
Enrollment | 509 |
Est. completion date | January 25, 2024 |
Est. primary completion date | April 5, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically or cytologically confirmed breast cancer that is either locally advanced or metastatic. Locally advanced breast cancer must not be amenable to surgical resection or radiation with curative intent. 2. Suspected deleterious or deleterious Breast Cancer Gene 1 (BRCA1) and/or Breast Cancer Gene 2 (BRCA2) germline mutation. 3. Breast cancer must be Human Epidermal Growth Factor Receptor 2 (HER2)-negative. 4. Measurable or non-measurable (but radiologically evaluable) disease per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1 on computed tomography (CT) scan (within 28 days of randomization) with at least one lesion outside previously irradiated areas. 5. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2. 6. Adequate hematologic, renal, and hepatic function (within 28 days of randomization). Exclusion Criteria: 1. More than two prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin, capecitabine) for metastatic disease. - Regimens received in the adjuvant/neoadjuvant setting or for locally advanced breast cancer within the past 6 months will also be considered toward the maximum of 2 prior lines of therapy. Adjuvant/neoadjuvant chemotherapy for one cancer event will count as one prior line of therapy, if received within the past 6 months. - Previous treatments with hormonal therapy (tamoxifen, aromatase inhibitors) and signal transduction agents (e.g., erlotinib, gefitinib, everolimus, bevacizumab) are allowed and are not counted towards the prior line of therapy. 2. Progressed or recurred within 12 months of completing platinum therapy or received > 1 prior line of platinum therapy for breast cancer in any setting (adjuvant, neoadjuvant, or metastatic). 3. Prior therapy with Poly(ADP-ribose)-Polymerase (PARP) inhibitors. 4. Prior taxane therapy administered for the treatment of metastatic breast cancer with the below exceptions. - Prior taxane therapy for metastatic breast cancer is allowed if the patient received = 1 full cycle (i.e., therapy discontinued within 4 weeks for subjects receiving weekly paclitaxel or Abraxane; therapy discontinued within 3 weeks for subjects receiving paclitaxel or docetaxel every 3 weeks) in the absence of progression or if taxane therapy for metastatic disease was > 12 months prior to Cycle 1 Day-2 (C1D-2). - Use of taxanes as adjuvant therapy or to treat locally advanced disease is permitted, if given more than 6 months prior to C1D-2 5. Known history of allergic reaction to cremophor-paclitaxel, carboplatin, Azo-Colourant Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug. 6. Active CNS metastases or leptomeningeal disease. |
Country | Name | City | State |
---|---|---|---|
Argentina | COIBA Centro de Oncologia e Investigacion de Buenos Aires /ID# 124839 | Berazategui | Buenos Aires |
Argentina | Centro Oncologico Riojano Integral /ID# 127938 | La Rioja | |
Argentina | Clinica Pergamino /ID# 127158 | Pergamino | Buenos Aires |
Argentina | Instituto de Oncoloia de Rosario /ID# 127157 | Rosario | Santa Fe |
Australia | Duplicate_Flinders Centre for Innovation /ID# 127535 | Bedford Park | South Australia |
Australia | Townsville University Hospital /ID# 126731 | Douglas | Queensland |
Australia | Royal Hobart Hospital /ID# 124849 | Hobart | Tasmania |
Australia | St George Hospital /ID# 129416 | Kogarah | New South Wales |
Australia | Hollywood Private Hospital /ID# 124843 | Nedlands | Western Australia |
Australia | The Royal Melbourne Hospital /ID# 124846 | Parkville | Victoria |
Australia | Duplicate_The Prince of Wales Hospital /ID# 124845 | Randwick | New South Wales |
Australia | Southern Medical Day Care Centre /ID# 124844 | Wollongong | New South Wales |
Austria | Medizinische Universitaet Graz /ID# 126450 | Graz | Steiermark |
Austria | Ordensklinikum Linz GmbH Elisabethinen /ID# 126185 | Linz | Oberoesterreich |
Austria | Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 126449 | Salzburg | |
Austria | Medizinische Universitaet Wien /ID# 126184 | Vienna | Wien |
