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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000568-28 | EudraCT Number |
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| Name | Class |
|---|---|
| SOLTI Breast Cancer Research Group | OTHER |
| Breast International Group | OTHER |
| Austrian Breast & Colorectal Cancer Study Group | NETWORK |
This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole + Placebo | Placebo Comparator | Participants will receive 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks. |
|
| Letrozole + Taselisib | Experimental | Participants will receive 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | Letrozole tablets will be administered orally at 2.5 mg QD for 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 | Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | From Baseline to 16 weeks |
| Percentage of Participants With Total Pathologic Complete Response (Total pCR), Defined as Having pCR in Both Breast and Axilla, Using American Joint Committee on Cancer (AJCC) Staging System | Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition). | From Baseline to 16 weeks |
| Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in Phosphatidylinositol-4,5-Bisphosphate 3-Kinase, Catalytic Subunit Alpha (PIK3CA) Mutant (MT) Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | From Baseline to 16 weeks |
| Percentage of Participants With Total pCR , Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA MT Participants | Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in PIK3CA Wildtype (WT) Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | From Baseline to 16 weeks |
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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 |
|---|---|---|---|---|---|---|
| Breastlink Med Group Inc | Santa Ana | California | 92705 | United States | ||
| MGH Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32188717 | Derived | Eiger D, Brandao M, de Azambuja E. Lessons learned at SABCS 2019 and to-dos from immunotherapy in breast cancer. ESMO Open. 2020 Mar;5(2):e000688. doi: 10.1136/esmoopen-2020-000688. No abstract available. | |
| 32079624 | Derived | Eiger D, Franzoi MA, Ponde N, Brandao M, de Angelis C, Schmitt Nogueira M, de Hemptinne Q, de Azambuja E. Cardiotoxicity of trastuzumab given for 12 months compared to shorter treatment periods: a systematic review and meta-analysis of six clinical trials. ESMO Open. 2020 Feb;5(1):e000659. doi: 10.1136/esmoopen-2019-000659. |
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The study recruited post-menopausal participants with breast cancer in 22 countries from November 2014 to March 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Taselisib + Letrozole | Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks. |
| FG001 | Placebo Comparator: Placebo + Letrozole |
| 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 | Yes | No | No | Study Protocol | Jul 27, 2015 | Mar 6, 2018 |
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| Placebo | Other | Placebo tablets matched to taselisib formulation will be administered orally daily on 5 days-on/2 days-off schedule for up to 16 weeks. |
|
| Taselisib | Drug | Taselisib will be administered orally at 4 mg (two 2 mg tablets) daily. |
|
|
| From Baseline to 16 weeks |
| Percentage of Participants With Total pCR Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA WT Participants | Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition). | From Baseline to 16 weeks |
| Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA MT Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | From Baseline to 16 weeks |
| Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA WT Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | From Baseline to 16 weeks |
| Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA MT Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | From Baseline to 16 weeks |
| Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA WT Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | From Baseline to 16 weeks |
| Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA MT Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | From Baseline to 16 weeks |
| Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA WT Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | From Baseline to 16 weeks |
| Central Assessments of Changes in Ki67 Levels | Ki67 is a prognostic marker and is used to evaluate the proliferative activity of breast cancer. | From Baseline to Week 3 and Surgery (Weeks 17-18); and Week 3 to Surgery (Weeks 17-18) |
| Preoperative Endocrine Prognostic Index (PEPI ) Score | To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each participant is the sum of the risk points derived from the primary tumor (pT) stage, regional lymph nodes (pN) stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each participant is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome). | Week 16 |
| Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI | From Baseline to Surgery (Weeks 17-18) |
| Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. Here, Post surgery= PS. | Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery |
| Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. Here, Post surgery= PS. | Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery |
| Percentage of Participants With Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Baseline up to 22 weeks |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| MSKCC at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| MSKCC @ Commack | Commack | New York | 11725 | United States |
