AzTrials
AzTrials

Breast CancerPhase 3SANDPIPERNCT02340221

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

A Phase 3 study testing Taselisib and Fulvestrant in people with Breast Cancer, run by Hoffmann-La Roche at 157 sites in 28 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Taselisib and Fulvestrant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
631 participants
Where
157 sitesin 28 countries
Study dates
9 Apr 2015to 29 Jun 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

157 sites in 28 countries.

157 sites in 28 countries

United States16 sites

  • Georgia Cancer Specialists - Northside

    Atlanta, Georgia, 30341

  • MSKCC at Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology

    Beaverton, Oregon, 97006

  • Dana Farber Can Ins

    Boston, Massachusetts, 02215

  • Memorial Sloan-Kettering; Cancer Center

    Commack, New York, 11725

  • John Theurer Cancer Ctr at Hackensack Univ Medical Ctr

    Hackensack, New Jersey, 07601

  • Pinnacle Health

    Harrisburg, Pennsylvania, 17110

  • Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester

    Harrison, New York, 10604

  • Ingalls Hospital

    Harvey, Illinois, 60426

  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

    Marietta, Georgia, 30060

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Maryland Oncology Hematology

    Rochville, Maryland, 20850

  • Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis

    St Louis, Missouri, 63141

  • Arizona Oncology

    Tucson, Arizona, 85704

  • Arizona Oncology Associates, P.C.

    Tucson, Arizona, 85710

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

Spain11 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología

    Barcelona, 08036

  • Hospital de Cruces; Servicio de Oncologia

    Bilbao, Vizcaya, 48903

  • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

    Madrid, 28033

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia

    Majadahonda, Madrid, 28222

  • Hospital Universitario de Canarias;servicio de Oncologia

    San Cristóbal de La Laguna, Tenerife, 38320

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

    Santiago de Compostela, LA Coruña, 15706

  • Fundación IVO

    Valencia, 46980

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009

Other trials in Spain

France10 sites

  • Centre Jean Perrin; Hopital De Semaine

    Clermont-Ferrand, 63011

  • Centre Georges François Leclerc; Service Pharmacie, Bp 77980

    Dijon, 21000

  • Hopital Prive Drome Ardeche; Chir 2A 2B

    Guilherand-Granges, 07500

  • CHD Vendée

    La Roche-sur-Yon, 85025

  • Hopital Dupuytren; Oncologie Medicale

    Limoges, 87042

  • Institut régional du Cancer Montpellier

    Montpellier, 34298

  • Institut Curie; Oncologie Medicale

    Paris, 75231

  • Ch Lyon Sud; Onco Secteur Jules Courmont

    Pierre-Bénite, 69495

  • Pole de Cancerologie Prive Strasbourgeois

    Strasbourg, 67000

  • Centre Alexis Vautrin; Oncologie Medicale

    Vandœuvre-lès-Nancy, 54519

Other trials in France

Italy10 sites

  • Centro Catanese Di Oncologia; Oncologia Medica

    Catania, Sicily, 95126

  • Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

    Florence, Tuscany, 50134

  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

    Genoa, Liguria, 16132

  • Azienda USL 9 Grosseto; Dipartimento Politiche del Farmaco

    Grosseto, Tuscany, 58100

  • AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica

    Mestre, Veneto, 30174

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

    Naples, Campania, 80131

  • Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

    Pontedera, Tuscany, 56025

  • ARCISPEDALE S. MARIA NUOVA - REGGIO EMILIA; Struttura Semplice Coordinamento Breast Unit Integrata

    Reggio Emilia, Emilia-Romagna, 42100

  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Poland10 sites

  • Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

    Bialystok, 15-027

  • Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii

    Bydgoszcz, 85-796

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-214

  • Przychodnia Lekarska KOMED, Roman Karaszewski

    Konin, 62-500

  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

    Krakow, 30-688

  • Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii

    Lodz, 93-513

  • Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

    Lublin, 20-090

  • Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

    Szczecin, 71-730

  • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

    Warsaw, 02-781

  • Wojewodzki Szpital Specjalistyczny; Osrodek Badawczo-Rozwojowy, Oddzial Chemioterapii

