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A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy (SANDPIPER)

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Taselisib
Placebo
Fulvestrant
Sponsored by
Hoffmann-La Roche
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:

  • Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen receptor (ER) positive breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
  • Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer
  • Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an aromatase inhibitor (AI), or progression while on or within 1 month of the end of prior AI treatment for locally advanced or metastatic breast cancer
  • Measurable disease via Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) or non-measurable, evaluable disease with at least one evaluable bone lesion via RECIST v1.1
  • Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing
  • A valid cobas PIK3CA mutation result by central testing is required
  • Adequate hematologic and end-organ function within 28 days prior to treatment initiation

Exclusion Criteria:

  • Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization positive)
  • Prior treatment with fulvestrant
  • Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian target of rapamycin (mTOR) inhibitor (e.g. everolimus), or protein kinase B (AKT) inhibitor
  • Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1
  • Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1
  • All acute treatment-related toxicity must have resolved to Grade less than or equal to (</=) 1 or be deemed stable by the Investigator
  • Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer
  • Concurrent hormone replacement therapy
  • Known untreated or active central nervous system (CNS) metastases
  • Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications
  • History of inflammatory bowel disease or active bowel inflammation
  • Clinically significant cardiac or pulmonary dysfunction
  • Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B or C virus

Sites / Locations

  • Arizona Oncology
  • Arizona Oncology Associates, P.C.
  • Georgia Cancer Specialists - Northside
  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
  • Ingalls Hospital
  • Maryland Oncology Hematology
  • Dana Farber Can Ins
  • Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis
  • MSKCC at Basking Ridge
  • John Theurer Cancer Ctr at Hackensack Univ Medical Ctr
  • Memorial Sloan-Kettering; Cancer Center
  • Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Nassau
  • Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology
  • Pinnacle Health
  • Liverpool Hospital; Cancer Therapy Centre
  • Macquarie University Hospital
  • Newcastle Mater Misericordiae Hospital; Oncology
  • Mater Hospital; Oncology
  • Austin Hospital; Medical Oncology
  • Sunshine Hospital; Oncology Research
  • St John of God Murdoch Hospital; Oncology West
  • Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
  • Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
  • University Clinical Center of the Republic of Srpska
  • Clinic of Oncology, University Clinical Center Sarajevo
  • Complex Oncological Center - Plovdiv, EOOD
  • MHAT Nadezhda
  • SHATO - Sofia
  • SHATOD Dr. Marko Antonov Markov-Varna, EOOD
  • Cross Cancer Institute
  • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
  • Grand River Hospital
  • The Ottawa Hospital Cancer Centre; Oncology
  • Sunnybrook Health Science Centre
  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
  • Hospital Du Saint-Sacrement
  • the First Hospital of Jilin University
  • Jilin Cancer Hospital
  • Jiangsu Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Zhejiang Cancer Hospital
  • Clinica del Country
  • Oncomedica S.A.
  • University Hospital; Oncology and Radiotherapy
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Vseobecna fakultni nemocnice v Praze
  • KYS Sadesairaala; Syopatautien poliklinikka
  • Turku Uni Central Hospital; Oncology Clinics
  • Centre Jean Perrin; Hopital De Semaine
  • Centre Georges François Leclerc; Service Pharmacie, Bp 77980
  • Hopital Prive Drome Ardeche; Chir 2A 2B
  • CHD Vendée
  • Hopital Dupuytren; Oncologie Medicale
  • Institut régional du Cancer Montpellier
  • Institut Curie; Oncologie Medicale
