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Breast CancerPhase 2NCT02273973

A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

A Phase 2 study testing Letrozole and Taselisib in people with Breast Cancer, run by Genentech, Inc. at 117 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Letrozole and Taselisib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
334 participants
Where
117 sitesin 22 countries
Study dates
12 Nov 2014to 13 Mar 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female participants
  • Postmenopausal status
  • Histologically confirmed invasive breast carcinoma, with all of the following characteristics: (i) Primary tumor greater than or equal to (>/=) 2 centimeters (cm) in largest diameter (cT1-3) by MRI; (ii) Stage I to operable Stage III breast cancer; (iii) Documented absence of distant metastases (M0)
  • Estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer
  • Breast cancer eligible for primary surgery
  • Tumor tissue from formalin-fixed paraffin-embedded cores (FFPE) core biopsy of breast primary tumor that is confirmed as evaluable for phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation status by central histopathology laboratory
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Fasting glucose less than or equal to (</=) 125 milligrams per deciliter (mg/dL)
  • Adequate hematological, renal, and hepatic function
  • Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol, in the investigator's judgment

Who cannot join

  • Any prior treatment for primary invasive breast cancer
  • Participants with cT4 or cN3 stage breast tumors
  • Bilateral invasive, multicentric, or metastatic breast cancer
  • Participants who have undergone excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy
  • Type 1 or 2 diabetes requiring antihyperglycemic medication
  • Inability or unwillingness to swallow pills
Show all 20Show fewer
  • Malabsorption syndrome or other condition that would interfere with enteric absorption
  • History of prior or currently active small or large intestine inflammation (such as Crohn's disease or ulcerative colitis). Any predisposition for gastrointestinal (GI) toxicity requires prior approval from the Medical Monitor.
  • Congenital long QT syndrome or QT interval corrected using Fridericia's formula (QTcF) >470 milliseconds (msec)
  • Diffusing capacity of the lungs for carbon monoxide (DLCO) <60% of the predicted values
  • Clinically significant (i.e., active) cardiovascular disease, uncontrolled hypertension, unstable angina, history of myocardial infarction, cardiac failure class II-IV
  • Any contraindication to MRI examination
  • Active infection requiring intravenous antibiotics
  • Participants requiring any daily supplemental oxygen
  • Clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis
  • Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the participants at high risk from treatment complications
  • Significant traumatic injury within 3 weeks prior to initiation of study treatment
  • Major surgical procedure within 4 weeks prior to initiation of study treatment
  • Inability to comply with study and follow-up procedures
  • History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer

Trial locations and contacts

117 sites in 22 countries.

117 sites in 22 countries

Spain17 sites

  • Instituto Universitario Dexeus; Servicio de Oncología

    Barcelona, 08028

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Institut Catala d Oncologia Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital San Pedro De Alcantara; Servicio de Oncologia

    Cáceres, 10003

  • Hospital Provincial de Castellon; Servicio de Oncologia

    Castellon, Castellon, 12002

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

  • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

    Girona, 17007

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

    Jaén, 23007

  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

    Lleida, 25198

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

    Madrid, 28050

  • Hospital Universitario de Fuenlabrada; Servicio de Oncologia

    Madrid, 28943

  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia

    Seville, 41013

  • Hospital Clinico Universitario; Oncologia

    Valencia, 46010

  • Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

    Valencia, 46015

  • Fundación IVO

    Valencia, 46980

Other trials in Spain

Germany13 sites

  • Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

    Berlin, 10367

  • Studienzentrum Berlin City

    Berlin, 14169

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, 33604

  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

    Dresden, 01307

  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

    Essen, 45136

  • Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum

    Gelsenkirchen, 45879

  • Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie

    Hamburg, 20246

  • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

    Hanover, 30625

  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

    Lübeck, 23538

  • Rotkreuzklinikum München; Frauenklinik

    München, 80637

  • Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

    Münster, 48149

  • Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

    Ulm, 89075

  • Marien-Hospital Witten; Frauenklinik Brustzentrum

    Witten, 58452

Other trials in Germany

Austria10 sites

  • Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie

    Graz, 8036

  • LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

    Graz, 8036

  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

    Innsbruck, 6020

  • Ordensklinikum Linz Barmherzige Schwestern ; Abt. f. Allgemein- und Viszeralchirurgie

    Linz, 4010

  • Brustzentrum - Ordination Dr. Wette

    Saint Veit/Glan, 9300

  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

    Salzburg, 5020

  • Medizinische Universität Wien; Univ.Klinik für Chirurgie - Abt. für Allgemeinchirurgie

    Vienna, 1090

  • Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

    Vienna, 1090

  • Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe

    Vienna, 1130

  • Klinikum Kreuzschwestern Wels; Iii. Interne Abt.