Belarus | Bobruysk Interdistrict Onco. /ID# 137729 | Bobruisk | |
Belarus | State Institution Republican Scientific Practical Center of Oncology and Medical /ID# 125223 | Minsk | |
Belarus | Duplicate_Mogilev Reg Clin Oncology Dis /ID# 137728 | Mogilev | |
Belarus | Vitebsk Regional Clinical Oncology Dispensary /ID# 125219 | Vitebsk | |
Belgium | ZNA Middelheim /ID# 124978 | Antwerp | |
Belgium | Duplicate_AZ St-Jan Brugge-Oostende AV /ID# 124975 | Brugge | West-Vlaanderen |
Belgium | Grand Hôpital de Charleroi /ID# 124981 | Charleroi | Hainaut |
Belgium | Universitair Ziekenhuis Antwerpen /ID# 124977 | Edegem | Antwerpen |
Belgium | Universitair Ziekenhuis Leuven /ID# 124980 | Leuven | Vlaams-Brabant |
Belgium | CHU UCL Namur - Sainte Elisabeth /ID# 124979 | Namur | |
Belgium | UCL Saint-Luc /ID# 124976 | Woluwe-Saint-Lambert | Bruxelles-Capitale |
Canada | Duplicate_Jewish General Hospital /ID# 124880 | Montreal | Quebec |
Canada | CHUM - Notre-Dame Hospital /ID# 124879 | Montréal | Quebec |
Canada | Duplicate_CHUQ-Hospital St. Sacrement /ID# 124881 | Quebec City | Quebec |
Canada | Duplicate_Sunnybrook Health Sciences Ctr /ID# 124882 | Toronto | Ontario |
Chile | Instituto Nacional del Cancer /ID# 129343 | Santiago | |
Chile | ICOS - Inst Clinic Oncology /ID# 125236 | Temuco | |
Chile | Hospital Clinico Vina del Mar /ID# 130100 | Vina Del Mar | Valparaíso |
Chile | Hospital Clinico Vina del Mar /ID# 148502 | Vina Del Mar | Valparaíso |
Colombia | Administradora del Country_S.A-Clinica Del Country /ID# 125255 | Bogota | Cundinamarca |
Colombia | Hospital Univ San Ignacio /ID# 126655 | Bogota | Cundinamarca |
Colombia | Centro Medico Imbanaco de Cali /ID# 126656 | Cali | |
Colombia | Hospital Pablo Tobon Uribe /ID# 126657 | Medellín | Antioquia |
Colombia | Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 129211 | Monteria | Cordoba |
Czechia | Fakultni Nemocnice Brno /ID# 128176 | Brno | |
Czechia | Masarykuv onkologicky ustav /ID# 124886 | Brno | |
Czechia | Duplicate_FN Hradec Kralove /ID# 127080 | Hradec Kralove | |
Czechia | Fakultni nemocnice Olomouc /ID# 124885 | Olomouc | |
Czechia | Vseobecna fakultni nemocnice v Praze /ID# 124887 | Praha | |
Denmark | Rigshospitalet /ID# 124891 | Copenhagen Ø | Hovedstaden |
Denmark | Sygehus Lillebælt, Vejle /ID# 124892 | Vejle | Syddanmark |
Estonia | East Tallinn Central Hospital /ID# 126475 | Kesklinna Linnaosa | Harjumaa |
Finland | Docrates Cancer Center /ID# 124896 | Helsinki | |
Finland | Duplicate_Helsinki Univ Central Hospital /ID# 124897 | Helsinki | |
Finland | Duplicate_Tampere University Hospital /ID# 124898 | Tampere | |
Finland | Vaasa Central Hospital /ID# 132548 | Vaasa | |
France | Institut Paoli-Calmettes /ID# 124903 | Marseille | Bouches-du-Rhone |
France | Institut Curie /ID# 124902 | Paris CEDEX 05 | Ile-de-France |
France | Institut Curie - site CLCC René Huguenin /ID# 124904 | Saint-cloud | |
France | Institut de Cancérologie de l'Ouest René Gauducheau /ID# 137726 | St Herblain CEDEX | Loire-Atlantique |
Germany | Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127180 | Dresden | |
Germany | Universitaetsklinik Heidelberg /ID# 126664 | Heidelberg | Baden-Wuerttemberg |
Germany | Universitaetsklinikum Koeln /ID# 126905 | Köln | Nordrhein-Westfalen |
Germany | Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 125256 | Munich | |
Germany | Sana Klinikum Offenbach /ID# 126733 | Offenbach am Main | |
Germany | Universitaetsklinimum Tuebingen /ID# 129968 | Tubingen | Baden-Wuerttemberg |
Germany | Universitaetsklinikum Ulm /ID# 135230 | Ulm | Baden-Wuerttemberg |
Hungary | Semmelweis Egyetem /ID# 132485 | Budapest | |
Hungary | Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 125259 | Pecs | |
Hungary | Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 124911 | Szolnok | |
Hungary | Duplicate_Zala Megyei Korhaz /ID# 131341 | Zalaegerszeg | |
Israel | Duplicate_Soroka University Medical Center /ID# 124917 | Be'er Sheva | |
Israel | Assaf Harofeh Medical Center /ID# 124915 | Be'Er Ya'Akov | |
Israel | Rambam Health Care Campus /ID# 124916 | Haifa | |
Israel | Gastroenterology Institute, Division of Medicine /ID# 124919 | Jerusalem | |
