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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Letrozole
Placebo
Taselisib
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Breastlink Med Group Inc
  • MGH Cancer Center
  • MSKCC at Basking Ridge
  • MSKCC @ Commack
  • MSKCC @ West Harrison
  • Memorial Sloan-Kettering Cancer Center; Hematology/Oncology
  • MSKC @ Rockville
  • MD Anderson Cancer Center
  • Kinghorn Cancer Centre; St Vincents Hospital
  • Newcastle Mater Misericordiae Hospital; Oncology
  • Victorian Breast and Oncology Care
  • Cabrini Medical Centre; Oncology
  • Fiona Stanley Hospital
  • Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
  • LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
  • Ordensklinikum Linz Barmherzige Schwestern ; Abt. f. Allgemein- und Viszeralchirurgie
  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  • Brustzentrum - Ordination Dr. Wette
  • Klinikum Kreuzschwestern Wels; Iii. Interne Abt.
  • Medizinische Universität Wien; Univ.Klinik für Chirurgie - Abt. für Allgemeinchirurgie
  • Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
  • Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe
  • Institut Jules Bordet
  • CHU Brugmann (Victor Horta)
  • Cliniques Universitaires St-Luc
  • UZ Antwerpen
  • Clinique Ste-Elisabeth
  • Hospital Sao Lucas - PUCRS
  • Clinica de Neoplasias Litoral
  • Hospital de Cancer de Barretos
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia
  • Hospital Clinico Vina del Mar
  • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • MULTISCAN, s.r.o., Radiologicke centrum Pardubice
  • Oblastni nemocnice Pribram
  • Hospital Oncologia; Oncology
  • Centre Jean Perrin; Division De Recherche Clinique
  • Centre Jean Bernard
  • Institut Curie; Oncologie Medicale
  • Hopital Saint Louis; Service Onco Thoracique
  • Centre Rene Huguenin; ONCOLOGIE GENETIQUE
  • CHI de Toulon - Hôpital Sainte Musse
  • Institut de Cancérologie de Lorraine
  • Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
  • Studienzentrum Berlin City
  • Onkologische Schwerpunktpraxis Bielefeld
  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
  • Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum
  • Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie
  • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
  • Rotkreuzklinikum München; Frauenklinik
  • Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
  • Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
  • Marien-Hospital Witten; Frauenklinik Brustzentrum
  • Grupo Angeles
  • Centro Oncológico Sixtino / Centro Oncológico SA
  • Szent Margit Hospital; Dept. of Oncology
  • Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
  • Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
  • B-A-Z County Hospital
  • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
  • Ospedale degli Infermi
  • Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico
  • ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
  • Ospedale Per Acuti Mater Salutis Di Legnago
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
  • Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
  • National Cancer Center; Medical Oncology
  • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
  • Yonsei University Severance Hospital; Medical Oncology
  • Samsung Medical Centre; Division of Hematology/Oncology
  • Centro Estatal de Cancerología
  • Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
  • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
  • Centro Oncologico America
  • Hospital Nacional Cayetano Heredia; Hematology - Oncology
  • Oncosalud Sac; Oncología
  • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
  • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
  • Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Oddział Chemioterapii
  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
  • Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie
  • Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon
  • IPO de Lisboa; Servico de Oncologia Medica
  • Centro Clinico Champalimaud; Oncologia Medica
  • IPO do Porto; Servico de Oncologia Medica
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Instituto Universitario Dexeus; Servicio de Oncología
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Institut Catala d Oncologia Hospital Duran i Reynals
  • Hospital San Pedro De Alcantara; Servicio de Oncologia
  • Hospital Provincial de Castellon; Servicio de Oncologia
  • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
  • Hospital Universitario de Fuenlabrada; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Hospital Clinico Universitario; Oncologia
  • Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
  • Fundación IVO
  • Kantonsspital Baden; Frauenklinik
  • Kantonsspital Graubünden;Onkologie und Hämatologie
  • Fondazione Oncologia Lago Maggiore
  • Royal Bournemouth General Hospital; Oncology
  • Frimley Park Hospital; Breast Resaerch Team
  • Beatson West of Scotland Cancer Centre
  • Christie Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Letrozole + Placebo

Letrozole + Taselisib

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).
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.
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).