  • Ch Lyon Sud; Onco Secteur Jules Courmont
  • Pole de Cancerologie Prive Strasbourgeois
  • Centre Alexis Vautrin; Oncologie Medicale
  • Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie
  • Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
  • Onkologische Schwerpunktpraxis Kurfürstendamm
  • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
  • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
  • Klinikum der Universität München; Frauenklinik - Onkologie II
  • Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I
  • Alexandras General Hospital of Athens; Oncology Department
  • IASO General Hospital of Athens
  • Univ General Hosp Heraklion; Medical Oncology
  • University Hospital of Patras Medical Oncology
  • Euromedical General Clinic of Thessaloniki; Oncology Department
  • Papageorgiou General Hospital; Medical Oncology
  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
  • ARCISPEDALE S. MARIA NUOVA - REGGIO EMILIA; Struttura Semplice Coordinamento Breast Unit Integrata
  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
  • Istituto Europeo Di Oncologia
  • Centro Catanese Di Oncologia; Oncologia Medica
  • Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
  • Azienda USL 9 Grosseto; Dipartimento Politiche del Farmaco
  • Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
  • AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica
  • Inje university Haeundae Paik Hospital
  • Chungbuk National University Hospital
  • National Cancer Center
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Ulsan University Hosiptal
  • Iem-Fucam
  • Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
  • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
  • Hospital San Jose Del Tec. de Monterrey; Oncology
  • Oaxaca Site Management Organization
  • Medisch Centrum Alkmaar
  • Ziekenhuis Rijnstate
  • Instituto Nacional de Enfermedades Neoplasicas
  • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
  • Oncocenter Peru S.A.C.; Oncosalud
  • Instituto Regional de Enfermedades Neoplasicas - IREN Norte
  • Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
  • Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
  • Przychodnia Lekarska KOMED, Roman Karaszewski
  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
  • Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
  • Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
  • Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
  • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
  • Wojewodzki Szpital Specjalistyczny; Osrodek Badawczo-Rozwojowy, Oddzial Chemioterapii
  • Hospital Garcia de Orta; Servico de Oncologia Medica
  • IPO de Lisboa; Servico de Oncologia Medica
  • Hospital da Luz; Departamento de Oncologia Medica
  • Hospital de Santa Maria; Servico de Oncologia Medica
  • IPO do Porto; Servico de Oncologia Medica
  • Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department
  • Prof. Dr. I. Chiricuta Institute of Oncology
  • Oncology Center Sf. Nectarie
  • Euroclinic Center of Oncology SRL
  • Moscow City Oncology Hospital #62
  • Regional Clinical Oncology Dispensary; Surgery Dept, Thoracic
  • Ivanovo Regional Oncology Dispensary
  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
  • State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
  • Institute for Onc/Rad Serbia
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
  • Hospital Universitario de Canarias;servicio de Oncologia
  • Hospital de Cruces; Servicio de Oncologia
  • Hospital Universitari Vall d'Hebron
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
  • Fundación IVO
  • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Uni Hospital Linkoeping; Dept. of Oncology
  • Sodersjukhuset; Onkologkliniken
  • Akademiska sjukhuset, Onkologkliniken
  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
  • VETERANS GENERAL HOSPITAL; Department of General Surgery
  • National Taiwan Uni Hospital; General Surgery
  • Mackay Memorial Hospital; Dept of Surgery
  • Department of Surgery, King Chulalongkorn Memorial Hospital
  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
  • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
  • Ege Uni Medical Faculty; Oncology Dept
  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Taselisib + Fulvestrant

