PALOMA-3 Trial Design

IBRANCE + fulvestrant in first line or later

MBC=metastatic breast cancer.
 
Primary endpoint1: Investigator-assessed progression-free survival
Secondary endpoints1: Overall response rate (ORR)* and overall survival (OS)

FOR A BROAD RANGE OF WOMEN

Choose IBRANCE + fulvestrant for pre-/peri-/postmenopausal patients with HR+/HER2- MBC whose disease progressed on or after endocrine therapy in the adjuvant or metastatic setting

*ORR was defined as the number (%) of patients with confirmed complete response or partial response.1
tPre-/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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REFERENCE
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.
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.
Palbociclib (IBRANCE) + fulvestrant
was the first treatment option to receive a category 1 recommendation from NCCN® for HR+/HER2- MBC3§||
§For postmenopausal women or premenopausal women receiving ovarian suppression with an LHRH agonist with HR+/HER2- MBC that has progressed on or after prior adjuvant or metastatic endocrine therapy.3
NCCN®=National Comprehensive Cancer Network®.
||Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate. 3
If there is disease progression while on CDK4/6 inhibitor therapy, there are no data to support an additional line of therapy with another CDK4/6-containing regimen.3
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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.
3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2017. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed February 8, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.