A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer

Metastatic Breast Cancer Clinical Trial

— proMONARCH

Official title:
A Single-Arm, Global, Phase 4 Study of Abemaciclib, a CDK 4 & 6 Inhibitor, in Combination With Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer With Poor Prognostic Factors

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number	NCT03988114
Other study ID #	17395
Secondary ID	I3Y-MC-JPCX2019-
Status	Withdrawn
Phase	Phase 4
First received
Last updated
Start date	September 16, 2019
Est. completion date	March 23, 2023

Study information
Verified date	September 2019
Source	Eli Lilly and Company
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial Summary

The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) advanced breast cancer that have certain disease characteristics.

Recruitment information / eligibility
Status	Withdrawn
Enrollment	0
Est. completion date	March 23, 2023
Est. primary completion date	March 23, 2022
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	Inclusion Criteria: - Participants must have completed (neo) adjuvant endocrine therapy and have cancer return after at least 12 months or have de novo cancer that has spread to other organs at diagnosis - Participants must have 1 or more of the following: - A high grade tumor in tissue - Negative progesterone receptor (PR) status - Have cancer that has spread to the liver - Have a treatment-free interval (TFI) <36 months - Participants must have HR+, HER2- breast cancer - Participants must have adequate organ function Exclusion Criteria: - Participants must not have cancer that has spread to other organs that has severely affected their function - Participants must not have cancer that has spread to the brain that is unstable or untreated - Participants must not have received endocrine therapy in the metastatic setting - Participants must not have known active infection - Participants must not have received prior endocrine therapy and had disease return within 12 months from completion of treatment - Participants must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 & 6 inhibitor or everolimus

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Abemaciclib
Administered orally
• Nonsteroidal Aromatase Inhibitor (NSAI)
Letrozole administered orally or anastrozole administered orally (physician choice)