Placebo + Fulvestrant

Arm Description

Participants received taselisib 4 milligrams (mg) taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.

Participants received placebo taken orally once daily (QD) beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by intramuscular (IM) injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis
PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis
PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.

Secondary Outcome Measures

Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis
PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).
Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis
PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).
Overall Survival (OS) at Primary Analysis
OS was defined as the time from the date of randomization to the date of death due to any cause.
OS at Final Analysis
OS was defined as the time from the date of randomization to the date of death due to any cause.
Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis
Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis
Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis
Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis
Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis
PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis
PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Percentage of Participants With Adverse Events at Primary Analysis
An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Percentage of Participants With Adverse Events at Final Analysis
An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Maximum Observed Plasma Concentration (Cmax) of Taselisib
Minimum Observed Plasma Concentration (Cmin) of Taselisib
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score
The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life [QoL]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of "the past week." Most questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent). Scores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms.
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to a 0-100 scale. Higher scores for the functional scales indicated a higher/better level of functioning/healthy functioning. Higher scores for the symptom scales indicated worse symptoms.

Full Information

First Posted
January 13, 2015
Last Updated
July 11, 2022
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02340221
Brief Title
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
Acronym
SANDPIPER
Official Title
A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
The Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability.
Study Start Date
April 9, 2015 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
June 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
631 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taselisib + Fulvestrant
Arm Type
Experimental
Arm Description
Participants received taselisib 4 milligrams (mg) taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Arm Title
Placebo + Fulvestrant
Arm Type
Placebo Comparator
Arm Description
Participants received placebo taken orally once daily (QD) beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by intramuscular (IM) injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Intervention Type
Drug
Intervention Name(s)
Taselisib
Other Intervention Name(s)
GDC-0032, RO5537381
Intervention Description
Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to taselisib was administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Other Intervention Name(s)
Faslodex
Intervention Description
Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis
Description
PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time Frame
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Title
PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis
Description
PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time Frame
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis
Description
PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).
Time Frame
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Title
Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis
Description
PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).
Time Frame
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Title
Overall Survival (OS) at Primary Analysis
Description
OS was defined as the time from the date of randomization to the date of death due to any cause.
Time Frame
From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Title
OS at Final Analysis
Description
OS was defined as the time from the date of randomization to the date of death due to any cause.
Time Frame
From randomization up to death from any cause (up to approximately 6.2 years)
Title
Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis
Description
Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time Frame
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Title
Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis
Description
Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time Frame
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Title
Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis
Description
Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time Frame
Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Title
Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis
Description
Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time Frame
Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Title
PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis
Description
PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time Frame
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Title
PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis
Description
PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Time Frame
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Title
Percentage of Participants With Adverse Events at Primary Analysis
Description
An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Time Frame
From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.
Title
Percentage of Participants With Adverse Events at Final Analysis
Description
An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Time Frame
From randomization up to approximately 6.2 years
Title
Maximum Observed Plasma Concentration (Cmax) of Taselisib
Time Frame
1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days)
Title
Minimum Observed Plasma Concentration (Cmin) of Taselisib
Time Frame
1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days)
Title
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score
Description
The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life [QoL]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of "the past week." Most questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent). Scores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms.
Time Frame
Baseline, C2D1 up to C7D1 (each cycle=28 days)
Title
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score
Description
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to a 0-100 scale. Higher scores for the functional scales indicated a higher/better level of functioning/healthy functioning. Higher scores for the symptom scales indicated worse symptoms.
Time Frame
Baseline, C2D1 up to C7D1 (each cycle=28 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen receptor (ER) positive breast cancer Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an aromatase inhibitor (AI), or progression while on or within 1 month of the end of prior AI treatment for locally advanced or metastatic breast cancer Measurable disease via Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) or non-measurable, evaluable disease with at least one evaluable bone lesion via RECIST v1.1 Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing A valid cobas PIK3CA mutation result by central testing is required Adequate hematologic and end-organ function within 28 days prior to treatment initiation Exclusion Criteria: Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization positive) Prior treatment with fulvestrant Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian target of rapamycin (mTOR) inhibitor (e.g. everolimus), or protein kinase B (AKT) inhibitor Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1 Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1 All acute treatment-related toxicity must have resolved to Grade less than or equal to (</=) 1 or be deemed stable by the Investigator Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer Concurrent hormone replacement therapy Known untreated or active central nervous system (CNS) metastases Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications History of inflammatory bowel disease or active bowel inflammation Clinically significant cardiac or pulmonary dysfunction Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B or C virus
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
Arizona Oncology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arizona Oncology Associates, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Georgia Cancer Specialists - Northside
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Ingalls Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Maryland Oncology Hematology
City
Rochville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Dana Farber Can Ins
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
