PALOMA-3
Trial question
What is the effect of palbociclib plus fulvestrant in premenopausal and postmenopausal Asian patients with endocrine therapy-resistant metastatic breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
105 female patients
Inclusion criteria: premenopausal and postmenopausal Asian female patients with HR+/HER2- 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
52
70.0 %
52.5 %
35.0 %
17.5 %
0.0 %
Palbociclib plus
fulvestrant
Fulvestrant
alone
No significant
difference ↔
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
Significant difference in overall incidence of serious adverse events (14% vs. 23%).
Conclusion
In premenopausal and postmenopausal Asian female patients with HR+/HER2- 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.
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