Breast Cancer Clinical Trial
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
Summary
To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.
Eligibility Criteria
Inclusion Criteria:
If female, patient is postmenopausal
Patient has identified PIK3CA status
Patients may be:
relapsed with documented evidence of progression while on (neo) adjuvant endocrine therapy or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease;
relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy and then subsequently; progressed with documented evidence of progression while on or after only one line of endocrine therapy for metastatic disease;
newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression while on or after only one line of endocrine therapy
Patient has recurrence or progression of disease during or after AI therapy (i.e.
letrozole, anastrozole, exemestane).
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory and has HER2 negative breast cancer
Patient has either measurable disease per RECIST 1.1 criteria OR at least one predominantly lytic bone lesion must be present
Patient has adequate bone marrow function
Exclusion Criteria:
Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment
Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor (pre-treatment with CDK4/6 inhibitors is allowed)
Patient with inflammatory breast cancer at screening
Patients with Child pugh score B or C
Patients with an established diagnosis of diabetes mellitus type I or not controlled type II
Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or more
Patient with CNS involvement unless he/she is at least 4 weeks from prior therapy completion to starting the study treatment and has stable CNS tumor at time of screening and not receiving steroids and/or enzyme inducing ant-epileptic medications for brain metastases
Patient has participated in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer
Patient has a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis
Patient who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
Other protocol-defined inclusion/esclusion criteria may apply.
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There are 194 Locations for this study
Chandler Arizona, 85224, United States
Scottsdale Arizona, 85259, United States
Fayetteville Arkansas, 72703, United States
Beverly Hills California, 90211, United States
Duarte California, 91010, United States
La Jolla California, 92037, United States
San Diego California, 92120, United States
San Francisco California, 94115, United States
Fort Myers Florida, 33901, United States
Saint Petersburg Florida, 33705, United States
Chicago Illinois, 60612, United States
Evanston Illinois, 60201, United States
Naperville Illinois, 60540, United States
Fort Wayne Indiana, 46815, United States
Topeka Kansas, 66606, United States
Baltimore Maryland, 21202, United States
Boston Massachusetts, 02114, United States
Burlington Massachusetts, 01805, United States
Owosso Michigan, 48867, United States
Kansas City Missouri, 64111, United States
Billings Montana, 59102, United States
New Brunswick New Jersey, 08903, United States
Cleveland Ohio, 44106, United States
Corvallis Oregon, 97330, United States
Lancaster Pennsylvania, 17604, United States
Greenville South Carolina, 29615, United States
Sioux Falls South Dakota, 57105, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75231, United States
El Paso Texas, 79902, United States
San Antonio Texas, 78229, United States
Tyler Texas, 75702, United States
Fairfax Virginia, 22031, United States
Wenatchee Washington, 98801, United States
Berazategui Buenos Aires, B1884, Argentina
Caba Buenos Aires, C1125, Argentina
Rio Negro Viedma, 8500, Argentina
La Rioja , 5300, Argentina
Wahroonga New South Wales, 2076, Australia
Wooloongabba Queensland, 4102, Australia
Elizabeth Vale South Australia, 5112, Australia
Melbourne Victoria, 3000, Australia
Linz , 4010, Austria
Vienna , 1090, Austria
Edegem Antwerpen, 2650, Belgium
Jette Brussel, 1090, Belgium
Sint Niklaas Vlaams Brabant, 9100, Belgium
Bruxelles , 1000, Belgium
Libramont , 6800, Belgium
Ottignies , 1340, Belgium
Verviers , 4800, Belgium
Natal RN, 59075, Brazil
Lajeado RS, 95900, Brazil
Sao Paulo SP, 03102, Brazil
