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

Neoplasm Metastasis Clinical Trial

— postMONARCH  

Official title:

postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05169567
• Other study ID #: 18238
• Secondary ID: I3Y-MC-JPEF2021-
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 11, 2022
• Est. completion date: February 16, 2026

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 368
• Est. completion date: February 16, 2026
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• Abemaciclib
Administered orally.
• Fulvestrant
Administered IM.
• Placebo
Administered orally.

Locations

Country	Name	City	State
Argentina	Fundación Respirar	Buenos Aires	Buenos Air
Argentina	Fundación Cenit Para La Investigación En Neurociencias	Caba	Ciudad Autónoma De Buenos Aires
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Air
Argentina	Instituto Médico Río Cuarto	Río Cuarto	Córdoba
Argentina	CER San Juan	San Juan
Argentina	Centro Medico San Roque	San Miguel de Tucumán	Tucumán
Belgium	Algemeen Ziekenhuis klina	Brasschaat	Antwerpen
Belgium	CHU UCL Namur/Site Sainte Elisabeth	Namur
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Multiscan	Pardubice	Pardubický Kraj
Denmark	Herlev and Gentofte Hospital	Copenhagen	Hovedstaden
Denmark	Regionshospitalet Herning	Herning	Midtjylland
France	Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest	Bordeaux	Aquitaine
France	Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan	Brest	Bretagne
France	CHD Vendee	La Roche-sur-Yon	Vendée
France	Hôpital privé du Confluent SAS	Nantes	Loire-Atlantique
Greece	Alexandra Hospital	Athens	Attikí
Greece	University General Hospital of Heraklion	Heraklion	Irakleío
Greece	University Hospital of Patras	Patras	Acha?a
Greece	Euromedica General Clinic of Thessaloniki	Thessaloniki
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Országos Onkológiai Intézet	Budapest
Hungary	Petz Aladar Egyetemi Oktato Korhaz	Gyor	Gyor-Moson-Sopron
Hungary	Bacs-Kiskun Varmegyei Oktatokorhaz	Kecskemét	Bács-Kiskun
Israel	Soroka Medical Center	Be'er Sheva	HaDarom
Israel	Hadassah Medical Center	Jerusalem	Yerushalayim
Israel	Rabin Medical Center	Petah-Tikva	HaMerkaz
Israel	Sheba Medical Center	Ramat Gan	HaMerkaz
Israel	Sourasky Medical Center	Tel Aviv	Tell Abib
Italy	Instituto Tumori Giovanni Paolo II	Bari
Italy	Ospedale Misericordia di Grosseto	Grosseto
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori	Meldola	Emilia-Romagna
Italy	Ospedale San Raffaele	Milano
Italy	P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale	Udine	Friuli-Venezia Giulia
Italy	ASL Viterbo Ospedale Belcolle	Viterbo
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu	Taegu-Kwangyokshi
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi-do
Korea, Republic of	Korea University Anam Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Mexico	Centro Oncológico Internacional (COI)	Guadalajara	Jalisco
Mexico	Centro de Investigacion en Artritis y Osteoporosis SC	Mexicali	Baja California
Mexico	Centro Regiomontano de Investigación	Monterrey	Nuevo León
Mexico	Oncologico Potosino, S.C.	San Luis Potosi	San Luis Potosí
Mexico	COI Tijuana - Centro Oncológico Internacional	Tijuana	Baja California
Poland	Europejskie Centrum Zdrowia - Oddzial Onkologii	Otwock	Mazowieckie
Spain	CHUAC-Hospital Teresa Herrera	A Coruña	A Coruña [La Coruña]
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Clínic de Barcelona	Barcelona	Catalunya [Cataluña]
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar	Murcia, Región De
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	H.R.U Málaga - Hospital Materno-infantil	Malaga	Málaga
Spain	Hospital Universitari Son Espases	Palma	Balears [Baleares]
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Universitari Sant Joan de Reus	Reus	Tarragona [Tarragona]
Spain	Hospital Universitario de Toledo	Toledo
Spain	Hospital Universitario Doctor Peset	Valencia	Valenciana, Comunitat
Sweden	Universitetssjukhuset Örebro	Örebro	Örebro Län [se-18]
Sweden	Karolinska Universitetssjukhuset Solna	Stockholm	Stockholms
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	Taipei Tzu Chi General Hospital	New Taipei City
Taiwan	Chi Mei Medical Center	Tainan City	Tainan
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan
Turkey	Adana City Hospital	Adana
Turkey	Gulhane Egitim Arastirma Hastanesi	Ankara
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	Izmir Medical Park Hospital	Karsiyaka	Izmir
Turkey	Inönü Üniversitesi Turgut Özal Tip Merkezi Egitim ve Arastirma Hastanesi	Malatya
Turkey	Necmettin Erbakan Meram Medical Fac.	Meram	Konya
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico
United States	Mfsmc-Hjwci	Baltimore	Maryland
United States	Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI	Baton Rouge	Louisiana
United States	Texas Oncology - Bedford	Bedford	Texas
United States	St. Vincent Frontier Cancer Center	Billings	Montana
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The University of Vermont Medical Center Inc.	Burlington	Vermont