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
John Theurer Cancer Ctr at Hackensack Univ Medical Ctr
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Memorial Sloan-Kettering; Cancer Center
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology
City
Beaverton
State/Province
Oregon
ZIP/Postal Code
97006
Country
United States
Facility Name
Pinnacle Health
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Liverpool Hospital; Cancer Therapy Centre
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Macquarie University Hospital
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Newcastle Mater Misericordiae Hospital; Oncology
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Mater Hospital; Oncology
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Austin Hospital; Medical Oncology
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Sunshine Hospital; Oncology Research
City
St Albans
State/Province
Victoria
Country
Australia
Facility Name
St John of God Murdoch Hospital; Oncology West
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
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. fur Innere Medizin 1
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
University Clinical Center of the Republic of Srpska
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Clinic of Oncology, University Clinical Center Sarajevo
City
Sarajevo
ZIP/Postal Code
7100
Country
Bosnia and Herzegovina
Facility Name
Complex Oncological Center - Plovdiv, EOOD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
MHAT Nadezhda
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
SHATO - Sofia
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
SHATOD Dr. Marko Antonov Markov-Varna, EOOD
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Grand River Hospital
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre; Oncology
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hospital Du Saint-Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
the First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
ZIP/Postal Code
132013
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing City
ZIP/Postal Code
211100
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Clinica del Country
City
Bogota
ZIP/Postal Code
11001
Country
Colombia
Facility Name
Oncomedica S.A.
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Facility Name
University Hospital; Oncology and Radiotherapy
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
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
KYS Sadesairaala; Syopatautien poliklinikka
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Turku Uni Central Hospital; Oncology Clinics
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Centre Jean Perrin; Hopital De Semaine
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Prive Drome Ardeche; Chir 2A 2B
City
Guilherand Granges
ZIP/Postal Code
07500
Country
France
Facility Name
CHD Vendée
City
La Roche Sur Yon
ZIP/Postal Code
85025
Country
France
Facility Name
Hopital Dupuytren; Oncologie Medicale
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Institut régional du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Ch Lyon Sud; Onco Secteur Jules Courmont
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Pole de Cancerologie Prive Strasbourgeois
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Alexis Vautrin; Oncologie Medicale
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Kurfürstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Facility Name
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
Facility Name
Klinikum der Universität München; Frauenklinik - Onkologie II
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I
City
Trier
ZIP/Postal Code
54290
Country
Germany
Facility Name
Alexandras General Hospital of Athens; Oncology Department
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
IASO General Hospital of Athens
City
Athens
ZIP/Postal Code
155 62
Country
Greece
Facility Name
Univ General Hosp Heraklion; Medical Oncology
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
University Hospital of Patras Medical Oncology
City
Patras
ZIP/Postal Code
265 04
Country
Greece
Facility Name
Euromedical General Clinic of Thessaloniki; Oncology Department
City
Thessaloniki
ZIP/Postal Code
546450
Country
Greece
Facility Name
Papageorgiou General Hospital; Medical Oncology
City
Thessaloniki
ZIP/Postal Code
564 29
Country
Greece
Facility Name
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
ARCISPEDALE S. MARIA NUOVA - REGGIO EMILIA; Struttura Semplice Coordinamento Breast Unit Integrata
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
Facility Name
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Europeo Di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Centro Catanese Di Oncologia; Oncologia Medica
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95126
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Azienda USL 9 Grosseto; Dipartimento Politiche del Farmaco
City
Grosseto
State/Province
Toscana
ZIP/Postal Code
58100
Country
Italy
Facility Name
Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
City
Pontedera
State/Province
Toscana
ZIP/Postal Code
56025
Country
Italy
Facility Name
AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica
City
Mestre
State/Province
Veneto
ZIP/Postal Code
30174
Country
Italy
Facility Name
Inje university Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Ulsan University Hosiptal
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Iem-Fucam
City
D.f.
ZIP/Postal Code
04980
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
Hospital San Jose Del Tec. de Monterrey; Oncology
City
Monterrey
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Oaxaca Site Management Organization
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Ziekenhuis Rijnstate
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Instituto Nacional de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
Lima 34
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
Oncocenter Peru S.A.C.; Oncosalud
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Facility Name
Instituto Regional de Enfermedades Neoplasicas - IREN Norte
City
Trujillo
ZIP/Postal Code
13014
Country
Peru
Facility Name
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Przychodnia Lekarska KOMED, Roman Karaszewski
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
City
Szczecin
ZIP/Postal Code
71-730
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny; Osrodek Badawczo-Rozwojowy, Oddzial Chemioterapii
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Hospital Garcia de Orta; Servico de Oncologia Medica
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
IPO de Lisboa; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Hospital da Luz; Departamento de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Hospital de Santa Maria; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Prof. Dr. I. Chiricuta Institute of Oncology
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Oncology Center Sf. Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Euroclinic Center of Oncology SRL
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Moscow City Oncology Hospital #62
City
Moscovskaya Oblast
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Regional Clinical Oncology Dispensary; Surgery Dept, Thoracic
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Institute for Onc/Rad Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
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
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario de Canarias;servicio de Oncologia
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital de Cruces; Servicio de Oncologia
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Fundación IVO
City
Valencia
ZIP/Postal Code
46980
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Uni Hospital Linkoeping; Dept. of Oncology
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Sodersjukhuset; Onkologkliniken
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Akademiska sjukhuset, Onkologkliniken
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
City
Taipei City
ZIP/Postal Code
11259
Country
Taiwan
Facility Name
VETERANS GENERAL HOSPITAL; Department of General Surgery
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; General Surgery
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Mackay Memorial Hospital; Dept of Surgery
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Department of Surgery, King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01230
Country
Turkey
Facility Name
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
City
Edirne
ZIP/Postal Code
22770
Country
Turkey
Facility Name
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
City
Istanbul
ZIP/Postal Code
34300
Country
Turkey
Facility Name
Ege Uni Medical Faculty; Oncology Dept
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Sihhiye/Ankara
ZIP/Postal Code
06230
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
33186740
Citation
Dent S, Cortes J, Im YH, Dieras V, Harbeck N, Krop IE, Wilson TR, Cui N, Schimmoller F, Hsu JY, He J, De Laurentiis M, Sousa S, Drullinsky P, Jacot W. Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial. Ann Oncol. 2021 Feb;32(2):197-207. doi: 10.1016/j.annonc.2020.10.596. Epub 2020 Nov 10.
Results Reference
derived

Learn more about this trial

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

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