Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer. (NCT04305834) | Clinical Trial Compass
RecruitingPhase 2
Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.
United States43 participantsStarted 2020-03-25
Plain-language summary
This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.
Who can participate
Age range70 Years
SexALL
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Inclusion Criteria:
* Documented informed consent of the participant
* Age \>= 70 years
* Life expectancy \> 6 months
* Ability to read and understand English or Spanish
* Measurable or non-measurable disease
* Histologically or cytologically confirmed diagnosis of:
* Estrogen-receptor positive and/or progesterone receptor positive breast cancer determined by immunohistochemistry (IHC) methods according to the local institution standard protocol
* HER2-negative breast cancer defined as negative if the IHC status is 0 or 1+, or if IHC is 2+ and in situ hybridization assay is negative per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
* Radiographically confirmed metastatic breast cancer
* Progressed on prior endocrine therapy or palbociclib or ribociclib or chemotherapy
* Patients who received chemotherapy recovered from the acute side effects to prior cancer therapy (except alopecia or residual grade 2 peripheral neuropathy) to =\< grade 1 or baseline. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy)
* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization
* Absence of central nervous system (CNS) involvement unless they meet ONE of the following criteria:
* Untreated …