A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
- Conditions
- Breast Neoplasms
- Interventions
- Registration Number
- NCT04752332
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 111
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Have confirmed HR+, HER2+ early invasive breast cancer without evidence of disease recurrence or distant metastases
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Have undergone definitive surgery of the primary breast tumor(s)
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Have tumor tissue from breast (preferred) or lymph node
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Have received a minimum of four cycles of chemotherapy in either the neoadjuvant or adjuvant setting per standard of care
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Have completed approximately nine to 20 months of standard HER2-targeted therapy (neoadjuvant/adjuvant combined duration)
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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.
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Have high risk disease, defined by one of the following criteria:
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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.
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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
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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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 150 mg Abemaciclib + Endocrine Therapy (ET) Abemaciclib Participants received 150 milligrams (mg) of abemaciclib administered twice daily (BID) orally along with standard adjuvant endocrine therapy (ET). 150 mg Abemaciclib + Endocrine Therapy (ET) Standard Adjuvant ET Participants received 150 milligrams (mg) of abemaciclib administered twice daily (BID) orally along with standard adjuvant endocrine therapy (ET). Placebo + ET Standard Adjuvant ET Participants received placebo administered BID orally along with standard adjuvant ET. Placebo + ET Placebo Participants received placebo administered BID orally along with standard adjuvant ET.
- Primary Outcome Measures
Name Time Method Invasive Disease Free Survival (IDFS) Randomization to Recurrence or Death from Any Cause (up to 890 days) IDFS, as defined by the STEEP System, is measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Randomization to Death from Any Cause (up to 890 days) OS is defined as the time from randomization until death from any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Distant Relapse-Free Survival (DRFS) Randomization to Distant Recurrence or Death from Any Cause (up to 890 days) DRFS is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first.
Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.Percentage of Participants With Central Nervous System (CNS) Metastases as First Site of Disease Recurrence Randomization to Distant Recurrence or Death from Any Cause (up to 890 days) Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score Cycle 1 up to 390 days The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation will be applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Change From Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score Cycle 1 up to 390 days The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which are anchored on a scale of 0 to 1 with a higher score representing better health status. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib Day 1 of Cycles 1-3 (Cycle = 28 days) Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Trial Locations
- Locations (114)
Palo Verde Cancer Specialists
🇺🇸Glendale, Arizona, United States
TRIO-US (Translational Research in Oncology-US)
🇺🇸Los Angeles, California, United States
Millennium Oncology - Hollywood
🇺🇸Hollywood, Florida, United States
Florida Cancer Specialists - North
🇺🇸Saint 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
🇺🇸The Woodlands, Texas, United States
Northwest Cancer Specialists PC
🇺🇸The Woodlands, Texas, United States
Scroll for more (104 remaining)Palo Verde Cancer Specialists🇺🇸Glendale, Arizona, United States