| advanced breast cancer (metastatic) | versus endocrine therapy alone palbociclib + letrozole superior to letrozole alone in terms of progression free survival in PALOMA-2, 2016 (first line patients) palbociclib + fulvestrant superior to fulvestrant alone in terms of progression free survival in PALOMA 3, 2015 (2nd line patients) | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PALOMA-2, 2016 | palbociclib + letrozole vs letrozole alone | progression free survival 0.58 [0.46; 0.73] median 24.8 mo vs. 14.5 mo Demonstrated | | | | PALOMA 3, 2015 | palbociclib + fulvestrant vs fulvestrant alone | progression free survival 0.42 [0.32; 0.56] median 9.2 mo vs. 3.8 mo Demonstrated | | | | PALOMA 1/TRIO-18, 2015 | palbociclib + letrozole vs letrozole alone | progression free survival 0.49 [0.32; 0.75] | | |
| Trial | Treatments | Patients | Method |
|---|
| PALOMA-2, 2016 | PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).) (n=666) vs. Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously (n=0) | postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease | double-blind Parallel groups Sample size: 666/0 Primary endpoint: PFS FU duration: | | PALOMA 3, 2015 | palbociclib (125 mg per day orally for 3 weeks,
followed by 1 week off) and fulvestrant (500 mg
intramuscularly per standard of care every 14 days
for the first three injections and then every
28 days) (n=347) vs. placebo and fulvestrant (n=174) | women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy | double-blind Parallel groups Sample size: 347/174 Primary endpoint: investigator-assessed PFS FU duration: | | PALOMA 1/TRIO-18, 2015 | continuous oral letrozole 2.5 mg daily plus oral palbociclib 125 mg, given once daily for 3 weeks followed by 1 week off over 28-day cycles (n=84) vs. continuous oral letrozole 2.5 mg daily (n=81) | postmenopausal women with advanced oestrogen receptor-positive and HER2-negative breast cancer who had not received any systemic treatment for their advanced disease | open-label Parallel groups Sample size: 84/81 Primary endpoint: investigator-assessed progression-free survival FU duration: phase 2 |
|