Sao Jose do Rio Preto , 15090, Brazil
Sao Paulo , 01236, Brazil
Plovdiv , 4004, Bulgaria
Sofia , 1756, Bulgaria
Varna , 9002, Bulgaria
Varna , 9010, Bulgaria
Calgary Alberta, T2N 4, Canada
Cambridge Ontario, N1R 3, Canada
Ottawa Ontario, KIH 7, Canada
Toronto Ontario, M5B 1, Canada
Quebec , G1S 4, Canada
Temuco Araucania, 48104, Chile
Santiago , 84203, Chile
Vina del Mar , 25206, Chile
Hradec Kralove Czech Republic, 500 0, Czechia
Praha 4 Czech Republic, 140 4, Czechia
Zlin Czech Republic, 762 7, Czechia
Prague 8 , 180 0, Czechia
Marseille cedex 20 Bouches Du Rhone, 13915, France
Angers cedex 02 , 49055, France
Avignon Cedex , 84082, France
Caen Cedex , 14021, France
Clermont Ferrand , 63011, France
Creteil , 94010, France
La Roche sur Yon cedex 9 , 85925, France
Le Chesnay , 78157, France
Levallois-Perret , 92309, France
Lyon Cedex 08 , 69373, France
Montpellier , 34070, France
Nimes , 30029, France
Rouen Cedex 1 , 76038, France
Saint-Herblain Cédex , 44805, France
Toulouse Cedex 9 , 31059, France
Villejuif Cedex , 94800, France
Recklinghausen North Rhine-westphalia, 45657, Germany
Leipzig Sachsen, 04277, Germany
Luebeck Schleswig-holstein, 23563, Germany
Aschaffenburg , 63739, Germany
Frankfurt , 60389, Germany
Friedrichshafen , 88045, Germany
Hannover , 30625, Germany
Homburg , 66421, Germany
Kiel , 24105, Germany
Mainz , 55131, Germany
Potsdam , 14467, Germany
Rostock , 18059, Germany
Ulm , 89081, Germany
Velbert , 42551, Germany
Thessaloniki GR, 564 2, Greece
Athens , 115 2, Greece
Athens , 18547, Greece
Hong Kong , , Hong Kong
Budapest , 1134, Hungary
Budapest , H 112, Hungary
Nyiregyhaza , 4400, Hungary
Szekszard , 7100, Hungary
Vijayawada Andhra Pradesh, 52000, India
Nagpur - Maharashtra Maharashtra, 44001, India
Mumbai , 400 0, India
Beer-Sheva , 84571, Israel
Haifa , 31096, Israel
Petach Tikva , 49414, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Ancona AN, 60126, Italy
Chieti CH, 66100, Italy
Meldola FC, 47014, Italy
Milano MI, 20133, Italy
Palermo PA, 90127, Italy
Padova PD, 35100, Italy
Pontedera PI, 56025, Italy
Aviano PN, 33081, Italy
Rionero in Vulture PZ, 85028, Italy
Roma RM, 00155, Italy
Sassari SS, 07100, Italy
Savona SV, 17100, Italy
Torino TO, 10126, Italy
Negrar VR, 37024, Italy
Nagoya Aichi, 464 8, Japan
Matsuyama Ehime, 791-0, Japan
Maebashi city Gunma, 371 8, Japan
Sapporo-city Hokkaido, 003-0, Japan
Akashi Hyogo, 673-8, Japan
Kagoshima-city Kagoshima, 892-0, Japan
Isehara Kanagawa, 259-1, Japan
Yokohama-city Kanagawa, 241-8, Japan
Kumamoto City Kumamoto, 860-8, Japan
Osaka-city Osaka, 540-0, Japan
Osaka-city Osaka, 541-8, Japan
Kitaadachi-gun Saitama, 362-0, Japan
Chuo ku Tokyo, 104-8, Japan
Minato ku Tokyo, 105-8, Japan
Bundang Gu Gyeonggi Do, 13620, Korea, Republic of
Gyeonggi do Korea, 10408, Korea, Republic of
Seoul Korea, 05505, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Ashrafieh , 16683, Lebanon
Beirut , , Lebanon
Saida , 652, Lebanon
Monterrey NL Monterrey, 64320, Mexico
San Luis Potosi , 78200, Mexico
Venray CE, 5801, Netherlands
Terneuzen , 4535 , Netherlands
San Borja Lima, 41, Peru
Surquillo Lima, 34, Peru
Lima , LIMA , Peru
Floresti Cluj, 40728, Romania
Craiova Dolj, 20034, Romania
Iasi , 70048, Romania
Arkhangelsk , 16304, Russian Federation
Ryazan , 39001, Russian Federation
St Petersburg , 19775, Russian Federation
Sevilla Andalucia, 41013, Spain
Jerez Cadiz, 11407, Spain
Badalona Catalunya, 08916, Spain
Barcelona Cataluña, 08024, Spain
Alicante Comunidad Valenciana, 03010, Spain
Castellon Comunidad Valenciana, 12002, Spain
Valencia Comunidad Valenciana, 46010, Spain
Badajoz Extremadura, 06080, Spain
Caceres Extremadura, 10003, Spain
Santiago de Compostela Galicia, 15706, Spain
Palma De Mallorca Islas Baleares, 07120, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
El Palmar Murcia, 30120, Spain
La Laguna Santa Cruz De Tenerife, 38320, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Gavle , SE-80, Sweden
Oerebro , 70185, Sweden
Vasteras , 721 8, Sweden
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Bangkok THA, 10330, Thailand
Bangkok , 10700, Thailand
Plymouth Devon, PL6 8, United Kingdom
Leicester , LE1 5, United Kingdom
London , SE1 9, United Kingdom
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