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The only FDA-approved first-line maintenance
therapy combination with a CDK4/6 inhibitor
for patients with HR+/HER2+ LA/mBC following induction therapy1,2The only FDA-approved first-line maintenance therapy combination with
a CDK4/6 inhibitor for patients with HR+/HER2+ LA/mBC following induction therapy1,2PATINA trial design
PATINA (NCT02947685) was a randomized (1:1), open-label trial evaluating IBRANCE with trastuzumab +/- pertuzumab and ET vs trastuzumab +/- pertuzumab and ET in patients with HR+/HER2+ LA or mBC who had no evidence of disease progression after induction treatment for their advanced disease. Patients received either IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy (n=261) or trastuzumab, with or without pertuzumab, and endocrine therapy alone (n=257). IBRANCE was given orally at a dose of 125 mg daily for 21 consecutive days followed by 7 days off treatment to comprise a cycle of 28 days.1,2
Induction treatment was defined as 4-8 cycles of a taxane in combination with trastuzumab, with or without pertuzumab, and patients were determined to have no evidence of disease progression prior to randomization.1,2Refer to the Full Prescribing Information for recommended dosage for ET, trastuzumab, and pertuzumab administered in combination with IBRANCE.1,2ET options included fulvestrant or aromatase inhibitors (anastrozole, letrozole, or exemestane).1,2PATINA trial resultsPrimary endpoint
HR+/HER2+ LA/mBC: IBRANCE plus trastuzumab +/- pertuzumab plus ET
Primary endpoint
In a 1:1 randomized, open-label trial evaluating IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy in adult patients with HR+/HER2+ LA/mBC who had no evidence of disease progression after induction treatment for their advanced disease1,2:
Statistically significant 24% reduction in risk of disease progression or death with IBRANCE + trastuzumab, with or without pertuzumab, + ET compared with the control arm1,2
Scroll left to view table
Median PFS cannot be adequately described because of censoring1,2
124 (47.5%) PFS events occurred with IBRANCE + trastuzumab, with or without pertuzumab, + ET vs 133 (51.8%) PFS events with trastuzumab, with or without pertuzumab, + ET1,2
At the time of the PFS analysis, OS data were not mature with 24% of deaths in the overall population1,2
HR+/HER2+ LA/mBC: IBRANCE plus trastuzumab +/- pertuzumab plus ET
Adverse reactions reported in PATINA
The adverse reactions reported below occurred in ≥10% of patients who received IBRANCE in combination with trastuzumab +/- pertuzumab and ET in PATINA.1,2
ET=endocrine therapy; HER2+=human epidermal growth factor receptor 2-positive; HR+=hormone receptor-positive; LA=locally advanced; mBC=metastatic breast cancer.Preferred terms (PTs) are listed according to MedDRA 27.0.1,2Infections include any reported PTs that are part of the System Organ Class Infections and infestations.1,2Stomatitis includes the following PTs: aphthous ulcer, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal discomfort, oropharyngeal pain, and stomatitis.1,2Rash includes the following PTs: rash, rash maculo-papular, rash pruritic, rash erythematous, rash popular, dermatitis, dermatitis acneiform, and toxic skin eruption.1,2Clinically relevant adverse reactions in <10% of patients who received IBRANCE + trastuzumab +/- pertuzumab + ET in PATINA included alopecia, lacrimation increased, dry eye, dysgeusia, vision blurred, palmar-plantar erythrodysesthesia syndrome, interstitial lung disease/pneumonitis, and febrile neutropenia.1,2Lab abnormalities
HR+/HER2+ LA/mBC: IBRANCE plus trastuzumab +/- pertuzumab plus ET
Lab abnormalities
The laboratory abnormalities reported below occurred in ≥10% of patients, with ≥2% higher incidence in the IBRANCE + trastuzumab +/- pertuzumab + ET arm in PATINA.1,2
Grading according to CTCAE version 4.0.1,2
Grades appearing as N/A – CTCAE not defined in the corresponding laboratory test.1,2
CTCAE=Common Terminology Criteria for Adverse Events; ET=endocrine therapy; HER2+=human epidermal growth factor receptor 2-positive; HR+=hormone receptor-positive; LA=locally advanced; mBC=metastatic breast cancer; N/A=not applicable.Discontinuations and dose reductions
HR+/HER2+ LA/mBC: IBRANCE plus trastuzumab +/- pertuzumab plus ET
Discontinuations and dose reductions due to adverse reactions in PATINAAdverse reactions leading to discontinuation of IBRANCE in ≥1% of patients in combination with trastuzumab +/- pertuzumab and ET included neutropenia (3.8%), infections (1.5%), stomatitis (1.5%), and fatigue (1.2%).1,2
Dose reductions of IBRANCE due to adverse reactions occurred in 53% of patients receiving IBRANCE plus trastuzumab +/- pertuzumab plus ET. Adverse reactions leading to dose reductions of IBRANCE in ≥2% of patients receiving IBRANCE plus trastuzumab +/- pertuzumab plus ET were neutropenia (38%), diarrhea (6%), stomatitis (6%), fatigue (2.7%), infections (2.7%), leukopenia (2.7%), and thrombocytopenia (2.3%).1,2
Dose interruptions of IBRANCE due to an adverse reaction occurred in 181 (70%) of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. Adverse reactions leading to dose interruptions of IBRANCE in ≥2% of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy were neutropenia (54%), infections (22%), stomatitis (8%), diarrhea (7%), leukopenia (5%), thrombocytopenia (3.8%), anemia and abdominal pain (2.7% each), and cough (2.3%).1,2AR=adverse reaction; ET=endocrine therapy; HER2=human epidermal growth factor receptor 2; HER2+=human epidermal growth factor receptor 2-positive; HR+=hormone receptor-positive; LA=locally advanced; mBC=metastatic breast cancer.Safety information