Locations
Country	Name	City	State
Argentina	Centro de Oncologia e Investigacion Buenos Aires	Berazategui	Buenos Aires
Argentina	CEMEDIC	Caba	Buenos Aires
Argentina	CENIT Centro de Neurociencias, Investigación y Tratamiento	Caba	Ciudad Autonoma Buenos Aires
Argentina	Clinica Adventista de Belgrano	Ciudad Autonoma Buenos Aires
Argentina	Sanatorio Parque	Salta
Argentina	Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan	San Juan
Argentina	Centro Medico San Roque	San Miguel de Tucumán	Tucuman
Argentina	Centro para la Atencion Integral del Paciente Oncologico	Tucumain
Austria	Universitätsklinikum Graz	Graz	Steiermark
Austria	Universitätsklinik Innsbruck	Innsbruck	Tirol
Austria	Universitätsklinikum Salzburg	Salzburg
Austria	AKH	Wien
Belgium	Algemeen Ziekenhuis St Jan Brugge	Brugge
Belgium	Hopital De Jolimont	Haine-St.- Paul
Belgium	VZW REgional Ziekenhuis Jan Yperman	Ieper
Belgium	Clinique Saint Pierre Ottignies	Ottignies
Brazil	Fundação PIO XII	Barretos	Sao Paulo
Brazil	Hospital de Caridade Ijui	Ijui	Rio Grande Do Sul
Brazil	Hospital Bruno Born de Lajeado	Lajeado	RS
Brazil	Instituto de Cancer de Londrina	Londrina	Parana
Brazil	Hospital São Lucas - PUCRS - ONCOLOGY	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da FMRP	Ribeirao Preto	São Paulo
Brazil	INCA - Instituto Nacional Do Cancer	Rio de Janeiro
Brazil	Instituto COI de Pesquisa Educação e Gestão	Rio de Janeiro	RJ
Brazil	Núcleo de Oncologia da Bahia	Salvador	Bahia
Brazil	Faculdade de Medicina do ABC	Santo Andre	SP
Brazil	Hospital de Base Fac de Medicina de Sao Jose do Rio Preto	Sao Jose Rio Preto	Sao Paulo
Brazil	Fundacao Antonio Prudente-Hosp. do Cancer AC Camargo	Sao Paulo
Brazil	Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária	São Paulo
Brazil	Clinica Onco Star	São Paulo
Brazil	Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology	São Paulo
Germany	Hämatologisch-Onkologische Praxis Augsburg	Augsburg	Bavaria
Germany	Universität Leipzig - Universitätsklinikum	Leipzig	Sachsen
Germany	St. Vincenz-Krankenhaus GmbH-Frauen- und Kinderklinik St. Louise	Paderborn
Italy	Policlinico S. Orsola Malpighi - Universita di Bologna	Bologna
Italy	Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro	Candiolo	Torino
Italy	Azienda Ospedaliera Universitaria Ospedale San Martino di Genova	Genova
Italy	IRCCS Ospedale San Raffaele	Milano
Italy	Istituto Tumori Fondazione G. Pascale IRCCS	Napoli	Naples
Italy	Istituto Oncologico Veneto	Padova
Italy	Centro di Riferimento Oncologico	Udine
Puerto Rico	Puerto Rico Hematology/Oncology Group	Bayamon
Puerto Rico	Ad-Vance Medical Research	Ponce
Taiwan	E-DA Cancer Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Koo Foundation Sun Yan-Sen Cancer Center	Taipei
Taiwan	MacKay Memorial Hospital	Taipei
United States	Texas Oncology - Abilene	Abilene	Texas
United States	Texas Oncology - Amarillo	Amarillo	Texas
United States	Texas Oncology-Arlington South	Arlington	Texas
United States	Texas Oncology Cancer Center	Austin	Texas
United States	Texas Oncology - Bedford	Bedford	Texas
United States	Charleston Hematology Oncology Associates	Charleston	South Carolina
United States	BayCare Medical Group	Clearwater	Florida
United States	Memorial Hospital	Colorado Springs	Colorado
United States	Texas Oncology - Dallas Presbyterian Hospital	Dallas	Texas
United States	Texas Oncology - Marnie McFadden Ward Cancer Center	Dallas	Texas
United States	Texas Oncology - Medical City Dallas	Dallas	Texas
United States	Texas Oncology P.A.	Dallas	Texas
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Southern Cancer Center, P.C.	Daphne	Alabama
United States	Texas Oncology P.A.	El Paso	Texas
United States	Texas Oncology Flower Mound	Flower Mound	Texas
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Compassionate Cancer Care Medical Group Inc	Fountain Valley	California
United States	Hematology Oncology Associates of Fredericksburg Inc.	Fredericksburg	Virginia
United States	California Cancer Associates Research and Excellence (cCARE)	Fresno	California
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Beaver Medical Group	Highland	California
United States	Abington Hematology Oncology Associates	Horsham	Pennsylvania
United States	Renovatio Clinical	Houston	Texas
United States	Texas Oncology-Memorial City	Houston	Texas
United States	Community Health Network	Indianapolis	Indiana
United States	Broome Oncology LLC	Johnson City	New York
United States	HCA Midwest	Kansas City	Missouri
United States	Central Maine Medical Center	Lewiston	Maine
United States	Rocky Mountain Cancer Center	Lone Tree	Colorado
United States	Texas Oncology - McAllen	McAllen	Texas
United States	Texas Oncology-McKinney	McKinney	Texas
United States	Texas Oncology- Mesquite	Mesquite	Texas
United States	Texas Oncology - Midland Allison Cancer Center	Midland	Texas
United States	Pacific Cancer Care	Monterey	California
United States	Sarah Cannon Research Institute SCRI	Nashville	Tennessee
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	Medical Oncology Hematology Consultants, PA	Newark	Delaware
United States	Illinois Cancer Specialists-Niles	Niles	Illinois
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Oncology Hematology West	Omaha	Nebraska
United States	St. Joseph Hospital	Orange	California
United States	Comprehensive Cancer Centers of the Desert	Palm Springs	California
United States	Valley Health System	Paramus	New Jersey
United States	Texas Oncology - Paris	Paris	Texas
United States	Woodlands Medical Specialists	Pensacola	Florida
United States	Texas Oncology-Plano East	Plano	Texas
United States	Texas Oncology-Plano West	Plano	Texas
United States	Cancer Specialists of North Florida -St Augustine	Saint Augustine	Florida
United States	Intermountain Medical Center	Saint George	Utah
United States	Florida Cancer Specialists	Saint Petersburg	Florida
United States	Oncology and Hematology Associates of Southwest Virginia Inc	Salem	Virginia
United States	Texas Oncology - San Antonio Medical Center	San Antonio	Texas
United States	California Cancer Associates in Research and Excellence	San Marcos	California
United States	Cancer Center of Santa Barbara with Sansum Clinic	Santa Barbara	California
United States	Summit Cancer Care	Savannah	Georgia
United States	Texas Oncology-Sherman	Sherman	Texas
United States	Florida Cancer Specialists	Tallahassee	Florida
United States	Arizona Oncology Associates, P.C.	Tempe	Arizona
United States	US Oncology	The Woodlands	Texas
United States	UCLA Medical Center	Torrance	California
United States	Tyler Cancer Center	Tyler	Texas
United States	Texas Oncology-Deke Slayton Cancer Center	Webster	Texas
United States	Florida Cancer Specialists	West Palm Beach	Florida
United States	Cleveland Clinic of Florida	Weston	Florida
United States	Texas Oncology-Wichital Falls Texoma Cancer Center	Wichita Falls	Texas
United States	Shenandoah Oncology, P.C.	Winchester	Virginia
United States	York Hospital	York	Maine

