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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2033
  • participants needed
    2450
  • sponsor
    Eli Lilly and Company
Updated on 12 September 2021
hormone therapy
pertuzumab
HER2
trastuzumab
erbb2
invasive breast cancer

Summary

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.

Details
Condition Breast Cancer, breast tumors, tumor of the breast, breast tumor
Treatment Placebo, Abemaciclib, Standard Adjuvant ET
Clinical Study IdentifierNCT04752332
SponsorEli Lilly and Company
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Have confirmed HR+, HER2+ in initial diagnostic tissue, 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 therapy
Have completed approximately nine months to one year of standard HER2-targeted therapy without evidence of disease recurrence (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 (chemotherapy administered with HER2-targeted therapy): Single agent adjuvant ado-trastuzumab emtansine or
For participants not treated with neoadjuvant therapy: Adjuvant pertuzumab with trastuzumab
Have high risk disease, defined by one of the following
For participants treated with neoadjuvant therapy (as defined above): Pathologically detected axillary nodal disease in the surgical specimen
For participants not treated with neoadjuvant therapy: Axillary node positive disease meeting one of the following criteria
Pathological tumor involvement in greater than or equal to () four ipsilateral axillary lymph nodes OR
Pathological tumor involvement in one to three ipsilateral axillary lymph node(s) and at least 1 of the following criteria
Histological Grade 3
Primary invasive tumor size 5 centimeters determined pathologically

Exclusion Criteria

Have breast cancer with any of the following features
Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)
Lymph node-negative status
Pathological complete response from any prior systemic treatments for early breast cancer
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, investigational HER2 directed therapy, or trastuzumab deruxtecan 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 therapy for their breast cancer at study enrollment
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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