Study Stopped
The Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability.
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
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
2 other identifiers
interventional
631
26 countries
152
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Apr 2015
Typical duration for phase_3 breast-cancer
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2015
CompletedFirst Posted
Study publicly available on registry
January 16, 2015
CompletedStudy Start
First participant enrolled
April 9, 2015
CompletedResults Posted
Study results publicly available
January 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2021
CompletedJuly 12, 2022
July 1, 2022
6.2 years
January 13, 2015
December 18, 2018
July 11, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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
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 Outcomes (16)
Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis
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
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
From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
OS at Final Analysis
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
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)
- +11 more secondary outcomes
Study Arms (2)
Taselisib + Fulvestrant
EXPERIMENTALParticipants 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.
Placebo + Fulvestrant
PLACEBO 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.
Interventions
Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm.
Placebo matching to taselisib was administered as per the schedule specified in the respective arm.
Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (157)
Arizona Oncology
Tucson, Arizona, 85704, United States
Arizona Oncology Associates, P.C.
Tucson, Arizona, 85710, United States
Georgia Cancer Specialists - Northside
Atlanta, Georgia, 30341, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Marietta, Georgia, 30060, United States
Ingalls Hospital
Harvey, Illinois, 60426, United States
Maryland Oncology Hematology
Rochville, Maryland, 20850, United States
Dana Farber Can Ins
Boston, Massachusetts, 02215, United States
Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
MSKCC at Basking Ridge
Basking Ridge, New Jersey, 07920, United States
John Theurer Cancer Ctr at Hackensack Univ Medical Ctr
Hackensack, New Jersey, 07601, United States
Memorial Sloan-Kettering; Cancer Center
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology
Beaverton, Oregon, 97006, United States
Pinnacle Health
Harrisburg, Pennsylvania, 17110, United States
Liverpool Hospital; Cancer Therapy Centre
Liverpool, New South Wales, 2170, Australia
Macquarie University Hospital
Macquarie Park, New South Wales, 2109, Australia
Newcastle Mater Misericordiae Hospital; Oncology
Waratah, New South Wales, 2298, Australia
Mater Hospital; Oncology
Brisbane, Queensland, 4101, Australia
Austin Hospital; Medical Oncology
Heidelberg, Victoria, 3084, Australia
Sunshine Hospital; Oncology Research
St Albans, Victoria, Australia
St John of God Murdoch Hospital; Oncology West
Murdoch, Western Australia, 6150, Australia
Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
Graz, 8036, Austria
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
Innsbruck, 6020, Austria
Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
Linz, 4010, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
Vienna, 1090, Austria
University Clinical Center of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
Clinic of Oncology, University Clinical Center Sarajevo
Sarajevo, 7100, Bosnia and Herzegovina
Complex Oncological Center - Plovdiv, EOOD
Plovdiv, 4004, Bulgaria
MHAT Nadezhda
Sofia, 1330, Bulgaria
SHATO - Sofia
Sofia, 1756, Bulgaria
SHATOD Dr. Marko Antonov Markov-Varna, EOOD
Varna, 9010, Bulgaria
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Grand River Hospital
Kitchener, Ontario, N2G 1G3, Canada
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, H3T 1E2, Canada
Hospital Du Saint-Sacrement
Québec, Quebec, G1S 4L8, Canada
the First Hospital of Jilin University
Changchun, 130021, China
Jilin Cancer Hospital
Changchun, 132013, China
Jiangsu Cancer Hospital
Nanjing, 211100, China
Fudan University Shanghai Cancer Center
Shanghai, 200120, China
Zhejiang Cancer Hospital
Zhejiang, 310022, China
Clinica del Country
Bogotá, 11001, Colombia
Oncomedica S.A.
