Breast Cancer Clinical Trial
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
Summary
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).
Eligibility Criteria
Inclusion Criteria:
Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
Confirmed diagnosis of HR+/HER2- breast cancer
Any menopausal status
Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy
On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex ®) at time of randomization.
Measurable disease defined by RECIST version 1.1, or bone-only disease
Eastern Cooperative Oncology Group (ECOG) PS 0-1
Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
Patient must agree to provide tumor tissue from metastatic tissue at baseline
Exclusion Criteria:
Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that inhibits the PI3K-mTOR pathway
Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
Major surgery or any anti-cancer therapy within 2 weeks of randomization
Prior stem cell or bone marrow transplantation
Use of potent CYP3A4 inhibitors or inducers
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There are 210 Locations for this study
Birmingham Alabama, 35233, United States
Birmingham Alabama, 35249, United States
Birmingham Alabama, 35249, United States
Daphne Alabama, 36526, United States
Mobile Alabama, 36607, United States
Mobile Alabama, 36608, United States
Mobile Alabama, 36608, United States
Avondale Arizona, 85323, United States
Chandler Arizona, 85224, United States
Flagstaff Arizona, 86001, United States
Gilbert Arizona, 85297, United States
Glendale Arizona, 85304, United States
Glendale Arizona, 85306, United States
Goodyear Arizona, 85338, United States
Mesa Arizona, 85202, United States
Mesa Arizona, 85206, United States
Prescott Valley Arizona, 86314, United States
Sedona Arizona, 86336, United States
Surprise Arizona, 85374, United States
Tucson Arizona, 85719, United States
Tucson Arizona, 85724, United States
Bakersfield California, 93309, United States
Culver City California, 90232, United States
Duarte California, 91010, United States
Fullerton California, 92835, United States
Glendale California, 91204, United States
La Jolla California, 92037, United States
La Jolla California, 92093, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Orange California, 92868, United States
Orange California, 92868, United States
Pasadena California, 91105, United States
San Diego California, 92103, United States
San Francisco California, 94115, United States
San Luis Obispo California, 93401, United States
Santa Ana California, 92705, United States
Santa Maria California, 93454, United States
Santa Monica California, 90404, United States
South Pasadena California, 91030, United States
Torrance California, 90505, United States
Torrance California, 90505, United States
West Hills California, 91307, United States
Westlake Village California, 91361, United States
Aurora Colorado, 80045, United States
Aurora Colorado, 80045, United States
Aurora Colorado, 80045, United States
Aventura Florida, 33180, United States
Deerfield Beach Florida, 33442, United States
Deerfield Beach Florida, 33442, United States
Fort Lauderdale Florida, 33308, United States
Hollywood Florida, 33021, United States
Hollywood Florida, 33021, United States
Hollywood Florida, 33021, United States
Miami Beach Florida, 33140, United States
Miami Beach Florida, 33140, United States
Miami Florida, 33136, United States
Ocoee Florida, 34761, United States
Orlando Florida, 32806, United States
Pembroke Pines Florida, 33028, United States
Pembroke Pines Florida, 33028, United States
Pembroke Pines Florida, 33028, United States
Plantation Florida, 33324, United States
Atlanta Georgia, 30318, United States
Austell Georgia, 30106, United States
Cartersville Georgia, 30121, United States
Fayetteville Georgia, 30214, United States
Marietta Georgia, 30060, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60612, United States
Zion Illinois, 60099, United States
Brunswick Maine, 04011, United States
Kennebunk Maine, 04043, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21231, United States
Lutherville Maryland, 21093, United States
Ann Arbor Michigan, 48109, United States
Grand Rapids Michigan, 49503, United States
Edina Minnesota, 55435, United States
Minneapolis Minnesota, 55455, United States
Minneapolis Minnesota, 55455, United States
Ballwin Missouri, 63011, United States
Chesterfield Missouri, 63017, United States
Saint Louis Missouri, 63109, United States
Saint Louis Missouri, 63141, United States
Saint Louis Missouri, 63141, United States
Henderson Nevada, 89052, United States
Henderson Nevada, 89074, United States
Las Vegas Nevada, 89052, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89169, United States
New Brunswick New Jersey, 08903, United States
Brewster New York, 10509, United States
Lake Success New York, 11042, United States
Mount Kisco New York, 10549, United States
Mount Kisco New York, 10549, United States
