Table 2.
Ongoing trials with preoperative or adjuvant CDK4/6 inhibitors in primary BC
| Clinical trial.gov identifier | Therapy | Phase | Patient characteristics | Number of patients | Primary end points | Estimated study completion |
|---|---|---|---|---|---|---|
| Adjuvant | ||||||
| Palbociclib | ||||||
| NCT02040857 | Palbociclib + AI or tamoxifen | II | HR+, HER2- stage 2 or 3 (+ men) |
160 | Treatment discontinuation rate | June 2019, recruiting |
| NCT18644746 | Palbociclib (13 cycles) + Standard ET Placebo + Standard ET |
III, PENELOPE-B | HR+, HER2- Residual invasive disease after neoadjuvant chemotherapy; adequate surgery High CPS-EG score |
1100 | Invasive DFS | November 2023, recruiting |
| NCT02513394 | Palbociclib 2 years + standard ET Standard ET |
III, PALLAS | HR+, HER2- Stage 2 or 3 (+men) |
4600 | Invasive DFS | September 2025, recruiting |
| Presurgical | ||||||
| Palbociclib | ||||||
| NCT01709370 | Palbociclib + letrozole (16 weeks) | II | OR+, HER2- Postmenopausal tumour≥2 cm Not T3N1, T4, N2 or N3 |
45 | RR | NR, study status last verified October 2012 |
| NCT01723774 | Anastrozole + goserelin (if premenopausal) + palbociclib |
II | OR+, HER2- stage 2 or 3 |
29 | Complete cell cycle arrest in women without PIK3CA hot spot mutation | February 2016, recruiting |
| NCT02296801 | Letrozole Letrozole → palbociclib + letrozole Palboclib → palbociclib +letrozole Palcociclib + letrozole 14 weeks |
II, PALLET neoadjuvant |
OR+, HER2-postmenopausal operable, tumour≥2 cm |
306 | Proliferation (Ki67) | January 2015, recruiting |
| NCT02400567 | FEC→ docetaxel palbociclib + letrozole |
II, NeoPAL Randomised, | Luminal A + nodal involvement or luminal B postmenopausal stage −2–3A |
132 | Number with residual tumour in breast or lymph node | April 2019, recruiting |
| Eudract number 2014-000809-12 | Palbociclib + standard ET standard ET |
II, PREDIXLumA (part of a translational study based of molecular subtypes) | Luminal A >2 cm, no lymph node metastases | 200 (whole trial) | pCR | NR, recruiting |
| Eudract number 2014-000810-12 | Palbociclib + standard ET standard ET |
II, PREDIXLumB (part of a translational study based of molecular subtypes) | Luminal B>2 cm and/or lymph node metastases | 200 (whole trial) | pCR | NR, recruiting |
| NCT02008734 | Control palbociclib (125 m/day for 14 days) Palbociclib (100 mg/d for 21 days) |
II, POP Randomised (3:1) |
Untreated, operable early BC (≥15 mm) Not candidate for neoadjuvant chemotherapy |
105 | Antiproliferative response | January 2016, recruiting |
| Abemaciclib | ||||||
| NCT02441946 | Abemaciclib + loperamide 2 weeks Abemaciclib + loperamide + anastrozole 2 weeks Anastrozole 2 weeks Followed by 14 weeks abemaciclib + anastrozole + loperamide |
II, NeoMONARCH | ER+, HER2-Postmenopausal tumour≥1 cm, ET deemed suitable | 220 | Ki67 expression at 2 weeks | February 2017, recruiting |
| Ribociclib | ||||||
| NCT01919229 | Ribociclib (400 mg) + letrozole Ribociclib (600 mg) + letrozole Letrozole |
II, MONALEESA-1 | HR+, HER2- Postmenopausal, tumour≥1.0 cm |
14 | Cell cycle response rate | Completed, no results published |
AI, aromatase inhibitor; BC, breast cancer; CPS-OG, clinical-pathological stage-oestrogen/grade score; ET, endocrine therapy; HR, hormone receptor; NR, not reported; pCR, pathological complete response; RR response rate; DFS, disease free survival.