Israel | Shaare Zedek Medical Center /ID# 130275 | Jerusalem | |
Israel | The Chaim Sheba Medical Center /ID# 124918 | Ramat Gan | Tel-Aviv |
Israel | Kaplan Medical Center /ID# 124914 | Rehovot | |
Israel | Tel Aviv Sourasky Medical Center /ID# 130276 | Tel Aviv-Yafo | Tel-Aviv |
Italy | Centro di Riferimento Oncologico /ID# 126738 | Aviano | |
Italy | IEO -Istituto Europeo di Oncologia /ID# 125260 | Milan | Milano |
Italy | Ospedale San Raffaele IRCCS /ID# 125261 | Milan | Lombardia |
Italy | IRCCS Ospedale Sacro Cuore Don Calabria /ID# 125262 | Negrar | Verona |
Italy | Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 125263 | Reggio Calabria | |
Korea, Republic of | National Cancer Center /ID# 125602 | Goyang | Gyeonggido |
Korea, Republic of | Asan Medical Center /ID# 125601 | Seoul | |
Korea, Republic of | Korea University Anam Hospital /ID# 128968 | Seoul | |
Korea, Republic of | Samsung Medical Center /ID# 125598 | Seoul | |
Korea, Republic of | Seoul National University Hospital /ID# 125600 | Seoul | |
Korea, Republic of | Yonsei University Health System Severance Hospital /ID# 125599 | Seoul | Seoul Teugbyeolsi |
Latvia | Pauls Stradins Clinical University Hospital /ID# 125264 | Riga | |
Latvia | Riga East Clinical University Hospital /ID# 125265 | Riga | |
Lithuania | Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 125266 | Kaunas | |
Lithuania | National Cancer Institute /ID# 125267 | Vilnius | |
Mexico | Centro Oncologico de Chihuahua /ID# 128679 | Chihuahua | |
Mexico | Instituto Nacional de Cancerología INCAN /ID# 128676 | Ciudad de Mexico | |
Mexico | Centro de Estudios Clínicos Especializados /ID# 128680 | Mérida | Yucatan |
Netherlands | Universitair Medisch Centrum Groningen /ID# 129069 | Groningen | |
Netherlands | Maastricht Universitair Medisch Centrum /ID# 129068 | Maastricht | |
Netherlands | Erasmus Medisch Centrum /ID# 124935 | Rotterdam | Zuid-Holland |
Norway | Haukeland University Hospital /ID# 150177 | Bergen | Hordaland |
Poland | Centrum Onkologii Lukaszczyka /ID# 124938 | Bydgoszcz | Kujawsko-pomorskie |
Poland | Wojewodzki Szpital Zespolony /ID# 126998 | Elblag | Warminsko-mazurskie |
Poland | Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 126999 | Lodz | Lodzkie |
Poland | MRUK-MED I Spolka z ograniczona odpowiedzialnoscia /ID# 124939 | Rzeszow | Podkarpackie |
Poland | Wojewodzki Szpital Specjalistyczny /ID# 127258 | Wroclaw | Dolnoslaskie |
Portugal | Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 125298 | Faro | |
Portugal | Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 125299 | Lisboa | |
Portugal | Unidade Local de Saúde de Matosinhos, EPE /ID# 126511 | Matosinhos | |
Portugal | Centro Hospitalar Universitario de Sao Joao, EPE /ID# 126508 | Porto | |
Portugal | IPO Porto FG, EPE /ID# 125297 | Porto | |
Portugal | Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 126510 | Vila Nova De Gaia | Porto |
Puerto Rico | Ad-Vance Medical Research, LLC /ID# 126043 | Ponce | |
Puerto Rico | San Juan Municipal Hospital /ID# 124695 | San Juan | |
Romania | Duplicate_lnstitutul Oncologic Prof Dr Alexandru Trestioreanu /ID# 124943 | Bucharest | |
Romania | Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 124945 | Cluj-Napoca | |
Romania | S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 124948 | Craiova | Dolj |
Romania | Oncomed SRL /ID# 127598 | Timisoara | |
Russian Federation | Duplicate_archangel Clinical Oncology /ID# 126031 | Arkhangelsk | |
Russian Federation | Altay Regional Oncological Dispesary /ID# 127160 | Barnaul | |
Russian Federation | Belgorod Oncology Dispensary /ID# 129315 | Belgorod | |
Russian Federation | Regional Oncology Dispensary /ID# 125936 | Kursk | Tatarstan, Respublika |
Russian Federation | Duplicate_Saratov State Medical University n.s. Chernyshevskiy /ID# 139395 | Saratov | |
Russian Federation | LLC BioEq Ltd. /ID# 134529 | St. Petersburg | |
Russian Federation | Siberian State Medical University /ID# 127161 | Tomsk | |
Russian Federation | Volgograd Regional Clinical Oncology Dispensary /ID# 124952 | Volzhsky | |
Russian Federation | Sverdlovsk Regional Oncology Dispensary /ID# 130950 | Yekaterinburg | Sverdlovskaya Oblast |
