JRCT ID: jRCT2041210026
Registered date:31/05/2021
A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Breast Neoplasms |
Date of first enrollment | 06/07/2021 |
Target sample size | 170 |
Countries of recruitment | Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,China,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Mexico,Japan,Puerto Rico,Japan,Romania,Japan,Russian Federation,Japan,Spain,Japan,Switzerland,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan |
Study type | Interventional |
Intervention(s) | Intervention Drug: Abemaciclib Administered orally. Other Name: LY2835219 Drug: Standard Adjuvant ET Administered according to label instructions. Drug: Placebo Administered orally. Study Arms -Experimental: Abemaciclib Plus (+) Endocrine Therapy (ET) Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label. Interventions: Drug: Abemaciclib Drug: Standard Adjuvant ET Active Comparator: Placebo + ET Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label. Interventions: Drug: Standard Adjuvant ET Drug: Placebo |
Outcome(s)
Primary Outcome | Invasive Disease Free Survival (IDFS) [ Time Frame: Randomization to Recurrence or Death from Any Cause (up to 10 Years) ] IDFS as defined by the STEEP System |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 (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 - 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. |
Exclude 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 |
Related Information
Primary Sponsor | Masaki Takeshi |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Trial Guide Call Center |
Address | 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086 |
Telephone | +81-120-023-812 |
LTG_CallCenter@lists.lilly.com | |
Affiliation | Eli Lilly Japan K.K. |
Scientific contact | |
Name | Takeshi Masaki |
Address | 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086 |
Telephone | +81-120-023-812 |
LTG_CallCenter@lists.lilly.com | |
Affiliation | Eli Lilly Japan K.K. |