The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain and Northern Ireland. IBRANCE® (palbociclib) Prescribing Information for Great Britain and Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
Confidence in a Treatment that’s setting the standard1-3
PALOMA-3 was a double-blind, randomised phase III study that assessed the efficacy and safety of IBRANCE® plus fulvestrant versus fulvestrant plus placebo as second-line therapy in women with HR+/HER2- locally advanced and metastatic breast cancer that had progressed on previous ET.1-3
Patients with uncontrolled brain metastases or extensive, symptomatic visceral spread who were at risk of life-threatening complications in the short term were excluded from the study.1-3
* Disease relapse or progression had to occur after previous ET (with an aromatase inhibitor if the patient was postmenopausal or with tamoxifen if premenopausal or perimenopausal) while on or within 1 month after treatment in the advanced setting, or while on or within 12 months of completion of adjuvant therapy irrespective of menopausal status.1
† All pre- or perimenopausal women received an LHRH agonist for at least 4 weeks prior to, and for the duration of, the trial.1,2
‡ Investigator-assessed PFS according to RECIST (version 1.1).1,2
Adapted from Cristofanilli M, et al. 2016.1
§ As per protocol, visceral refers to lung, liver, brain, pleural and peritoneal involvement and was a study stratification factor.1
¶ Data were unavailable for one patient in the intent-to-treat fulvestrant plus placebo group.1
** Disease-free interval was defined as time from diagnosis of primary breast cancer to first relapse in patients who received adjuvant therapy. Data for disease-free interval were available only for patients who were initially diagnosed with early breast cancer and then experienced disease relapse; percentages are calculated on the basis of available data.1
†† Previous sensitivity to ET was based on randomisation.1
AI : Aromatase Inhibitor, CBR : Clinical Benefit Rate (complete response, partial response or stable disease for 24 weeks duration or longer), DoR : Duration of Response, ECOG : Eastern Cooperative Oncology Group, ECOG PS : Eastern Cooperative Oncology Group Performance Status, ET : Endocrine Therapy, HR+/HER2- : Hormone Receptor Positive / Human Epidermal growth factor Receptor 2-negative, IM : Intramuscular, ITT : Intention-To-Treat, LHRH : Luteinising Hormone-Releasing Hormone, mBC : metastatic Breast Cancer, OD : Once Daily, ORR : Objective Response Rate (complete or partial response), OS : Overall Survival, PFS : Progression-Free Survival, PO : Oral, PRO : Patient-Reported Outcome, RECIST : Response Evaluation Criteria In Solid Tumours, SmPC : Summary of Product Characteristics
IBRANCE® + Fulvestrant (Ful) Clinical Trial Results
This text is for block level content. P tags can go in here too
IBRANCE® safety information and outcomes
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-PFE-GBR-3863. November 2021
OK, We will need you to sign in before we can determine if you are aligned with a Pﬁzer promotional colleague.This is an interstitial message to prompt a HCP before they login.
If you have already registered with pfizerpro.co.uk and select ‘yes’, you will be directed to the sign-in page where you will be required to enter your username and password.
Would you like to register or sign in now?