A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Breast Neoplasms

In brief

The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.

Key facts

Study ID: NCT04752332
Run by: Eli Lilly and Company
People needed: 111
Starts: 2021-05-10
Expected to finish: 2024-06-26
Last updated by the study team: 2025-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

TRIO-US (Translational Research in Oncology-US) — Los Angeles, California, United States
Millennium Oncology - Hollywood — Hollywood, Florida, United States
Florida Cancer Specialists - North — St. Petersburg, Florida, United States
Mt. Sinai Hospital PRiSMS — Chicago, Illinois, United States
Cornell-Beshore Cancer Institute — Joplin, Missouri, United States
The Valley Hospital — Ridgewood, New Jersey, United States
Sarah Cannon Research Institute SCRI — Nashville, Tennessee, United States
Texas Oncology - Medical City Dallas — Dallas, Texas, United States
Northwest Cancer Specialists PC — The Woodlands, Texas, United States
Texas Oncology - Medical City Dallas — The Woodlands, Texas, United States
US Oncology — The Woodlands, Texas, United States
USO-Southern Cancer Center, P.C. — The Woodlands, Texas, United States
Instituto de Investigaciones Clínicas Mar del Plata — Mar del Plata, Buenos Aires, Argentina
Fundación Cenit Para La Investigación En Neurociencias — CABA, Buenos Aires F.D., Argentina
Centro Medico Privado CEMAIC — Capital, Córdoba Province, Argentina
Centro Medico San Roque — San Miguel de Tucumán, Tucumán Province, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer — La Rioja, Argentina
Sanatorio Parque — Salta, Argentina
CER San Juan — San Juan, Argentina
Calvary Mater Newcastle — Waratah, New South Wales, Australia
Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
Medizinische Universität Wien — Vienna, State of Vienna, Austria
Ordensklinikum Linz — Linz, Upper Austria, Austria
AZ Maria Middelares — Ghent, Oost-Vlaanderen, Belgium
Palo Verde Cancer Specialists — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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