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)

July 11, 2022 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

631

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital; Cancer Therapy Centre
      • Macquarie Park, New South Wales, Australia, 2109
        • Macquarie University Hospital
      • Waratah, New South Wales, Australia, 2298
        • Newcastle Mater Misericordiae Hospital; Oncology
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Mater Hospital; Oncology
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital; Medical Oncology
      • St Albans, Victoria, Australia
        • Sunshine Hospital; Oncology Research
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • St John of God Murdoch Hospital; Oncology West
      • Graz, Austria, 8036
        • Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
      • Innsbruck, Austria, 6020
        • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
      • Linz, Austria, 4010
        • Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
      • Wien, Austria, 1090
        • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
      • Banja Luka, Bosnia and Herzegovina, 78000
        • University clinical center of the Republic of Srpska
      • Sarajevo, Bosnia and Herzegovina, 7100
        • Clinic of Oncology, University Clinical Center Sarajevo
      • Plovdiv, Bulgaria, 4004
        • Complex Oncological Center - Plovdiv, EOOD
      • Sofia, Bulgaria, 1756
        • SHATO - Sofia
      • Sofia, Bulgaria, 1330
        • MHAT Nadezhda
      • Varna, Bulgaria, 9010
        • SHATOD Dr. Marko Antonov Markov-Varna, EOOD
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre; Oncology
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Science Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
      • Quebec City, Quebec, Canada, G1S 4L8
        • Hospital Du Saint-Sacrement
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Changchun, China, 132013
        • Jilin Cancer Hospital
      • Nanjing City, China, 211100
        • Jiangsu Cancer Hospital
      • Shanghai City, China, 200120
        • Fudan University Shanghai Cancer Center
      • Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Bogota, Colombia, 11001
        • Clinica del Country
      • Monteria, Colombia, 230002
        • Oncomedica S.A.
      • Hradec Kralove, Czechia, 500 05
        • University Hospital; Oncology and Radiotherapy
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc; Onkologicka klinika
      • Praha 2, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
      • Kuopio, Finland, 70210
        • KYS Sadesairaala; Syopatautien poliklinikka
      • Turku, Finland, 20520
        • Turku Uni Central Hospital; Oncology Clinics
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin; Hopital De Semaine
      • Dijon, France, 21000
        • Centre Georges François Leclerc; Service Pharmacie, Bp 77980
      • Guilherand Granges, France, 07500
        • Hopital Prive Drome Ardeche; Chir 2A 2B
      • La Roche Sur Yon, France, 85025
        • CHD Vendée
      • Limoges, France, 87042
        • Hopital Dupuytren; Oncologie Medicale
      • Montpellier, France, 34298
        • Institut regional du Cancer Montpellier
      • Paris, France, 75231
        • Institut Curie; Oncologie Medicale
      • Pierre Benite, France, 69495
        • Ch Lyon Sud; Onco Secteur Jules Courmont
      • Strasbourg, France, 67000
        • Pole de Cancerologie Prive Strasbourgeois
      • Vandoeuvre-les-nancy, France, 54519
        • Centre Alexis Vautrin; Oncologie Medicale
      • Bad Nauheim, Germany, 61231
        • Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie
      • Berlin, Germany, 10707
        • Onkologische Schwerpunktpraxis Kurfürstendamm
      • Berlin, Germany, 10367
        • Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
      • Essen, Germany, 45122
        • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
      • Hamburg, Germany, 20357
        • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
      • München, Germany, 80337
        • Klinikum der Universität München; Frauenklinik - Onkologie II
      • Trier, Germany, 54290
        • Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I
      • Athens, Greece, 155 62
        • IASO General Hospital of Athens
      • Athens, Greece, 115 28
        • Alexandras General Hospital of Athens; Oncology Department
      • Heraklion, Greece, 711 10
        • Univ General Hosp Heraklion; Medical Oncology
      • Patras, Greece, 265 04
        • University Hospital of Patras Medical Oncology
      • Thessaloniki, Greece, 564 29
        • Papageorgiou General Hospital; Medical Oncology
      • Thessaloniki, Greece, 546450
        • Euromedical General Clinic of Thessaloniki; Oncology Department
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
    • Emilia-Romagna
      • Reggio Emilia, Emilia-Romagna, Italy, 42100
        • ARCISPEDALE S. MARIA NUOVA - REGGIO EMILIA; Struttura Semplice Coordinamento Breast Unit Integrata
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy, 33100
        • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
    • Liguria
      • Genova, Liguria, Italy, 16132
        • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
    • Lombardia
      • Milano, Lombardia, Italy, 20141
        • Istituto Europeo di Oncologia
    • Sicilia
      • Catania, Sicilia, Italy, 95126
        • Centro Catanese Di Oncologia; Oncologia Medica
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
      • Grosseto, Toscana, Italy, 58100
        • Azienda USL 9 Grosseto; Dipartimento Politiche del Farmaco
      • Pontedera, Toscana, Italy, 56025
        • Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
    • Veneto
      • Mestre, Veneto, Italy, 30174
        • AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Cheongju-si, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Goyang-si, Korea, Republic of, 10408
        • National Cancer Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hosiptal
      • D.f., Mexico, 04980
        • Iem-Fucam
      • Distrito Federal, Mexico, 14000
        • Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
      • Mexico City, Mexico, 03100
        • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
      • Monterrey, Mexico, 64020
        • Hospital San Jose Del Tec. de Monterrey; Oncology
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization
      • Alkmaar, Netherlands, 1815 JD
        • Medisch Centrum Alkmaar
      • Arnhem, Netherlands, 6815 AD
        • Ziekenhuis Rijnstate
      • Lima, Peru, Lima 41
        • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
