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IBRANCE + aromatase inhibitor

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​​​​​​​IBRANCE + aromatase inhibitor

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Neutropenia and lab abnormalities

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​​​​​​​Real-World Evidence​​​​​​​

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  • Prescribing Information for Capsules
  • Prescribing Information for Tablets
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  • Real-World Evidence

    Clinical trial summary

    Real-world evidence complements data from randomized clinical trials. It is important to understand both the randomized clinical trial results and the limitations of this observational retrospective real-world study. 

    Expand here to view

    • Review results from PALOMA-2, the randomized clinical trial that evaluated IBRANCE + letrozole in postmenopausal women with estrogen receptor-positive (ER+)/HER2- mBC and no prior treatment in the metastatic setting
    • Understand the limitations of this observational retrospective real-world study:
      • This study is a retrospective database study of electronic health records, which may have missing or erroneous data entry and cannot determine causal relationship1,2
      • Disease progression was based on the treating physician’s clinical assessment or interpretation of radiographic or pathologic results rather than standard criteria (e.g., Response Evaluation Criteria in Solid Tumors)1,2
      • While stabilized inverse probability treatment weighting and propensity score matching were used to balance baseline and clinical patient characteristics, unobserved variables cannot be fully addressed through these methods1,2
      • Findings presented here may not be generalizable to patient populations not represented in the Flatiron Database1,2
      • Safety data were not collected as part of the study

    PALOMA-2 randomized clinical trial

    In combination with letrozole, IBRANCE delivered more than 2 years of median progression-free survival (mPFS) in first-line mBC*

    Study design3

    2:1 randomized, double-blind, Phase 3 trial studying IBRANCE + letrozole vs placebo + letrozole in postmenopausal women receiving first-line treatment for estrogen receptor-positive (ER+)/HER2- mBC (N=666)

    Primary endpoint3​​​​​​

    Investigator-assessed progression-free survival (PFS)

    • 24.8 months of mPFS with IBRANCE + letrozole (n=444; 95% CI: 22.1-not estimable [NE]) vs 14.5 months with placebo + letrozole (n=222; 95% CI: 12.9-17.1); HR=0.58 (95% CI: 0.46-0.72); P<0.0001
    • Number of PFS events: 194 (43.7%) in the IBRANCE + letrozole arm and 137 (61.7%) in the placebo + letrozole arm
    • IBRANCE + letrozole reduced the risk of disease progression or death by 42% vs placebo + letrozole 

    Select secondary endpoints2-4

    • Overall response rate (ORR): 55.3% (95% CI: 49.9-60.7) of patients with measurable disease achieved an objective response with IBRANCE + letrozole vs 44.4% (95% CI: 36.9-52.2) with placebo + letrozole (IBRANCE + letrozole n=338; placebo + letrozole n=171)
    • Overall survival (OS): With a median follow-up of 7.5 years, median OS was 53.9 months (95% CI: 49.8-60.8) in the IBRANCE + letrozole arm vs 51.2 months (95% CI: 43.7-58.9) in the placebo + letrozole arm (HR=0.96; 95% CI: 0.78-1.18; P=0.3378; 405 events [61% of trial population]). The result did not meet the secondary endpoint§

        PO=by mouth.

    *   Unless otherwise stated, PALOMA-2 data are based on the February 2016 data cut (final prespecified analysis).3

       PALOMA-2 studied IBRANCE 125 mg PO once daily taken 3 weeks on, 1 week off + letrozole 2.5 mg PO once daily vs placebo + letrozole in postmenopausal women.3

       ORR was defined as the number (%) of patients with confirmed complete response or partial response.3

    §   Based on November 2021 data cut (final OS analysis), with a median follow-up of 90 months.2,4

    Adverse reactions (ARs) reported in ≥10% of patients in PALOMA-2

         Grading according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    ||    Infections include all reported preferred terms (PTs) that are part of the System Organ Class Infections and infestations; most common infections (≥1%) include nasopharyngitis, upper respiratory tract infection, urinary tract infection, oral herpes, sinusitis, rhinitis, bronchitis, influenza, pneumonia, gastroenteritis, conjunctivitis, herpes zoster, pharyngitis, cellulitis, cystitis, lower respiratory tract infection, tooth infection, gingivitis, skin infection, gastroenteritis viral, respiratory tract infection, respiratory tract infection viral, and folliculitis.

       In the IBRANCE + letrozole arm, 30% of patients had Grade 1 alopecia and 3% had Grade 2. In the placebo + letrozole arm, 15% of patients had Grade 1 alopecia and 1% had Grade 2.

