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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003185-25 | EudraCT Number |
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The Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability.
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This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taselisib + Fulvestrant | Experimental | Participants received taselisib 4 milligrams (mg) taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. |
|
| Placebo + Fulvestrant | Placebo Comparator | Participants received placebo taken orally once daily (QD) beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by intramuscular (IM) injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taselisib | Drug | Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis | PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) |
| PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis | PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis | PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology | Tucson | Arizona | 85704 | United States | ||
| Arizona Oncology Associates, P.C. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38937298 | Derived | Moein A, Jin JY, Wright MR, Wong H. Quantitative characterization of the effects of fulvestrant alone or in combination with taselisib (PI3Kinase inhibitor) on longitudinal tumor growth in patients with estrogen receptor-positive, HER2-negative, PIK3CA-mutant, advanced or metastatic breast cancer. Cancer Chemother Pharmacol. 2024 Sep;94(3):421-436. doi: 10.1007/s00280-024-04690-4. Epub 2024 Jun 27. | |
| 33186740 |
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The study enrolled postmenopausal women with estrogen receptor-positive and human epidermal receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who had disease recurrence or progression during or after aromatase inhibitor therapy. Randomization was stratified by three factors: 1) visceral versus non-visceral disease, 2) sensitivity versus non-sensitivity to most recent endocrine therapy, and 3) geographical region.
This study was conducted at 155 centers in 28 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo+Fulvestrant | Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2018 |
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| Placebo | Drug | Placebo matching to taselisib was administered as per the schedule specified in the respective arm. |
|
| Fulvestrant | Drug | Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms. |
|
|
| From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) |
| Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis | PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) |
| Overall Survival (OS) at Primary Analysis | OS was defined as the time from the date of randomization to the date of death due to any cause. | From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) |
| OS at Final Analysis | OS was defined as the time from the date of randomization to the date of death due to any cause. | From randomization up to death from any cause (up to approximately 6.2 years) |
| Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis | Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) |
| Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis | Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) |
| Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis | Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) |
| Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis | Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) |
| PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis | PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) |
| PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis | PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) |
| Percentage of Participants With Adverse Events at Primary Analysis | An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. | From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years. |
| Percentage of Participants With Adverse Events at Final Analysis | An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. | From randomization up to approximately 6.2 years |
| Maximum Observed Plasma Concentration (Cmax) of Taselisib | 1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days) |
| Minimum Observed Plasma Concentration (Cmin) of Taselisib | 1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days) |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life [QoL]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of "the past week." Most questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent). Scores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms. | Baseline, C2D1 up to C7D1 (each cycle=28 days) |
| Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to a 0-100 scale. Higher scores for the functional scales indicated a higher/better level of functioning/healthy functioning. Higher scores for the symptom scales indicated worse symptoms. | Baseline, C2D1 up to C7D1 (each cycle=28 days) |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Georgia Cancer Specialists - Northside | Atlanta | Georgia | 30341 | United States |
| Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital | Marietta | Georgia | 30060 | United States |
| Ingalls Hospital | Harvey | Illinois | 60426 | United States |
| Maryland Oncology Hematology | Rochville | Maryland | 20850 | United States |
| Dana Farber Can Ins | Boston | Massachusetts | 02215 | United States |
| Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis | St Louis | Missouri | 63141 | United States |
| MSKCC at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| John Theurer Cancer Ctr at Hackensack Univ Medical Ctr | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan-Kettering; Cancer Center | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | United States |
| Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology | Beaverton | Oregon | 97006 | United States |