| MSKCC @ West Harrison | Harrison | New York | 10604 | United States |
| Memorial Sloan-Kettering Cancer Center; Hematology/Oncology | New York | New York | 10065 | United States |
| MSKC @ Rockville | Rockville Centre | New York | 11570 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Kinghorn Cancer Centre; St Vincents Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| Newcastle Mater Misericordiae Hospital; Oncology | Waratah | New South Wales | 2298 | Australia |
| Victorian Breast and Oncology Care | East Melbourne | Victoria | Australia |
| Cabrini Medical Centre; Oncology | Malvern | Victoria | 3144 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie | Graz | 8036 | Austria |
| LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie | Graz | 8036 | Austria |
| Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie | Innsbruck | 6020 | Austria |
| Ordensklinikum Linz Barmherzige Schwestern ; Abt. f. Allgemein- und Viszeralchirurgie | Linz | 4010 | Austria |
| Brustzentrum - Ordination Dr. Wette | Saint Veit/Glan | 9300 | Austria |
| Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. | Salzburg | 5020 | Austria |
| Medizinische Universität Wien; Univ.Klinik für Chirurgie - Abt. für Allgemeinchirurgie | Vienna | 1090 | Austria |
| Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie | Vienna | 1090 | Austria |
| Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe | Vienna | 1130 | Austria |
| Klinikum Kreuzschwestern Wels; Iii. Interne Abt. | Wels | 4600 | Austria |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| CHU Brugmann (Victor Horta) | Brussels | 1020 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| Clinique Ste-Elisabeth | Namur | 5000 | Belgium |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Clinica de Neoplasias Litoral | Itajaí | Santa Catarina | 88301-220 | Brazil |
| Hospital de Cancer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia | São Paulo | São Paulo | 03102-002 | Brazil |
| Hospital Clinico Vina del Mar | Viña del Mar | 2520612 | Chile |
| Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | 779 00 | Czechia |
| MULTISCAN, s.r.o., Radiologicke centrum Pardubice | Pardubice | 532 03 | Czechia |
| Oblastni nemocnice Pribram | Příbram | 261 01 | Czechia |
| Hospital Oncologia; Oncology | San Salvador | 01101 | El Salvador |
| Centre Jean Perrin; Division De Recherche Clinique | Clermont-Ferrand | 63011 | France |
| Centre Jean Bernard | Le Mans | 72015 | France |
| Institut Curie; Oncologie Medicale | Paris | 75231 | France |
| Hopital Saint Louis; Service Onco Thoracique | Paris | 75475 | France |
| Centre Rene Huguenin; ONCOLOGIE GENETIQUE | Saint-Cloud | 92210 | France |
| CHI de Toulon - Hôpital Sainte Musse | Toulon | 83056 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare) | Berlin | 10367 | Germany |
| Studienzentrum Berlin City | Berlin | 14169 | Germany |
| Onkologische Schwerpunktpraxis Bielefeld | Bielefeld | 33604 | Germany |
| Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden | Dresden | 01307 | Germany |
| Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum | Essen | 45136 | Germany |
| Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum | Gelsenkirchen | 45879 | Germany |
| Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe | Hanover | 30625 | Germany |
| Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe | Lübeck | 23538 | Germany |
| Rotkreuzklinikum München; Frauenklinik | München | 80637 | Germany |
| Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe | Münster | 48149 | Germany |
| Universitätsklinikum Ulm Am Michelsberg; Frauenklinik | Ulm | 89075 | Germany |
| Marien-Hospital Witten; Frauenklinik Brustzentrum | Witten | 58452 | Germany |
| Centro Oncológico Sixtino / Centro Oncológico SA | Guatemala City | 01010 | Guatemala |
| Grupo Angeles | Guatemala City | 01015 | Guatemala |
| Szent Margit Hospital; Dept. of Oncology | Budapest | 1032 | Hungary |
| Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika | Debrecen | 4032 | Hungary |
| Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont | Kecskemét | 6000 | Hungary |
| B-A-Z County Hospital | Miskolc | 3526 | Hungary |
| Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika | Szeged | 6720 | Hungary |
| Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica | Bologna | Emilia-Romagna | 40138 | Italy |
| Ospedale degli Infermi | Rimini | Emilia-Romagna | 47923 | Italy |
| Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico | Genoa | Liguria | 16132 | Italy |
| ASST DI CREMONA; Dip. Medicina - S.C. Oncologia | Cremona | Lombardy | 26100 | Italy |
| Ospedale Per Acuti Mater Salutis Di Legnago | Legnago | Lombardy | 37045 | Italy |
| Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1 | Milan | Lombardy | 20133 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica | Milan | Lombardy | 20141 | Italy |
| Centro Estatal de Cancerología | Chihuahua City | 31000 | 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 |
| Centro Oncologico America | Panama City | 0834-02723 | Panama |
| Hospital Nacional Cayetano Heredia; Hematology - Oncology | Lima | 31 | Peru |
| Oncosalud Sac; Oncología | Lima | 41 | Peru |
| Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional | Lima | Lima 41 | Peru |
| Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii | Bydgoszcz | 85-796 | Poland |
| Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii | Gdansk | 80-952 | Poland |
| Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Oddział Chemioterapii | Lodz | 93-513 | Poland |
| Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii | Otwock | 05-400 | Poland |
| Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie | Poznan | 61-866 | Poland |
| Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon | Warsaw | 02-781 | Poland |
| IPO de Lisboa; Servico de Oncologia Medica | Lisbon | 1099-023 | Portugal |
| Centro Clinico Champalimaud; Oncologia Medica | Lisbon | 1400-038 | Portugal |
| IPO do Porto; Servico de Oncologia Medica | Porto | 4200-072 | Portugal |
| National Cancer Center; Medical Oncology | Gyeonggi-do | 410-769 | South Korea |
| Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology | Seoul | 03080 | South Korea |
| Yonsei University Severance Hospital; Medical Oncology | Seoul | 120-752 | South Korea |
| Samsung Medical Centre; Division of Hematology/Oncology | Seoul | 135-710 | South Korea |
| Hospital Provincial de Castellon; Servicio de Oncologia | Castellon | Castellon | 12002 | Spain |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | 14004 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia | Santiago de Compostela | LA Coruña | 15706 | Spain |
| Instituto Universitario Dexeus; Servicio de Oncología | Barcelona | 08028 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Institut Catala d Oncologia Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Hospital San Pedro De Alcantara; Servicio de Oncologia | Cáceres | 10003 | Spain |
| Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia | Girona | 17007 | Spain |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Jaén | 23007 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia | Lleida | 25198 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica | Madrid | 28050 | Spain |
| Hospital Universitario de Fuenlabrada; Servicio de Oncologia | Madrid | 28943 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Seville | 41013 | Spain |
| Hospital Clinico Universitario; Oncologia | Valencia | 46010 | Spain |
| Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia | Valencia | 46015 | Spain |
| Fundación IVO | Valencia | 46980 | Spain |
| Kantonsspital Baden; Frauenklinik | Baden | 5405 | Switzerland |
| Kantonsspital Graubünden;Onkologie und Hämatologie | Chur | 7000 | Switzerland |
| Fondazione Oncologia Lago Maggiore | Locarno | 6600 | Switzerland |
| Royal Bournemouth General Hospital; Oncology | Bournemouth | BH7 7DW | United Kingdom |
| Frimley Park Hospital; Breast Resaerch Team | Camberley | GU16 7UJ | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| Christie Hospital | Manchester | M20 3BG | United Kingdom |
| 31402321 | Derived | Saura C, Hlauschek D, Oliveira M, Zardavas D, Jallitsch-Halper A, de la Pena L, Nuciforo P, Ballestrero A, Dubsky P, Lombard JM, Vuylsteke P, Castaneda CA, Colleoni M, Santos Borges G, Ciruelos E, Fornier M, Boer K, Bardia A, Wilson TR, Stout TJ, Hsu JY, Shi Y, Piccart M, Gnant M, Baselga J, de Azambuja E. Neoadjuvant letrozole plus taselisib versus letrozole plus placebo in postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2019 Sep;20(9):1226-1238. doi: 10.1016/S1470-2045(19)30334-1. Epub 2019 Aug 8. |
Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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Intention-to-Treat (ITT) population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Taselisib + Letrozole | Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks. |
| BG001 | Placebo Comparator: Placebo + Letrozole | Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 | Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | percentage of participants | From Baseline to 16 weeks |
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| Primary | Percentage of Participants With Total Pathologic Complete Response (Total pCR), Defined as Having pCR in Both Breast and Axilla, Using American Joint Committee on Cancer (AJCC) Staging System | Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition). | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | percentage of participants | From Baseline to 16 weeks |
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| Primary | Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in Phosphatidylinositol-4,5-Bisphosphate 3-Kinase, Catalytic Subunit Alpha (PIK3CA) Mutant (MT) Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | percentage of participants | From Baseline to 16 weeks |
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| Primary | Percentage of Participants With Total pCR , Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA MT Participants | Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition). | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | percentage of participants | From Baseline to 16 weeks |
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| Secondary | Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in PIK3CA Wildtype (WT) Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | percentage of participants | From Baseline to 16 weeks |
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| Secondary | Percentage of Participants With Total pCR Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA WT Participants | Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition). | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | percentage of participants | From Baseline to 16 weeks |
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| Secondary | Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA MT Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | percentage of participants | From Baseline to 16 weeks |
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| Secondary | Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA WT Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | percentage of participants | From Baseline to 16 weeks |
