Skip to Content

Ibrance

Generic Name: Palbociclib
Class: Antineoplastic Agents
Chemical Name: 6 - Acetyl - 8 - cyclopentyl - 5 - methyl - 2 - [[5 - (1 - piperazinyl) - 2 - pyridinyl]amino] - pyrido[2,3 - d]pyrimidin - 7(8H) - one
Molecular Formula: C24H29N7O2
CAS Number: 571190-30-2

Introduction

Antineoplastic agent; a reversible and selective inhibitor of cyclin-dependent kinase (CDK) 4 and 6.1 2 3 5 6 7 10

Uses for Ibrance

Breast Cancer

In combination with letrozole for initial treatment of hormone receptor-positive, human epidermal growth factor receptor type 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal women.1 2

Accelerated approval for combination therapy with letrozole based on progression-free survival.1 Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.1

In combination with fulvestrant for treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in women with disease progression following endocrine therapy.1 15

Ibrance Dosage and Administration

General

  • Obtain CBC at baseline, prior to initiation of each cycle, on day 14 of cycles 1 and 2, and as clinically indicated.1 More frequent monitoring may be required in patients who develop hematologic toxicity during therapy.1 (See Dosage Modification for Toxicity under Dosage and Administration.)

  • Consult respective manufacturers' labelings for information on dosage adjustments, adverse effects, and contraindications of other antineoplastic agents used in combination regimens.1

Restricted Distribution

  • Must obtain palbociclib through a specialty pharmacy.4

  • Consult the Ibrance website (http://www.ibrance.com/getting-ibrance) for specific availability information.4

Administration

Oral Administration

Administer orally once daily with food at approximately the same time each day.1 (See Absorption under Pharmacokinetics.)

Swallow palbociclib capsules whole; do not chew, crush, or open.1

If a dose is missed or vomited, take the next dose at the regularly scheduled time.1 Do not double the dose or take extra doses.1

Dosage

Adults

Breast Cancer
Initial Therapy for Advanced Breast Cancer
Oral

125 mg once daily on days 1–21 of each 28-day cycle in combination with letrozole 2.5 mg orally once daily given continuously during 28-day cycle.1 In principal efficacy study, therapy was continued until disease progression or unacceptable toxicity occurred.1

Previously Treated Advanced Breast Cancer
Oral

125 mg once daily on days 1–21 of each 28-day cycle in combination with fulvestrant 500 mg IM on days 1 and 15 of cycle 1, and then on day 1 of each 28-day cycle thereafter.1 In principal efficacy study, therapy was continued until disease progression or unacceptable toxicity occurred.1 15

Treat premenopausal or perimenopausal women receiving combination therapy with palbociclib and fulvestrant with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin) according to current standards of care.1

Dosage Modification for Toxicity
Oral

Adverse effects may require temporary interruption, dosage reduction, and/or permanent discontinuance.1 Adjust dosage based on individual safety and tolerability.1

Up to 2 dosage reductions for toxicity may be made.1 If dosage reduction from 125 mg once daily is necessary, initially reduce dosage to 100 mg once daily.1

If further dosage reduction necessary, reduce dosage to 75 mg once daily.1

Dosages <75 mg once daily not recommended.1

Hematologic Toxicity
Oral

If grade 3 febrile neutropenia (ANC 500 to <1000/mm3 with fever ≥38.5ºC and/or infection) occurs, temporarily interrupt palbociclib therapy.1 When ANC is ≥1000/mm3, resume therapy at reduced dosage.1

If grade 3 hematologic toxicity reported after CBC monitoring on day 1 of any cycle, temporarily interrupt palbociclib therapy; repeat CBC monitoring within 1 week.1 Delay next cycle until toxicity resolves to grade 2 or less; then continue palbociclib at the same dosage.1

If grade 3 hematologic toxicity reported after CBC monitoring on day 14 of cycle 1 or 2, continue palbociclib at the same dosage; repeat CBC monitoring on day 21.1