Montería, 230002, Colombia
University Hospital; Oncology and Radiotherapy
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
KYS Sadesairaala; Syopatautien poliklinikka
Kuopio, 70210, Finland
Turku Uni Central Hospital; Oncology Clinics
Turku, 20520, Finland
Centre Jean Perrin; Hopital De Semaine
Clermont-Ferrand, 63011, France
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
Dijon, 21000, France
Hopital Prive Drome Ardeche; Chir 2A 2B
Guilherand-Granges, 07500, France
CHD Vendée
La Roche-sur-Yon, 85025, France
Hopital Dupuytren; Oncologie Medicale
Limoges, 87042, France
Institut régional du Cancer Montpellier
Montpellier, 34298, France
Institut Curie; Oncologie Medicale
Paris, 75231, France
Ch Lyon Sud; Onco Secteur Jules Courmont
Pierre-Bénite, 69495, France
Pole de Cancerologie Prive Strasbourgeois
Strasbourg, 67000, France
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, 54519, France
Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie
Bad Nauheim, 61231, Germany
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
Berlin, 10367, Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, 10707, Germany
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
Essen, 45122, Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg, 20357, Germany
Klinikum der Universität München; Frauenklinik - Onkologie II
München, 80337, Germany
Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I
Trier, 54290, Germany
Alexandras General Hospital of Athens; Oncology Department
Athens, 115 28, Greece
IASO General Hospital of Athens
Athens, 155 62, Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion, 711 10, Greece
University Hospital of Patras Medical Oncology
Pátrai, 265 04, Greece
Euromedical General Clinic of Thessaloniki; Oncology Department
Thessaloniki, 546450, Greece
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, 564 29, Greece
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
Napoli, Campania, 80131, Italy
ARCISPEDALE S. MARIA NUOVA - REGGIO EMILIA; Struttura Semplice Coordinamento Breast Unit Integrata
Reggio Emilia, Emilia-Romagna, 42100, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
Udine, Friuli Venezia Giulia, 33100, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genoa, Liguria, 16132, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, 20141, Italy
Centro Catanese Di Oncologia; Oncologia Medica
Catania, Sicily, 95126, Italy
Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
Florence, Tuscany, 50134, Italy
Azienda USL 9 Grosseto; Dipartimento Politiche del Farmaco
Grosseto, Tuscany, 58100, Italy
Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
Pontedera, Tuscany, 56025, Italy
AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica
Mestre, Veneto, 30174, Italy
Iem-Fucam
D.F., 04980, Mexico
Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
Distrito Federal, 14000, Mexico
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
Mexico City, 03100, Mexico
Hospital San Jose Del Tec. de Monterrey; Oncology
Monterrey, 64020, Mexico
Oaxaca Site Management Organization
Oaxaca City, 68000, Mexico
Medisch Centrum Alkmaar
Alkmaar, 1815 JD, Netherlands
Ziekenhuis Rijnstate
Arnhem, 6815 AD, Netherlands
Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima 34, Peru
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima, Lima 41, Peru
Oncocenter Peru S.A.C.; Oncosalud
Lima, Lima 41, Peru
Instituto Regional de Enfermedades Neoplasicas - IREN Norte
Trujillo, 13014, Peru
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
Bialystok, 15-027, Poland
Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
Bydgoszcz, 85-796, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, 80-214, Poland
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, 62-500, Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, 30-688, Poland
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
Lodz, 93-513, Poland
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
Lublin, 20-090, Poland
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
Szczecin, 71-730, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warsaw, 02-781, Poland
Wojewodzki Szpital Specjalistyczny; Osrodek Badawczo-Rozwojowy, Oddzial Chemioterapii
Wroclaw, 51-124, Poland
Hospital Garcia de Orta; Servico de Oncologia Medica
Almada, 2801-951, Portugal
IPO de Lisboa; Servico de Oncologia Medica
Lisbon, 1099-023, Portugal
Hospital da Luz; Departamento de Oncologia Medica
Lisbon, 1500-650, Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisbon, 1649-035, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072, Portugal
Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department
Bucharest, 022328, Romania
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, 400015, Romania
Oncology Center Sf. Nectarie
Craiova, 200347, Romania
Euroclinic Center of Oncology SRL
Iași, 700106, Romania
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, 143423, Russia
Regional Clinical Oncology Dispensary; Surgery Dept, Thoracic
Arkhangelsk, 163045, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040, Russia
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan', 420029, Russia
State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
Orenburg, 460021, Russia
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint Petersburg, 197758, Russia
Institute for Onc/Rad Serbia
Belgrade, 11000, Serbia
Inje university Haeundae Paik Hospital
Busan, 48108, South Korea
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Ulsan University Hosiptal
Ulsan, 44033, South Korea
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, 15706, Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Majadahonda, Madrid, 28222, Spain
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Hospital de Cruces; Servicio de Oncologia
Bilbao, Vizcaya, 48903, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036, Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid, 28033, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034, Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid, 28050, Spain
Fundación IVO
Valencia, 46980, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, 50009, Spain
Uni Hospital Linkoeping; Dept. of Oncology
Linköping, 58185, Sweden
Sodersjukhuset; Onkologkliniken
Stockholm, 118 83, Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, 751 85, Sweden
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei, 00112, Taiwan
National Taiwan Uni Hospital; General Surgery
Taipei, 100, Taiwan
Mackay Memorial Hospital; Dept of Surgery
Taipei, 104, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei, 11259, Taiwan
Department of Surgery, King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, 10400, Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
Chiang Mai, 50200, Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, 01230, Turkey (Türkiye)
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, 22770, Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, 34300, Turkey (Türkiye)
Ege Uni Medical Faculty; Oncology Dept
Izmir, 35100, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sihhiye/Ankara, 06230, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 38937298DERIVEDDent 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.
PMID: 33186740DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2015
First Posted
January 16, 2015
Study Start
April 9, 2015
Primary Completion
June 29, 2021
Study Completion
June 29, 2021
Last Updated
July 12, 2022
Results First Posted
January 25, 2019
Record last verified: 2022-07