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| Secondary | Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA MT Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | percentage of participants | From Baseline to 16 weeks |
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| Secondary | Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA WT Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | percentage of participants | From Baseline to 16 weeks |
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| Secondary | Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA MT Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | percentage of participants | From Baseline to 16 weeks |
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| Secondary | Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA WT Participants | ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | percentage of participants | From Baseline to 16 weeks |
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| Secondary | Central Assessments of Changes in Ki67 Levels | Ki67 is a prognostic marker and is used to evaluate the proliferative activity of breast cancer. | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | 95% Confidence Interval | percentage | From Baseline to Week 3 and Surgery (Weeks 17-18); and Week 3 to Surgery (Weeks 17-18) |
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| Secondary | Preoperative Endocrine Prognostic Index (PEPI ) Score | To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each participant is the sum of the risk points derived from the primary tumor (pT) stage, regional lymph nodes (pN) stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each participant is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome). | Data were not collected for this outcome measure. | Posted | Week 16 |
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| Secondary | Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Number | 95% Confidence Interval | percent change | From Baseline to Surgery (Weeks 17-18) |
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| Secondary | Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30) | EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. Here, Post surgery= PS. | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Mean | Standard Deviation | score on a scale | Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery |
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| Secondary | Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23) | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. Here, Post surgery= PS. | ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo). | Posted | Mean | Standard Deviation | score on a scale | Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery |
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| Secondary | Percentage of Participants With Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | The safety population includes all randomized participants who received at least one dose of taselisib or placebo. | Posted | Number | percentage of participants | Baseline up to 22 weeks |
|
|
Baseline up to 22 weeks
The safety population includes all randomized participants who received at least one dose of taselisib or placebo.
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 | Experimental: Taselisib + Letrozole | Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks. | 1 | 167 | 20 | 167 | 130 | 167 |
| EG001 | Placebo Comparator: Placebo + Letrozole | Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks. | 0 | 167 | 4 | 167 | 126 | 167 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative wound infection | Infections and infestations | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Bacterial diarrhoea | Infections and infestations | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Hypertensive encephalopathy | Nervous system disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA V19.0,19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA V19.0,19.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA V19.0,19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V19.0,19.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA V19.0,19.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA V19.0,19.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA V19.0,19.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA V19.0,19.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA V19.0,19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V19.0,19.1 | 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 | 1-800-821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2018 | Mar 6, 2018 | SAP_001.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 |
|---|---|
| D000077289 | Letrozole |
| 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 |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| American Indian or Alaskan Native |
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| Asian |
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| Black or African American |
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| Multiple |
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| Other |
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| Missing |
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| Not Hispanic or Latino |
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| Not Reported |
|
| Unknown |
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| Counts |
|---|
| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks. |
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