PALOMA-3 Trial Design

MBC=metastatic breast cancer; LHRH=luteinizing hormone-releasing hormone.
*Pre-/perimenopausal women enrolled in PALOMA-3 received the LHRH agonist goserelin for at least 4 weeks prior to and for the duration of the trial.
Primary endpoint1: Investigator-assessed progression-free survival
Secondary endpoints1,2: Overall response rate (ORR), overall survival (OS), safety, and tolerability
FOR A BROAD RANGE OF ADULT PATIENTS
Choose IBRANCE + fulvestrant for patients with HR+/HER2- MBC whose disease progressed on or after endocrine therapy in the adjuvant or metastatic setting
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REFERENCES
1. Turner NC, Ro J, André F, et al; PALOMA3 Study Group. Palbociclib in hormone-receptor-positive advanced breast cancer. N Engl J Med. 2015;373(3):209-219.
2. Data on file. Pfizer Inc, New York, NY.
PALOMA-3 evaluated a broad range of women1,2

PALOMA-3 included women with varying sites of disease and prior treatment histories, and regardless of menopausal status.* 

No significant differences in the clinical and pathological characteristics of the patients were identified between the 2 treatment groups (IBRANCE + fulvestrant n=347; placebo + fulvestrant n=174). 

Selected baseline characteristics for the IBRANCE arm

*Randomization was also stratified according to the presence or absence of visceral metastasis, menopausal status at study entry (postmenopausal vs premenopausal or perimenopausal), and sensitivity to prior endocrine therapy. Patients were defined as sensitive to prior endocrine therapy if they had a relapse after 24 months of adjuvant endocrine therapy or had a clinical benefit (objective response [complete or partial] or stable disease lasting ≥24 weeks) from prior endocrine therapy in the context of advanced disease.1
Other is defined as bone with other nonvisceral disease site or other disease site alone. Bone was the site of disease in 75.8% of patients in the IBRANCE + fulvestrant arm vs 74.1% in the placebo + fulvestrant arm.2
Pre-/perimenopausal women enrolled in PALOMA-3 received the LHRH agonist goserelin for at least 4 weeks prior to and for the duration of the trial.
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REFERENCES
1. Turner NC, Ro J, André F, et al; PALOMA3 Study Group. Palbociclib in hormone-receptor-positive advanced breast cancer. N Engl J Med. 2015;373(3):209-219.
2. Data on file. Pfizer Inc, New York, NY.