Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
- Conditions
- Neoplasm MetastasisBreast Neoplasm
- Interventions
- Registration Number
- NCT05169567
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 368
-
Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
-
Have radiologic evidence of disease progression or recurrence either
- On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
- On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
-
Must be deemed appropriate for treatment with ET
-
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
-
Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)
-
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
-
Have adequate renal, hematologic, and hepatic organ function
-
Must be able to swallow capsules/tablets
- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
- Have symptomatic or untreated central nervous system metastasis
- Have received any systemic therapy between disease recurrence/progression and study screening
- Have received more than 1 line of therapy for advanced or metastatic disease.
- Have received prior chemotherapy for metastatic breast cancer (MBC)
- Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Abemaciclib plus Fulvestrant Abemaciclib Abemaciclib 150 milligram (mg) administered orally twice daily (BID) on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met. Arm A: Abemaciclib plus Fulvestrant Fulvestrant Abemaciclib 150 milligram (mg) administered orally twice daily (BID) on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met. Arm B: Placebo plus Fulvestrant Fulvestrant Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met. Arm B: Placebo plus Fulvestrant Placebo Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Randomization to the date of first documented progression of disease or death from any cause (Up to 21 Months) PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) Randomization to the date of first documented progression of disease or death from any cause (Up to 22 Months) PFS is defined as the time from the date of randomization to the earliest date of disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.
Objective Response Rate (ORR): Percentage of Participants Who Achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) Randomization until measured progressive disease (Up to 22 Months) ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Trial Locations
- Locations (133)
Taipei Tzu Chi General Hospital
🇨🇳New Taipei City, Taiwan
Regionshospitalet Gødstrup
🇩🇰Herning, Midtjylland, Denmark
Bacs-Kiskun Megyei Korhaz
ðŸ‡ðŸ‡ºKecskemét, Bács-Kiskun, Hungary
Ankara Gülhane Eitim ve Aratrma Hastanesi
🇹🇷Ankara, Turkey
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Providence Medical Foundation
🇺🇸Fullerton, California, United States
Cancer and Blood Specialty Clinic
🇺🇸Los Alamitos, California, United States
TRIO-US (Translational Research in Oncology-US)
🇺🇸Los Angeles, California, United States
Keck School of Medicine of USC
🇺🇸Los Angeles, California, United States
UCLA Hematology/Oncology - Parkside
🇺🇸Santa Monica, California, United States
Olive View-UCLA Medical Center
🇺🇸Sylmar, California, United States
Torrance Memorial Physician Network / Cancer Care
🇺🇸Torrance, California, United States
PIH Health Hematology Medical Oncology
🇺🇸Whittier, California, United States
Rocky Mountain Cancer Center - Hale Parkway
🇺🇸Denver, Colorado, United States
Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI
🇺🇸Sarasota, Florida, United States
Millennium Oncology Research Clinic
🇺🇸Hollywood, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
🇺🇸Miami, Florida, United States
Woodlands Medical Specialists, PA
🇺🇸Mesquite, Texas, United States
Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI
🇺🇸West Palm Beach, Florida, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Central Georgia Cancer Care
🇺🇸Macon, Georgia, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI
🇺🇸Baton Rouge, Louisiana, United States
Clinical Trials of SWLA
🇺🇸Lake Charles, Louisiana, United States
Central Maine Medical Center
🇺🇸Lewiston, Maine, United States
Mfsmc-Hjwci
🇺🇸Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A. - Clinton
🇺🇸Clinton, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸South Weymouth, Massachusetts, United States
MGH Northshore Cancer Center
🇺🇸Danvers, Massachusetts, United States
Southcoast Centers for Cancer Care
🇺🇸Fairhaven, Massachusetts, United States
Dana-Farber Cancer Institute - Foxborough
🇺🇸Foxboro, Massachusetts, United States
Dana Farber Cancer Center Merrimack Valley
🇺🇸Methuen, Massachusetts, United States
Mass General Cancer Center
🇺🇸Newton, Massachusetts, United States
Reliant Medical Group
🇺🇸Worcester, Massachusetts, United States
St. Vincent Frontier Cancer Center
🇺🇸Billings, Montana, United States
Dana Farber Cancer Center Londonderry
🇺🇸Londonderry, New Hampshire, United States
University of New Mexico Comprehensive Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Lifespan Cancer Institute
🇺🇸Providence, Rhode Island, United States
Tennessee Oncology-Chattanooga /Sarah Cannon Research Institute/SCRI
🇺🇸Chattanooga, Tennessee, United States
Sarah Cannon Research Institute/SCRI
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute/SCRI
🇺🇸Nashville, Tennessee, United States
Texas Oncology - Bedford
🇺🇸Bedford, Texas, United States
Texas Oncology - Denton
🇺🇸Denton, Texas, United States
Texas Oncology, P.A.
🇺🇸El Paso, Texas, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Texas Oncology - McKinney
🇺🇸McKinney, Texas, United States
Texas Oncology - Plano East
🇺🇸Plano, Texas, United States
Texas Oncology-Plano West
🇺🇸Plano, Texas, United States
Mays Cancer Center
🇺🇸San Antonio, Texas, United States
US Oncology
🇺🇸The Woodlands, Texas, United States
Texas Oncology - Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Intermountain Healthcare - St. George
🇺🇸Saint George, Utah, United States
The University of Vermont Medical Center Inc.