| Pinnacle Health | Harrisburg | Pennsylvania | 17110 | United States |
| Liverpool Hospital; Cancer Therapy Centre | Liverpool | New South Wales | 2170 | Australia |
| Macquarie University Hospital | Macquarie Park | New South Wales | 2109 | Australia |
| Newcastle Mater Misericordiae Hospital; Oncology | Waratah | New South Wales | 2298 | Australia |
| Mater Hospital; Oncology | Brisbane | Queensland | 4101 | Australia |
| Austin Hospital; Medical Oncology | Heidelberg | Victoria | 3084 | Australia |
| Sunshine Hospital; Oncology Research | St Albans | Victoria | Australia |
| St John of God Murdoch Hospital; Oncology West | Murdoch | Western Australia | 6150 | Australia |
| Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I | Graz | 8036 | Austria |
| Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie | Innsbruck | 6020 | Austria |
| Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1 | Linz | 4010 | Austria |
| Medizinische Universität Wien; Univ.Klinik für Innere Medizin I | Vienna | 1090 | Austria |
| University Clinical Center of the Republic of Srpska | Banja Luka | 78000 | Bosnia and Herzegovina |
| Clinic of Oncology, University Clinical Center Sarajevo | Sarajevo | 7100 | Bosnia and Herzegovina |
| Complex Oncological Center - Plovdiv, EOOD | Plovdiv | 4004 | Bulgaria |
| MHAT Nadezhda | Sofia | 1330 | Bulgaria |
| SHATO - Sofia | Sofia | 1756 | Bulgaria |
| SHATOD Dr. Marko Antonov Markov-Varna, EOOD | Varna | 9010 | Bulgaria |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Grand River Hospital | Kitchener | Ontario | N2G 1G3 | Canada |
| The Ottawa Hospital Cancer Centre; Oncology | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Health Science Centre | Toronto | Ontario | M4N 3M5 | Canada |
| McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec | H3T 1E2 | Canada |
| Hospital Du Saint-Sacrement | Québec | Quebec | G1S 4L8 | Canada |
| the First Hospital of Jilin University | Changchun | 130021 | China |
| Jilin Cancer Hospital | Changchun | 132013 | China |
| Jiangsu Cancer Hospital | Nanjing | 211100 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Zhejiang Cancer Hospital | Zhejiang | 310022 | China |
| Clinica del Country | Bogotá | 11001 | Colombia |
| Oncomedica S.A. | Montería | 230002 | Colombia |
| University Hospital; Oncology and Radiotherapy | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | 779 00 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| KYS Sadesairaala; Syopatautien poliklinikka | Kuopio | 70210 | Finland |
| Turku Uni Central Hospital; Oncology Clinics | Turku | 20520 | Finland |
| Centre Jean Perrin; Hopital De Semaine | Clermont-Ferrand | 63011 | France |
| Centre Georges François Leclerc; Service Pharmacie, Bp 77980 | Dijon | 21000 | France |
| Hopital Prive Drome Ardeche; Chir 2A 2B | Guilherand-Granges | 07500 | France |
| CHD Vendée | La Roche-sur-Yon | 85025 | France |
| Hopital Dupuytren; Oncologie Medicale | Limoges | 87042 | France |
| Institut régional du Cancer Montpellier | Montpellier | 34298 | France |
| Institut Curie; Oncologie Medicale | Paris | 75231 | France |
| Ch Lyon Sud; Onco Secteur Jules Courmont | Pierre-Bénite | 69495 | France |
| Pole de Cancerologie Prive Strasbourgeois | Strasbourg | 67000 | France |
| Centre Alexis Vautrin; Oncologie Medicale | Vandœuvre-lès-Nancy | 54519 | France |
| Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie | Bad Nauheim | 61231 | Germany |
| Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare) | Berlin | 10367 | Germany |
| Onkologische Schwerpunktpraxis Kurfürstendamm | Berlin | 10707 | Germany |
| Universitätsklinikum Essen; Zentrum Für Frauenheilkunde | Essen | 45122 | Germany |
| Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem | Hamburg | 20357 | Germany |
| Klinikum der Universität München; Frauenklinik - Onkologie II | München | 80337 | Germany |
| Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I | Trier | 54290 | Germany |
| Alexandras General Hospital of Athens; Oncology Department | Athens | 115 28 | Greece |
| IASO General Hospital of Athens | Athens | 155 62 | Greece |
| Univ General Hosp Heraklion; Medical Oncology | Heraklion | 711 10 | Greece |
| University Hospital of Patras Medical Oncology | Pátrai | 265 04 | Greece |
| Euromedical General Clinic of Thessaloniki; Oncology Department | Thessaloniki | 546450 | Greece |
| Papageorgiou General Hospital; Medical Oncology | Thessaloniki | 564 29 | Greece |
| Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica | Naples | Campania | 80131 | Italy |
| ARCISPEDALE S. MARIA NUOVA - REGGIO EMILIA; Struttura Semplice Coordinamento Breast Unit Integrata | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia | Udine | Friuli Venezia Giulia | 33100 | Italy |
| IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A | Genoa | Liguria | 16132 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| Centro Catanese Di Oncologia; Oncologia Medica | Catania | Sicily | 95126 | Italy |
| Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia | Florence | Tuscany | 50134 | Italy |
| Azienda USL 9 Grosseto; Dipartimento Politiche del Farmaco | Grosseto | Tuscany | 58100 | Italy |
| Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia | Pontedera | Tuscany | 56025 | Italy |
| AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica | Mestre | Veneto | 30174 | Italy |
| Iem-Fucam | D.F. | 04980 | Mexico |
| Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios | Distrito Federal | 14000 | Mexico |
| Consultorio de Medicina Especializada; Dentro de Condominio San Francisco | Mexico City | 03100 | Mexico |
| Hospital San Jose Del Tec. de Monterrey; Oncology | Monterrey | 64020 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | 68000 | Mexico |
| Medisch Centrum Alkmaar | Alkmaar | 1815 JD | Netherlands |
| Ziekenhuis Rijnstate | Arnhem | 6815 AD | Netherlands |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | Lima 34 | Peru |
| Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional | Lima | Lima 41 | Peru |
| Oncocenter Peru S.A.C.; Oncosalud | Lima | Lima 41 | Peru |
| Instituto Regional de Enfermedades Neoplasicas - IREN Norte | Trujillo | 13014 | Peru |
| Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej | Bialystok | 15-027 | Poland |
| Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii | Bydgoszcz | 85-796 | Poland |
| Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii | Gdansk | 80-214 | Poland |
| Przychodnia Lekarska KOMED, Roman Karaszewski | Konin | 62-500 | Poland |
| Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii | Krakow | 30-688 | Poland |
| Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii | Lodz | 93-513 | Poland |
| Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii | Lublin | 20-090 | Poland |
| Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych | Szczecin | 71-730 | Poland |
| Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii | Warsaw | 02-781 | Poland |
| Wojewodzki Szpital Specjalistyczny; Osrodek Badawczo-Rozwojowy, Oddzial Chemioterapii | Wroclaw | 51-124 | Poland |
| Hospital Garcia de Orta; Servico de Oncologia Medica | Almada | 2801-951 | Portugal |
| IPO de Lisboa; Servico de Oncologia Medica | Lisbon | 1099-023 | Portugal |
| Hospital da Luz; Departamento de Oncologia Medica | Lisbon | 1500-650 | Portugal |
| Hospital de Santa Maria; Servico de Oncologia Medica | Lisbon | 1649-035 | Portugal |
| IPO do Porto; Servico de Oncologia Medica | Porto | 4200-072 | Portugal |
| Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department | Bucharest | 022328 | Romania |
| Prof. Dr. I. Chiricuta Institute of Oncology | Cluj-Napoca | 400015 | Romania |
| Oncology Center Sf. Nectarie | Craiova | 200347 | Romania |
| Euroclinic Center of Oncology SRL | Iași | 700106 | Romania |
| Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moscow Oblast | 143423 | Russia |
| Regional Clinical Oncology Dispensary; Surgery Dept, Thoracic | Arkhangelsk | 163045 | Russia |
| Ivanovo Regional Oncology Dispensary | Ivanovo | 153040 | Russia |
| Clinical Oncology Dispensary of Ministry of Health of Tatarstan | Kazan' | 420029 | Russia |
| State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis | Orenburg | 460021 | Russia |
| S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) | Saint Petersburg | 197758 | Russia |
| Institute for Onc/Rad Serbia | Belgrade | 11000 | Serbia |
| Inje university Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Ulsan University Hosiptal | Ulsan | 44033 | South Korea |
| Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia | Santiago de Compostela | LA Coruña | 15706 | Spain |
| Hospital Universitario Puerta de Hierro; Servicio de Oncologia | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario de Canarias;servicio de Oncologia | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital de Cruces; Servicio de Oncologia | Bilbao | Vizcaya | 48903 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Barcelona | 08036 | Spain |
| Centro Oncologico MD Anderson Internacional; Servicio de Oncologia | Madrid | 28033 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia | Madrid | 28050 | Spain |
| Fundación IVO | Valencia | 46980 | Spain |
| Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | 50009 | Spain |
| Uni Hospital Linkoeping; Dept. of Oncology | Linköping | 58185 | Sweden |
| Sodersjukhuset; Onkologkliniken | Stockholm | 118 83 | Sweden |
| Akademiska sjukhuset, Onkologkliniken | Uppsala | 751 85 | Sweden |
| VETERANS GENERAL HOSPITAL; Department of General Surgery | Taipei | 00112 | Taiwan |
| National Taiwan Uni Hospital; General Surgery | Taipei | 100 | Taiwan |
| Mackay Memorial Hospital; Dept of Surgery | Taipei | 104 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology | Taipei | 11259 | Taiwan |
| Department of Surgery, King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | 10400 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial | Chiang Mai | 50200 | Thailand |
| Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology | Adana | 01230 | Turkey (Türkiye) |
| Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department | Edirne | 22770 | Turkey (Türkiye) |
| Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology | Istanbul | 34300 | Turkey (Türkiye) |
| Ege Uni Medical Faculty; Oncology Dept | Izmir | 35100 | Turkey (Türkiye) |
| Hacettepe Uni Medical Faculty Hospital; Oncology Dept | Sihhiye/Ankara | 06230 | Turkey (Türkiye) |
| Derived |
| Dent S, Cortes J, Im YH, Dieras V, Harbeck N, Krop IE, Wilson TR, Cui N, Schimmoller F, Hsu JY, He J, De Laurentiis M, Sousa S, Drullinsky P, Jacot W. Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial. Ann Oncol. 2021 Feb;32(2):197-207. doi: 10.1016/j.annonc.2020.10.596. Epub 2020 Nov 10. |
| Taselisib+Fulvestrant |
Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intent-to-treat (ITT) population included all randomized participants regardless of whether they received any amount of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo+Fulvestrant | Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. |
| BG001 | Taselisib+Fulvestrant | Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis | PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) |
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| Primary | PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis | PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) |
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| Secondary | Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis | PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). | Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) |
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| Secondary | Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis | PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). | Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) |