If prolonged grade 3 neutropenia (i.e., lasting >7 days) occurs or grade 3 neutropenia recurs in subsequent cycles, resume therapy at reduced dosage.1

If grade 4 hematologic toxicity occurs, temporarily interrupt palbociclib therapy.1 When toxicity resolves to grade 2 or less, resume therapy at reduced dosage.1

Exception made for grade 3 or 4 lymphopenia without an associated clinical event (e.g., opportunistic infection); no dosage modification required in such patients.1 14

Nonhematologic Toxicity
Oral

If persistent grade 3 or greater nonhematologic toxicity occurs despite appropriate medical management, temporarily interrupt palbociclib therapy.1 When toxicity resolves to grade 1 or less or to grade 2 or less (if toxicity not considered a safety risk for the patient), resume therapy at reduced dosage.1

Concomitant Use with Drugs Affecting Hepatic Microsomal Enzymes
Oral

If used concomitantly with a potent CYP3A inhibitor, reduce palbociclib dosage to 75 mg once daily.1 (See Drugs Affecting Hepatic Microsomal Enzymes under Interactions.)

Prescribing Limits

Adults

Breast Cancer
Oral

Dosages <75 mg once daily not recommended.1

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.1 (See Hepatic Impairment under Cautions.)

Renal Impairment

No specific dosage recommendations at this time.1 (See Renal Impairment under Cautions.)

Geriatric Patients

No specific dosage recommendations at this time.1 (See Geriatric Use under Cautions.)

Cautions for Ibrance

Contraindications

  • Manufacturer states none known.1

Warnings/Precautions

Neutropenia

Grade 3 or 4 neutropenia occurs frequently.1 2 15 Median time to onset: 15 days.1 Median duration of grade 3 or greater neutropenia: 7 days.1 Febrile neutropenia (temperature ≥38.5°C) and fatal neutropenic sepsis also reported.1

Monitor CBC at baseline, prior to initiation of each cycle, on day 14 of cycles 1 and 2, and as clinically indicated.1 If neutropenia occurs, more frequent CBC monitoring may be necessary.1 If neutropenia occurs, temporary interruption, dosage reduction, or treatment delay may be necessary depending on severity.1 (See Dosage Modification for Toxicity under Dosage and Administration.)

Pulmonary Embolism

Pulmonary embolism reported.1 2 15

Monitor for signs and symptoms.1 If pulmonary embolism occurs, initiate appropriate treatment.1

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; embryofetal toxicity and teratogenicity demonstrated in animals.1

Advise women of childbearing potential and men who are partners of such women to use effective contraception during treatment and for at least 3 weeks in women and for 3 months in men following drug discontinuance.1

If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard.1

Impairment of Male Fertility

May impair male fertility.1 Decreased fertility and adverse effects on male reproductive organs and sperm observed in animal studies; male reproductive organ effects partially reversible following drug discontinuance.1

Specific Populations

Pregnancy

May cause fetal harm.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether distributed into milk.1 Discontinue nursing during treatment and for 3 weeks following drug discontinuance.1

Effects of drug on nursing infants or milk production unknown.1

Pediatric Use

Safety and efficacy not established in pediatric patients <18 years of age.1

Geriatric Use

No overall differences in safety and efficacy relative to younger patients.1

Hepatic Impairment

Mild hepatic impairment does not substantially alter systemic exposure.1 (See Special Populations under Pharmacokinetics.)

Not studied in patients with moderate to severe hepatic impairment.1

Renal Impairment

Mild to moderate renal impairment (Clcr 30 to <90 mL/minute) does not substantially alter systemic exposure.1 (See Special Populations under Pharmacokinetics.)

