Breast Cancer Clinical Trial
Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer
Summary
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .
Full Description
This is an international, multicenter, randomized, open-label, active-controlled, event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men with advanced or metastatic ER+/HER2- breast cancer, either in subjects with tumors that harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene (ESR1-mut subjects) or in all subjects regardless of ESR1 status (ESR1-mut and ESR1 wild type [ESR1-WT]) and whose disease has relapsed or progressed on at least one and no more than two prior lines of endocrine therapy (with documented progression), which must have included prior CDK4/6 inhibitor therapy in combination with fulvestrant or an aromatase inhibitor (AI) and for whom hormonal monotherapy with one of the SoC drugs (fulvestrant, anastrozole, letrozole, exemestane) is an appropriate treatment option.
Eligibility Criteria
Critical Inclusion Criteria:
Subjects with proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy.
Subjects must be appropriate candidates for endocrine monotherapy
Subjects must have measurable disease or, nonmeasurable (evaluable) bone-only disease
Female or male subjects age ≥ 18 years; female subjects must be postmenopausal women and male subjects must not allow pregnancy with their sperm (abstain, do not donate sperm, etc).
Subjects must have ER+/HER2-tumor status
Subjects must have previously received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer and meet additional previous treatment criteria.
Subjects must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI).
Subjects may have received no more than one line of chemotherapy in the advanced/metastatic setting.
Subjects must have ctDNA ESR1-mut or ESR1-WT status as determined by central testing with Guardant360CDx® before subject is randomized.
Critical Exclusion Criteria:
Prior treatment with elacestrant, GDC-0810, GDC-0927, GDC-9545, LSZ102, AZD9496, bazedoxifene, or other investigational SERD or investigational ER antagonist.
Prior anticancer or investigational drug treatment within the following windows:
Fulvestrant treatment < 28 days before first dose of study drug
Any endocrine therapy < 14 days before first dose of study drug (with the exception of GnRH agonist therapy in male subjects)
Chemotherapy < 21 days before first dose of study drug
Any investigational anti-cancer drug therapy < 28 days or five half-lives (whichever is shorter) before the first dose of study drug. Enrollment of subjects whose most recent therapy was an investigational agent should be discussed with the Sponsor
Presence of symptomatic visceral disease as defined in protocol.
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There are 153 Locations for this study
Tucson Arizona, 85724, United States
Fullerton California, 92835, United States
Glendale California, 91206, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Redondo Beach California, 90277, United States
Sacramento California, 95817, United States
Denver Colorado, 80218, United States
Fort Collins Colorado, 80528, United States
Washington District of Columbia, 20010, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30318, United States
Lawrenceville Georgia, 30046, United States
Chicago Illinois, 60141, United States
Chicago Illinois, 60612, United States
Tinley Park Illinois, 60487, United States
Louisville Kentucky, 40207, United States
Pikeville Kentucky, 41501, United States
Scarborough Maine, 04074, United States
Frederick Maryland, 21702, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02462, United States
Danvers Massachusetts, 01923, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55404, United States
Rochester Minnesota, 55905, United States
Jackson Mississippi, 39202, United States
Freehold New Jersey, 07728, United States
Livingston New Jersey, 07039, United States
Albuquerque New Mexico, 87109, United States
Albuquerque New Mexico, 87131, United States
Bronx New York, 10461, United States