    Wroclaw, 51-124

Other trials in Poland

South Korea9 sites

  • Inje university Haeundae Paik Hospital

    Busan, 48108

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • National Cancer Center

    Goyang-si, 10408

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Ulsan University Hosiptal

    Ulsan, 44033

Other trials in South Korea

Australia7 sites

  • Mater Hospital; Oncology

    Brisbane, Queensland, 4101

  • Austin Hospital; Medical Oncology

    Heidelberg, Victoria, 3084

  • Liverpool Hospital; Cancer Therapy Centre

    Liverpool, New South Wales, 2170

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2109

  • St John of God Murdoch Hospital; Oncology West

    Murdoch, Western Australia, 6150

  • Sunshine Hospital; Oncology Research

    St Albans, Victoria

  • Newcastle Mater Misericordiae Hospital; Oncology

    Waratah, New South Wales, 2298

Other trials in Australia

Canada7 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Grand River Hospital

    Kitchener, Ontario, N2G 1G3

  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

    Montreal, Quebec, H3T 1E2

  • The Ottawa Hospital Cancer Centre; Oncology

    Ottawa, Ontario, K1H 8L6

  • Hospital Du Saint-Sacrement

    Québec, Quebec, G1S 4L8

  • Sunnybrook Health Science Centre

    Toronto, Ontario, M4N 3M5

  • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Germany7 sites

  • Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie

    Bad Nauheim, 61231

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

    Berlin, 10367

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707

  • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

    Essen, 45122

  • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

    Hamburg, 20357

  • Klinikum der Universität München; Frauenklinik - Onkologie II

    München, 80337

  • Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I

    Trier, 54290

Other trials in Germany

Greece6 sites

  • Alexandras General Hospital of Athens; Oncology Department

    Athens, 115 28

  • IASO General Hospital of Athens

    Athens, 155 62

  • Univ General Hosp Heraklion; Medical Oncology

    Heraklion, 711 10

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

  • Euromedical General Clinic of Thessaloniki; Oncology Department

    Thessaloniki, 546450

  • Papageorgiou General Hospital; Medical Oncology

    Thessaloniki, 564 29

Other trials in Greece

Russia6 sites

  • Regional Clinical Oncology Dispensary; Surgery Dept, Thoracic

    Arkhangelsk, 163045

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan

    Kazan', 420029

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

    Orenburg, 460021

  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

    Saint Petersburg, 197758

Other trials in Russia

China5 sites

  • the First Hospital of Jilin University

    Changchun, 130021

  • Jilin Cancer Hospital

    Changchun, 132013

  • Jiangsu Cancer Hospital

    Nanjing, 211100

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

Other trials in China

Mexico5 sites

  • Iem-Fucam

    D.F., 04980

  • Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

    Distrito Federal, 14000

  • Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

    Mexico City, 03100

  • Hospital San Jose Del Tec. de Monterrey; Oncology

    Monterrey, 64020

  • Oaxaca Site Management Organization

    Oaxaca City, 68000

Other trials in Mexico

Portugal5 sites

  • Hospital Garcia de Orta; Servico de Oncologia Medica

    Almada, 2801-951

  • IPO de Lisboa; Servico de Oncologia Medica

    Lisbon, 1099-023

  • Hospital da Luz; Departamento de Oncologia Medica

    Lisbon, 1500-650

  • Hospital de Santa Maria; Servico de Oncologia Medica

    Lisbon, 1649-035

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Turkey (Türkiye)5 sites

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

    Adana, 01230

  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

    Edirne, 22770

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

    Istanbul, 34300

  • Ege Uni Medical Faculty; Oncology Dept

    Izmir, 35100

  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

    Sihhiye/Ankara, 06230

Other trials in Turkey (Türkiye)

Austria4 sites

  • Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

    Graz, 8036

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

    Innsbruck, 6020

  • Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

    Linz, 4010

  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

    Vienna, 1090

Other trials in Austria

Bulgaria4 sites

  • Complex Oncological Center - Plovdiv, EOOD

    Plovdiv, 4004

  • MHAT Nadezhda

    Sofia, 1330

  • SHATO - Sofia

    Sofia, 1756

  • SHATOD Dr. Marko Antonov Markov-Varna, EOOD

    Varna, 9010

Other trials in Bulgaria

Peru4 sites

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34

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

    Lima, Lima 41

  • Oncocenter Peru S.A.C.; Oncosalud

    Lima, Lima 41

  • Instituto Regional de Enfermedades Neoplasicas - IREN Norte

    Trujillo, 13014

Other trials in Peru

Romania4 sites

  • Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

    Bucharest, 022328

  • Prof. Dr. I. Chiricuta Institute of Oncology

    Cluj-Napoca, 400015

  • Oncology Center Sf. Nectarie

    Craiova, 200347

  • Euroclinic Center of Oncology SRL

    Iași, 700106

Other trials in Romania

Taiwan4 sites

  • VETERANS GENERAL HOSPITAL; Department of General Surgery

    Taipei, 00112

  • National Taiwan Uni Hospital; General Surgery

    Taipei, 100

  • Mackay Memorial Hospital; Dept of Surgery

    Taipei, 104

  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

    Taipei, 11259

Other trials in Taiwan

Czechia3 sites

  • University Hospital; Oncology and Radiotherapy

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc; Onkologicka klinika

    Olomouc, 779 00

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Sweden3 sites

  • Uni Hospital Linkoeping; Dept. of Oncology

    Linköping, 58185

  • Sodersjukhuset; Onkologkliniken

    Stockholm, 118 83

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 751 85

Other trials in Sweden

Thailand3 sites

  • Department of Surgery, King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