Singapore | Johns Hopkins Singapore IMC /ID# 125316 | Singapore | |
Singapore | National University Hospital /ID# 125315 | Singapore | |
South Africa | University of Free State, Universitas Annex (National Hospital Grounds) /ID# 128499 | Bloemfontein | Free State |
South Africa | Netcare Oncology Intervent Ctr /ID# 125320 | Cape Town | Western Cape |
South Africa | The Oncology Centre /ID# 126104 | Durban | Kwazulu-Natal |
South Africa | Cancercare Outeniqua Oncology Centre /ID# 125319 | George | Western Cape |
South Africa | GVI Oncology /ID# 125321 | Gqeberha | Eastern Cape |
South Africa | Medical Oncology Ctr Rosebank /ID# 125322 | Johannesburg | Gauteng |
South Africa | Sandton Oncology Medical Group PTY Ltd /ID# 125323 | Johannesburg | Gauteng |
South Africa | Wits Clinical Research Site /ID# 125317 | Johannesburg | Gauteng |
South Africa | Mary Potter Oncology Centre /ID# 133269 | Pretoria | Gauteng |
Spain | Hospital Santa Creu i Sant Pau /ID# 124963 | Barcelona | |
Spain | Hospital General Universitario Gregorio Maranon /ID# 124962 | Madrid | |
Spain | Hospital Universitario HM Sanchinarro /ID# 124960 | Madrid | |
Spain | Hospital Universitario Virgen de la Victoria /ID# 124961 | Malaga | |
Spain | Hospital Clinico Universitario de Valencia /ID# 124959 | Valencia | |
Sweden | Sahlgrenska University Hospital /ID# 124965 | Gothenburg | Vastra Gotalands Lan |
Sweden | Linkoping University Hospital /ID# 126795 | Linkoping | |
Sweden | Skane University hospital /ID# 124966 | Malmo | Skane Lan |
Sweden | Duplicate_Karolinska Univ Sjukhuset /ID# 124964 | Solna | |
Sweden | Norrlands University hospital /ID# 124967 | Umea | Vasterbottens Lan |
Sweden | Uppsala University Hospital /ID# 126512 | Uppsala | |
Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 125575 | Kaohsiung | |
Taiwan | National Taiwan University Hospital /ID# 125324 | Taipei City | |
Turkey | Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 125337 | Ankara | |
Turkey | Hacettepe University Faculty of Medicine /ID# 125336 | Ankara | |
Turkey | Duplicate_Akdeniz University Medical Fac /ID# 125339 | Antalya | |
Turkey | Bezmi Alem Univ Med Fac Hosp /ID# 127901 | Istanbul | |
Turkey | Istanbul University Istanbul Medical Faculty /ID# 145144 | Istanbul | |
Ukraine | ME Kryviy Rih Oncology Dispensary /ID# 129806 | ?????? ??? | |
Ukraine | Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 124968 | Dnipro | |
Ukraine | Donetsk Regional Antitumor Ctr /ID# 124970 | Donetsk | |
Ukraine | Communal non-profit enterprise Regional Center of Oncology /ID# 124972 | Kharkiv | |
Ukraine | Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 124974 | Lviv | |
Ukraine | Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 124969 | Poltava | |
Ukraine | Zaporizhzhia Med. Academy MOH /ID# 129800 | Zaporizhia | |
United Kingdom | University Hospitals Birmingham NHS Foundation Trust /ID# 125342 | Birmingham | |
United Kingdom | University Hospitals Bristol /ID# 128343 | Bristol | Bristol, City Of |
United Kingdom | Hull University Teaching Hospitals NHS Trust /ID# 133030 | Hull | East Riding Of Yorkshire |
United Kingdom | Nottingham University Hospitals NHS Trust /ID# 125340 | Nottingham | Nottinghamshire |
United States | University of New Mexico /ID# 125349 | Albuquerque | New Mexico |
United States | Lehigh Valley Health Network /ID# 130059 | Allentown | Pennsylvania |
United States | McFarland Clinic, PC /ID# 129904 | Ames | Iowa |
United States | Texas Health Physicians Group /ID# 137740 | Arlington | Texas |
United States | Mission Cancer Center /ID# 134248 | Asheville | North Carolina |
United States | Emory Midtown Infectious Disease Clinic /ID# 133192 | Atlanta | Georgia |
United States | Univ of Colorado Cancer Center /ID# 124983 | Aurora | Colorado |
United States | Johns Hopkins University /ID# 125015 | Baltimore | Maryland |
United States | Lehigh Valley Hosp/Muhlenberg /ID# 130277 | Bethlehem | Pennsylvania |
United States | Lynn Cancer Institute, Boca /ID# 125013 | Boca Raton | Florida |
United States | University of Vermont Medical Center /ID# 125350 | Burlington | Vermont |
United States | University of Illinois - Chicago /ID# 127576 | Chicago | Illinois |