Secondary Outcome Measures

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.
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).
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.
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.
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.
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.
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.
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.
Central Assessments of Changes in Ki67 Levels
Ki67 is a prognostic marker and is used to evaluate the proliferative activity of breast cancer.
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).
Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI
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.
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.
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.

Full Information

First Posted
October 22, 2014
Last Updated
April 20, 2018
Sponsor
Genentech, Inc.
Collaborators
SOLTI Breast Cancer Research Group, Breast International Group, Austrian Breast and Colorectal Cancer Group
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1. Study Identification

Unique Protocol Identification Number
NCT02273973
Brief Title
A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 12, 2014 (Actual)
Primary Completion Date
March 13, 2017 (Actual)
Study Completion Date
March 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
SOLTI Breast Cancer Research Group, Breast International Group, Austrian Breast and Colorectal Cancer Group

4. Oversight

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Letrozole + Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Letrozole + Taselisib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
Letrozole tablets will be administered orally at 2.5 mg QD for 16 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets matched to taselisib formulation will be administered orally daily on 5 days-on/2 days-off schedule for up to 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Taselisib
Other Intervention Name(s)
GDC-0032
Intervention Description
Taselisib will be administered orally at 4 mg (two 2 mg tablets) daily.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
From Baseline to 16 weeks
Title
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
Description
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).
Time Frame
From Baseline to 16 weeks
Title
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
Description
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.
Time Frame
From Baseline to 16 weeks
Title
Percentage of Participants With Total pCR , Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA MT Participants
Description
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).
Time Frame
From Baseline to 16 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in PIK3CA Wildtype (WT) Participants
Description
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.
Time Frame
From Baseline to 16 weeks
Title
Percentage of Participants With Total pCR Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA WT Participants
Description
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).
Time Frame
From Baseline to 16 weeks
Title
Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA MT Participants
Description
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.
Time Frame
From Baseline to 16 weeks
Title
Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA WT Participants
Description
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.
Time Frame
From Baseline to 16 weeks
Title
Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA MT Participants
Description
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.
Time Frame
From Baseline to 16 weeks
Title
Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA WT Participants
Description
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.
Time Frame
From Baseline to 16 weeks
Title
Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA MT Participants
Description
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.
Time Frame
From Baseline to 16 weeks
Title
Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA WT Participants
Description
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.
Time Frame
From Baseline to 16 weeks
Title
Central Assessments of Changes in Ki67 Levels
Description
Ki67 is a prognostic marker and is used to evaluate the proliferative activity of breast cancer.
Time Frame
From Baseline to Week 3 and Surgery (Weeks 17-18); and Week 3 to Surgery (Weeks 17-18)
Title
Preoperative Endocrine Prognostic Index (PEPI ) Score
Description
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).
Time Frame
Week 16
Title
Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI
Time Frame
From Baseline to Surgery (Weeks 17-18)
Title
Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)
Description
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.
Time Frame
Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery
Title
Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)
Description
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.
Time Frame
Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery
Title
Percentage of Participants With Adverse Events
Description
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.
Time Frame
Baseline up to 22 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Breastlink Med Group Inc
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
MGH Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
MSKCC at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
MSKCC @ Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
MSKCC @ West Harrison
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center; Hematology/Oncology
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
MSKC @ Rockville
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Kinghorn Cancer Centre; St Vincents Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Newcastle Mater Misericordiae Hospital; Oncology
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Victorian Breast and Oncology Care
City
East Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Cabrini Medical Centre; Oncology
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Ordensklinikum Linz Barmherzige Schwestern ; Abt. f. Allgemein- und Viszeralchirurgie
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Brustzentrum - Ordination Dr. Wette
City
St. Veit/Glan
ZIP/Postal Code
9300
Country
Austria
Facility Name
Klinikum Kreuzschwestern Wels; Iii. Interne Abt.
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Chirurgie - Abt. für Allgemeinchirurgie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
CHU Brugmann (Victor Horta)
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Clinique Ste-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Clinica de Neoplasias Litoral
City
Itajai
State/Province
SC
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia
City
São Paulo
State/Province
SP
ZIP/Postal Code
03102-002
Country
Brazil
Facility Name
Hospital Clinico Vina del Mar
City
Viña del Mar
ZIP/Postal Code
2520612
Country
Chile
Facility Name
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc; Onkologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
MULTISCAN, s.r.o., Radiologicke centrum Pardubice
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Oblastni nemocnice Pribram
City
Pribram
ZIP/Postal Code
261 01
Country
Czechia
Facility Name
Hospital Oncologia; Oncology
City
Salvador
ZIP/Postal Code
01101
Country
El Salvador
Facility Name
Centre Jean Perrin; Division De Recherche Clinique
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72015
Country
France
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Hopital Saint Louis; Service Onco Thoracique
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Rene Huguenin; ONCOLOGIE GENETIQUE
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
CHI de Toulon - Hôpital Sainte Musse
City
Toulon
ZIP/Postal Code
83056
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre-Les-Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Studienzentrum Berlin City
City
Berlin
ZIP/Postal Code
14169
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Bielefeld
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum
City
Gelsenkirchen
ZIP/Postal Code
45879
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Rotkreuzklinikum München; Frauenklinik
City
Muenchen
ZIP/Postal Code
80637
Country
Germany
Facility Name
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Marien-Hospital Witten; Frauenklinik Brustzentrum
City
Witten
ZIP/Postal Code
58452
Country
Germany
Facility Name
Grupo Angeles
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Centro Oncológico Sixtino / Centro Oncológico SA
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Szent Margit Hospital; Dept. of Oncology
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
B-A-Z County Hospital
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale degli Infermi
City
Rimini
State/Province
Emilia-Romagna
ZIP/Postal Code
47923
Country
Italy
Facility Name
Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
ASST DI CREMONA; Dip. Medicina - S.C. Oncologia
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
Facility Name
Ospedale Per Acuti Mater Salutis Di Legnago
City
Legnago
State/Province
Lombardia
ZIP/Postal Code
37045
Country
Italy
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
National Cancer Center; Medical Oncology
City
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital; Medical Oncology
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Centre; Division of Hematology/Oncology
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Centro Estatal de Cancerología
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
City
Distrito Federal
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Centro Oncologico America
City
Panama
ZIP/Postal Code
0834-02723
Country
Panama
Facility Name
Hospital Nacional Cayetano Heredia; Hematology - Oncology
City
Lima
ZIP/Postal Code
31
Country
Peru
Facility Name
Oncosalud Sac; Oncología
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Facility Name
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Oddział Chemioterapii
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
IPO de Lisboa; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Centro Clinico Champalimaud; Oncologia Medica
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Hospital Universitario Reina Sofia; Servicio de Oncologia
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Instituto Universitario Dexeus; Servicio de Oncología
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Institut Catala d Oncologia Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital San Pedro De Alcantara; Servicio de Oncologia
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Provincial de Castellon; Servicio de Oncologia
City
Castellon
ZIP/Postal Code
12002
Country
Spain
Facility Name
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
City
Lerida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28943
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario; Oncologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Fundación IVO
City
Valencia
ZIP/Postal Code
46980
Country
Spain
Facility Name
Kantonsspital Baden; Frauenklinik
City
Baden
ZIP/Postal Code
5405
Country
Switzerland
Facility Name
Kantonsspital Graubünden;Onkologie und Hämatologie
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Fondazione Oncologia Lago Maggiore
City
Locarno
ZIP/Postal Code
6600
Country
Switzerland
Facility Name
Royal Bournemouth General Hospital; Oncology
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Frimley Park Hospital; Breast Resaerch Team
City
Camberley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 3BG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32188717
Citation
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.
Results Reference
derived
PubMed Identifier
32079624
Citation
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.
Results Reference
derived
PubMed Identifier
31402321
Citation
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.
Results Reference
derived

Learn more about this trial

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

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