    Bangkok, 10400

  • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

    Chiang Mai, 50200

Other trials in Thailand

Bosnia and Herzegovina2 sites

  • University Clinical Center of the Republic of Srpska

    Banja Luka, 78000

  • Clinic of Oncology, University Clinical Center Sarajevo

    Sarajevo, 7100

Other trials in Bosnia and Herzegovina

Colombia2 sites

  • Clinica del Country

    Bogotá, 11001

  • Oncomedica S.A.

    Montería, 230002

Other trials in Colombia

Finland2 sites

  • KYS Sadesairaala; Syopatautien poliklinikka

    Kuopio, 70210

  • Turku Uni Central Hospital; Oncology Clinics

    Turku, 20520

Other trials in Finland

Netherlands2 sites

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD

  • Ziekenhuis Rijnstate

    Arnhem, 6815 AD

Other trials in Netherlands

Serbia1 site

  • Institute for Onc/Rad Serbia

    Belgrade, 11000

Other trials in Serbia

About this study

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

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.

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

What participants receive

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

  • TaselisibDrug

    Also called GDC-0032, RO5537381

    Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm.

  • PlaceboDrug

    Placebo matching to taselisib was administered as per the schedule specified in the respective arm.

  • FulvestrantDrug

    Also called Faslodex

    Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.

Study groups in NCT02340221
Study groupRoleWhat they receive
Taselisib + FulvestrantExperimentalParticipants 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.
Receives: Drug: Taselisib; Drug: Fulvestrant
Placebo + FulvestrantPlacebo comparatorParticipants 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.
Receives: Drug: Placebo; Drug: Fulvestrant

What is being measured

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

  1. 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.

    Measured: 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)

  2. 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.

    Measured: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)

Secondary outcomes (16)

  1. 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).

    Measured: 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)

  2. 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).

    Measured: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)

  3. 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.

    Measured: From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)

  4. OS at Final Analysis

    OS was defined as the time from the date of randomization to the date of death due to any cause.

    Measured: From randomization up to death from any cause (up to approximately 6.2 years)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)

  7. 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.

    Measured: 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)

  8. 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.

    Measured: 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)

  9. 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.

    Measured: 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)

  10. 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.

    Measured: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)

  11. 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.

    Measured: From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.

  12. 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.

    Measured: From randomization up to approximately 6.2 years

  13. Maximum Observed Plasma Concentration (Cmax) of Taselisib

    Measured: 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)

  14. Minimum Observed Plasma Concentration (Cmin) of Taselisib

    Measured: 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)

  15. 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.

    Measured: Baseline, C2D1 up to C7D1 (each cycle=28 days)

  16. 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.

    Measured: Baseline, C2D1 up to C7D1 (each cycle=28 days)

Timeline

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

  1. First posted16 Jan 2015 (estimated)
  2. Study start9 Apr 2015
  3. Primary completion29 Jun 2021
  4. Study completion29 Jun 2021

Why it stopped: The Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability.

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
631 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02340221
Sponsor's protocol ID
GO29058
Other IDs
2014-003185-25, 2014
Acronym
SANDPIPER
Status last verified
Jul 2022
First submitted
13 Jan 2015
Last updated
12 Jul 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Moein A, Jin JY, Wright MR, Wong H. Quantitative characterization of the effects of fulvestrant alone or in combination with taselisib (PI3Kinase inhibitor) on longitudinal tumor growth in patients with estrogen receptor-positive, HER2-negative, PIK3CA-mutant, advanced or metastatic breast cancer. Cancer Chemother Pharmacol. 2024 Sep;94(3):421-436. doi: 10.1007/s00280-024-04690-4. Epub 2024 Jun 27.

    PubMed 38937298

  • 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.

    PubMed 33186740

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Taselisib and Fulvestrant in people with Breast Cancer, run by Hoffmann-La Roche at 157 sites in 28 countries.

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

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in United States, Spain, France, Italy, Poland and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02340221, which also lists 2 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.

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