Table 3.
Clinical trials involving progesterone receptor modulation
| NCT number | Compound/agent | Mode of action | Recruitment | Disease | Combined treatment | Outcome measures | Phases | Study type |
|---|---|---|---|---|---|---|---|---|
| NCT03306472 | Megestrol acetate | PR agonist | Recruiting | Breast cancer | Letrozole | Determination PD profile of orally administered megestrol acetate | 2 | Interventional |
| NCT01608451 | Inj. progesterone | PR agonist | Active | Advanced breast cancer | Cholecalciferol (vit D analogue) | To evaluate PFS and OS | 3 | Interventional |
| NCT00123669 | Hydroxyprogesterone caproate (OHPC) | PR agonist | Active | Breast neoplasms | To evaluate PFS and OS | 2/3 | Interventional | |
| NCT02651844 | Mifepristone | PR antagonist | Recruiting | Breast cancer | Determination PD profile of orally administered Mifepristone | 1/2 | Interventional | |
| NCT01138553 | Mifepristone | PR antagonist | Terminated | Advanced breast cancer | Determination PD profile of orally administered Mifepristone | 1 | Interventional | |
| NCT02046421 | Mifepristone | PR antagonist | Active | Advanced breast cancer | Carboplatin and gemcitabine hydrochloride | DLT and MTD of combination | 1 | Interventional |
| NCT02014337 | Mifepristone | PR antagonist | Active | Breast cancer | Eribulin | DLT and MTD of combination | 1 | Interventional |
| NCT01493310 | Mifepristone | PR antagonist | Active | Advanced breast cancer | Nab-paclitaxel | DLT and MTD of combination | 1 | Interventional |
| NCT01800422 | Telapristone acetate | Selective progesterone receptor modulator | Active | Breast cancer | Determination PD profile of orally administered telapristone acetate | 2 | Interventional | |
| NCT02314156 | Telapristone acetate | Selective progesterone receptor modulator | Recruiting | BRCA1 mutation carrier breast cancer | Determination PD/PK profile of telapristone acetate | 2 | Interventional | |
| NCT02052128 | Onapristone | Selective progesterone receptor modulator | Unknown status | Breast cancer | Determination PD/PK profile of onapristone | 1/2 | Interventional | |
| NCT02052128 | Onapristone | Selective progesterone receptor modulator | Unknown status | Breast cancer | Determination MTD and PK profile of onapristone | 1/2 | Interventional | |
| NCT02408770* | Ulipristal acetate | Selective progesterone receptor modulator | Unknown status | Normal breast tissue (breast cancer) | Determination PD profile of ulipristal acetate in normal breast epithelium | 2 | Interventional | |
| NCT00555919 | Lonaprisan | Selective progesterone receptor modulator | Completed | Metastatic breast cancer | To evaluate PFS, ORR and OS | 2 | Interventional |
DLT dose limiting toxicity, maximum tolerated dose, PFS progression-free survival, CBR clinical benefit rate, BORR best overall response rate, ORR objective response rate, OS overall survival. * Trial designed in the prevention setting