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Summary of Prescibing Information
What were the key features of the PALOMA-2 trial?
PALOMA-2 was a randomised, double-blind, placebo-controlled, Phase III study to assess the safety and efficacy of PALBACE® in combination with letrozole as first-line treatment in a wide range of postmenopausal women with ER+/HER2- mBC.1
PALOMA-2 Trial Design1
PALOMA-2 Inclusion and Exclusion Criteria1
Adapted from Finn RS, et al. 2016.1
*Evaluated according to RECIST version 1.1.1
†ORR was defined as confirmed CR or PR.1
‡CBR was defined as confirmed CR, PR or SD for ≥24 weeks.1
CBR, clinical benefit response; CNS, central nervous system; CR, complete response; DFI, disease-free interval; DoR, duration of response; ECOG, Eastern Cooperative Oncology Group; ER+/HER2-, oestrogen receptor-positive/human epidermal growth factor receptor 2-negative; HR+/HER2, hormone receptor-positive, human epidermal growth factor receptor 2; mBC, metastatic breast cancer; N, total number of patients; n, number of patients; ORR, objective response rate; OS, overall survival; PALOMA, PALbociclib: Ongoing trials in the Management of breast cAncer; PFS, progression-free survival; PR, partial response; QTc, QT interval corrected for heart rate; RECIST, Response Evaluation Criteria in Solid Tumours; SD, stable disease.
References:
Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.
Ibrance EPAR public assessment report.November 25,2016.EMA. accessed september 2023. Available on https://www.ema.europa.eu/en/documents/assessment-report/ibrance-epar-public-assessment-report_en.pdf
Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
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PP-IBR-IND-0626 September 2023
With RCT data, PALBACE® RWE can help improve the understanding of outcomes in patients with HR+/HER2- mBC
Recommended dosing schedule and dose modifications for AEs
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