Metastatic Breast Cancer Clinical Trial
— proMONARCHOfficial 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
| Verified date | September 2019 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Argentina, Austria, Belgium, Brazil, Germany, Italy, Puerto Rico, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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