Not studied in patients with severe renal impairment.1

Common Adverse Effects

Combination therapy with letrozole: Neutropenia,1 2 leukopenia,1 2 fatigue,1 2 anemia,1 2 upper respiratory infection (e.g., influenza, laryngitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis),1 2 nausea,1 2 stomatitis (e.g., oropharyngeal pain),1 2 alopecia,1 2 diarrhea,1 2 hot flush,2 arthralgia,2 thrombocytopenia,1 2 decreased appetite,1 2 vomiting,1 2 dyspnea,2 back pain,2 headache,2 asthenia,1 2 peripheral neuropathy,1 2 bone pain,2 constipation,2 cough,2 epistaxis,1 2 musculoskeletal pain,2 dizziness,2 extremity pain.2

Combination therapy with fulvestrant: Neutropenia,1 15 leukopenia,1 15 infections,1 15 fatigue,1 15 nausea,1 15 anemia,1 15 stomatitis,1 15 headache,1 15 diarrhea,1 15 thrombocytopenia,1 15 constipation,1 15 vomiting,1 15 alopecia,1 15 rash,1 decreased appetite,1 15 hot flush, 15 arthralgia,15 cough,15 pyrexia,1 15 back pain,15 dizziness,15 dyspnea.15

Interactions for Ibrance

Metabolized principally by CYP3A and sulfotransferase (SULT) 2A1.1

In vitro, not an inhibitor of CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, and 2D6 or inducer of CYP1A2, 2B6, 2C8, and 3A4 at clinically relevant concentrations.1 In vivo, weak time-dependent inhibitor of CYP3A.1

In vitro, low potential for inhibition of P-gp, breast cancer resistance protein (BCRP), organic cation transporter (OCT) 2, organic anion transporter (OAT) 1, OAT 3, organic anion transport protein (OATP) 1B1 and OATP1B3 at clinically relevant concentrations.1

Drugs Affecting Hepatic Microsomal Enzymes

Potent CYP3A inhibitors: Possible pharmacokinetic interaction (increased plasma concentrations and AUC of palbociclib).1 Avoid concomitant use; consider choosing alternative agent with no or minimal CYP3A inhibition potential.1 If concomitant use cannot be avoided, reduce palbociclib dosage to 75 mg once daily.1

If potent CYP3A inhibitor is discontinued, resume palbociclib (after 3–5 terminal half-lives of the CYP3A inhibitor) at dosage used prior to initiation of the potent CYP3A inhibitor.1 (See Specific Drugs and Foods under Interactions.)

Moderate and potent CYP3A inducers: Possible pharmacokinetic interaction (decreased plasma concentrations and AUC of palbociclib).1 Avoid concomitant use.1 (See Specific Drugs and Foods under Interactions.)

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP3A: Possible pharmacokinetic interaction (increased plasma concentrations of CYP3A substrate).1 If concomitant use of palbociclib and CYP3A substrates with a narrow therapeutic index cannot be avoided, consider dosage reduction of the CYP3A substrate.1 (See Specific Drugs and Foods under Interactions.)

Drugs Affecting Gastric Acidity

Potential pharmacokinetic interaction (decreased plasma concentrations and AUC of palbociclib) with drugs that increase gastric pH.1 (See Specific Drugs and Foods under Interactions.)

Specific Drugs and Foods

Drug

Interaction

Comments

Antacids

No clinically important effects on palbociclib exposure when administered under fed conditions1

Antifungals, azoles (e.g., itraconazole, ketoconazole, posaconazole, voriconazole)

Possible increased palbociclib exposure1

Itraconazole (200 mg daily) increased palbociclib (single 125-mg dose) AUC and peak concentrations by 87 and 34%, respectively1

Avoid concomitant use1

Select alternative agent with no or minimal CYP3A inhibition potential; if concomitant use unavoidable, reduce palbociclib dosage to 75 mg once daily1

If potent CYP3A inhibitor is discontinued, resume palbociclib (after 3–5 terminal half-lives of the CYP3A inhibitor) at dosage used prior to initiation of potent CYP3A inhibitor1

Antiretrovirals, HIV protease inhibitors (e.g., indinavir, nelfinavir, ritonavir, ritonavir-boosted lopinavir, saquinavir)

Possible increased palbociclib exposure1

Avoid concomitant use1

Select alternative agent with no or minimal CYP3A inhibition potential; if concomitant use unavoidable, reduce palbociclib dosage to 75 mg once daily1

