PALOMA-2 Trial Design

First-in-class IBRANCE + letrozole in first line

Trial Design

PALOMA-2: Phase 3 evidence for IBRANCE + letrozole in first line1,2
Primary endpoint: Investigator-assessed progression-free survival
Secondary endpoints: Overall survival, overall response rate, safety, and tolerability
ER=estrogen receptor; MBC=metastatic breast cancer.
IBRANCE was studied with letrozole in postmenopausal women but is FDA approved for use with any aromatase inhibitor as first-line treatment in postmenopausal women or in men with HR+/HER2- MBC
Next: Patient Characteristics >

Patient Characteristics

IBRANCE + letrozole was evaluated in a variety of first-line patients1
Patients receiving IBRANCE + letrozole varied in age, disease site, disease-free interval, and treatment history.*
There were no significant differences in baseline characteristics between the 2 treatment arms for age, disease site, disease-free interval, and prior hormonal therapy use in the adjuvant setting (IBRANCE + letrozole n=444; placebo + letrozole n=222).
PALOMA-2: Selected baseline patient characteristics for the IBRANCE arm
*Patients were stratified by site of disease, by disease-free interval since completion of prior neoadjuvant or adjuvant therapy, and by the nature of prior neoadjuvant or adjuvant anticancer treatment received prior to their diagnosis of advanced breast cancer.2
Disease-free interval was defined as the time from neoadjuvant or adjuvant therapy to recurrence.1
Patients who had received anastrozole or letrozole as a component of their adjuvant or neoadjuvant therapy were excluded from the study if they had disease progression while receiving the therapy or within 12 months after completing the therapy. 48% of patients had received chemotherapy in the neoadjuvant or adjuvant setting.1
Previous: Trial Design
REFERENCES
1. Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.
2. Data on file. Pfizer Inc, New York, NY.