In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. The names of the study drugs involved in this study are: * Abemaciclib (CDK4 and CDK6 inhibitor) * Tamoxifen (Selective estrogen receptor modulator) * Anastrozole/Letrozole (Non-steroidal aromatase inhibitors) * Exemestane (steroidal aromatase inhibitor) * LHRH (Gonadotropin-releasing hormone agonist, or Luteinizing hormone-releasing hormone agonist)
This research study is a prospective, single-arm, open label, phase 2 study designed to evaluate if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. This research study involves adjuvant abemaciclib plus endocrine (anti-hormone) therapy that works to target breast cancer. Adjuvant therapy is treatment given after surgery, chemotherapy, and/or radiation therapy. The U.S. Food and Drug Administration (FDA) has approved abemaciclib as a treatment option for early-stage high-risk hormone receptor breast cancer. The FDA has also approved hormonal therapies as treatment for hormone receptor positive breast cancer. The research study procedures include screening for eligibility, study treatment including laboratory evaluations and questionnaires, blood tests, tumor biopsies, and stool collections. Participation in this research study is expected to last for at least 2 years and up to 5 years. It is expected that about 90 people will take part in this research study. Eli Lilly and Company is supporting this study by providing funding for the study and supplying the study drug, abemaciclib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
CDK4 and CDK6 inhibitor, tablet taken orally
Selective estrogen receptor modulator, taken orally per institutional standard of care
Non-steroidal aromatase inhibitor, taken orally per institutional standard of care
Non-steroidal aromatase inhibitor, taken orally per institutional standard of care
Steroidal aromatase inhibitor, taken orally per institutional standard of care
Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Stamford Hospital
Stamford, Connecticut, United States
Eastern Maine Medical Center (Northern Light)
Brewer, Maine, United States
New England Cancer Specialists
Scarborough, Maine, United States
Boston Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber Cancer Institute at Steward St. Elizabeth's
Brighton, Massachusetts, United States
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, United States
Dana-Farber Cancer Institute at Merrimack Valley
Methuen, Massachusetts, United States
Dana-Farber Cancer Institute at Milford
Milford, Massachusetts, United States
...and 2 more locations
Composite Adverse Rate at 3 months
The rate of the composite endpoint will be reported, including disaggregated and combined rates of treatment discontinuations and/or dose reductions at 3 months.
Time frame: 3 months
Incidence of Grade 2-4 Diarrhea
Incidence of grade 2-4 diarrhea will be reported as frequencies and absolute numbers based on CTCAE5.0.
Time frame: Up to 26 weeks
Composite Rate of Abemaciclib
The composite rate will be reported, including disaggregated and combined rates of treatment discontinuations, dose reductions, dose holds, and inability to reach or maintain the target dose.
Time frame: Up to 25 weeks
Incidence of Treatment-Related Adverse Events
The incidence of treatment-related adverse events will be reported as frequencies and absolute numbers based on CTCAT5.0.
Time frame: Up to 25 weeks
Rate of Inability to Reach the Full Dose
Rate of inability to reach the full dose will be reported as the rate of participants who have never reached the full dose at 150mg BID.
Time frame: Up to 25 weeks
Therapeutic Adherence to Oral Adjuvant Therapy
Ratio of the self-reported number of pills taken and number of pills prescribed
Time frame: Up to 25 weeks
Dose Intensity of Abemaciclib
Rate of patients at full dose (150mg BID) at 12 w versus those unable to reach full dose
Time frame: 12 weeks
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