Breast Cancer Clinical Trial
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
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.
Eligibility Criteria
Inclusion Criteria:
Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen receptor (ER) positive breast cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer
Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an aromatase inhibitor (AI), or progression while on or within 1 month of the end of prior AI treatment for locally advanced or metastatic breast cancer
Measurable disease via Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) or non-measurable, evaluable disease with at least one evaluable bone lesion via RECIST v1.1
Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing
A valid cobas PIK3CA mutation result by central testing is required
Adequate hematologic and end-organ function within 28 days prior to treatment initiation
Exclusion Criteria:
Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization positive)
Prior treatment with fulvestrant
Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian target of rapamycin (mTOR) inhibitor (e.g. everolimus), or protein kinase B (AKT) inhibitor
Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1
Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1
All acute treatment-related toxicity must have resolved to Grade less than or equal to (=) 1 or be deemed stable by the Investigator
Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer
Concurrent hormone replacement therapy
Known untreated or active central nervous system (CNS) metastases
Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications
History of inflammatory bowel disease or active bowel inflammation
Clinically significant cardiac or pulmonary dysfunction
Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B or C virus
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There are 154 Locations for this study
Tucson Arizona, 85704, United States
Tucson Arizona, 85710, United States
Atlanta Georgia, 30341, United States
Marietta Georgia, 30060, United States
Harvey Illinois, 60426, United States
Rochville Maryland, 20850, United States
Boston Massachusetts, 02215, United States
Saint Louis Missouri, 63141, United States
Basking Ridge New Jersey, 07920, United States
Hackensack New Jersey, 07601, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Uniondale New York, 11553, United States
Beaverton Oregon, 97006, United States
Harrisburg Pennsylvania, 17110, United States
Liverpool New South Wales, 2170, Australia
Macquarie Park New South Wales, 2109, Australia
Waratah New South Wales, 2298, Australia
Brisbane Queensland, 4101, Australia
Heidelberg Victoria, 3084, Australia
St Albans Victoria, , Australia
Murdoch Western Australia, 6150, Australia
Graz , 8036, Austria
Innsbruck , 6020, Austria
Linz , 4010, Austria
Wien , 1090, Austria
Banja Luka , 78000, Bosnia and Herzegovina
Sarajevo , 7100, Bosnia and Herzegovina
Plovdiv , 4004, Bulgaria
Sofia , 1330, Bulgaria
Sofia , 1756, Bulgaria
Varna , 9010, Bulgaria
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Kitchener Ontario, N2G 1, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H3T 1, Canada
Quebec City Quebec, G1S 4, Canada
Changchun , 13002, China
Changchun , 13201, China
Nanjing City , 21110, China
Shanghai City , 20012, China
Zhejiang , 31002, China
Bogota , 11001, Colombia
Monteria , 23000, Colombia
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Praha 2 , 128 0, Czechia
Kuopio , 70210, Finland
Turku , 20520, Finland
Clermont-Ferrand , 63011, France
Dijon , 21000, France
Guilherand Granges , 07500, France
La Roche Sur Yon , 85025, France
Limoges , 87042, France
Montpellier , 34298, France
Paris , 75231, France
Pierre Benite , 69495, France
Strasbourg , 67000, France
Vandoeuvre-les-nancy , 54519, France
Bad Nauheim , 61231, Germany
Berlin , 10367, Germany
Berlin , 10707, Germany
Essen , 45122, Germany
Hamburg , 20357, Germany
München , 80337, Germany
Trier , 54290, Germany
Athens , 115 2, Greece
Athens , 155 6, Greece
Heraklion , 711 1, Greece
Patras , 265 0, Greece
Thessaloniki , 54645, Greece
Thessaloniki , 564 2, Greece
Napoli Campania, 80131, Italy
Reggio Emilia Emilia-Romagna, 42100, Italy
Udine Friuli-Venezia Giulia, 33100, Italy
Genova Liguria, 16132, Italy
Milano Lombardia, 20141, Italy
Catania Sicilia, 95126, Italy
Firenze Toscana, 50134, Italy
Grosseto Toscana, 58100, Italy
Pontedera Toscana, 56025, Italy
Mestre Veneto, 30174, Italy
Busan , 48108, Korea, Republic of
Cheongju-si , 28644, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Ulsan , 44033, Korea, Republic of
D.f. , 04980, Mexico
Distrito Federal , 14000, Mexico
Mexico City , 03100, Mexico
Monterrey , 64020, Mexico
Oaxaca , 68000, Mexico
Alkmaar , 1815 , Netherlands
Arnhem , 6815 , Netherlands
Lima , Lima , Peru
Lima , Lima , Peru
Lima , Lima , Peru
Trujillo , 13014, Peru
Bialystok , 15-02, Poland
Bydgoszcz , 85-79, Poland
Gdansk , 80-21, Poland
Konin , 62-50, Poland
Kraków , 30-68, Poland
Lodz , 93-51, Poland
Lublin , 20-09, Poland
Szczecin , 71-73, Poland
Warszawa , 02-78, Poland
Wroclaw , 51-12, Poland
Almada , 2801-, Portugal
Lisboa , 1099-, Portugal
Lisboa , 1500-, Portugal
Lisboa , 1649-, Portugal
Porto , 4200-, Portugal
Bucuresti , 02232, Romania
Cluj Napoca , 40001, Romania
Craiova , 20034, Romania
Iasi , 70010, Romania
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Arkhangelsk , 16304, Russian Federation
Ivanovo , 15304, Russian Federation
Kazan , 42002, Russian Federation
Orenburg , 46002, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Belgrade , 11000, Serbia
Santiago de Compostela LA Coruña, 15706, Spain
Majadahonda Madrid, 28222, Spain
La Laguna Tenerife, 38320, Spain
Bilbao Vizcaya, 48903, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28050, Spain
Valencia , 46980, Spain
Zaragoza , 50009, Spain
Linköping , 58185, Sweden
Stockholm , 118 8, Sweden
Uppsala , 751 8, Sweden
Taipei City , 11259, Taiwan
Taipei , 00112, Taiwan
Taipei , 100, Taiwan
Taipei , 104, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Chiang Mai , 50200, Thailand
Adana , 01230, Turkey
Edirne , 22770, Turkey
Istanbul , 34300, Turkey
Izmir , 35100, Turkey
Sihhiye/Ankara , 06230, Turkey
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