Table 2.
Selected Ongoing Phase 2 and Phase 3 Clinical Trials of CDK4/6 Inhibitors for ER+, HER2− Breast Cancera
| Acronym (If Any), NCT Number | Sponsor, Collaborator(s) | Interventions | Patient Population (All With HR+, HER2− Breast Cancer) | Phase (N) | Primary Endpoint | Start Date Primary Completionb Completion Date |
|---|---|---|---|---|---|---|
| MONARCH-2 NCT02107703 | Lilly | Abemaciclib + fulvestrant vs. fulvestrant + placebo | Postmenopausal women with locally aBrCa or mBrCa after failure on endocrine therapy | Phase 3 (N = 550) | PFS | July 2014 February 2017 February 2020 |
| MONARCH-3 NCT02246621 | Lilly | Abemaciclib + NSAI, placebo + NSAI | mBrCa in postmenopausal women who have not received systemic therapy | Phase 3 (N = 450) | PFS | November 2014 June 2017 July 2021 |
| NCT01857193 | Novartis | LEE011 + exemestane + everolimus and LEE011 + exemestane vs. everolimus + exemestane | Postmenopausal women with locally aBrCa or mBrCa after adjuvant NSAI failure | Phase 1b/2 (N = 185) | PFS, dose-limiting toxicity | September 2013 May 2016 May 2016 |
| MONALEESA-2 NCT01958021 | Novartis | LEE011 + letrozole vs. placebo + letrozole | Postmenopausal women with locoregionally recurrent or mBrCa and no prior systemic treatment | Phase 3 (N = 650) | PFS | December 2013 August 2017 August 2017 |
| MONALEESA-7 NCT02278120 | Novartis | LEE011 + tamoxifen or NSAI + goserelin vs. placebo + tamoxifen or NSAI + goserelin | Pre- or perimenopausal women with locoregionally recurrent or mBrCa and no prior hormonal therapy for aBrCa | Phase 3 (N = 660) | PFS | November 2014 February 2018 February 2018 |
| NCT02088684 | Novartis | LEE011 + buparlisib + fulvestrant vs. LEE011 + BYL719 + fulvestrant vs. LEE011 + fulvestrant | Postmenopausal women with HR+, HER2− locally aBrCa or mBrCa after endocrine therapy and/or chemotherapy | Phase 1b/2 (N = 216) | PFS (phase 2), dose-limiting toxicity (phase 1b) | May 2014 February 2019 February 2019 |
| PALOMA-3 NCT01942135 | Pfizer, AstraZeneca | Palbociclib + fulvestrant vs. fulvestrant + placebo | HR+, HER2− mBrCa progressing after endocrine therapy in women age ≥ 18 years | Phase 3 (N = 417) | PFS | September 2013 July 2015c January 2017 |
| PALOMA-2 NCT01740427 | Pfizer | Palbociclib + letrozole vs. letrozole + placebo | Postmenopausal women with aBrCa and no prior systemic therapy for aBrCa | Phase 3 N = 650) | PFS | February 2013 October 2015 October 2015 |
| NCT01723774 | Washington University | Palbociclib + anastrozole (+ goserelin if premenopausal) | Early (stage II or III) BrCa | Phase 2 (N = 29) | Complete cell-cycle arrest | June 2013 January 2016 February 2016 |
| PALLET NCT02296801 | NSABP Foundation; Pfizer, others | Letrozole alone vs. palbociclib + letrozole (3 regimens—see text) | Postmenopausal women with newly diagnosed primary BrCa | Phase 2 (N = 306) | Change in Ki67 from baseline; cCR | January 2015 July 2017 Not provided |
| NCT02040857 | Dana-Farber; Pfizer | Palbociclib + endocrine therapy (tamoxifen or AI) vs. endocrine therapy | Invasive BrCa (stage II, except T2N0, or stage III) in men and pre- or post-menopausal women | Phase 2 (N = 120) | Treatment discontinuation rate | January 2014 October 2017 June 2019 |
| PEARL NCT02028507 | Spanish Breast Cancer Research Group; Pfizer | Palbociclib + exemestane vs. capecitabine | mBrCa with NSAI resistance within 12 months after end of adjuvant therapy or 1 month after end of NSAI for aBrCa | Phase 3 (N = 348) | iDFS | March 2014 January 2018 January 2018 |
| PENELOPE-B NCT01864746 | German Breast Group; Pfizer | Palbociclib + endocrine therapy vs. endocrine therapy alone | Early-stage HR+, HER2− normal BrCa in women age ≥ 18 years at high risk of relapse after surgery and chemotherapy | Phase 3 (N = 800) | iDFS | November 2013 December 2019 November 2021 |
a
Source: ClinicalTrials.gov
b
Primary completion is the final data collection date for the primary outcome measure.
c
Terminated early, on April 15, 2015, because of efficacy.
aBrCa = advanced breast cancer; AI = aromatase inhibitor; BrCa = breast cancer; cCR = clinical complete response (number of patients with resolution of measurable lesions or no new lesions or other signs of disease progression); iDFS = invasive disease-free survival (see glossary for definition); mBrCa = metastatic breast cancer; NSAI = nonsteroidal aromatase inhibitor (i.e., anastrozole or letrozole); PFS = progression-free survival