United States | The Ohio State University /ID# 125022 | Columbus | Ohio |
United States | University of Texas Southwestern Medical Center /ID# 124989 | Dallas | Texas |
United States | The Cancer Ctr at DeKalb Med C /ID# 125024 | Decatur | Georgia |
United States | Saint Joseph Hospital /ID# 131768 | Denver | Colorado |
United States | Henry Ford Health System /ID# 134497 | Detroit | Michigan |
United States | City of Hope /ID# 127117 | Duarte | California |
United States | Duke Cancer Center /ID# 124999 | Durham | North Carolina |
United States | NorthShore University HealthSystem /ID# 124996 | Evanston | Illinois |
United States | Holy Cross Hospital /ID# 125012 | Fort Lauderdale | Florida |
United States | California Cancer Associates for Research & Excellence (cCARE) /ID# 136078 | Fresno | California |
United States | Banner MD Anderson Cancer Ctr /ID# 125011 | Gilbert | Arizona |
United States | Spectrum Health Medical Group /ID# 133568 | Grand Rapids | Michigan |
United States | Spectrum Health Medical Group /ID# 148471 | Grand Rapids | Michigan |
United States | Penn State University and Milton S. Hershey Medical Center /ID# 124997 | Hershey | Pennsylvania |
United States | University of Texas MD Anderson Cancer Center /ID# 125353 | Houston | Texas |
United States | Swedish Cancer Institute - Issaquah /ID# 131534 | Issaquah | Washington |
United States | Univ of Mississippi Med Ctr,US /ID# 131352 | Jackson | Mississippi |
United States | St. Lukes Cancer Institute /ID# 125023 | Kansas City | Missouri |
United States | Moores Cancer Center at UC San Diego /ID# 124991 | La Jolla | California |
United States | Nebraska Hematology Oncology /ID# 132711 | Lincoln | Nebraska |
United States | University of Arkansas for Medical Sciences /ID# 124992 | Little Rock | Arkansas |
United States | Rutgers Cancer Institute of New Jersey /ID# 125017 | New Brunswick | New Jersey |
United States | Beth Israel Medical Center /ID# 125001 | New York | New York |
United States | Mount Sinai St. Luke's /ID# 125003 | New York | New York |
United States | Hematology and Oncology Assoc /ID# 130058 | Newport Beach | California |
United States | Norwalk Hospital /ID# 133509 | Norwalk | Connecticut |
United States | Sacred Heart Hospital /ID# 128279 | Pensacola | Florida |
United States | Allegheny General Hospital /ID# 135094 | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh MC /ID# 125005 | Pittsburgh | Pennsylvania |
United States | Oregon Health and Science University /ID# 134229 | Portland | Oregon |
United States | William Beaumont Hospital /ID# 125019 | Royal Oak | Michigan |
United States | Washington University-School of Medicine /ID# 127575 | Saint Louis | Missouri |
United States | Cancer Research Collaboration /ID# 128860 | Santa Ana | California |
United States | Swedish Cancer Insititute - Ballard /ID# 131548 | Seattle | Washington |
United States | Swedish Cancer Institute - Edmonds /ID# 131549 | Seattle | Washington |
United States | Swedish Medical Center /ID# 125021 | Seattle | Washington |
United States | Baystate Medical Center /ID# 139461 | Springfield | Massachusetts |
United States | Northwest Medical Specialties - Tacoma /ID# 125344 | Tacoma | Washington |
United States | Moffitt Cancer Center /ID# 124990 | Tampa | Florida |
United States | University of Toledo /ID# 134849 | Toledo | Ohio |
United States | Florida Cancer Specialists - East /ID# 125007 | West Palm Beach | Florida |
United States | Icri /Id# 128520 | Whittier | California |
United States | UMass Chan Medical School /ID# 129067 | Worcester | Massachusetts |
United States | Midwestern Regional CTC /ID# 124986 | Zion | Illinois |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States, Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Colombia, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival (PFS) | Time to PFS is defined as the number of days from the date the participant was randomized to the date the participant experiences radiographic disease progression (as determined by the investigators), or to the date of death (all causes of mortality) if disease progression is not reached. All events of disease progression occurring on or before the Primary Analysis Cutoff date of 05 April 2019 were to be included, regardless of whether the event occurred while the participant was still taking study drug or had previously discontinued study drug. PFS was estimated for each treatment group using Kaplan-Meier methodology. | From randomization until the primary analysis data cut-off date of 05 April 2019; the median duration of follow-up was 35.5 months | |
