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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
111
Administered orally.
Administered according to label instructions.
Administered orally.
Invasive Disease Free Survival (IDFS)
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.
Time frame: Randomization to Recurrence or Death from Any Cause (up to 890 days)
Overall Survival (OS)
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.
Time frame: Randomization to Death from Any Cause (up to 890 days)
Distant Relapse-Free Survival (DRFS)
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.
Time frame: Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)
Percentage of Participants With Central Nervous System (CNS) Metastases as First Site of Disease Recurrence
Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Time frame: Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score
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.
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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
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
...and 105 more locations
Time frame: Cycle 1 up to 390 days
Change From Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score
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.
Time frame: Cycle 1 up to 390 days
Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib
Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Time frame: Day 1 of Cycles 1-3 (Cycle = 28 days)