    Wels, 4600

Other trials in Austria

United States8 sites

  • MSKCC at Basking Ridge

    Basking Ridge, New Jersey, 07920

  • MGH Cancer Center

    Boston, Massachusetts, 02114

  • MSKCC @ Commack

    Commack, New York, 11725

  • MSKCC @ West Harrison

    Harrison, New York, 10604

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Memorial Sloan-Kettering Cancer Center; Hematology/Oncology

    New York, New York, 10065

  • MSKC @ Rockville

    Rockville Centre, New York, 11570

  • Breastlink Med Group Inc

    Santa Ana, California, 92705

Other trials in United States

France7 sites

  • Centre Jean Perrin; Division De Recherche Clinique

    Clermont-Ferrand, 63011

  • Centre Jean Bernard

    Le Mans, 72015

  • Institut Curie; Oncologie Medicale

    Paris, 75231

  • Hopital Saint Louis; Service Onco Thoracique

    Paris, 75475

  • Centre Rene Huguenin; ONCOLOGIE GENETIQUE

    Saint-Cloud, 92210

  • CHI de Toulon - Hôpital Sainte Musse

    Toulon, 83056

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

Other trials in France

Italy7 sites

  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

    Bologna, Emilia-Romagna, 40138

  • ASST DI CREMONA; Dip. Medicina - S.C. Oncologia

    Cremona, Lombardy, 26100

  • Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico

    Genoa, Liguria, 16132

  • Ospedale Per Acuti Mater Salutis Di Legnago

    Legnago, Lombardy, 37045

  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

    Milan, Lombardy, 20133

  • Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica

    Milan, Lombardy, 20141

  • Ospedale degli Infermi

    Rimini, Emilia-Romagna, 47923

Other trials in Italy

Poland6 sites

  • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

    Bydgoszcz, 85-796

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-952

  • Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Oddział Chemioterapii

    Lodz, 93-513

  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

    Otwock, 05-400

  • Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie

    Poznan, 61-866

  • Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon

    Warsaw, 02-781

Other trials in Poland

Australia5 sites

  • Kinghorn Cancer Centre; St Vincents Hospital

    Darlinghurst, New South Wales, 2010

  • Victorian Breast and Oncology Care

    East Melbourne, Victoria

  • Cabrini Medical Centre; Oncology

    Malvern, Victoria, 3144

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Newcastle Mater Misericordiae Hospital; Oncology

    Waratah, New South Wales, 2298

Other trials in Australia

Belgium5 sites

  • Institut Jules Bordet

    Brussels, 1000

  • CHU Brugmann (Victor Horta)

    Brussels, 1020

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Antwerpen

    Edegem, 2650

  • Clinique Ste-Elisabeth

    Namur, 5000

Other trials in Belgium

Brazil5 sites

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia

    São Paulo, São Paulo, 03102-002

Other trials in Brazil

Hungary5 sites

  • Szent Margit Hospital; Dept. of Oncology

    Budapest, 1032

  • Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

    Debrecen, 4032

  • Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont

    Kecskemét, 6000

  • B-A-Z County Hospital

    Miskolc, 3526

  • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

    Szeged, 6720

Other trials in Hungary

Czechia4 sites

  • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc; Onkologicka klinika

    Olomouc, 779 00

  • MULTISCAN, s.r.o., Radiologicke centrum Pardubice

    Pardubice, 532 03

  • Oblastni nemocnice Pribram

    Příbram, 261 01

Other trials in Czechia

South Korea4 sites

  • National Cancer Center; Medical Oncology

    Gyeonggi-do, 410-769

  • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

    Seoul, 03080

  • Yonsei University Severance Hospital; Medical Oncology

    Seoul, 120-752

  • Samsung Medical Centre; Division of Hematology/Oncology

    Seoul, 135-710

Other trials in South Korea

United Kingdom4 sites

  • Royal Bournemouth General Hospital; Oncology

    Bournemouth, BH7 7DW

  • Frimley Park Hospital; Breast Resaerch Team

    Camberley, GU16 7UJ

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Christie Hospital

    Manchester, M20 3BG

Other trials in United Kingdom

Mexico3 sites

  • Centro Estatal de Cancerología

    Chihuahua City, 31000

  • Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

    Distrito Federal, 14000

  • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

    Mexico City, 03100

Other trials in Mexico

Peru3 sites

  • Hospital Nacional Cayetano Heredia; Hematology - Oncology

    Lima, 31

  • Oncosalud Sac; Oncología

    Lima, 41

  • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

    Lima, Lima 41

Other trials in Peru

Portugal3 sites

  • IPO de Lisboa; Servico de Oncologia Medica

    Lisbon, 1099-023

  • Centro Clinico Champalimaud; Oncologia Medica

    Lisbon, 1400-038

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Switzerland3 sites

  • Kantonsspital Baden; Frauenklinik

    Baden, 5405

  • Kantonsspital Graubünden;Onkologie und Hämatologie

    Chur, 7000

  • Fondazione Oncologia Lago Maggiore

    Locarno, 6600

Other trials in Switzerland

Guatemala2 sites

  • Centro Oncológico Sixtino / Centro Oncológico SA

    Guatemala City, 01010

  • Grupo Angeles

    Guatemala City, 01015

Other trials in Guatemala

Chile1 site

  • Hospital Clinico Vina del Mar

    Viña del Mar, 2520612

Other trials in Chile

El Salvador1 site

  • Hospital Oncologia; Oncology

    San Salvador, 01101

Other trials in El Salvador

Panama1 site

  • Centro Oncologico America

    Panama City, 0834-02723

Other trials in Panama

About this study

Official title: A Phase II Randomized, Double-Blind Study of Neoadjuvant Letrozole Plus GDC-0032 Versus Letrozole Plus Placebo in Postmenopausal Women With ER-positive/HER2-negative, Early Stage Breast Cancer

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.

Conditions
Breast Cancer
Being tested
Letrozole, Placebo, Taselisib
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LetrozoleDrug

    Letrozole tablets will be administered orally at 2.5 mg QD for 16 weeks.

  • PlaceboOther

    Placebo tablets matched to taselisib formulation will be administered orally daily on 5 days-on/2 days-off schedule for up to 16 weeks.

  • TaselisibDrug

    Also called GDC-0032

    Taselisib will be administered orally at 4 mg (two 2 mg tablets) daily.

Study groups in NCT02273973
Study groupRoleWhat they receive
Letrozole + PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Letrozole; Other: Placebo
Letrozole + TaselisibExperimentalParticipants 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.
Receives: Drug: Letrozole; Drug: Taselisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Baseline to 16 weeks

  2. 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).

    Measured: From Baseline to 16 weeks

  3. 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.

    Measured: From Baseline to 16 weeks

  4. 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).

    Measured: From Baseline to 16 weeks

Secondary outcomes (14)

  1. 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.

    Measured: From Baseline to 16 weeks

  2. 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).

    Measured: From Baseline to 16 weeks

  3. 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.

    Measured: From Baseline to 16 weeks

  4. 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.

    Measured: From Baseline to 16 weeks

  5. 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.

    Measured: From Baseline to 16 weeks

  6. 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.

    Measured: From Baseline to 16 weeks

  7. 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.

    Measured: From Baseline to 16 weeks

  8. 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.

    Measured: From Baseline to 16 weeks

  9. Central Assessments of Changes in Ki67 Levels

    Ki67 is a prognostic marker and is used to evaluate the proliferative activity of breast cancer.

    Measured: From Baseline to Week 3 and Surgery (Weeks 17-18); and Week 3 to Surgery (Weeks 17-18)

  10. 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).

    Measured: Week 16

  11. Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI

    Measured: From Baseline to Surgery (Weeks 17-18)

  12. 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.

    Measured: Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery

  13. 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.

    Measured: Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery

  14. 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.

    Measured: Baseline up to 22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2014 (estimated)
  2. Study start12 Nov 2014
  3. Primary completion13 Mar 2017
  4. Study completion13 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02273973
Sponsor's protocol ID
GO28888
Other IDs
2013-000568-28
Status last verified
Apr 2018
First submitted
22 Oct 2014
Last updated
21 May 2018

Publications

  • 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.

    PubMed 32188717

  • 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.

    PubMed 32079624

  • 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.

    PubMed 31402321

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Letrozole and Taselisib in people with Breast Cancer, run by Genentech, Inc. at 117 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in Spain, Germany, Austria, United States, France and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From Baseline to 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02273973, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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