    #   Stomatitis includes aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oral discomfort, oropharyngeal pain, and stomatitis.

    **  Rash includes the following PTs: rash, rash maculo-papular, rash pruritic, rash erythematous, rash papular, dermatitis, dermatitis acneiform, and toxic skin eruption.

    Updated non-prespecified analysis of PFS††

    27.6 months of mPFS with IBRANCE + letrozole (n=444; 95% CI: 22.4-30.3) vs 14.5 months with placebo + letrozole (n=222; 95% CI: 12.3-17.1); HR=0.56 (95% CI: 0.46-0.69).5 

    • Number of PFS events: 245 (55.2%) in the IBRANCE + letrozole arm and 160 (72.1%) in the placebo + letrozole arm2

    Selected adverse events (AEs) reported in an updated non-prespecified analysis (with a median follow-up of 38 months) of PALOMA-25††

    The most common selected AEs (≥10%, all causality)‡‡ of any grade reported in an updated non-prespecified analysis of PALOMA-2 for IBRANCE + letrozole vs placebo + letrozole were neutropenia (82% vs 6%), infections (63% vs 45%), leukopenia (40% vs 2%), fatigue (40% vs 28%), nausea (37% vs 27%), alopecia (34% vs 16%), stomatitis (32% vs 15%), diarrhea (28% vs 21%), anemia (26% vs 10%), rash (20% vs 13%), thrombocytopenia (20% vs 1%), asthenia (18% vs 12%), decreased appetite (17% vs 9%), vomiting (17% vs 17%), dry skin (13% vs 7%), pyrexia (13% vs 9%), alanine aminotransferase (ALT) increased (13% vs 6%), aspartate aminotransferase (AST) increased (12% vs 6%), and dysgeusia (10% vs 5%).

    Selected AEs reported in the final OS analysis (with a median follow-up of 90 months) of PALOMA-22,4***

    The most common selected adverse events (≥10%, all causality)‡‡ of any grade reported in the final OS analysis of PALOMA-2 for IBRANCE + letrozole vs placebo + letrozole were neutropenia (82% vs 6%), infections (64% vs 46%), leukopenia (43% vs 3%), fatigue (41% vs 29%), nausea (38% vs 27%), alopecia (34% vs 16%), stomatitis (33% vs 15%), diarrhea (30% vs 23%), anemia (28% vs 10%), rash (22% vs 13%), thrombocytopenia (21% vs 2%), asthenia (19% vs 12%), decreased appetite (20% vs 10%), vomiting (18% vs 18%), dry skin (15% vs 7%), pyrexia (15% vs 9%), alanine aminotransferase increased (15% vs 6%), aspartate aminotransferase increased (14% vs 6%), and dysgeusia (NR vs NR).

    In an updated non-prespecified PFS analysis and the final OS analysis no new safety signals were observed.2,4,5 

          NR=not reported. 

    †† Based on May 2017 data cut (non-prespecified analysis), with a median follow-up of 38 months.5

    ‡‡  Incidences of AEs are all causality, and the AEs were selected based on their designation as ARs (treatment-related) in PALOMA-2 in the IBRANCE Prescribing Information.5

    *** Based on November 2021 data cut (final OS analysis), with a median follow-up of 90 months.2,4

    Differences between clinical trials and real-world observational studies

    Take another look

    NEXT: Real-world study design and study limitations 

    Review this important context


    References:
    1. Rugo HS, Brufsky A, Liu X, et al. Overall survival with first-line palbociclib plus an aromatase inhibitor (AI) vs AI in metastatic breast cancer: a large real-world database analysis. Poster presented at European Society for Medical Oncology (ESMO) Breast Cancer 2022 Congress; May 3-5, 2022; Berlin, Germany. Poster 169P.
    2. Data on file. Pfizer Inc., New York, NY.
    3. Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.
    4. Finn RS, Rugo HS, Diéras V, et al. Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer (ER+/HER2- ABC): analyses from PALOMA-2. Oral presentation at American Society of Clinical Oncology 2022 Annual Meeting; June 3-7, 2022; Chicago, IL.
    5. Rugo HS, Finn RS, Diéras V, et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174(3):719-729. 

    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.

    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 in postmenopausal women or in men, or
    • fulvestrant in patients with disease progression following endocrine therapy

    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 in postmenopausal women or in men, or
    • fulvestrant in patients with disease progression following endocrine therapy

    Please see full Prescribing Information for IBRANCE capsules and tablets .

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