New York New York, 10016, United States
Stony Brook New York, 11794, United States
Cleveland Ohio, 44106, United States
Portland Oregon, 97239, United States
Harrisburg Pennsylvania, 17109, United States
Willow Grove Pennsylvania, 19090, United States
Germantown Tennessee, 38138, United States
Knoxville Tennessee, 37909, United States
Austin Texas, 78731, United States
Houston Texas, 77070, United States
Irving Texas, 75063, United States
McAllen Texas, 78053, United States
San Antonio Texas, 78229, United States
The Woodlands Texas, 77380, United States
Tyler Texas, 75702, United States
Salt Lake City Utah, 84124, United States
Charlottesville Virginia, 22908, United States
Fairfax Virginia, 22031, United States
Fort Belvoir Virginia, 22060, United States
Seattle Washington, 98101, United States
Buenos Aires Ciudad Autónoma De Buenos Aire, 1019, Argentina
Ciudad Autonoma de Buenos Aire , C1025, Argentina
Córdoba , 5004, Argentina
La Rioja , 5300, Argentina
Birtinya , 4575, Australia
Campbelltown , 2560, Australia
Fitzroy , 3065, Australia
Wels Oberösterreich, 4600, Austria
Leoben Steiermark, 8700, Austria
Innsbruck Tirol, 6020, Austria
Brasschaat Antwerpen, 2930, Belgium
Edegem Antwerpen, 2650, Belgium
Turnhout Antwerpen, 2300, Belgium
Brussels Brussels Capital Region, 1000, Belgium
Brussel Brussels Capital Region, 1090, Belgium
Bruxelles Brussels Capital Region, 1020, Belgium
Bruxelles Brussels Capital Region, 1200, Belgium
Charleroi Hainaut, 6000, Belgium
Haine-Saint-Paul Hainaut, 7100, Belgium
Libramont Luxembourg, 6800, Belgium
Aalst Oost-Vlaanderen, 9300, Belgium
Sint-Niklaas Oost-Vlaanderen, 9100, Belgium
Leuven Vlaams Brabant, 3000, Belgium
Brugge West-Vlaanderen, 8000, Belgium
Kortrijk West-Vlaanderen, 8500, Belgium
Kortrijk , 8500, Belgium
Namur , 5000, Belgium
Namur , 5000, Belgium
Ottignies , 1340, Belgium
Montreal Quebec, H2X 1, Canada
Montreal Quebec, H4A-3, Canada
Québec , G1S 4, Canada
Vejle South Denmark, 7100, Denmark
Næstved Zeeland, 4700, Denmark
Aalborg , 9100, Denmark
Odense , 5000, Denmark
Caen Calvados, 14076, France
Tours Indre-et-Loire, 37044, France
Clermont Ferrand Puy-de-Dôme, 63011, France
Caen , 14076, France
Dijon , 21079, France
Lyon , 69008, France
Montpellier , 34298, France
Paris , 75005, France
Saint-Cloud , 92210, France
Saint-Priest-en-Jarez , 42270, France
Toulouse , 31100, France
Patra Achaïa, 26504, Greece
Athens Attiki, 18547, Greece
Larissa Larisa, 41110, Greece
Thessaloniki , 54622, Greece
Pécs Baranya, 7623, Hungary
Debrecen Hajdú-Bihar, 4032, Hungary
Debrecen Hajdú-Bihar, 7032, Hungary
Szolnok Jász-Nagykun-Szolnok, 5004, Hungary
Nyiregyhaza Szabolcs-Szatmár-Bereg, 4400, Hungary
Budapest , 1145, Hungary
Budapest , H-108, Hungary
Budapest , H-112, Hungary
Cork City , , Ireland
Dublin , , Ireland
Sligo , F91 H, Ireland
Sligo , F91 H, Ireland
Sligo , F91 H, Ireland
Waterford , X91 E, Ireland
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Kfar-Saba , 44281, Israel
Nahariya , 22100, Israel
Petah Tikva , 49414, Israel
Tel-Aviv , 64239, Israel
Tel-Hashomer , 52656, Israel
Zerifin , 70300, Israel
Bologna , 40138, Italy
Cremona , 26100, Italy
Genova , 16132, Italy
Meldola , 47014, Italy
Modena , 41100, Italy
Monza , 20900, Italy
Novara , 28100, Italy
Parma , 43126, Italy
Pavia , 27100, Italy
Pisa , 56126, Italy
Roma , 00128, Italy
Roma , 00168, Italy
Udine , 33100, Italy
Goyang , 10408, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seongnam-si , 13620, 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
Coimbra , 3000-, Portugal
Guimarães , 4835-, Portugal
Lisboa , 1500-, Portugal
Porto , 4200-, Portugal
Elche Alicante, 03202, Spain
Sevilla AndalucÃa, 41013, Spain
Tenerife Canarias, 38320, Spain
Pamplona Navarra, 31008, Spain
Vigo Pontevedra, 36312, Spain
Barcelona , 08036, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Sevilla , 41009, Spain
Valencia , 46010, Spain
Cardiff , CF14 , United Kingdom
London , NW1 2, United Kingdom
London , W1G 6, United Kingdom
Taunton , TA1 5, United Kingdom
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