A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

NCT02747004 | Active Not Recruiting Phase 2 Results

• 3 other identifiers: 16339I3Y-MC-JPCG2016-000288-18
• Study Type: interventional
• Target: 234
• Locations: 14 countries
• Sites: 59

Brief Summary

The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression-free survival time was measured from the date of randomization to the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause, whichever occurred first. Progressive disease (PD) is defined as 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. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.

  Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months)

Secondary Outcomes (9)

• Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)

  Baseline to Objective Disease Progression (Up to 21 Months)

• Duration of Response (DoR)

  Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 21 Months)

• Overall Survival (OS)

  Baseline to Death from Any Cause (Approximately 36 Months)

• Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites

  Cycle (C) 1 Day (D) 1 post dose

• Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites

  Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose

Study Arms (3)

Abemaciclib + Tamoxifen

EXPERIMENTAL

Abemaciclib given orally every 12 hours (Q12H) in combination with tamoxifen given orally every day. Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Abemaciclib; Drug: Tamoxifen

Abemaciclib

EXPERIMENTAL

Abemaciclib given orally Q12H. Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Abemaciclib

Abemaciclib + Prophylactic Loperamide

EXPERIMENTAL

Abemaciclib given orally Q12H in combination with prophylactic loperamide given orally. Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Abemaciclib; Drug: Prophylactic Loperamide

Interventions

Abemaciclib DRUG

Administered orally

Also known as: LY2835219

Abemaciclib; Abemaciclib + Prophylactic Loperamide; Abemaciclib + Tamoxifen

Tamoxifen DRUG

Administered orally

Abemaciclib + Tamoxifen

Prophylactic Loperamide DRUG

Administered orally

Abemaciclib + Prophylactic Loperamide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of HR+, HER2- breast cancer.
• Relapsed or progressed following endocrine therapy.
• Have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting.
• Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
• Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy.
• Have adequate organ function.
• Have negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective precautions to prevent pregnancy during the study and for 3 weeks following last dose of study treatment.
• Are able to swallow oral medication.

You may not qualify if:

• Have clinical evidence or history of central nervous system metastasis.
• Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
• Have active bacterial or fungal infection (that is, requiring intravenous antibiotics at the time of initiating study treatment) and/or detectable viral infection.
• Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6 inhibitor.
• Have a preexisting chronic condition resulting in persistent diarrhea.
• Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (59)

The University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

University of Wisconsin Clinical Research Center

Madison, Wisconsin, 53705, United States

Location

CENIT Centro de Neurociencias, Investigación y Tratamiento

CABA, Buenos Aires, C1125ABD, Argentina

Location

Fundacion Ars Medica

San Salvador de Jujuy, Jujuy Province, Y4600APW, Argentina

Location

Clinica Viedma

Viedma, Río Negro Province, R8500ACE, Argentina

Location

Instituto de Oncología de Rosario

Rosario, Santa Fe Province, S2000KZE, Argentina

Location

Centro Para la Atención Integral del Paciente Oncologico (CAIPO)

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Sanatorio Parque

Salta, 4400, Argentina

Location

Medizinische Universitaet Graz

Graz, Styria, 8036, Austria

Location

Universitätsklinik Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

AKH

Vienna, 1090, Austria

Location

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

VITAZ

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

Grand Hopital de Charleroi-Site Notre-Dame

Charleroi, 6000, Belgium

Location

Centre Hospitalier Universitaire Sart Tilman

Liège, 4000, Belgium

Location

Hospital São Lucas - PUCRS - ONCOLOGY

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, 14784400, Brazil

Location

Icesp - Instituto Do Câncer Do Estado de São Paulo

São Paulo, 01246000, Brazil

Location

Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA

São Paulo, 01317-000, Brazil

Location

Masarykuv onkologicky ustav

Brno, Czech Republic, 656 53, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Fakultni Poliklinika VFN

Prague, 128 08, Czechia

Location

Fakultni Nemocnice v Motole

Prague, 150 06, Czechia

Location

Thomayerova nemocnice

Praha 4 - Krc, 140 59, Czechia

Location

Centre Oscar Lambret

Lille, Hauts-de-France, 59020, France

Location

Institut Paoli-Calmettes

Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France

Location

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Kath. Marienkrankenhaus gGmbH

Hamburg, 22087, Germany

Location

Polic.Umberto I -Univ. La Sapienza

Roma, Rome, 00161, Italy

Location

Ospedale Sacro Cuore Don G. Calabria

Negrar, Verona, 37024, Italy

Location

Ospedale Bellaria - Azienda USL di Bologna

Bologna, 40139, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Naples, 80131, Italy

Location

Neurociencias Estudios Clinicos

Culiacán, Sinaloa, 80020, Mexico

Location

Centro Hemato Oncologico Privado

San Bernardino, Toluca, 50080, Mexico

Location

Grupo Medico Camino Sc

Mexico City, 03310, Mexico

Location

Oaxaca Site Management Organization

Oaxaca City, 68000, Mexico

Location

Republic Oncology Dispensary of MoH of Republic Tatarstan

Kazan', 420029, Russia

Location

St-Petersburg scientifical practical center of specialized medical care

Saint Petersburg, 197758, Russia

Location

Saint-Petersburg city clinical oncology dispensary

Saint Petersburg, 198255, Russia

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, 28034, Spain

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Memorial Hospital - Linkou

Taoyuan, 33305, Taiwan

Location

Erciyes University Faculty of Medicine

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

Baskent University Dr. Turgut Noyan Research and Training Center

Adana, 1250, Turkey (Türkiye)

Location

Hacettepe University Faculty of Medicine

Ankara, 06100, Turkey (Türkiye)

Location

Medipol Mega University Hospital

Istanbul, 34214, Turkey (Türkiye)

Location

Marmara University Medical Faculty

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (1)

• Hamilton E, Cortes J, Ozyilkan O, Chen SC, Petrakova K, Manikhas A, Jerusalem G, Hegg R, Huober J, Zhang W, Chen Y, Martin M. nextMONARCH Phase 2 randomized clinical trial: overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with endocrine-refractory HR + , HER2- metastatic breast cancer. Breast Cancer Res Treat. 2022 Aug;195(1):55-64. doi: 10.1007/s10549-022-06662-9. Epub 2022 Jul 12.

  PMID: 35829935 DERIVED

Related Links

• A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (nextMONARCH 1)

MeSH Terms

Conditions

Breast Neoplasms

Interventions

abemaciclib; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 21, 2016
• Study Start: September 14, 2016
• Primary Completion: June 15, 2018
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2026
• Results First Posted: July 12, 2019

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

IT (4); RU (3); BE (4); TW (5); AR (6); AU (3); DE (2); US (5); BR (4); CZ (5); FR (2); ME (4); TU (5); ES (7)