      • Lima, Peru, Lima 34
        • Instituto Nacional de Enfermedades Neoplasicas
      • Lima, Peru, Lima 41
        • Oncocenter Peru S.A.C.; Oncosalud
      • Trujillo, Peru, 13014
        • Instituto Regional de Enfermedades Neoplasicas - IREN Norte
      • Bialystok, Poland, 15-027
        • Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
      • Bydgoszcz, Poland, 85-796
        • Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
      • Konin, Poland, 62-500
        • Przychodnia Lekarska KOMED, Roman Karaszewski
      • Kraków, Poland, 30-688
        • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
      • Lodz, Poland, 93-513
        • Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
      • Szczecin, Poland, 71-730
        • Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
      • Warszawa, Poland, 02-781
        • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
      • Wroclaw, Poland, 51-124
        • Wojewodzki Szpital Specjalistyczny; Osrodek Badawczo-Rozwojowy, Oddzial Chemioterapii
      • Almada, Portugal, 2801-951
        • Hospital Garcia de Orta; Servico de Oncologia Medica
      • Lisboa, Portugal, 1099-023
        • IPO de Lisboa; Servico de Oncologia Medica
      • Lisboa, Portugal, 1500-650
        • Hospital da Luz; Departamento de Oncologia Medica
      • Lisboa, Portugal, 1649-035
        • Hospital de Santa Maria; Servico de Oncologia Medica
      • Porto, Portugal, 4200-072
        • IPO do Porto; Servico de Oncologia Medica
      • Bucuresti, Romania, 022328
        • Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department
      • Cluj Napoca, Romania, 400015
        • Prof. Dr. I. Chiricuta Institute of Oncology
      • Craiova, Romania, 200347
        • Oncology Center Sf. Nectarie
      • Iasi, Romania, 700106
        • Euroclinic Center of Oncology SRL
      • Arkhangelsk, Russian Federation, 163045
        • Regional Clinical Oncology Dispensary; Surgery Dept, Thoracic
      • Ivanovo, Russian Federation, 153040
        • Ivanovo Regional Oncology Dispensary
      • Kazan, Russian Federation, 420029
        • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
      • Orenburg, Russian Federation, 460021
        • State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
      • Saint-Petersburg, Russian Federation, 197758
        • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
    • Moskovskaja Oblast
      • Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
        • Moscow City Oncology Hospital #62
      • Belgrade, Serbia, 11000
        • Institute for Onc/Rad Serbia
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebrón
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal; Servicio de Oncologia
      • Madrid, Spain, 28050
        • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
      • Madrid, Spain, 28033
        • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
      • Valencia, Spain, 46980
        • Fundación IVO
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet; Servicio Oncologia
    • LA Coruña
      • Santiago de Compostela, LA Coruña, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias;servicio de Oncologia
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48903
        • Hospital de Cruces; Servicio de Oncologia
      • Linköping, Sweden, 58185
        • Uni Hospital Linkoeping; Dept. of Oncology
      • Stockholm, Sweden, 118 83
        • Sodersjukhuset; Onkologkliniken
      • Uppsala, Sweden, 751 85
        • Akademiska sjukhuset, Onkologkliniken
      • Taipei, Taiwan, 00112
        • VETERANS GENERAL HOSPITAL; Department of General Surgery
      • Taipei, Taiwan, 100
        • National Taiwan Uni Hospital; General Surgery
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital; Dept of Surgery
      • Taipei City, Taiwan, 11259
        • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
      • Bangkok, Thailand, 10330
        • Department of Surgery, King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
      • Adana, Turkey, 01230
        • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
      • Edirne, Turkey, 22770
        • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
      • Istanbul, Turkey, 34300
        • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
      • Izmir, Turkey, 35100
        • Ege Uni Medical Faculty; Oncology Dept
      • Sihhiye/Ankara, Turkey, 06230
        • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology
      • Tucson, Arizona, United States, 85710
        • Arizona Oncology Associates, P.C.
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Georgia Cancer Specialists - Northside
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Ingalls Hospital
    • Maryland
      • Rochville, Maryland, United States, 20850
        • Maryland Oncology Hematology
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Can Ins
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • MSKCC at Basking Ridge
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Ctr at Hackensack Univ Medical Ctr
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan-Kettering; Cancer Center
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau
    • Oregon
      • Beaverton, Oregon, United States, 97006
        • Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Pinnacle Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Taselisib + Fulvestrant
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.
Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm.
Other Names:
  • GDC-0032, RO5537381
Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.
Other Names:
  • Faslodex
Placebo Comparator: Placebo + Fulvestrant
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.
Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.
Other Names:
  • Faslodex
Placebo matching to taselisib was administered as per the schedule specified in the respective arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis
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)
PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis
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)
PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)

Secondary Outcome Measures

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

Collaborators and Investigators

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Publications and helpful links

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2015

Primary Completion (Actual)

June 29, 2021

Study Completion (Actual)

June 29, 2021

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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