Ibrance

(Palbociclib)

ApprovedSmall molecule

Palbociclib is used to treat certain types of breast cancer, particularly hormone receptor-positive breast cancer in women. It works by slowing down the growth of cancer cells by blocking proteins that help them divide.[2] Ibrance is currently approved and in use across 67 indications[4].[1]

Ibrance is one of 1073 small molecule programs targeting Breast Cancer. It is currently in Approved.

Indications

303

Total Trials

Active Trials

1,072

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Breast CancerCompleted

Metastatic Colorectal CancerCompleted

Esophageal Squamous Cell CarcinomaNot yet recruiting

TreatmentRecruiting

Refractory Solid TumorsActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

Breast NeoplasmActive, not recruiting

Thymus NeoplasmApproved

Breast Ductal Carcinoma in SituApproved

Acute Myeloid LeukemiaApproved

Breast CancerApproved

Completed

Metastatic Colorectal CancerPhase 2

Completed

Esophageal Squamous Cell CarcinomaPhase 2

Not yet recruiting

TreatmentPhase 2

Recruiting

Refractory Solid TumorsPhase 2

Active, not recruiting

Hepatocellular CarcinomaPreclinical

Active, not recruiting

Breast NeoplasmApproved

Active, not recruiting

Thymus NeoplasmApproved

Approved

Breast Ductal Carcinoma in SituApproved

Approved

Acute Myeloid LeukemiaApproved

Approved

Showing 10 of 67 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Ibrance

Adenocard

2 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Duragesic

CCephalon

Preclinical

1 6

Chantix

PPrism Pharmaceuticals

Preclinical

1 7

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 8

Vfend

PPrism Pharmaceuticals

Rilvegostomig

1 10

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Abemaciclib

NCT05766410

Q4 2026

Not yet recruiting

Breast Cancer

NCT06076772

Phase 1Active, not recruiting

Mantle Cell Lymphoma

NCT02159755

Phase 2Not yet recruiting

Biomarker

NCT04605562

Phase 2Not yet recruiting

Breast Cancer

NCT05067530

Phase 2Active, not recruiting

Prostate Cancer

NCT02905318

Clinical

Trials by Indication[1]

Breast Cancer89 trials

Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

Unknown status·AAlliance for Clinical Trials in Oncology·Phase 2·NCT03633331·93 enrolled

T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer

Completed·UUniversity of Arizona·Phase 2·NCT03530696·55 enrolled

Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02738866·60 enrolled

Show 86 more trials

A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer

Terminated· Roche logo

Roche·Phase 1·NCT04060862·20 enrolled

Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer

Completed·NNSABP Foundation Inc·Phase 2·NCT03628066·24 enrolled

Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer

Terminated·WWashington University School of Medicine·Phase 2·NCT02907918·26 enrolled

Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

Terminated· Sanofi logo

Sanofi·Phase 3·NCT04478266·1,068 enrolled

Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer

Active, not recruiting· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 1·NCT05293964·214 enrolled

Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients

Active, not recruiting·UUNICANCER·N/A·NCT03870919·200 enrolled

Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression

Recruiting·RRoyal Marsden NHS Foundation Trust·Phase 2·NCT04920708·324 enrolled

A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer

Not yet recruiting· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 1·NCT06941142·382 enrolled

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

Recruiting· Relay Therapeutics logo

Relay Therapeutics·Phase 1·NCT05216432·930 enrolled

CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer

Withdrawn·WWeill Medical College of Cornell University·Phase 2·NCT04220476

Combined Immunotherapies in Metastatic ER+ Breast Cancer

Recruiting·WWeill Medical College of Cornell University·Phase 2·NCT04563507·102 enrolled

Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer

Completed·CCanadian Cancer Trials Group·Phase 2·NCT02630693·180 enrolled

Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant

Completed·IInternational Cancer Research Group, United Arab Emirates·Phase 3·NCT03447132·354 enrolled

Avelumab or Hydroxychloroquine with or Without Palbociclib to Eliminate Dormant Breast Cancer

Recruiting·—·Phase 2·NCT04841148·96 enrolled

HR+/HER2- Advanced Breast Cancer and Endocrine Resistance

Terminated·TTheodoros Foukakis·Phase 2·NCT03322215·42 enrolled

Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer

Terminated· Sanofi logo

Sanofi·Phase 1/2·NCT03284957·136 enrolled

ER+/HER2- Locally Advanced or Metastatic Breast Cancer (ENZENO Study)

