6/29/23, 1:34 AM PALOMA-3 Pathway Feedback Search Clinical Topics Home Studies PALOMA 3 PALOMA 3 Trial question What is the effect of palbociclib plus fulvestrant in premenopausal and postmenopausal Asian women who have endocrine therapy-resistant metastatic breast cancer? Study design Multi-center Double blinded RCT Population 105 female patients Inclusion criteria: premenopausal and postmenopausal Asian women with hormone receptor- positive/HER2-negative metastatic breast cancer with disease progression on endocrine therapy Interventions N=71 palbociclib plus fulvestrant (125 mg/d palbociclib PO for 3 weeks followed by 1 week off plus 500 mg fulvestrant administered IM on days 1 and 15 of cycle and then every 28 days thereafter starting from day 1 of cycle 1) N=31 fulvestrant alone (placebo plus fulvestrant 500 mg administered IM on days 1 and 15 of cycle 1 and then every 28 days thereafter starting from day 1 of cycle 1) Primary outcome Rate of complete response, partial response, or stable disease at 24 weeks 70.0 % 70 52.5 % 52 35.0 % 17.5 % No significant difference 0.0 % Palbociclib plus fulvestrant Fulvestrant alone No significant difference in the rate of complete response, partial response, or stable disease at 24 weeks (70% vs. 52%; OR 2.22, 95% CI 0.85 to 5.7) Safety outcomes https://web.pathway.md/studies/rec6tPf1ZuZy30iM3 1/2 6/29/23, 1:34 AM PALOMA-3 Pathway Significant difference in overall incidence of serious adverse events (14% vs. 23%). Conclusion In premenopausal and postmenopausal Asian women with hormone receptor-positive/HER2- negative metastatic breast cancer with disease progression on endocrine therapy, palbociclib plus fulvestrant was superior to fulvestrant alone with respect to the rate of complete response, partial response, or stable disease at 24 weeks. Reference Iwata H, Im SA, Masuda N et al. PALOMA-3: Phase III Trial of Fulvestrant With or Without Palbociclib in Premenopausal and Postmenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer That Progressed on Prior Endocrine Therapy-Safety and Efficacy in Asian Patients. J Glob Oncol. 2017 Apr 11;3(4):289-303. Open reference URL https://web.pathway.md/studies/rec6tPf1ZuZy30iM3 2/2