The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain. IBRANCE® (palbociclib) Prescribing Information for Great Britain click here. IBRANCE® (palbociclib) Prescribing Information for Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
PALOMA-2 Trial Quality of Life Outcomes
Confidence without Compromise1-2
The PALOMA-2 study shows that you can offer your patients efficacy without compromising QoL with IBRANCE® in combination with letrozole.1
Patient-reported health-related QOL (HRQOL) outcomes was a secondary objective in the PALOMA-2 trial.
A post-hoc analysis of median TTD in FACT-B scores showed a positive trend favouring IBRANCE® + letrozole vs placebo + letrozole (HR: 0.883; P=0.1900).1*
The difference did not reach statistical significance.1
PALOMA-2: Median TTD in FACT-B scores for the PRO-evaluable population in the ITT population4*†§
Adapted from Rugo HS, et al. Ann Oncol. 2018;29:888-94.1
* In a population of post-menopausal women with ER+/HER2- locally advanced or metastatic breast cancer who had received no prior systemic treatment for their advanced disease.2
† FACT-B is a 37-item self-reporting instrument containing the 27-question FACT-G survey and a 10-question breast cancer additional concerns scale. A higher score in any FACT-B assessment indicates better QoL. TTD for FACT-B was defined as the duration between baseline and first occurrence of a decrease of ≥7 points in FACT-B score with no subsequent observation of a <7-point decrease1
§ PRO analyses were based on the PRO-evaluable population (i.e., patients in the intent-to-treat [ITT] population with a baseline and >=1 post-baseline assessment before the end of study treatment)
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
- Rugo HS, et al. Ann Oncol. 2018;29:888-94.
- Finn RS, et al. N Engl J Med. 2016;375:1925-1936.
PALOMA-2 Trial
IBRANCE® + Aromatase Inhibitor (AI) Clinical Trial Results
IBRANCE® PALOMA-2 Trial Study Design Efficacy Outcomes Safety Profile IBRANCE® Mode of Action
Clinical Trials
- Clinical Trial results for IBRANCE®
IBRANCE® Clinical Trials PALOMA-2 Trial
Safety
IBRANCE® safety information and outcomes
IBRANCE® Safety Profile Neutropenia Adverse Event Management
Indication
- IBRANCE® is indicated for the treatment of HR+/HER2- locally advanced or metastatic breast cancer:
- In combination with an aromatase inhibitor; or
- In combination with fulvestrant in women who have received prior ET
In pre- or perimenopausal women, the ET should be combined with a LHRH agonist
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PP-PFE-GBR-3863. November 2021
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