Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

Phase 3

Active, not recruiting

• Conditions: Neoplasm Metastasis; Breast Neoplasm
• Interventions: Drug: Abemaciclib; Drug: Fulvestrant; Drug: Placebo

• 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

Study Timeline

• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2021-12-22
• Study First Posted: 2021-12-27
• Study Start: 2022-03-11
• Primary Completion: 2024-02-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Abemaciclib plus Fulvestrant	Abemaciclib	Abemaciclib administered orally in combination with fulvestrant administered intramuscularly (IM).
Arm B: Placebo plus Fulvestrant	Placebo	Placebo administered orally in combination with fulvestrant administered IM.
Arm B: Placebo plus Fulvestrant	Fulvestrant	Placebo administered orally in combination with fulvestrant administered IM.
Arm A: Abemaciclib plus Fulvestrant	Fulvestrant	Abemaciclib administered orally in combination with fulvestrant administered intramuscularly (IM).

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 (estimated as up to 3 years)	Investigator assessment

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DoR)	Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)	DoR
PFS	Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)	Blinded independent review
Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks	Randomization until measured progressive disease (estimated as up to 1 year)	CBR
Time to Deterioration in Physical Function	Randomization through Follow-up (estimated as up to 3 years)	Physical Function scale includes five items (trouble with strenuous activities; trouble with long walk; trouble with short walk; need to stay in bed or chair; need help with eating, dressing, washing, toilet) in the European Organization for Research and Treatment of Cancer Item Library 19 (EORTC-19). Response options range from 0 ("not all") to 4 ("very much.") Higher composite scale scores indicate higher function.
Overall Survival (OS)	Randomization until death from any cause (estimated as up to 5 years)	OS
Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)	Randomization until measured progressive disease (estimated as up to 1 year)	ORR
Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"	Randomization through Follow-up (estimated as up to 3 years)	The mBPI-sf "Worst pain" is a single self-reported item that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and stable disease (SD)	Randomization until measured progressive disease (estimated as up to 1 year)	DCR: Percentage of Participants with a Best Overall Response of CR, PR, and SD
Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib	Day 1 of Cycle 3 (Cycle = 28 days)	PK: Mean Steady State Concentrations of Abemaciclib

Trial Locations

Locations (133)

Taipei Tzu Chi General Hospital; 🇨🇳 New Taipei City, Taiwan

Regionshospitalet Gødstrup; 🇩🇰 Herning, Midtjylland, Denmark

Bacs-Kiskun Megyei Korhaz; 🇭🇺 Kecskemét, 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 Río Cuarto; 🇦🇷 Río 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, Attikí, Greece

University General Hospital of Heraklion; 🇬🇷 Heraklion, Irakleío, Greece

Euromedica General Clinic of Thessaloniki; 🇬🇷 Thessaloniki, Greece

Petz Aladar Egyetemi Oktato Korhaz; 🇭🇺 Gyor, Győr-Moson-Sopron, Hungary

Magyar Honvedseg Egeszsegugyi Kozpont; 🇭🇺 Budapest, Hungary

Országos Onkológiai Intézet; 🇭🇺 Budapest, 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 Potosí, 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 Clínic de Barcelona; 🇪🇸 Barcelona, Catalunya [Cataluña], Spain

Hospital Clínico 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 Üniversitesi; 🇹🇷 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