This phase IIA trial studies the side effects of ribociclib and aromatase inhibitor and how well they work in treating participants with hormone receptor positive breast cancer that has spread to other places in the body. Ribociclib and aromatase inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To estimate the safety and tolerability of the combination of ribociclib and an aromatase inhibitor in adults age 70 or older with hormone receptor positive metastatic breast cancer. SECONDARY OBJECTIVES: I. To describe the full toxicity profile including all grades. II. To estimate the rate of worst grades of myelosuppression (neutropenia, leukopenia, thrombocytopenia, and anemia), neutropenic fever, gastrointestinal (GI) side effects (nausea, diarrhea, decreased appetite, vomiting, stomatitis), fatigue, neuropathy, and thromboembolism. III. To describe rates of dose reductions, dose holds, and hospitalizations. IV. To estimate objective response rate and clinical benefit rate as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) criteria. V. To estimate median progression-free and overall survival. EXPLORATORY OBJECTIVES: I. To estimate the rate of adherence to ribociclib. II. To explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment. III. To describe the results of the Was It Worth It (WIWI) and the results of the Overall Treatment Utility (OTU) Questionnaires. OUTLINE: Participants receive ribociclib orally (PO) once daily (QD) on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 30 days, then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Aromatase inhibitor per treating investigator's discretion
Correlative studies
Correlative studies
Ancillary studies
Given PO
City of Hope Corona
Corona, California, United States
City of Hope Medical Center
Duarte, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
City of Hope Mission Hills
Mission Hills, California, United States
City of Hope Rancho Cucamonga
Rancho Cucamonga, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
City of Hope West Covina
West Covina, California, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Wilmot Cancer Institute
Rochester, New York, United States
Number of Participants With Grade 2 and Above Toxicities Attributed to Ribociclib
Number of participants with grade 2 and above toxicities attributed (possible, probable or definite) to ribociclib
Time frame: Up to 30 days of last study drug, about 3 years and 3 months
Number of Participants With Dose Reductions
Time frame: Up to 3.5 years
Number of Participants With Dose Delays
Time frame: Up to 3.5 years
Number of Participants With Dose Discontinuations
Time frame: Up to 3.5 years
Objective Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Objective response rate (defined as complete response \[CR\] + partial response \[PR\]) as determined by RECIST criteria Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 3.5 years
Clinical Benefit Rate as Determined by RECIST
Clinical benefit rate (defined as CR+PR+ stable disease) as determined by RECIST Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time frame: Up to 3.5 years
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