United States	Tennessee Oncology-Chattanooga /Sarah Cannon Research Institute/SCRI	Chattanooga	Tennessee
United States	Maryland Oncology Hematology, P.A. - Clinton	Clinton	Maryland
United States	MGH Northshore Cancer Center	Danvers	Massachusetts
United States	Texas Oncology - Denton	Denton	Texas
United States	Rocky Mountain Cancer Center - Hale Parkway	Denver	Colorado
United States	Texas Oncology, P.A.	El Paso	Texas
United States	Southcoast Centers for Cancer Care	Fairhaven	Massachusetts
United States	Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI	Fort Myers	Florida
United States	Dana-Farber Cancer Institute - Foxborough	Foxboro	Massachusetts
United States	Providence Medical Foundation	Fullerton	California
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Millennium Oncology - Hollywood	Hollywood	Florida
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Clinical Trials of SWLA	Lake Charles	Louisiana
United States	Central Maine Medical Center	Lewiston	Maine
United States	Dana Farber Cancer Center Londonderry	Londonderry	New Hampshire
United States	Cancer and Blood Specialty Clinic	Los Alamitos	California
United States	Keck School of Medicine of USC	Los Angeles	California
United States	TRIO-US (Translational Research in Oncology-US)	Los Angeles	California
United States	Central Georgia Cancer Care	Macon	Georgia
United States	Texas Oncology - McKinney	McKinney	Texas
United States	Woodlands Medical Specialists, PA	McKinney	Texas
United States	Woodlands Medical Specialists, PA	Mesquite	Texas
United States	Dana Farber Cancer Center Merrimack Valley	Methuen	Massachusetts
United States	University of Miami Hospital and Clinics, Sylvester Cancer Center	Miami	Florida
United States	Dana Farber Cancer Institute	Milford	Massachusetts
United States	Intermountain Medical Center	Murray	Utah
United States	Sarah Cannon Research Institute/SCRI	Nashville	Tennessee
United States	Tennessee Oncology-Nashville/Sarah Cannon Research Institute/SCRI	Nashville	Tennessee
United States	Mass General Cancer Center	Newton	Massachusetts
United States	Woodlands Medical Specialists, PA	Pensacola	Florida
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Texas Oncology - Plano East	Plano	Texas
United States	Texas Oncology-Plano West	Plano	Texas
United States	Lifespan Cancer Institute	Providence	Rhode Island
United States	Intermountain Healthcare - St. George	Saint George	Utah
United States	Mays Cancer Center	San Antonio	Texas
United States	UCLA Hematology/Oncology - Parkside	Santa Monica	California
United States	Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI	Sarasota	Florida
United States	Dana Farber Cancer Institute	South Weymouth	Massachusetts
United States	Olive View-UCLA Medical Center	Sylmar	California
United States	US Oncology	The Woodlands	Texas
United States	Torrance Memorial Physician Network / Cancer Care	Torrance	California
United States	Texas Oncology - Tyler Cancer Center	Tyler	Texas
United States	Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI	West Palm Beach	Florida
United States	PIH Health Hematology Medical Oncology	Whittier	California
United States	Shenandoah Oncology, P.C.	Winchester	Virginia
United States	Reliant Medical Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Czechia,  Denmark,  France,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Mexico,  Poland,  Spain,  Sweden,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	Investigator assessment	Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
Secondary	Overall Survival (OS)	OS	Randomization until death from any cause (estimated as up to 5 years)
Secondary	PFS	Blinded independent review	Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)
Secondary	Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)	ORR	Randomization until measured progressive disease (estimated as up to 1 year)
Secondary	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	CBR	Randomization until measured progressive disease (estimated as up to 1 year)
Secondary	Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and stable disease (SD)	DCR: Percentage of Participants with a Best Overall Response of CR, PR, and SD	Randomization until measured progressive disease (estimated as up to 1 year)
Secondary	Duration of Response (DoR)	DoR	Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)
Secondary	Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"	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).	Randomization through Follow-up (estimated as up to 3 years)
Secondary	Time to Deterioration in Physical Function	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.	Randomization through Follow-up (estimated as up to 3 years)
Secondary	Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib	PK: Mean Steady State Concentrations of Abemaciclib	Day 1 of Cycle 3 (Cycle = 28 days)

External Links

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