If potent CYP3A inhibitor is discontinued, resume palbociclib (after 3–5 terminal half-lives of the CYP3A inhibitor) at dosage used prior to initiation of potent CYP3A inhibitor1

Antiretrovirals, nonnucleoside reverse transcriptase inhibitors (NNRTIs) (e.g., efavirenz, etravirine)

Possible decreased palbociclib exposure1

Avoid concomitant use1

Bosentan

Possible decreased palbociclib exposure1

Avoid concomitant use1

Calcium-channel blocking agents, nondihydropyridine (e.g., verapamil)

Possible increased palbociclib exposure1

Avoid concomitant use1

Select alternative agent with no or minimal CYP3A inhibition potential; if concomitant use unavoidable, reduce palbociclib dosage to 75 mg once daily1

If potent CYP3A inhibitor is discontinued, resume palbociclib (after 3–5 terminal half-lives of the CYP3A inhibitor) at dosage used prior to initiation of potent CYP3A inhibitor1

Carbamazepine

Possible decreased palbociclib exposure1

Avoid concomitant use1

Ergot derivatives (e.g., dihydroergotamine, ergotamine)

Possible increased concentrations of ergot derivative1

Concomitant use not recommended; if concomitant use unavoidable, consider dosage reduction of ergot derivative1

Fulvestrant

No effect on pharmacokinetics of fulvestrant or palbociclib1

Goserelin

No effect on pharmacokinetics of goserelin or palbociclib1

Grapefruit or grapefruit juice

Possible increased palbociclib exposure1

Avoid concomitant use1

Histamine H2-receptor antagonists

No clinically important effects on palbociclib exposure when administered under fed conditions1

Immunosuppressive agents (e.g., cyclosporine, everolimus, sirolimus, tacrolimus)

Possible increased concentrations of immunosuppressive agents metabolized by CYP3A1

Concomitant use not recommended; if concomitant use unavoidable, consider dosage reduction of CYP3A substrate drug1

Letrozole

No effect on pharmacokinetics of letrozole or palbociclib1

Macrolides (e.g., clarithromycin, telithromycin)

Possible increased palbociclib exposure1

Avoid concomitant use1

Select alternative agent with no or minimal CYP3A inhibition potential; if concomitant use unavoidable, reduce palbociclib dosage to 75 mg once daily1

If potent CYP3A inhibitor is discontinued, resume palbociclib (after 3–5 terminal half-lives of the CYP3A inhibitor) at dosage used prior to initiation of potent CYP3A inhibitor1

Midazolam

Palbociclib (multiple 125-mg doses) increased midazolam AUC and peak concentrations by 61 and 37%, respectively1

Concomitant use not recommended; if concomitant use unavoidable, consider dosage reduction of midazolam1

Modafinil

Modafinil (400 mg daily) decreased palbociclib (single 125-mg dose) AUC and peak concentrations by 32 and 11%, respectively1

Avoid concomitant use1

Nafcillin

Possible decreased palbociclib exposure1

Avoid concomitant use1

Nefazodone

Possible increased palbociclib exposure1

Avoid concomitant use1

Select alternative agent with no or minimal CYP3A inhibition potential; if concomitant use unavoidable, reduce palbociclib dosage to 75 mg once daily1

If nefazodone is discontinued, resume palbociclib (after 3–5 terminal half-lives of nefazodone) at dosage used prior to initiation of nefazodone1

Opiate agonists (e.g., alfentanil, fentanyl)

Possible increased concentrations of opiate agonists metabolized by CYP3A1

Concomitant use not recommended; if concomitant use unavoidable, consider dosage reduction of CYP3A substrate drug1

Phenytoin

Possible decreased palbociclib exposure1

Avoid concomitant use1

Pimozide

Possible increased concentrations of pimozide1

Concomitant use not recommended; if concomitant use unavoidable, consider dosage reduction of pimozide1

