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AboutAboutIBRANCE experienceMechanism of actionDosing & MonitoringDosing & MonitoringDosing and administrationMonitoringRecommended dose modifications for IBRANCEWhat you need to know about IBRANCE tabletsClinical Trial DataClinical Trial DataIBR + AI Efficacy & SafetyIBR + AI Additional AnalysesIBR + Fulvestrant Efficacy & SafetyIBR + Fulvestrant Additional AnalysesReal-World Evidence​​​​​​​Real-World EvidenceIntroductionRandomized controlled trialReal-world study designReal-world study patient characteristicsReal-world effectiveness dataLabelLinkLinkLinkLinkLabelLinkLinkLinkLinkVideosPatient SupportPatient SupportMaterialsCoverage and accessPersonalized patient support
Prescribing Information for CapsulesPrescribing Information for Tablets Indications Patient Site
Real-World Evidence

Review results from PALOMA-2, the randomized controlled trial that evaluated IBRANCE + letrozole in postmenopausal women with estrogen receptor-positive (ER+)/HER2- mBC and no prior treatment in the metastatic setting.1

Real-world study design

Real-world evidence can complement data from randomized controlled trials. It is important to understand both the randomized controlled trial results and the limitations of real-world evidence. 

Understand the Study Limitations (expand here to view)
  • This study is a retrospective database study of electronic health records, which may have missing data (e.g., ECOG baseline scores [~30%]) or erroneous data entry 
  • Patients were not randomly assigned. Treatments were selected by prescribing physician
  • A causal relationship between treatments and outcomes cannot be determined
  • While statistical analyses* were used to balance baseline and clinical patient characteristics, unobserved variables cannot be fully addressed through these methods. The analysis may not adequately adjust for all variables (e.g., interval from initial breast cancer diagnosis to mBC diagnosis)
  • This analysis may not adjust for all sources of potential bias (e.g., immortal time bias)
  • May not fully account for intercurrent events (e.g., dose modifications, titration, ancillary and concomitant therapies)
  • Findings presented here may not be generalizable to patient populations not represented in the Flatiron Database2
  • Safety data were not collected as part of the study
Statistical analyses included sIPTW as the primary analysis and PSM as the sensitivity analysis.
P-REALITY X: Palbociclib Real-world First-line Comparative Effectiveness Study Extended2

Objective: To compare effectiveness outcomes of IBRANCE + AI versus AI alone as first-line treatment in postmenopausal women or in men with HR+/HER2- mBC.2 

Method: Observational retrospective analysis of electronic health records from the Flatiron Health Analytic Database.2

Study required both drugs to be started within 60 days of each other; 88% of these patients started both drugs within 28 days of each other.2

ReferencesDate of treatment initiation between February 2015 and March 2020 (data cut-off: September 2020).²ReferencesIncluding CDK4/6 inhibitor, tamoxifen, raloxifene, toremifene, fulvestrant, or chemotherapy.1Stabilized inverse probability treatment weighting (sIPTW; primary analysis) and propensity score matching (PSM; sensitivity analysis) control for observed confounders.2OS was defined as the time in months from the start of treatment with IBRANCE + an AI or with an AI alone to death from any cause.

Study limitations

  • This study is a retrospective database study of electronic health records, which may have missing data (e.g., ECOG baseline scores [~30%]) or erroneous data entry
  • Patients were not randomly assigned. Treatments were selected by prescribing physician
  • A causal relationship between treatments and outcomes cannot be determined
  • While statistical analyses§ were used to balance baseline and clinical patient characteristics, unobserved variables cannot be fully addressed through these methods. The analysis may not adequately adjust for all variables (e.g., interval from initial breast cancer diagnosis to mBC diagnosis)
  • This analysis may not adjust for all sources of potential bias (e.g., immortal time bias)
  • May not fully account for intercurrent events (e.g., dose modifications, titration, ancillary and concomitant therapies)
  • Findings presented here may not be generalizable to patient populations not represented in the Flatiron Database2
  • Safety data were not collected as part of the study 
Statistical analyses included sIPTW as the primary analysis and PSM as the sensitivity analysis.

Observational retrospective analyses are not intended for direct comparison with clinical trials and may introduce bias.

 Review the randomized controlled trial information Take another look Loading NEXT: Real-world study patient characteristics See the data LoadingReferences:Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936. doi:10.1056/NEJMoa1607303Rugo HS, Brufsky A, Liu X, et al. Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2- metastatic breast cancer. NPJ Breast Cancer. 2022;8(1):114. doi:10.1038/s41523-022-00479-xTo view a copy of the license for Rugo HS, Brufsky A, Liu X, et al (NPJ Breast Cancer. 2022;8(1):114), please visit https://creativecommons.org/licenses/by/4.0/Real-World Evidence

Access the publication.
The FDA-approved Prescribing Information for IBRANCE includes data from the PALOMA clinical trials. However, some data reported in this publication may be different from, or are not included in, the IBRANCE Prescribing Information. Please review results from PALOMA-2 (RCT) provided on this page. The study met its primary endpoint of progression-free survival but did not meet the secondary endpoint of overall survival.

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Indications IBRANCE® (palbociclib) 125 mg capsules and tablets are indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (mBC) in combination with:
 
  • an aromatase inhibitor as initial endocrine-based therapy, or
  • fulvestrant in patients with disease progression following endocrine therapy
Important Safety Information Neutropenia was the most frequently reported adverse reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients to promptly report any fever.

Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of first 2 cycles and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
 

Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.
 

Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g., hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis.
 

Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients to consider sperm preservation before taking IBRANCE. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants. 
 

The most common adverse reactions (≥10%) of any grade reported in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).
 

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).
 

Lab abnormalities of any grade occurring in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were decreased WBC (97% vs 25%), decreased neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), increased aspartate aminotransferase (52% vs 34%), and increased alanine aminotransferase (43% vs 30%). 

 

The most common adverse reactions (≥10%) of any grade reported in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).
 

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs 1%) and leukopenia (31% vs 2%). 
 

Lab abnormalities of any grade occurring in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs 10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine aminotransferase (36% vs 34%). 
 

Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.
 

For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. 

Please see full Prescribing Information for IBRANCE capsules and tablets.

IndicationsIBRANCE® (palbociclib) 125 mg capsules and tablets are indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (mBC) in combination with:
  • an aromatase inhibitor as initial endocrine-based therapy, or
  • fulvestrant in patients with disease progression following endocrine therapy