🇺🇸Burlington, Vermont, United States
Shenandoah Oncology, P.C.
🇺🇸Winchester, Virginia, United States
Fundación Respirar
🇦🇷Buenos Aires, Buenos Air, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina
Fundación Cenit Para La Investigación En Neurociencias
🇦🇷Caba, Ciudad Autónoma De Buenos Aires, Argentina
Instituto Médico RÃo Cuarto
🇦🇷RÃo Cuarto, Córdoba, Argentina
Centro Medico San Roque
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
CER San Juan
🇦🇷San Juan, Argentina
Algemeen Ziekenhuis klina
🇧🇪Brasschaat, Antwerpen, Belgium
Jessa Ziekenhuis
🇧🇪Hasselt, Limburg, Belgium
CHU UCL Namur/Site Sainte Elisabeth
🇧🇪Namur, Belgium
Multiscan
🇨🇿Pardubice, Pardubický Kraj, Czechia
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Herlev and Gentofte Hospital
🇩🇰Copenhagen, Hovedstaden, Denmark
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
🇫🇷Bordeaux, Aquitaine, France
CHRU de Brest
🇫🇷Brest, Finistère, France
Hôpital privé du Confluent SAS
🇫🇷Nantes, Loire-Atlantique, France
CHD Vendee
🇫🇷La Roche-sur-Yon, Vendée, France
University Hospital of Patras
🇬🇷Patras, Achaḯa, Greece
Alexandra Hospital
🇬🇷Athens, AttikÃ, Greece
University General Hospital of Heraklion
🇬🇷Heraklion, IrakleÃo, Greece
Euromedica General Clinic of Thessaloniki
🇬🇷Thessaloniki, Greece
Petz Aladar Egyetemi Oktato Korhaz
ðŸ‡ðŸ‡ºGyor, GyÅ‘r-Moson-Sopron, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
ðŸ‡ðŸ‡ºBudapest, Hungary
Országos Onkológiai Intézet
ðŸ‡ðŸ‡ºBudapest, Hungary
Soroka Medical Center
🇮🇱Be'er Sheva, HaDarom, Israel
Meir Medical Center
🇮🇱Kfar Saba, HaMerkaz, Israel
Rabin Medical Center
🇮🇱Petah-Tikva, HaMerkaz, Israel
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Tell Abīb, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Humanitas Istituto Clinico Catanese
🇮🇹Misterbianco, Catania, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
🇮🇹Meldola, Emilia-Romagna, Italy
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
🇮🇹Udine, Friuli-Venezia Giulia, Italy
Instituto Tumori Giovanni Paolo II
🇮🇹Bari, Italy
Ospedale Misericordia di Grosseto
🇮🇹Grosseto, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
ASL Viterbo Ospedale Belcolle
🇮🇹Viterbo, Italy
Seoul National University Bundang Hospital
🇰🇷Seongnam, Kyǒnggi-do, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Taegu-Kwangyǒkshi, Korea, Republic of
Centro de Investigacion en Artritis y Osteoporosis SC
🇲🇽Mexicali, Baja California, Mexico
COI Tijuana - Centro Oncológico Internacional
🇲🇽Tijuana, Baja California, Mexico
Centro Oncológico Internacional (COI)
🇲🇽Guadalajara, Jalisco, Mexico
Oncologico Potosino, S.C.
🇲🇽San Luis Potosi, San Luis PotosÃ, Mexico
Centro Regiomontano de Investigación
🇲🇽Monterrey, Nuevo León, Mexico
Europejskie Centrum Zdrowia - Oddzial Onkologii
🇵🇱Otwock, Mazowieckie, Poland
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
🇵🇱Opole, Opolskie, Poland
CHUAC-Hospital Teresa Herrera
🇪🇸A Coruña, A Coruña [La Coruña], Spain
Hospital Universitari Son Espases
🇪🇸Palma, Balears [Baleares], Spain
Parc de Salut Mar - Hospital del Mar
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital ClÃnic de Barcelona
🇪🇸Barcelona, Catalunya [Cataluña], Spain
Hospital ClÃnico Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Región De, Spain
H.R.U Málaga - Hospital Materno-infantil
🇪🇸Malaga, Málaga, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitari Sant Joan de Reus
🇪🇸Reus, Tarragona [Tarragona], Spain
Hospital Universitario Doctor Peset
🇪🇸Valencia, Valenciana, Comunitat, Spain
Hospital Infanta Cristina
🇪🇸Badajoz, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario de Toledo
🇪🇸Toledo, Spain
Karolinska Universitetssjukhuset Solna
🇸🇪Stockholm, Stockholms, Sweden
Universitetssjukhuset Örebro
🇸🇪Örebro, Örebro Län [se-18], Sweden
Chi Mei Medical Center
🇨🇳Tainan City, Tainan, Taiwan
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan
Izmir Medical Park Hospital
🇹🇷Karsiyaka, İzmir, Turkey
Necmettin Erbakan Meram Medical Fac.
🇹🇷Meram, Konya, Turkey
Adana City Hospital
🇹🇷Adana, Turkey
Memorial Ankara Hastanesi
🇹🇷Ankara, Turkey
Dicle Ãœniversitesi
🇹🇷Diyarbakir, Turkey
Trakya University
🇹🇷Edirne, Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
🇹🇷Istanbul, Turkey
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
🇹🇷Malatya, Turkey