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)

• ClinicalTrials.gov Identifier: NCT02340221
• Recruitment Status: Terminated
• First Posted: January 16, 2015
• Results First Posted: January 25, 2019
• Last Update Posted: July 12, 2022
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Taselisib; Drug: Placebo; Drug: Fulvestrant	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 631 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 9, 2015
• Actual Primary Completion Date: June 29, 2021
• Actual Study Completion Date: June 29, 2021

Arms and Interventions

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.	Drug: Taselisib; Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm.; Other Name: GDC-0032, RO5537381; Drug: Fulvestrant; Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.; Other Name: 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.	Drug: Placebo; Placebo matching to taselisib was administered as per the schedule specified in the respective arm.; Drug: Fulvestrant; Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.; Other Name: Faslodex

Outcome Measures

Primary Outcome Measures :

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 [ 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.
2. 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.

Secondary Outcome Measures :

1. 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).
2. 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).
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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) ]
14. 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) ]
15. 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.
16. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Arizona

Arizona Oncology

Tucson, Arizona, United States, 85704

Arizona Oncology Associates, P.C.

Tucson, Arizona, United States, 85710

United States, Georgia

Georgia Cancer Specialists - Northside

Atlanta, Georgia, United States, 30341

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Marietta, Georgia, United States, 30060

United States, Illinois

Ingalls Hospital

Harvey, Illinois, United States, 60426

United States, Maryland

Maryland Oncology Hematology

Rochville, Maryland, United States, 20850

United States, Massachusetts

Dana Farber Can Ins

Boston, Massachusetts, United States, 02215

United States, Missouri

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

Saint Louis, Missouri, United States, 63141

United States, New Jersey

MSKCC at Basking Ridge

Basking Ridge, New Jersey, United States, 07920

John Theurer Cancer Ctr at Hackensack Univ Medical Ctr

Hackensack, New Jersey, United States, 07601

United States, New York

Memorial Sloan-Kettering; Cancer Center

Commack, New York, United States, 11725

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

Harrison, New York, United States, 10604

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Memorial Sloan Kettering Nassau

Uniondale, New York, United States, 11553

United States, Oregon

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

Beaverton, Oregon, United States, 97006

United States, Pennsylvania

Pinnacle Health

Harrisburg, Pennsylvania, United States, 17110

Australia, New South Wales

Liverpool Hospital; Cancer Therapy Centre

Liverpool, New South Wales, Australia, 2170

Macquarie University Hospital

Macquarie Park, New South Wales, Australia, 2109

Newcastle Mater Misericordiae Hospital; Oncology

Waratah, New South Wales, Australia, 2298

Australia, Queensland

Mater Hospital; Oncology

Brisbane, Queensland, Australia, 4101

Australia, Victoria

Austin Hospital; Medical Oncology

Heidelberg, Victoria, Australia, 3084

Sunshine Hospital; Oncology Research

St Albans, Victoria, Australia

Australia, Western Australia

St John of God Murdoch Hospital; Oncology West

Murdoch, Western Australia, Australia, 6150

Austria

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

Graz, Austria, 8036

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

Innsbruck, Austria, 6020

Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

Linz, Austria, 4010

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

Wien, Austria, 1090

Bosnia and Herzegovina

University Clinical Center of the Republic of Srpska

Banja Luka, Bosnia and Herzegovina, 78000

Clinic of Oncology, University Clinical Center Sarajevo

Sarajevo, Bosnia and Herzegovina, 7100

Bulgaria

Complex Oncological Center - Plovdiv, EOOD

Plovdiv, Bulgaria, 4004

MHAT Nadezhda

Sofia, Bulgaria, 1330

SHATO - Sofia

Sofia, Bulgaria, 1756

SHATOD Dr. Marko Antonov Markov-Varna, EOOD

Varna, Bulgaria, 9010

Canada, Alberta

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Canada, British Columbia

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

Vancouver, British Columbia, Canada, V5Z 4E6

Canada, Ontario

Grand River Hospital

Kitchener, Ontario, Canada, N2G 1G3

The Ottawa Hospital Cancer Centre; Oncology

Ottawa, Ontario, Canada, K1H 8L6

Sunnybrook Health Science Centre

Toronto, Ontario, Canada, M4N 3M5

Canada, Quebec

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

Montreal, Quebec, Canada, H3T 1E2

Hospital Du Saint-Sacrement

Quebec City, Quebec, Canada, G1S 4L8

China

the First Hospital of Jilin University

Changchun, China, 130021

Jilin Cancer Hospital

Changchun, China, 132013

Jiangsu Cancer Hospital

Nanjing City, China, 211100

Fudan University Shanghai Cancer Center

Shanghai City, China, 200120

Zhejiang Cancer Hospital

Zhejiang, China, 310022

Colombia

Clinica del Country

Bogota, Colombia, 11001

Oncomedica S.A.