Sponsors *(1)*
Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States, Argentina, Austria, Belgium, Brazil, Germany, Italy, Puerto Rico, Taiwan,

Outcome
Type	Measure	Description	Time frame
Primary	Progression Free Survival (PFS)	PFS	Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)
Primary	Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)	ORR	Baseline to Objective Disease Progression (Estimated up to 26 Months)
Secondary	Duration of Response (DoR)	DoR	Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months)
Secondary	Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD)	DCR	Baseline to Objective Disease Progression (Estimated up to 26 Months)
Secondary	Clinical Benefit Rate (CBR): Proportion of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months	CBR	Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months)
Secondary	Time to Response (TTR)	TTR	Baseline to Date of CR or PR (Estimated up to 26 Months)

See also
Status	Clinical Trial	Phase
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Terminated	`NCT02202746` - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer	Phase 2
Completed	`NCT02506556` - Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer	Phase 2
Recruiting	`NCT05534438` - A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer	Phase 2
Recruiting	`NCT03368729` - Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer	Phase 1/Phase 2
Completed	`NCT04103853` - Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer	Phase 1
Terminated	`NCT01847599` - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib	N/A
Active, not recruiting	`NCT03147287` - Palbociclib After CDK and Endocrine Therapy (PACE)	Phase 2
Not yet recruiting	`NCT06062498` - Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer	Phase 2
Recruiting	`NCT05383196` - Onvansertib + Paclitaxel In TNBC	Phase 1/Phase 2
Recruiting	`NCT04095390` - A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer	Phase 2
Active, not recruiting	`NCT04432454` - Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation	Phase 2
Recruiting	`NCT03323346` - Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer	Phase 2
Recruiting	`NCT05744375` - Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab	Phase 2
Completed	`NCT02924883` - A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy	Phase 2
Completed	`NCT01942135` - Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)	Phase 3
Completed	`NCT01881230` - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)	Phase 2/Phase 3
Active, not recruiting	`NCT04448886` - Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC	Phase 2
Completed	`NCT01401959` - Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy	Phase 2
Terminated	`NCT04720664` - Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer	Phase 2

External Links