Proton-pump inhibitors (e.g., rabeprazole)

Possible decreased palbociclib exposure1

Rabeprazole decreased palbociclib (single 125-mg dose) AUC and peak concentrations by 13 and 41%, respectively, when administered under fed conditions, and by 62 and 80%, respectively, under fasting conditions1

No clinically important effects on palbociclib exposure when administered under fed conditions1

Quinidine

Possible increased concentrations of quinidine1

Concomitant use not recommended; if concomitant use unavoidable, consider dosage reduction of quinidine1

Rifampin

Rifampin (600 mg daily) decreased AUC and peak concentrations of palbociclib (single 125-mg dose) by 85 and 70%, respectively1

Avoid concomitant use1

St. John’s wort (Hypericum perforatum)

Possible decreased palbociclib exposure1

Avoid concomitant use1

Ibrance Pharmacokinetics

Absorption

Bioavailability

Mean absolute bioavailability is 46%.1

Following oral administration, peak plasma concentrations attained in 6–12 hours.1

Exposure is dose proportional over dosage range of 25–225 mg; median accumulation ratio is 2.4.1

Steady-state concentrations achieved in 8 days.1

Food

Administration in a fasting state decreased absorption and systemic exposure in approximately 13% of patients.1 Systemic exposure increased when drug was administered with food in these individuals; no effect on systemic exposure in other individuals.1 Administration with food reduces interindividual variability in systemic exposure.1

Special Populations

Mild hepatic impairment (total bilirubin concentrations not exceeding ULN with AST concentrations exceeding ULN, or total bilirubin concentrations >1 to 1.5 times ULN with any AST concentrations) does not substantially affect systemic exposure.1 Pharmacokinetics not studied in moderate or severe (total bilirubin concentrations >1.5 times ULN with any AST concentrations) hepatic impairment.1

Mild (Clcr 60 to <90 mL/minute) or moderate (Clcr 30 to <60 mL/minute) renal impairment does not substantially affect systemic exposure.1 Pharmacokinetics not studied in severe renal impairment.1

Age, gender, and body weight do not have clinically important effects on palbociclib exposure.1

Distribution

Extent

Not known whether distributed into human milk.1

Plasma Protein Binding

Approximately 85%.1

Elimination

Metabolism

Principally metabolized by CYP3A and SULT2A1.1

Elimination Route

Eliminated in feces (74.1%) and urine (17.5%), mainly as metabolites.1

Half-life

29 hours.1

Stability

Storage

Oral

Capsules

20–25°C (may be exposed to 15–30°C).1

Actions

  • Reversible and selective inhibitor of cyclin-dependent kinase (CDK) 4 and 6.1 2 3 5 6 7 10

  • CDK4 and 6 involved in regulation of progression from the G1 into S phase of the cell cycle through regulation of phosphorylation of the tumor suppressor protein retinoblastoma.2 8

  • Inhibits the G1 into S phase of the cell cycle and reduces cellular proliferation of estrogen receptor-positive breast cancer cells.1

  • Increased cell growth arrest in breast cancer cells treated with palbociclib and antiestrogens compared with either drug alone.1

  • Increased cell senescence for up to 6 days following discontinuance of therapy in estrogen receptor-positive breast cancer cells treated with palbociclib and antiestrogens.1

  • Increased inhibition of retinoblastoma phosphorylation, downstream signaling, and tumor growth when treated with palbociclib and letrozole compared with either drug alone in patient-derived estrogen receptor-positive breast tumor xenografts.1

Advice to Patients

  • Importance of taking palbociclib with food.1 Avoid grapefruit and grapefruit juice while taking the drug.1

  • Importance of advising patients to swallow capsules whole and not to chew, crush, or open capsules.1

  • If a dose of palbociclib is missed or vomited, take the next dose at the regularly scheduled time; do not double the dose or take extra doses.1

  • Risk of myelosuppression or infection.1 Importance of contacting clinician promptly if signs or symptoms of myelosuppression or infection (e.g., fever, chills, dizziness, shortness of breath, weakness, increased tendency to bleed and/or bruise) occur.1

  • Risk of pulmonary embolism.1 Importance of contacting clinician promptly if signs or symptoms of pulmonary embolism (e.g., shortness of breath, chest pain, tachypnea, tachycardia) occur.1

  • Risk of fetal harm.1 Necessity of advising women of childbearing potential and men who are partners of such women to use effective contraception during treatment and for at least 3 weeks in women and for 3 months in men after discontinuance of therapy.1 Importance of women informing clinicians if they are or plan to become pregnant.1 If pregnancy occurs, advise patient of potential fetal risk.1

  • Risk of serious adverse reactions in nursing infants.1 Importance of advising women to discontinue nursing during treatment and for 3 weeks following drug discontinuance.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements (e.g., St. John’s wort), as well as any concomitant illnesses.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Distribution of palbociclib is restricted.4 (See Restricted Distribution under Dosage and Administration.)

Palbociclib

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

75 mg

Ibrance

Pfizer

100 mg

Ibrance

Pfizer

125 mg

Ibrance

Pfizer

AHFS DI Essentials. © Copyright 2016, Selected Revisions October 14, 2016. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Pfizer. Ibrance (palbociclib) capsules prescribing information. New York, NY; 2016 Feb.

2. Finn RS, Crown JP, Lang I et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015; 16:25-35. [PubMed 25524798]

3. Hosford SR, Miller TW. Clinical potential of novel therapeutic targets in breast cancer: CDK4/6, Src, JAK/STAT, PARP, HDAC, and PI3K/AKT/mTOR pathways. Pharmgenomics Pers Med. 2014; 7:203-15. [PubMed 25206307]

4. Pfizer. Specialty Pharmacy Providers (SPPs). From Ibrance website. Accessed 2015 Dec 16.

5. Morikawa A, Henry NL. Palbociclib for the Treatment of Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer. Clin Cancer Res. 2015; 21:3591-6. [PubMed 26100274]

6. Rocca A, Farolfi A, Bravaccini S et al. Palbociclib (PD 0332991) : targeting the cell cycle machinery in breast cancer. Expert Opin Pharmacother. 2014; 15:407-20. [PubMed 24369047]

7. Murphy CG, Dickler MN. The Role of CDK4/6 Inhibition in Breast Cancer. Oncologist. 2015; 20:483-90. [PubMed 25876993]

8. Mangini NS, Wesolowski R, Ramaswamy B et al. Palbociclib: A Novel Cyclin-Dependent Kinase Inhibitor for Hormone Receptor-Positive Advanced Breast Cancer. Ann Pharmacother. 2015; 49:1252-60. [PubMed 26324355]

9. Vidula N, Rugo HS. Cyclin-Dependent Kinase 4/6 Inhibitors for the Treatment of Breast Cancer: A Review of Preclinical and Clinical Data. Clin Breast Cancer. 2016; 16:8-17. [PubMed 26303211]

10. Cadoo KA, Gucalp A, Traina TA. Palbociclib: an evidence-based review of its potential in the treatment of breast cancer. Breast Cancer (Dove Med Press). 2014; 6:123-33. [PubMed 25177151]

11. Finn RS, Dering J, Conklin D et al. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res. 2009; 11:R77. [PubMed 19874578]

12. Sutherland RL, Musgrove EA. CDK inhibitors as potential breast cancer therapeutics: new evidence for enhanced efficacy in ER+ disease. Breast Cancer Res. 2009; 11:112. [PubMed 20067604]

13. DeMichele A, Clark AS, Tan KS et al. CDK 4/6 inhibitor palbociclib (PD0332991) in Rb+ advanced breast cancer: phase II activity, safety, and predictive biomarker assessment. Clin Cancer Res. 2015; 21:995-1001. [PubMed 25501126]

14. Pfizer Inc. New York, NY: Personal communication.

15. Cristofanilli M, Turner NC, Bondarenko I et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016; :. [PubMed 26947331]

Hide