HR+/HER2+ LA/mBC: IBRANCE plus trastuzumab +/- pertuzumab plus ET
Safety information1,2
Neutropenia1,2
Neutropenia was the most frequently reported adverse reaction in PATINA with an incidence of 78%. A Grade ≥3 decrease in neutrophil counts was reported in 61% of patients receiving IBRANCE combination with trastuzumab, with or without pertuzumab, and endocrine therapy. The median time to first episode of any grade neutropenia was 22 days and the median duration of Grade ≥3 neutropenia events was 9 days
Febrile neutropenia has been reported in 0.8% of patients exposed to IBRANCE in the PATINA study
Inform patients to promptly report any fever
Monitor complete blood count (CBC) prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of the 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
Interstitial lung disease (ILD)/pneumonitis1,2
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
In PATINA, 1% of IBRANCE-treated patients had ILD/pneumonitis of any grade. No Grade 3, 4, or 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 (eg, 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
Embryo-fetal toxicity1,2
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
CDK4/6=cyclin-dependent kinases 4 and 6; ET=endocrine therapy; HER2+=human epidermal growth factor receptor 2-positive; HR+=hormone receptor-positive; LA=locally advanced; mBC=metastatic breast cancer.Palbociclib (IBRANCE®) in combination with an aromatase inhibitor and pertuzumab and trastuzumab as a maintenance treatment option for HR+/HER2+ mBC is recommended by the National Comprehensive Cancer Network® (NCCN®)3
For the treatment of women who are postmenopausal or premenopausal receiving ovarian ablation or suppression with HR+/HER2+ mBC following induction with chemotherapy + pertuzumab + trastuzumab and chemotherapy was stopped.3
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INDICATIONSHER2-Negative Metastatic Breast Cancer
IBRANCE® (palbociclib) 125 mg capsules and tablets are indicated
For the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
an aromatase inhibitor as initial endocrine-based therapy; or
fulvestrant in patients with disease progression following endocrine therapy.
in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, following recurrence on or after completing adjuvant endocrine therapy.
HER2-Positive Metastatic Breast Cancer
IBRANCE® (palbociclib) 125 mg capsules and tablets are indicated in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
IMPORTANT SAFETY INFORMATIONNeutropenia 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. In PATINA, neutropenia was the most frequently reported adverse reaction with an incidence of 78%, and Grade ≥3 neutropenia was reported in 61% of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. Based on laboratory findings, 93% had a decrease in neutrophil counts including 47% with Grade 3 and 3.1% with Grade 4. 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. Febrile neutropenia has been reported in 0.8% of patients exposed to IBRANCE in the PATINA study. 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% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. In PATINA, 1% of IBRANCE-treated patients had ILD/pneumonitis of any grade and no Grade 3, 4, or 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. Serious adverse reactions occurred in 25% of patients in PATINA who received IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. Serious adverse reactions in ≥1% of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy included infections (8%), headache and pyrexia (1.5% each), and femur fracture (1.2%). Fatal adverse reactions occurred in 1.2% of patients in PATINA who received IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy including (0.4% each) death, hepatic hemorrhage, and sepsis. The most common adverse reactions (≥20%) occurring in PATINA, including laboratory abnormalities, for IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy vs trastuzumab, with or without pertuzumab, and endocrine therapy were white blood cell decreased (94% vs 25%), neutrophil count decreased (93% vs 19%), creatinine increased (92% vs 87%), hemoglobin decreased (81% vs 47%), diarrhea (70% vs 37%), infections (64% vs 43%), platelet count decreased (59% vs 6%), stomatitis (44% vs 11%), aspartate aminotransferase increased (39% vs 25%), decreased calcium (39% vs 30%), alanine aminotransferase increased (38% vs 28%), decreased potassium (33% vs 17%), fatigue (32% vs 21%), alkaline phosphatase increased (31% vs 23%), nausea (30% vs 15%), asthenia (27% vs 21%), headache (26% vs 18%), rash (22% vs 17%), pruritus (21% vs 17%), and muscle spasms (20% vs 11%). Other Clinical Trials Experience: venous thromboembolism has been reported as an adverse reaction following administration of IBRANCE. 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. INDICATIONHER2-Positive Metastatic Breast CancerIBRANCE® (palbociclib) 125 mg capsules and tablets are indicated in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
