Prior therapy with any CDK inhibitor.
Prior treatment with CDK4/6 inhibitor
Patient who received any CDK4/6 inhibitor
Prior treatment with a CDK 4/6 inhibitor.
Patient has a known hypersensitivity to ribociclib or any of its excipients, or prior treatment with CDK 4/6 inhibitor
For enrollment to arm 2: participants must have a confirmed CDK4 or CDK6 high-level amplification, identified via DFCI/BWH OncoPanel or any CLIA-certified method
Participants who have received prior treatment with a CDK4/6 inhibitor
Prior exposure to transcriptional kinase family CDK inhibitors, such as the CDK7 and CDK9 inhibitors alvocidib (Flavopiridol), dinaciclib, and seliciclib. Exception: previous exposure to cell cycle CDK inhibitors such as CDK4 and CDK6 (eg, palbociclib) is allowed
Previous treatment with a CDK 4/6 inhibitor or an mTOR inhibitor
Prior therapy with any CDK inhibitor
Prior treatment on a CDK inhibitor
have a diagnosis of metastatic ER+ breast cancer in patients who received and progressed on at least two lines of endocrine therapy, with one that included a CDK4/CDK6 inhibitor (e.g., palbociclib or ribociclib);
Received a prior CDK4/6 inhibitor
No prior therapy with any CDK 4/6 inhibitors.
Prior use of CDK4/6 inhibitors
Patient who received any CDK4/6 inhibitor
Patients who have received prior treatment with a selective CDK4 inhibitor
Previous CDK4/6 inhibitor
Patient has had prior toxicity from a CDK 4/6 inhibitor necessitating discontinuation of the drug; patient may have had prior treatment with a cdk 4/6 inhibitor in the adjuvant or metastatic setting
Received any previous treatment with alvocidib or any other CDK inhibitor
Documented evidence of tumor progression on or after CDK 4/ 6 inhibitor combination treatment; CDK 4/6 inhibitor must be the last treatment regimen prior to study entry,
Participants who have received prior treatment with a CDK4/6 inhibitor
Patients who have been in the past enrolled on a study of a Cdk inhibitor
Prior treatment with CDK4/6 inhibitor
Prior treatment with any CDK4/6 inhibitor.
Group 1 - Patients must not have received prior treatment with any CDK4/6 inhibitors
Group 2 - Patients must have disease progression while on or within one month after CDK4/6 inhibitor based therapy
Group 3 - Patients must have disease progression while on or within one month after CDK4/6 inhibitor based therapy (except those patients who received prior LEE011 based therapy).
Prior treatment with any CDK 4/6 inhibitor
Patient who has received a prior CDK4/6 inhibitor
Prior treatment with any CDK 4/6 inhibitor.
Prior treatment with a CDK4/6 inhibitor and/or bazedoxifene
Patient who received any CDK4/6 inhibitor.
The participant has previously received treatment with any CDK4 and CDK6 inhibitor.
Participants must have radiological or objective evidence of progression on an endocrine and CDK 4/6 inhibitor regimen in the metastatic setting, and/or relapse/progression during or within 12 months of completion of an endocrine and CDK4/6 inhibitor regimen in the adjuvant setting\r\n* Participants must have previously been exposed to CDK4/6 inhibitor therapy in combination with endocrine therapy; exposure to any prior CDK4/6 inhibitor, (including palbociclib, abemaciclib, and ribociclib) is allowed; patients may have a line of endocrine therapy after combination endocrine and CDK4/6 inhibitor exposure\r\n* Participants must have remained on prior endocrine and CDK4/6 therapy in the metastatic setting without progression for at least 6 months prior to study entry\r\n* It is not mandatory to have a CDK 4/6 inhibitor containing regimen as the most recent treatment
Previously treated on any CDK 4/6 inhibitor.
Progressed on more than one CDK 4/6 inhibitor
Prior treatment with any CDK4/6 inhibitor therapy
Prior treatment with a MEK inhibitor or a CDK4/6 inhibitor.
Patients who have received prior treatment with a CDK inhibitor within 12 months of study enrollment.
Prior neoadjuvant therapy (endocrine therapy or chemotherapy) or CDK4/6 inhibitor
No history of prior CDK 4/6 inhibitor use