A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer (eMonarcHER)
Breast Neoplasms
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Have confirmed HR+, HER2+ early invasive breast cancer without evidence of disease recurrence or distant metastases
- Have undergone definitive surgery of the primary breast tumor(s)
- Have tumor tissue from breast (preferred) or lymph node
- Have received a minimum of four cycles of chemotherapy in either the neoadjuvant or adjuvant setting per standard of care
- Have completed approximately nine to 20 months of standard HER2-targeted therapy (neoadjuvant/adjuvant combined duration)
Have received one of the following eligible HER2-targeted adjuvant regimens AND be randomized within 12 weeks of completing the regimen:
- For participants treated with neoadjuvant therapy and HER2-targeted therapy: A minimum of 4 cycles of T-DM1 in the adjuvant setting. NOTE: Participants may have received up to approximately 6 cycles of adjuvant trastuzumab prior to initiation of T-DM1. Additionally, participants may have switched to trastuzumab-based therapy (monotherapy or in combination with other HER2-targeted therapies) after 4 cycles of T-DM1
- For participants who had definitive surgery prior to systemic therapy, a minimum of 4 cycles of adjuvant pertuzumab with trastuzumab.
Have high risk disease, defined by one of the following criteria:
Those who received neoadjuvant chemotherapy along with HER2-targeted treatment must have:
- residual disease in at least one axillary lymph node, or
- a residual tumor ≥ 5 cm, or
- a residual tumor of any size that has direct extension to the chest wall and/or skin (ulceration or skin nodules).
Those who had definitive surgery prior to systemic therapy and completed adjuvant chemotherapy along with HER2-targeted therapies (trastuzumab and pertuzumab) must have
- tumor involvement in ≥4 ipsilateral axillary lymph nodes, or
- tumor involvement in 1 to 3 ipsilateral axillary lymph node(s) and histological Grade 3, or
- primary invasive tumor size of ≥ 5 cm on pathological evaluation.
Exclusion Criteria:
Have breast cancer with any of the following features:
- Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)
- Pathological complete response from any prior early breast cancer treatments. Participants are required to have residual primary tumor and/or lymph node disease at the time of definitive surgery as indicated in inclusion criteria.
- Inflammatory breast cancer
Have other medical conditions including:
- Previous breast cancer (Exceptions: Ipsilateral ductal carcinoma in situ [DCIS] treated by locoregional therapy alone ≥5 years ago; contralateral DCIS treated by locoregional therapy at any time)
- Other cancer being treated and/or not in complete remission within the last 5 years (Exceptions: Appropriately treated non-melanomatous skin cancer or carcinoma in situ of cervix, bladder, or colon)
- Females who are pregnant or lactating
- History of venous thromboembolism
- Other serious medical conditions
Have previously received treatment with:
- Any cyclin-dependent kinase (CDK)4 and CDK6 inhibitor
- Prior adjuvant treatment with immunotherapy, tucatinib, neratinib, any investigational HER2 directed therapy, or T-DXd (DS8201) for treatment of breast cancer
- Endocrine therapy (ET) (i.e., tamoxifen, raloxifene or aromatase inhibitor) for breast cancer prevention (without diagnosis of breast cancer)
- Additional chemotherapy, anti-cancer ET, or HER2-targeted therapy beyond standard of care at study enrollment
Sites / Locations
- USO-Southern Cancer Center, P.C.
- Palo Verde Cancer Specialists
- TRIO-US (Translational Research in Oncology-US)
- Millennium Oncology - Hollywood
- Florida Cancer Specialists - North
- Mt. Sinai Hospital PRiSMS
- Cornell-Beshore Cancer Institute
- The Valley Hospital
- Northwest Cancer Specialists PC
- Texas Oncology - Medical City Dallas
- US Oncology
- Instituto de Investigaciones Clínicas Mar del Plata
- Fundación Cenit Para La Investigación En Neurociencias
- Centro Medico Privado CEMAIC
- Centro Medico San Roque
- Fundación CORI para la Investigación y Prevención del Cáncer
- Sanatorio Parque
- CER San Juan
- CHU de Charleroi - Hopital Civil Marie Curie
- Jessa Ziekenhuis
- CHR Verviers - La Tourelle
- Clinique Saint Pierre
- Jan Yperman ziekenhuis
- AZ Delta vzw
- Instituto de Educação, Pesquisa e Gestão em Saúde
- NotreDame Intermedica Saude S.A
- Núcleo de Pesquisa Clínica da Rede São Camilo
- Instituto de Ensino e Pesquisa São Lucas
- Guangdong Provincial People's Hospital
- Hainan Cancer Hospital
- Tongji Medical College of Huazhong University of Science and Technology
- Hubei Cancer Hospital
- Xiangya Hospital Central South University
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
- The Third Hospital of Nanchang
- West China Hospital of Sichuan University
- Sichuan Cancer hospital
- Xinjiang Medical University Cancer Hospital - Urumqi
- The First Affiliated Hospital, Zhejiang University
- The First People's Hospital of Hangzhou
- Institut de Cancérologie de Lorraine Alexis Vautrin
- Centre Oscar Lambret
- Ospedale San Giovanni Moscati
- Ospedale Generale Provinciale Macerata
- Nagoya City University Hospital
- Gunma Prefectural Cancer Center
- Tsukuba University Hospital
- Ishikawa Prefectural Central Hospital
- St. Marianna University Hospital
- Juntendo University Hospital
- National Cancer Center Hospital
- Japanese Foundation for Cancer Research
- Showa University Hospital
- National Hospital Organization Kyushu Cancer Center
- Hiroshima University Hospital
- Kumamoto Shinto General Hospital
- National Hospital Organization Osaka Medical Center
- Shizuoka General Hospital
- St. Luke's International Hospital
- Inha University Hospital
- CHA Bundang Medical Center, CHA University
- Seoul National University Bundang Hospital
- Korea University Anam Hospital
- Severance Hospital, Yonsei University Health System
- Hospital Universitario de Canarias
- Brustzentrum Ostschweiz
- Kantonsspital Winterthur
- National Taiwan University Hospital
- Koo Foundation Sun Yat-Sen Cancer Center
- Chang Gung Medical Foundation-Linkou Branch
- Charing Cross Hospital
- Royal Marsden Hospital
- Ipswich Hospital
- Royal Marsden Hospital (Sutton)
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Abemaciclib Plus (+) Endocrine Therapy (ET)
Placebo + ET
Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label.
Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label.