Unknown status·EEnhancedBio USA Inc.·Phase 1/2·NCT04669587·106 enrolled

Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT03774472·15 enrolled

Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer

Active, not recruiting·—·Phase 2·NCT02778685·47 enrolled

Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery

Completed·OOhio State University Comprehensive Cancer Center·Phase 2·NCT02760030·14 enrolled

Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04256941·4 enrolled

The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer

Unknown status·ZZhejiang Cancer Hospital·N/A·NCT03756090·100 enrolled

WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor

Completed·GGeorgetown University·Phase 1·NCT03854903·19 enrolled

A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer

Completed·NNSABP Foundation Inc·Phase 2·NCT02296801·307 enrolled

PalbocIclib in PreMenopausal Women With ER Positive/HER-2 Negative MetAstatic Breast Cancer

Unknown status·—·Phase 2·NCT02917005·160 enrolled

Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis

Terminated·NNorthwestern University·Phase 2·NCT02774681·12 enrolled

Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 1·NCT02499146·26 enrolled

Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study

Recruiting·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano··NCT06805812·3,500 enrolled

A Study of ZN-c5 in Subjects With Breast Cancer

Completed·ZZeno Alpha Inc.·Phase 1/2·NCT03560531·181 enrolled

Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

No longer available· Pfizer logo

Pfizer··NCT02142868

Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.

Not yet recruiting·HHelwan University··NCT06338644·100 enrolled

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

Active, not recruiting·CCelcuity Inc·Phase 3·NCT05501886·701 enrolled

A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer

Withdrawn·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT04872608

Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programe

Completed·FFernando Moreno Antón··NCT04109261·237 enrolled

Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer

Unknown status·HHaihe Biopharma Co., Ltd.·Phase 1·NCT04856371·228 enrolled

Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer

Terminated·JJonsson Comprehensive Cancer Center·Phase 1·NCT03128619·10 enrolled

Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors

Completed· Novartis logo

Novartis··NCT05153135·4,320 enrolled

Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy

Terminated·PPalleos Healthcare GmbH·Phase 4·NCT03220178·532 enrolled

Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients

Not yet recruiting·—··NCT06076772·54 enrolled

A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

Completed·UUniversity of California, San Francisco·Phase 2·NCT02384239·70 enrolled

Neoadjuvant With Trastuzumab, Pyrotinib Plus Palbociclib and Fulvestrant in HER2-positive, ER-positive Breast Cancer

Unknown status·FFudan University·Phase 2·NCT05076695·37 enrolled

A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer

Recruiting·FFudan University·N/A·NCT06856200·36 enrolled

Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan

Completed· Pfizer logo

Pfizer··NCT05399329·688 enrolled

G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer

Completed·GG1 Therapeutics, Inc.·Phase 1·NCT03455270·107 enrolled

Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer

Completed·SSOLTI Breast Cancer Research Group·Phase 2·NCT02448420·73 enrolled

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

Completed· Relay Therapeutics logo

Relay Therapeutics·Phase 1·NCT05759949·41 enrolled

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

Completed· Pfizer logo

Pfizer·Phase 3·NCT01942135·521 enrolled

Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

Terminated·UUniversity of Kansas Medical Center·Phase 1/2·NCT03709082·3 enrolled

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

Completed·CCelcuity Inc·Phase 1·NCT02684032·141 enrolled

Adjuvant Palbociclib in Elderly Patients With Breast Cancer

Active, not recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT03609047·366 enrolled

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

Active, not recruiting·AAlliance Foundation Trials, LLC.·Phase 3·NCT02947685·518 enrolled

Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant

Completed·IiOMEDICO AG·Phase 2·NCT02894398·388 enrolled

Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

Completed·KKyoto Breast Cancer Research Network·Phase 3·NCT03969121·141 enrolled

A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors

Completed· Novartis logo

Novartis··NCT05141240·4,650 enrolled

Predicted Biomarkers of CDK4/6 Inhibitors (Palbociclib) in ER-positive Metastasis Breast Cancer

Unknown status·CChinese Academy of Medical Sciences··NCT04289974·100 enrolled

A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer

Suspended· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 1/2·NCT04946864·65 enrolled

ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

Active, not recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 1·NCT06570031·46 enrolled

A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04711252·1,370 enrolled

A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]

Completed· Pfizer logo

Pfizer·Phase 3·NCT02297438·340 enrolled

Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

Completed·—·Phase 2·NCT02668666·49 enrolled

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Recruiting·SStemline Therapeutics, Inc.·Phase 1/2·NCT05563220·435 enrolled

Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate

Completed· Pfizer logo

Pfizer·Phase 3·NCT02600923·131 enrolled

Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 1·NCT03238196·35 enrolled

Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer

Completed·WWashington University School of Medicine·Phase 2·NCT03007979·55 enrolled

Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women

Completed·UUNICANCER·Phase 2·NCT02400567·125 enrolled

Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03573648·33 enrolled

Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02599714·54 enrolled

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)

Completed· Roche logo

Roche·Phase 2·NCT04436744·221 enrolled

High Risk ER+HER2- T1-2N0-1 Early Breast Cancer With Palbociclib Plus Endocrine Therapy(HIPEx)

Unknown status·SSamsung Medical Center·Phase 2·NCT04247633·578 enrolled

Fulvestrant and Palbociclib With or Without Copanlisib in Treating Patients With Hormone Receptor Positive, HER2 Negative, Stage IV Breast Cancer

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT03377101

Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 4·NCT02679755·252 enrolled

PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY

Active, not recruiting·NNational Cancer Center, Japan·Phase 3·NCT03423199·180 enrolled

A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer

Completed·IInventisBio Co., Ltd·Phase 1·NCT03471663·200 enrolled

HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer

Completed·—·Phase 1·NCT03685331·9 enrolled

A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer

Completed· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 2·NCT04224272·51 enrolled

A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT04075604·23 enrolled

Palbociclib Plus Fulvestrant in Women With Hormone Receptor Positive and Human Epidermal Growth Factor Receptor Type 2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination With Hormonal Therapy

Unknown status·CConsorzio Oncotech·Phase 2·NCT04318223·168 enrolled

Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer

Active, not recruiting·PPeter MacCallum Cancer Centre, Australia·Phase 1·NCT03900884·17 enrolled

Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib

Completed·SShannon Puhalla·Phase 1·NCT02913430·7 enrolled

Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study

Not yet recruiting·MMedical University of Gdansk·Phase 2·NCT05067530·126 enrolled

Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer

Completed·—·Phase 2·NCT02040857·162 enrolled

PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)

Completed·MMedSIR·Phase 2·NCT03809988·198 enrolled

Neoadjuvant Biomarker ResearcH Study of Palbociclib Combined With Endocrine Therapy in Estrogen Receptor Positive/HER2 Negative Breast CAncer (NeoRHEA)

Completed·JJules Bordet Institute·Phase 2·NCT03065621·100 enrolled

First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.

Active, not recruiting· Pfizer logo

Pfizer··NCT04767594·1,409 enrolled

Evaluation of Geriatric Questionnaires to Predict Toxicities of CDK 4/6 Inhibitors in Older Breast Cancer Patients?

Unknown status·NNamik Kemal University··NCT05051956·140 enrolled

Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer

Unknown status·SShengjing Hospital·Phase 3·NCT04047758·420 enrolled

Head and Neck Squamous Cell Carcinoma4 trials

Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT03194373·21 enrolled

Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor

Recruiting·WWashington University School of Medicine·Phase 3·NCT04966481·81 enrolled

Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Active, not recruiting·KKathryn Gold·Phase 1·NCT03498378·24 enrolled

Show 1 more trial

Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma

Active, not recruiting·WWashington University School of Medicine·Phase 2·NCT03389477·26 enrolled

Trial4 trials

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

CARE Initiative: Real-world Emulation of the PALOMA-2 Trial

Completed·AAetion, Inc.··NCT06607601·724 enrolled

Show 1 more trial

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

Recruiting·CCanadian Cancer Trials Group·Phase 2·NCT03297606·720 enrolled

Esophageal Squamous Cell Carcinoma3 trials

A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma

Recruiting·WWest China Hospital·Phase 1/2·NCT06753747·45 enrolled

Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas

Recruiting·WWest China Hospital·Phase 1·NCT06654297·6 enrolled

Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinoma

Not yet recruiting·WWest China Hospital·Phase 2·NCT07191977·41 enrolled

Acute Lymphoblastic Leukemia3 trials

Treatment With Combination Chemotherapy for Relapsed or Refractory Acute Lymphoblastic Leukemia

Terminated·SSt. Jude Children's Research Hospital·Phase 1·NCT03515200·12 enrolled

Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

Completed·CChildren's Oncology Group·Phase 1·NCT03792256·12 enrolled

Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (RELPALL2)

Recruiting·TTanja Andrea Gruber·Phase 1·NCT04996160·22 enrolled

75 more indications

Treatment3 trials

Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS

Not yet recruiting·PPeking University Shenzhen Hospital·Phase 2·NCT06692491·200 enrolled

A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel.

Completed· Pfizer logo

Pfizer··NCT04671615·559 enrolled

SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT05238831

Patients With Advanced Solid Tumors3 trials

Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)

Completed·MMirati Therapeutics Inc.·Phase 1·NCT05178888·11 enrolled

Study of AVZO-021 in Patients With Advanced Solid Tumors

Recruiting·AAvenzo Therapeutics, Inc.·Phase 1/2·NCT05867251·430 enrolled

A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations

Recruiting·SSun Yat-sen University·Phase 1/2·NCT06947811·71 enrolled

Advanced Solid Tumors3 trials

Interventional Study to Evaluate the Combination of Palbociclib + Sunitinib as a Treatment for Advanced Solid Tumors

Recruiting·RRabin Medical Center·Phase 1/2·NCT06940349·100 enrolled

Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors

Completed·EEmory University·Phase 1·NCT02897375·71 enrolled

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Active, not recruiting· Amgen logo

Amgen·Phase 1·NCT04185883·610 enrolled

Effectiveness3 trials

Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor

Completed· Pfizer logo

Pfizer··NCT05361655·2,888 enrolled

Comparative Effectiveness of Palbociclib Plus AI Versus Fulvestrant for HR+/HER2- ABC

Unknown status·CChinese Academy of Medical Sciences··NCT05000736·600 enrolled

Comparative Effectiveness of PAL Based-therapy as Initial ET Versus PAL Based-therapy After ChT for HR+/HER2- ABC

Unknown status·CChinese Academy of Medical Sciences··NCT05343117·400 enrolled

Metastatic Colorectal Cancer2 trials

Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer

Recruiting·OOslo University Hospital·Phase 2·NCT05725200·40 enrolled

Palbociclib and Cetuximab in Metastatic Colorectal Cancer

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT03446157·24 enrolled

Endocrine Therapy2 trials

To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy

Completed·FFondazione Sandro Pitigliani·Phase 2·NCT02549430·115 enrolled

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

Completed·SSpanish Breast Cancer Research Group·Phase 3·NCT02028507·693 enrolled

Overall Survival2 trials

Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study)

Completed·MMedSIR··NCT06525675·419 enrolled

Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.

Completed· Pfizer logo

Pfizer··NCT06086340·779 enrolled

Cancer2 trials

TAS-116 Plus Palbociclib in Breast and Rb-null Cancer

Withdrawn·—·Phase 1·NCT05655598

OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults

Unknown status·UUniversity Medical Center Groningen·Phase 4·NCT05949424·30 enrolled

Tumor2 trials

PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection

Completed·UUNICANCER·Phase 3·NCT03079011·1,017 enrolled

Tumor Response Time of Palbociclib in Combination With AI in Real-world Chinese Patients

Unknown status·ZZhejiang Cancer Hospital·Phase 2·NCT04858997·150 enrolled

Non-Small Cell Lung Cancer2 trials

Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer

Completed·—·Phase 1·NCT03170206·34 enrolled

National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer

Active, not recruiting·UUniversity of Birmingham·Phase 2·NCT02664935·423 enrolled

Lung Cancer2 trials

Lung-MAP: Palbociclib as Second-Line Therapy in Treating Cell Cycle Gene Alteration Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer

Completed·SSWOG Cancer Research Network·Phase 2/3·NCT02785939·53 enrolled

Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer

Completed·SSWOG Cancer Research Network··NCT02154490·1,864 enrolled

Solid Tumors2 trials

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-Cancer Activity of Trametinib in Combination With Palbociclib in Subjects With Solid Tumors

Completed· GSK logo

GSK·Phase 1·NCT02065063·28 enrolled

PALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors

Completed·—·Phase 1·NCT02022982·60 enrolled

Biomarker2 trials

Biomarker-based Study in R/M SCCHN

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT03088059·340 enrolled

Umbrella Biomarker-Guided Therapy in NPC

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT04605562·206 enrolled

Tic Disorder1 trial

Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03526250·23 enrolled

Pancreatic Cancer1 trial

Binimetinib and Palbociclib Before Surgery for the Treatment of Operable KRAS-Positive Lung, Colorectal, or Pancreatic Cancer

Withdrawn·RRoswell Park Cancer Institute·Phase 1·NCT04870034

Chordoma1 trial

CDK4/6 Inhibition in Locally Advanced/Metastatic Chordoma

Completed·UUniversity Hospital Heidelberg·Phase 2·NCT03110744·43 enrolled

Thromboembolism1 trial

Exploring Cancer-Associated Thromboembolism Prognosis Biomarkers and Polymorphisms

Unknown status·LLebanese University·Phase 1·NCT06065592·500 enrolled

Tics1 trial

A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT02059330·27 enrolled

GIST1 trial

Swedish Ibrance Registries Insights (SIRI)

Active, not recruiting· Pfizer logo

Pfizer··NCT04654208·1,500 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Precision Therapy in Refractory Tumor

Unknown status·BBaodong Qin·Phase 2·NCT03239015·300 enrolled

Rare Tumor1 trial

PLATFORM Study of Precision Medicine for Rare Tumors

Recruiting·—·Phase 2·NCT04423185·770 enrolled

Phase IB1 trial

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC

Recruiting·FForward Pharmaceuticals Co., Ltd.·Phase 1/2·NCT07002177·196 enrolled

Hepatocellular Carcinoma1 trial

Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib

Recruiting·HHenan Cancer Hospital·N/A·NCT06478927·22 enrolled

Advanced Cancer1 trial

Histology-Independent Study of Palbociclib in Patients With Advanced Cancer

Withdrawn·—·Phase 2·NCT03123744

Precision Therapy1 trial

Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA

Recruiting·LLebanese University·Phase 1·NCT06307249·50 enrolled

Liposarcoma1 trial

PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01209598·90 enrolled

Ovarian Cancer1 trial

Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer

Completed·LLatin American Cooperative Oncology Group·Phase 2·NCT03936270·43 enrolled

Hepatic Function1 trial

A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib

Completed· Pfizer logo

Pfizer·Phase 1·NCT02334800·28 enrolled

Renal Cell Carcinoma1 trial

Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc)

Terminated·NNiKang Therapeutics, Inc.·Phase 2·NCT05935748·18 enrolled

Bone Metastasis1 trial

Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis

Completed·EEmory University·Phase 2·NCT03691493·36 enrolled

Metastatic Melanoma1 trial

Encorafenib, Binimetinib and Palbociclib in BRAF-mutant Metastatic Melanoma CELEBRATE

Unknown status·PPeter MacCallum Cancer Centre, Australia·Phase 1/2·NCT04720768·78 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Hormone Receptor Positive Tumor1 trial

Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors

Active, not recruiting·TThomas Hatschek·Phase 2·NCT02592083·10 enrolled

Advanced Soft-tissue Sarcoma1 trial

Molecular Profiling of Advanced Soft-tissue Sarcomas

Active, not recruiting·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 3·NCT03784014·603 enrolled

Adjuvant1 trial

PALbociclib CoLlaborative Adjuvant Study

Active, not recruiting·AAlliance Foundation Trials, LLC.·Phase 3·NCT02513394·5,796 enrolled

Gynecologic Cancer1 trial

Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer

Withdrawn·PPamela Munster·Phase 1·NCT04498520

Advanced or Metastatic Solid Tumors1 trial

Study of PF-07248144 in Advanced or Metastatic Solid Tumors

Recruiting· Pfizer logo

Pfizer·Phase 1·NCT04606446·320 enrolled

Hormone Receptor Positive1 trial

Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy

Completed·SSOLTI Breast Cancer Research Group·Phase 1·NCT04130152·22 enrolled

Resistance1 trial

Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge in ER+ mBC

Completed·MMedSIR·Phase 2·NCT03184090·33 enrolled

B-cell acute lymphoblastic leukemia1 trial

Palbociclib and Dexamethasone in Treating Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT03472573·7 enrolled

Pilot Study1 trial

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Terminated·PPeter MacCallum Cancer Centre, Australia·N/A·NCT04801966·3 enrolled

PET1 trial

Palbociclib and FES PET

Completed·UUniversity Medical Center Groningen·Phase 2·NCT02806050·30 enrolled

Metastatic Urothelial Cancer1 trial

Phase II Trial of Palbociclib in Patients With Metastatic Urothelial Cancer After Failure of First-Line Chemotherapy

Terminated·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT02334527·12 enrolled

Advanced Sarcoma1 trial

Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.

Unknown status·GGrupo Espanol de Investigacion en Sarcomas·Phase 2·NCT03242382·40 enrolled

Acute Leukemia1 trial

Study of Palbociclib in MLL-rearranged Acute Leukemias

Unknown status·UUniversity of Ulm·Phase 1/2·NCT02310243·50 enrolled

TED1 trial

Study Of Real-World Evidence In Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period

Unknown status·AAsociatia Oncohelp - Centrul de Oncologie Oncohelp··NCT05135104·650 enrolled

Survival1 trial

Survival Prolongation by Rationale Innovative Genomics

Terminated·WWorldwide Innovative Network Association·Phase 1/2·NCT03386929·15 enrolled

Advanced1 trial

Avelumab, Palbociclib and Axitinib in Advanced RCC

Withdrawn·—·Phase 2·NCT05176288

COVID-191 trial

Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation

Withdrawn·Bbiotx.ai GmbH·Phase 2·NCT05371275

Ptosis1 trial

"Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment "

Completed·FFondazione Michelangelo·Phase 2·NCT02530424·102 enrolled

Head and Neck Cancer1 trial

Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT02499120·125 enrolled

Gastroesophageal Junction1 trial

Palbociclib Combined With Afatinib for Advanced Squamous Carcinoma of Esophagus or Gastroesophageal Junction

Recruiting·AAiping Zhou·Phase 2·NCT05865132·30 enrolled

Other Solid Tumors1 trial

Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors

Suspended·—·Phase 1·NCT03065062·75 enrolled

Thymic Epithelial Tumor1 trial

A Phase II Study of Palbociclib for Recurrent or Refractory Advanced Thymic Epithelial Tumor

Unknown status·SSamsung Medical Center·Phase 2·NCT03219554·33 enrolled

R/R AML1 trial

Tazemetostat and Palbociclib With CPX-351for R/R AML

Recruiting·TThomas Jefferson University·Phase 1·NCT05627232·24 enrolled

Ewing sarcoma1 trial

Palbociclib + Ganitumab In Ewing Sarcoma

Terminated·—·Phase 2·NCT04129151·10 enrolled

Renal Impairment1 trial

Study Of Palbociclib (PD-0332991) In Renal Impairment

Completed· Pfizer logo

Pfizer·Phase 1·NCT02085538·31 enrolled

Leukemia1 trial

Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT03132454·32 enrolled

Pembrolizumab1 trial

Palbociclib and Pembrolizumab in Sarcoma

Recruiting·JJohn Rieth·Phase 1·NCT06113809·8 enrolled

Prostate Cancer1 trial

Palbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting·CCanadian Cancer Trials Group·Phase 2·NCT02905318·19 enrolled

Squamous Cell Carcinoma1 trial

Palbociclib With Cetuximab and IMRT for Locally Advanced Squamous Cell Carcinoma

Active, not recruiting·MMahidol University·Phase 1/2·NCT03024489·27 enrolled

Refractory Solid Tumors1 trial

Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors

Active, not recruiting· Pfizer logo

Pfizer·Phase 2·NCT03709680·128 enrolled

Observational Study1 trial

Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.

Unknown status·—··NCT04852081·1,000 enrolled

Multiple Myeloma1 trial

Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma

Terminated·WWeill Medical College of Cornell University·Phase 1·NCT02030483·9 enrolled

Interaction1 trial

A Study To Investigate The Drug-Drug Interaction Potential Of Rifampin OnThe Investigational Agent Palbociclib (PD-0332991)

Completed· Pfizer logo

Pfizer·Phase 1·NCT01953731·15 enrolled

Gastrointestinal1 trial

A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies

Completed·EErasca, Inc.·Phase 1/2·NCT05039177·101 enrolled

PET/CT1 trial

Prediction of 18F-FES-PET/CT Parameters on Palbociclib Combined With ET

Completed·FFudan University··NCT04992156·50 enrolled

Preoperative1 trial

Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery

Terminated·GGeorgetown University·Phase 2·NCT03535506·17 enrolled

Pancreatic Neuroendocrine Tumor1 trial

A Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors (pNET)

Completed·GGrupo Espanol de Tumores Neuroendocrinos·Phase 2·NCT02806648·21 enrolled

Mantle Cell Lymphoma1 trial

Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT02159755·28 enrolled

Glioblastoma1 trial

Pilot Trial for Treatment of Recurrent Glioblastoma

Recruiting·AAHS Cancer Control Alberta·Phase 1·NCT05432518·10 enrolled

EGFR Mutation1 trial

Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)

Terminated· Pfizer logo

Pfizer·Phase 1/2·NCT02349633·65 enrolled

Colorectal Cancer1 trial

Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer

Completed·—·Phase 2·NCT03981614·102 enrolled

Abemaciclib1 trial

A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC

Recruiting·NNational Taiwan University Hospital·Phase 2·NCT05766410·60 enrolled

Unspecified6 trials

Patterns of Prescribing and Monitoring of Palbociclib

Completed·RRush University Medical Center··NCT03285568·67 enrolled

Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg

Completed·MMegalabs·Phase 4·NCT06331715·24 enrolled

UK Ibrance Patient Program (IPP) Study

Completed· Pfizer logo

Pfizer··NCT03921866·191 enrolled

Show 3 more trials

NCT Neuro Master Match - N²M² (NOA-20)

Completed·UUniversity Hospital Heidelberg·Phase 1/2·NCT03158389·228 enrolled

Palbociclib With Everolimus + Exemestane In BC

Completed·—·Phase 1/2·NCT02871791·41 enrolled

Proton Pump Inhibitor (PPI, Rabeprazole) Effect On Tablet Formulation Of Palbociclib

Completed· Pfizer logo

Pfizer·Phase 1·NCT03220191·12 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 3, 2015

IBRANCE

NDA NDA207103

Dec 17, 2015

IBRANCE

NDA NDA207103

Feb 19, 2016

IBRANCE

NDA NDA207103

Mar 31, 2017

IBRANCE

NDA NDA207103

Feb 6, 2018

IBRANCE

NDA NDA207103

Feb 19, 2019

IBRANCE

NDA NDA207103

Apr 4, 2019

IBRANCE

NDA NDA207103

Sep 9, 2019

IBRANCE

NDA NDA207103

Sep 9, 2019

IBRANCE

NDA NDA207103

Nov 1, 2019

IBRANCE

NDA NDA212436

Nov 1, 2019

IBRANCE

NDA NDA212436

Dec 13, 2022

IBRANCE

NDA NDA212436

Dec 13, 2022

IBRANCE

NDA NDA207103

Sep 6, 2023

IBRANCE

NDA NDA207103

Sep 6, 2023

IBRANCE

NDA NDA207103

Sep 6, 2023

IBRANCE

NDA NDA212436

Sep 6, 2023

IBRANCE

NDA NDA212436

Dec 20, 2024

IBRANCE

NDA NDA207103

Dec 20, 2024

IBRANCE

NDA NDA212436

Mar 6, 2025

IBRANCE

NDA NDA207103

Mar 6, 2025

IBRANCE

NDA NDA212436

Apr 23, 2025

IBRANCE

NDA NDA207103

Apr 23, 2025

IBRANCE

NDA NDA212436

Sep 16, 2025

IBRANCE

NDA NDA207103

Sep 16, 2025

IBRANCE

NDA NDA212436

Jun 24, 2026

IBRANCE

NDA NDA212436

Jun 24, 2026

IBRANCE

NDA NDA207103

Sources

References

[1]
ClinicalTrials.gov — 303 trial records for Palbociclib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ibrance drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Palbociclib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Palbociclib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212436). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Ibrance. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclin-Dependent Kinase 4/cyclin D1 Inhibitor; Cdk6/cyclin D1 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[6]

Patent Cliff

Mar 5, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE47739Mar 5, 2027

RE47739*PEDSep 5, 2027

10723730Feb 8, 2034

10723730*PEDAug 8, 2034

11065250Aug 19, 2036

1 more patents

11065250*PEDFeb 19, 2037