Secondary | Overall Survival (OS) | Time to death (overall survival) is defined as the number of days from the date the participant was randomized to the date of the participant's death. All events of death which occur up to the analysis cutoff date are to be included, regardless of whether the event occurred while the participant was still taking study drug or after the participant discontinued study drug. If a participant has not died, the data for the participant is to be censored at the date last known to be alive or at the analysis cutoff date if that is earlier.
The final analysis of OS will occur when the pre-specified number of events has occurred in the ITT population. |
Approximately 8 years from randomization | |
Secondary | Clinical Benefit Rate (CBR) | The clinical benefit rate (CBR) for each treatment group was to be obtained from a time-to-event analysis of radiographic disease progression per the investigator. CBR is defined as the progression-free rate at 24 weeks (168 days), estimated for each treatment arm using Kaplan Meier methodology. All events of disease progression in the primary progression free survival analysis database were to be included, regardless of whether the event occurred while the participant was still taking, or had previously discontinued, study drug. If the participant had not yet progressed then their data was to be censored at the date of the last evaluable disease progression assessment. Participants without post-baseline assessments were to be censored at the date of randomization.
The final analysis of CBR will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure. |
Through the end of Week 24 | |
Secondary | Objective Response Rate (ORR) | The objective response rate (ORR) is calculated as the percentage of participants who have a confirmed partial response (PR) or complete response (CR) based on assessment by the investigators per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. All participants who had at least one measurable lesion at baseline were to be included in the ORR calculation.
The final analysis of ORR will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure. |
Approximately 8 years from randomization | |
Secondary | Progression-Free Survival on Subsequent Therapy (PFS2) | PFS2 is defined as the number of days from the date of randomization to the time of disease progression on subsequent therapy or death from any cause. The distribution of PFS2 was to be estimated for each treatment group using Kaplan-Meier methodology.
The final analysis of PFS2 will occur when the pre-specified number of Overall Survival events have occurred in the ITT population, per the fixed sequence testing procedure. |
Approximately 8 years from randomization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
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NCT04095390 -
A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04432454 -
Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
|
Phase 2 | |
Recruiting |
NCT03323346 -
Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05744375 -
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
|
Phase 2 | |
Completed |
NCT02924883 -
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy
|
Phase 2 | |
Completed |
NCT01942135 -
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
|
Phase 3 | |
Completed |
NCT01881230 -
Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04448886 -
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
|
Phase 2 | |
Completed |
NCT01401959 -
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
|
Phase 2 | |
Terminated |
NCT04720664 -
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
|
Phase 2 |