3.
CDK4/6-selective Small-molecule Inhibitors Currently used in Clinical Trials*
| Clinical trials identifier | Patients/diseases included | Trial stage | Trial status | Drugs |
| *Data retrieved from www.clinicaltrials.gov and current as of March 2017. | ||||
| Palbociclib
(PD-0332991) |
||||
| NCT00141297 | Advanced cancer | 1 | Completed | Palbociclib |
| NCT01037790 | Advanced and metastatic colorectal cancer | 2 | Recruiting participants | Palbociclib |
| NCT00721409 | ER-positive/HER2-negative advanced breast cancer in postmenopausal women | 1/2 | Ongoing, but not recruiting participants | Palbociclib; letrozole |
| NCT01740427 | Postmenopausal women with
ER-positive/HER2-negative breast cancer who have not received any prior systemic anti-cancer treatment for advanced disease |
3 | Ongoing, but not recruiting participants | Palbociclib; letrozole |
| NCT02513394 | Patients with HR-positive/HER2-negative early-stage breast cancer | 3 | Recruiting participants | Palbociclib; standard adjuvant endocrine therapy |
| NCT01864746 | HR-positive/HER2-normal patients with residual disease after neoadjuvant chemotherapy and surgery | 3 | Recruiting participants | Palbociclib |
| NCT01942135 | HR-positive/HER2-negative metastatic breast cancer after endocrine treatment failure | 3 | Ongoing, but not recruiting participants | Palbociclib; fulvestrant |
| Ribociclib (LEE011) | ||||
| NCT01237236 | Advanced solid tumors and lymphoma | 1 | Completed | LEE011 |
| NCT01958021 | Postmenopausal women with HR-positive/HER2-negative advanced breast cancer who received no prior therapy for advanced disease | 3 | Ongoing, but not recruiting participants | LEE011; Letrozole;
LEE011 + placebo |
| NCT02278120 | Premenopausal women with HR-positive/HER2-negative
advanced breast cancer |
3 | Ongoing, but not recruiting participants | LEE011; tamoxifen; Letrozole; anastrozole; goserelin; LEE011 + placebo |
| NCT02422615 | Men and postmenopausal women with HR-positive/HER2-negative advanced breast cancer who have received no or only 1 line of prior endocrine treatment | 3 | Ongoing, but not recruiting participants | LEE011; fulvestrant; LEE011 + placebo |
| NCT01872260 | Advanced ER-positive breast cancer | 1 | Recruiting participants | LEE011; letrozole; BYL719 |
| NCT01857193 | HR-positive/HER2-negative advanced breast cancer | 1 | Recruiting participants | LEE011; exemestane; everolimus |
| Abemaciclib (LY2835219) | ||||
| NCT01394016 | Advanced cancer | 1 | Ongoing, but not recruiting participants | Abemaciclib; fulvestrant |
| NCT02107703 | Women with HR-positive/HER2-negative locally advanced or metastatic breast cancer | 3 | Ongoing, but not recruiting participants | Abemaciclib; fulvestrant; placebo |