Monteria, Colombia, 230002

Czechia

University Hospital; Oncology and Radiotherapy

Hradec Kralove, Czechia, 500 05

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, Czechia, 779 00

Vseobecna fakultni nemocnice v Praze

Praha 2, Czechia, 128 08

Finland

KYS Sadesairaala; Syopatautien poliklinikka

Kuopio, Finland, 70210

Turku Uni Central Hospital; Oncology Clinics

Turku, Finland, 20520

France

Centre Jean Perrin; Hopital De Semaine

Clermont-Ferrand, France, 63011

Centre Georges François Leclerc; Service Pharmacie, Bp 77980

Dijon, France, 21000

Hopital Prive Drome Ardeche; Chir 2A 2B

Guilherand Granges, France, 07500

CHD Vendée

La Roche Sur Yon, France, 85025

Hopital Dupuytren; Oncologie Medicale

Limoges, France, 87042

Institut régional du Cancer Montpellier

Montpellier, France, 34298

Institut Curie; Oncologie Medicale

Paris, France, 75231

Ch Lyon Sud; Onco Secteur Jules Courmont

Pierre Benite, France, 69495

Pole de Cancerologie Prive Strasbourgeois

Strasbourg, France, 67000

Centre Alexis Vautrin; Oncologie Medicale

Vandoeuvre-les-nancy, France, 54519

Germany

Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie

Bad Nauheim, Germany, 61231

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

Berlin, Germany, 10367

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, Germany, 10707

Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

Essen, Germany, 45122

Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

Hamburg, Germany, 20357

Klinikum der Universität München; Frauenklinik - Onkologie II

München, Germany, 80337

Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I

Trier, Germany, 54290

Greece

Alexandras General Hospital of Athens; Oncology Department

Athens, Greece, 115 28

IASO General Hospital of Athens

Athens, Greece, 155 62

Univ General Hosp Heraklion; Medical Oncology

Heraklion, Greece, 711 10

University Hospital of Patras Medical Oncology

Patras, Greece, 265 04

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, Greece, 546450

Papageorgiou General Hospital; Medical Oncology

Thessaloniki, Greece, 564 29

Italy

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

Napoli, Campania, Italy, 80131

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

Reggio Emilia, Emilia-Romagna, Italy, 42100

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

Udine, Friuli-Venezia Giulia, Italy, 33100

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

Genova, Liguria, Italy, 16132

Istituto Europeo Di Oncologia

Milano, Lombardia, Italy, 20141

Centro Catanese Di Oncologia; Oncologia Medica

Catania, Sicilia, Italy, 95126

Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

Firenze, Toscana, Italy, 50134

Azienda USL 9 Grosseto; Dipartimento Politiche del Farmaco

Grosseto, Toscana, Italy, 58100

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

Pontedera, Toscana, Italy, 56025

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

Mestre, Veneto, Italy, 30174

Korea, Republic of

Inje university Haeundae Paik Hospital

Busan, Korea, Republic of, 48108

Chungbuk National University Hospital

Cheongju-si, Korea, Republic of, 28644

National Cancer Center

Goyang-si, Korea, Republic of, 10408

Korea University Anam Hospital

Seoul, Korea, Republic of, 02841

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Ulsan University Hosiptal

Ulsan, Korea, Republic of, 44033

Mexico

Iem-Fucam

D.f., Mexico, 04980

Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

Distrito Federal, Mexico, 14000

Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

Mexico City, Mexico, 03100

Hospital San Jose Del Tec. de Monterrey; Oncology

Monterrey, Mexico, 64020

Oaxaca Site Management Organization

Oaxaca, Mexico, 68000

Netherlands

Medisch Centrum Alkmaar

Alkmaar, Netherlands, 1815 JD

Ziekenhuis Rijnstate

Arnhem, Netherlands, 6815 AD

Peru

Instituto Nacional de Enfermedades Neoplasicas

Lima, Peru, Lima 34

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

Lima, Peru, Lima 41

Oncocenter Peru S.A.C.; Oncosalud

Lima, Peru, Lima 41

Instituto Regional de Enfermedades Neoplasicas - IREN Norte

Trujillo, Peru, 13014

Poland

Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

Bialystok, Poland, 15-027

Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii

Bydgoszcz, Poland, 85-796

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, Poland, 80-214

Przychodnia Lekarska KOMED, Roman Karaszewski

Konin, Poland, 62-500