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| Secondary | Overall Survival (OS) at Primary Analysis | OS was defined as the time from the date of randomization to the date of death due to any cause. | Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) |
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| Secondary | OS at Final Analysis | OS was defined as the time from the date of randomization to the date of death due to any cause. | Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization up to death from any cause (up to approximately 6.2 years) |
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| Secondary | Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis | Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) |
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| Secondary | Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis | Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) |
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| Secondary | Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis | Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment. Data are reported for participants with responses. | Posted | Median | 95% Confidence Interval | months | Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) |
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| Secondary | Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis | Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment. Data are reported for participants with responses. | Posted | Median | 95% Confidence Interval | months | Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) |
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| Secondary | PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis | PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) |
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| Secondary | PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis | PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. | Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) |
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| Secondary | Percentage of Participants With Adverse Events at Primary Analysis | An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. | The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant. | Posted | Number | percentage of participants | From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years. |
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| Secondary | Percentage of Participants With Adverse Events at Final Analysis | An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. | The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant. | Posted | Number | percentage of participants | From randomization up to approximately 6.2 years |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Taselisib | The Pharmacokinetic (PK) population included all participants who received at least one dose of taselisib and provided valid (adequately documented dose time and PK sample time) PK assessments. | Posted | Mean | Standard Deviation | ng/mL | 1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days) |
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| Secondary | Minimum Observed Plasma Concentration (Cmin) of Taselisib | The PK population included all participants who received at least one dose of taselisib and provided valid (adequately documented dose time and PK sample time) PK assessments. | Posted | Mean | Standard Deviation | ng/mL | 1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days) |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score | The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life [QoL]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of "the past week." Most questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent). Scores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms. | Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. Data are reported for evaluable participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, C2D1 up to C7D1 (each cycle=28 days) |
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| Secondary | Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to a 0-100 scale. Higher scores for the functional scales indicated a higher/better level of functioning/healthy functioning. Higher scores for the symptom scales indicated worse symptoms. | Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. Data are reported for evaluable participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, C2D1 up to C7D1 (each cycle=28 days) |
|
From randomization up to the end of study, approximately 6.2 years
All-cause mortality was reported based on the ITT population: all randomized participants regardless of whether they received any amount of study treatment. Serious and non-serious adverse events were reported based on the safety-evaluable population: all randomized participants who received at least one dose of taselisib, placebo or fulvestrant regardless of the PIK3CA-mutation status of their tumors with participants allocated to the treatment arm associated with the regimen actually received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo+Fulvestrant | Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. | 100 | 214 | 23 | 213 | 183 | 213 |
| EG001 | Taselisib+Fulvestrant | Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. | 197 | 417 | 154 | 416 | 396 | 416 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
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| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| ALCOHOLIC PANCREATITIS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| COLITIS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| DYSPHAGIA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| OESOPHAGEAL ULCER | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| OESOPHAGITIS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| PANCREATITIS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| CHEST DISCOMFORT | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| DEATH | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| MUCOSAL INFLAMMATION | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| PAIN | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| SWELLING FACE | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
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| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
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| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ANAPHYLACTIC SHOCK | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| APPENDICITIS PERFORATED | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| ATYPICAL MYCOBACTERIAL PNEUMONIA | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| CHOLERA | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| CYSTITIS ESCHERICHIA | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| DIARRHOEA INFECTIOUS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| ENTEROCOLITIS INFECTIOUS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| HERPES ZOSTER | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| SEPTIC ARTHRITIS STAPHYLOCOCCAL | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
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| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
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| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
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| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
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| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
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| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
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| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| COCCYDYNIA | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| OSTEONECROSIS OF JAW | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| RHABDOMYOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| HEPATOCELLULAR CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
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| INTRACRANIAL TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
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| CEREBRAL HAEMATOMA | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| FACIAL PARALYSIS | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| HYPOAESTHESIA | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| TRIGEMINAL NEURALGIA | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| VITH NERVE PARALYSIS | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| CONFUSIONAL STATE | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
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| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
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| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
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| HAEMATURIA | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
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| RENAL FAILURE | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
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| URETEROLITHIASIS | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
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| INTERMENSTRUAL BLEEDING | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
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| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| PLEURITIC PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| TOXIC SKIN ERUPTION | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| EMBOLISM | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| EMBOLISM VENOUS | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| SHOCK | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| MUCOSAL INFLAMMATION | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
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| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
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| BLOOD CREATININE INCREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
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| HOT FLUSH | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Dec 18, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582924 | 2-(3-(2-(1-isopropyl-3-methyl-1H-1,2-4-triazol-5-yl)-5,6-dihydrobenzo(f)imidazo(1,2-d)(1,4)oxazepin-9-yl)-1H-pyrazol-1-yl)-2-methylpropanamide |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Male |
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| Hispanic or Latino |
|
| Not Stated |
|
| Unknown |
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| Asian |
|
| Unknown |
|
| American Indian or Alaska Native |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| Multiple |
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| OG001 | Taselisib+Fulvestrant | Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. |
|
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| OG001 | Taselisib+Fulvestrant | Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. |
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| OG001 | Taselisib+Fulvestrant | Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. |
|
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| OG001 | Taselisib+Fulvestrant | Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor. |
|
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Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
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| Participants |
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| Participants |
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Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
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