Asheville North Carolina, 28806, United States
Asheville North Carolina, 28806, United States
Monroeville Pennsylvania, 15146, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15232, United States
Germantown Tennessee, 38138, United States
Dallas Texas, 75231, United States
Fort Worth Texas, 76177, United States
Irving Texas, 75063, United States
Irving Texas, 75063, United States
Longview Texas, 75601, United States
McAllen Texas, 78503, United States
San Antonio Texas, 78212, United States
San Antonio Texas, 78217, United States
San Antonio Texas, 78258, United States
Tyler Texas, 75702, United States
Weslaco Texas, 78596, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84112, United States
Arlington Virginia, 22205, United States
Charlottesville Virginia, 22903, United States
Fairfax Virginia, 22031, United States
Fairfax Virginia, 22031, United States
Fairfax Virginia, 22031, United States
Leesburg Virginia, 20176, United States
Norfolk Virginia, 23502, United States
Virginia Beach Virginia, 23456, United States
Winchester Virginia, 22601, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98122, United States
Mequon Wisconsin, 53097, United States
Milwaukee Wisconsin, 53211, United States
Bankstown New South Wales, 2200, Australia
Waratah New South Wales, 2298, Australia
Auchenflower Queensland, 4066, Australia
Nambour Queensland, 4560, Australia
Southport Queensland, 4215, Australia
Brighton Victoria, 3186, Australia
Clayton Victoria, 3168, Australia
Frankston Victoria, 3199, Australia
Geelong Victoria, 3220, Australia
Malvern Victoria, 3144, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3000, Australia
St Albans Victoria, 3021, Australia
St Albans Victoria, 3021, Australia
Murdoch Western Australia, 6150, Australia
Edegem Antwerpen, 2650, Belgium
Ottignies Brabant Wallon, 1340, Belgium
Bruxelles Bruxelles Capitale, 1000, Belgium
Charleroi Hainaut, 6000, Belgium
Haine St. Paul Hainaut, 7100, Belgium
Tournai Hainaut, 7500, Belgium
Libramont-Chevigny Luxembourg, 6800, Belgium
Bruxelles Region DE Bruxelles-capital, 1070, Belgium
Bonheiden , 2820, Belgium
Bruxelles , 1200, Belgium
Leuven , 3000, Belgium
Namur , 5000, Belgium
Wilrijk , 2610, Belgium
Kelowna British Columbia, V1Y 5, Canada
Surrey British Columbia, V3V 1, Canada
Barrie Ontario, L4M 6, Canada
Kingston Ontario, K7L 2, Canada
Oshawa Ontario, L1G 2, Canada
Ottawa Ontario, K1H 8, Canada
St. Catharines Ontario, L2S 0, Canada
Toronto Ontario, M4C 3, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
Leipzig , 04103, Germany
Leipzig , 04103, Germany
München , 80336, Germany
München , 80337, Germany
Cork , , Ireland
Bagno A Ripoli (FI) , 50012, Italy
Bagno A Ripoli (FI) , 50012, Italy
Bologna , 40138, Italy
Catania , 95123, Italy
Legnago (VR) , 37045, Italy
Legnago (VR) , 37045, Italy
Meldola (FC) , 47014, Italy
Milano , 20132, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Milano , 20141, Italy
Modena , 41124, Italy
Napoli , 80131, Italy
Roma , 00168, Italy
Roma , 00168, Italy
Terni , 05100, Italy
Nagoya Aichi, 464-8, Japan
Kashiwa Chiba, 277-8, Japan
Matsuyama-city Ehime, 791-0, Japan
Kita-adachi-gun Saitama,japan, 362-0, Japan
Chiba , 260-8, Japan
Fukuoka , 811-1, Japan
Kagoshima , 892-0, Japan
Osaka , 540-0, Japan
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seongnam-si Gyeonggi-do, 463-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Maastricht Limburg, 6229 , Netherlands
Sittard-Geleen Limburg, 6162 , Netherlands
Tilburg Noord-brabant, 5042A, Netherlands
Den Haag Zuid-holland, 2545 , Netherlands
Leiden Zuid-holland, 2333Z, Netherlands
Rotterdam Zuid-holland, 3083 , Netherlands
Lisboa , 1400-, Portugal
Porto , 4200-, Portugal
Bucharest , 01146, Romania
Ploiesti , 10033, Romania
Suceava , 72023, Romania
Tg. Mures , 54014, Romania
Belgorod, Belgorodskaya Oblast',, 30801, Russian Federation
Stariy Oskol Belgorodskaya Oblast', 30950, Russian Federation
Village Kuzmolovsky Leningradskaya Oblast', 18866, Russian Federation
Ufa Republic OF Bashkortostan, 45005, Russian Federation
Lermontov Stavropol Territory, 35734, Russian Federation
Pyatigorsk, Stavropol Territory, 35750, Russian Federation
Chelyabinsk , 45408, Russian Federation
Moscow , 11547, Russian Federation
Saint Petersburg , 19702, Russian Federation
Saint Petersburg , 19825, Russian Federation
Stavropol , 35504, Russian Federation
Village Pesochny , 19775, Russian Federation
Tainan , 704, Taiwan
Taipei , 100, Taiwan
Izmir Bornova, 35040, Turkey
Chernivtsi , 58013, Ukraine
Dnipro , 49102, Ukraine
Kharkiv , 61070, Ukraine
Lviv , 79031, Ukraine
Odesa , 65025, Ukraine
Vinnytsia , 21029, Ukraine
Portsmouth Hampshire, PO6 3, United Kingdom
Cardiff South Glamorgan, CF14 , United Kingdom
Sheffield South Yorkshire, S10 2, United Kingdom
Sheffield South Yorkshire, S10 2, United Kingdom
London , SW3 6, United Kingdom
Sutton , SM2 5, United Kingdom
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