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

Kraków, Poland, 30-688

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

Lodz, Poland, 93-513

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

Lublin, Poland, 20-090

Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

Szczecin, Poland, 71-730

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

Warszawa, Poland, 02-781

Wojewodzki Szpital Specjalistyczny; Osrodek Badawczo-Rozwojowy, Oddzial Chemioterapii

Wroclaw, Poland, 51-124

Portugal

Hospital Garcia de Orta; Servico de Oncologia Medica

Almada, Portugal, 2801-951

IPO de Lisboa; Servico de Oncologia Medica

Lisboa, Portugal, 1099-023

Hospital da Luz; Departamento de Oncologia Medica

Lisboa, Portugal, 1500-650

Hospital de Santa Maria; Servico de Oncologia Medica

Lisboa, Portugal, 1649-035

IPO do Porto; Servico de Oncologia Medica

Porto, Portugal, 4200-072

Romania

Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

Bucuresti, Romania, 022328

Prof. Dr. I. Chiricuta Institute of Oncology

Cluj Napoca, Romania, 400015

Oncology Center Sf. Nectarie

Craiova, Romania, 200347

Euroclinic Center of Oncology SRL

Iasi, Romania, 700106

Russian Federation

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423

Regional Clinical Oncology Dispensary; Surgery Dept, Thoracic

Arkhangelsk, Russian Federation, 163045

Ivanovo Regional Oncology Dispensary

Ivanovo, Russian Federation, 153040

Clinical Oncology Dispensary of Ministry of Health of Tatarstan

Kazan, Russian Federation, 420029

State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

Orenburg, Russian Federation, 460021

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

Saint-Petersburg, Russian Federation, 197758

Serbia

Institute for Onc/Rad Serbia

Belgrade, Serbia, 11000

Spain

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

Santiago de Compostela, LA Coruña, Spain, 15706

Hospital Universitario Puerta de Hierro; Servicio de Oncologia

Majadahonda, Madrid, Spain, 28222

Hospital Universitario de Canarias;servicio de Oncologia

La Laguna, Tenerife, Spain, 38320

Hospital de Cruces; Servicio de Oncologia

Bilbao, Vizcaya, Spain, 48903

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Hospital Clínic i Provincial; Servicio de Hematología y Oncología

Barcelona, Spain, 08036

Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

Madrid, Spain, 28033

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, Spain, 28034

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

Madrid, Spain, 28050

Fundación IVO

Valencia, Spain, 46980

Hospital Universitario Miguel Servet; Servicio Oncologia

Zaragoza, Spain, 50009

Sweden

Uni Hospital Linkoeping; Dept. of Oncology

Linköping, Sweden, 58185

Sodersjukhuset; Onkologkliniken

Stockholm, Sweden, 118 83

Akademiska sjukhuset, Onkologkliniken

Uppsala, Sweden, 751 85

Taiwan

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

Taipei City, Taiwan, 11259

VETERANS GENERAL HOSPITAL; Department of General Surgery

Taipei, Taiwan, 00112

National Taiwan Uni Hospital; General Surgery

Taipei, Taiwan, 100

Mackay Memorial Hospital; Dept of Surgery

Taipei, Taiwan, 104

Thailand

Department of Surgery, King Chulalongkorn Memorial Hospital

Bangkok, Thailand, 10330

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

Bangkok, Thailand, 10400

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

Chiang Mai, Thailand, 50200

Turkey

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

Adana, Turkey, 01230

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

Edirne, Turkey, 22770

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

Istanbul, Turkey, 34300

Ege Uni Medical Faculty; Oncology Dept

Izmir, Turkey, 35100

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sihhiye/Ankara, Turkey, 06230

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol and Statistical Analysis Plan  [PDF] June 24, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02340221
• Other Study ID Numbers: GO29058; 2014-003185-25 ( EudraCT Number )
• First Posted: January 16, 2015
• Results First Posted: January 25, 2019
• Last Update Posted: July 12, 2022
• Last Verified: July 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Recurrence; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Disease Attributes; Pathologic Processes; Fulvestrant; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Estrogen Receptor Antagonists; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs