Ibrance (palbociclib) / Pfizer, Amgen  >>  Phase 3
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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Ibrance (palbociclib) / Pfizer
2014-004226-18: Metasztatikus ER+ HER2- férfi emlőrák fulvestant és CKD 4/6 inhibitor palbociclib kezelésae többszörös megelőző kemoterápia, endokrin terápia és molekuláris célzott terápia után

Ongoing
3
1
Europe
Palbociclib,
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Onkotrápiás Klinika
 
 
PALOMA-2, NCT01740427 / 2012-004601-27: A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer

Checkmark Data from PALOMA-2 trial in 1st line ER+/HER2-mBC
Jun 2022 - Jun 2022: Data from PALOMA-2 trial in 1st line ER+/HER2-mBC
Checkmark From PALOMA-2 trial in 1st line HR+/HER2-mBC
Dec 2017 - Dec 2017: From PALOMA-2 trial in 1st line HR+/HER2-mBC
Checkmark ESMO 2016
More
Completed
3
666
Europe, Canada, Japan, US, RoW
PD-0332991, Letrozole, Placebo
Pfizer
Breast Neoplasms
02/16
11/23
2017-002851-27: GENETIC SEQUENCING FOR THE TREATMENT OF ADVANCED SOFT-TISSUE SARCOMAS SEQUENCAGE GENETIQUE POUR LE TRAITEMENT DES SARCOMES DES TISSUS MOUS

Not yet recruiting
3
960
Europe
CAPMATINIB, OLAPARIB, DURVALUMAB, GLASDEGIB, TAS-120, INC280, AZD2281, MEDI4736, PF-04449913, TAS-120, Capsule, hard, Film-coated tablet, Concentrate for solution for infusion, Tablet, TASIGNA, ZYKADIA, TYVERB, MEKINIST, TAFINLAR, LYNPARZA, IBRANCE
INSERM, Institut National du Cancer (INCa)
Adult patients with locally advanced/unresectable and/or metastatic soft-tissue sarcoma, Adult patients with advanced soft-tissue sarcoma, Diseases [C] - Cancer [C04]
 
 
2019-001072-11: 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 Un estudio de Ipatasertib Plus Palbociclib y Fulvestrant Versus Placebo Plus Palbociclib y Fulvestrant en Cáncer de mama positivo para receptores hormonales y negativo para HER2 localmente avanzado o metastásico inoperable

Not yet recruiting
3
370
Europe
ipatasertib 100 mg, ipatasertib 200 mg, RO5532961, Film-coated tablet, Capsule, hard, Solution for injection, Ibrance 75 mg, Ibrance 100 mg, Ibrance 125 mg, Faslodex
Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche Ltd
Hormone receptor (HR)-positive/HER2-negative locally advanced unresectable or metastatic breast cancer CÁNCER DE MAMA POSITIVO PARA RECEPTORES HORMONALES Y NEGATIVO PARA HER2 LOCALMENTE AVANZADO O METASTÁSICO, HRs are found inside breast cells, HER2 is found on surface of breast cells. Cancers with detectable HR that do not have high levels of HER2 gene/HER2 protein are called HR-positive; HER2-negative Los RH se encuentran dentro de las cél mam, HER2 se encuentra en la superficie de las células mam. Los cánceres con HR detec q no tienen niveles altos de gen HER2/prot HER2 se llaman HR-positHER2 neg, Diseases [C] - Cancer [C04]
 
 
PALOMA-4, NCT02297438: A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer []

Active, not recruiting
3
340
RoW
Palbociclib, PD-0332991, Letrozole, Placebo
Pfizer
Breast Neoplasms
08/20
12/24
PENELOPE-B, NCT01864746 / 2013-001040-62: A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

Calendar Sep 2020 - Dec 2025: Regulatory approval for HR+/HER+ metastatic breast cancer
Hourglass Nov 2021 - Nov 2021 : Final completion of P3 PENELOPE-B study (palbociclib vs. PBO) in HR+, Her2 normal breast cancer
Checkmark From PENELOPE-B trial for breast cancer
Oct 2020 - Oct 2020: From PENELOPE-B trial for breast cancer
Completed
3
1250
Europe, Canada, Japan, US, RoW
Palbociclib PD-0332991, Ibrance, Placebo
German Breast Group, Pfizer, AGO Study Group, NSABP Foundation Inc, Breast International Group
Breast Cancer, Hormonreceptor Positive, Her2-normal, Postneoadjuvant Treatment With CDK 4/6 Inhibitor, CPS-EG Score
08/20
12/20
PALLAS, NCT02513394 / 2014-005181-30: PALbociclib CoLlaborative Adjuvant Study

Checkmark Presentation of data from PALLAS trial for ER+/HER2- breast cancer at ASCO 2022
Oct 2022 - Oct 2022: Presentation of data from PALLAS trial for ER+/HER2- breast cancer at ASCO 2022
Hourglass Jan 2021 - Jun 2021 : For early-stage breast cancer (PALLAS study)
Checkmark From PALLAS trial for HR+/HER2- breast cancer at ESMO 2020
Sep 2020 - Sep 2020: From PALLAS trial for HR+/HER2- breast cancer at ESMO 2020
More
Active, not recruiting
3
5796
Europe, Canada, Japan, US, RoW
Palbociclib, Standard Adjuvant Endocrine Therapy
Alliance Foundation Trials, LLC., Austrian Breast & Colorectal Cancer Study Group, NSABP Foundation Inc, PrECOG, LLC., Breast International Group, Pfizer
Breast Cancer
11/20
09/25
PADA-1, NCT03079011 / 2016-004360-18: PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection

Active, not recruiting
3
1017
Europe
Palbociclib 125mg, Aromatase Inhibitors, Letrozole, Anastrozole or exemestane, Fulvestrant Injectable Product
UNICANCER, Pfizer
Metastatic Breast Cancer
04/21
06/25
2020-004637-20: Phase Ib/III Study of Capivasertib + CDK4/6i + Fulvestrant as Treatment for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

Not yet recruiting
3
850
Europe
capivasertib 160mg film-coated tablet, capivasertib 200mg film-coated tablet, Faslodex 250mg per 5mL solution for injection, IBRANCE Hard Capsules, IBRANCE Film-coated Tablets, KISQALI film-coated tablets, VERZENIOS film-coated tablets, AZD5363, ZD9238, L01EF03, Film-coated tablet, Solution for injection, Capsule, hard, Faslodex 250 mg solution for injection, IBRANCE Hard Capsules, IBRANCE Film-coated tablets, KISQALI film-coated tablets, VERZENIOS film-coated tablets
AstraZeneca AB, AstraZeneca AB
Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer, HR positive HER2 negative advanced breast cancer, Diseases [C] - Cancer [C04]
 
 
NCT04047758: Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer

Recruiting
3
420
RoW
Palbociclib + Letrozole, Letrozole
Shengjing Hospital
Breast Cancer
09/21
09/22
NCT03969121: Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

Completed
3
141
Japan, RoW
Palbociclib, Endocrine therapy
Kyoto Breast Cancer Research Network, Pfizer
Breast Cancer Female, Hormone Receptor Positive Malignant Neoplasm of Breast
12/21
12/21
2021-002027-38: Comparative study of ribociclib and palbociclib in patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer - HARMONIA trial Estudio para comparar ribociclib y palbociclib en pacientes con cáncer de mama avanzado con receptores hormonales positivos/HER2 negativo/HER2 enriquecido - ensayo HARMONIA

Not yet recruiting
3
516
Europe
Ribociclib, Palbociclib, LEE011, PD-0332991, Film-coated tablet, KISQALI 200 MG, IBRANCE 75 MG, IBRANCE 100 MG, IBRANCE 125 MG
SOLTI, NOVARTIS PHARMA AG
Patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer Pacientes con cáncer de mama avanzado con receptores hormonales positivos/HER2 negativo/HER2 enriquecido (HER2-E), Advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer Cáncer de mama avanzado con receptores hormonales positivos/HER2 negativo/HER2 enriquecido (HER2-E), Diseases [C] - Cancer [C04]
 
 
AMEERA-5, NCT04478266 / 2020-001824-33: Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

Terminated
3
1068
Europe, Canada, Japan, US, RoW
Amcenestrant-matching placebo, SAR439859, Amcenestrant, Palbociclib, Ibrance, Letrozole, Goserelin, Letrozole-matching placebo
Sanofi
Breast Cancer
06/22
05/23
SONIA, NCT03425838 / 2017-002334-23: Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone () Receptor Positive Advanced Breast Cancer

Active, not recruiting
3
1050
Europe
CDK 4/6 inhibitor, palbociclib,Ibrance,ribociclib,Kisqali,abemaciclib,Verzenio, Non-Steroidal Aromatase Inhibitor, NSAI, letrozole, Femara®, anastrozole, Arimidex®, Fulvestrant, SERD, Faslodex®
Borstkanker Onderzoek Groep
Breast Neoplasm Female
03/23
12/25
IPATunity150, NCT04060862: 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

Hourglass Apr 2023 - Jun 2023 : From IPATunity150 trial in combination with Ipatasertib and fulvestrant for advanced breast cancer
Terminated
3
20
Europe, Canada, Japan, US, RoW
Ipatasertib, RO5532961, GDC-0068, Placebo, Palbociclib, Fulvestrant
Hoffmann-La Roche
Breast Cancer
08/23
08/23
ENABLAR-2, NCT05065411: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer

Terminated
3
5
US
Enobosarm & Abemaciclib Combo, VERU-024, Verzenio, non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant, exemestane, fulvestrant, exemestane plus everolimus
Veru Inc.
Metastatic Breast Cancer
10/23
01/24
MULTISARC, NCT03784014: Molecular Profiling of Advanced Soft-tissue Sarcomas

Active, not recruiting
3
603
Europe
Nilotinib, TASIGNA, Ceritinib, ZYKADIA, Capmatinib, Lapatinib, TYVERB, Trametinib, MEKINIST, Trametinib and Dabrafenib, MEKINIST and TAFINLAR, Olaparib and Durvalumab, LYNPARZA, MEDI4736, Palbociclib, IBRANCE, PD-0332991, Glasdegib, PF-04449913, TAS-120, Next Generation sequencing exome, RNA Seq, NGS, High throughput sequencing
Institut National de la Santé Et de la Recherche Médicale, France, Commissariat A L'energie Atomique, Institut Bergonié, Plateforme labellisée Inca - Institut Bergonié, Bordeaux, Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris, EUCLID Clinical Trial Platform
Soft Tissue Sarcoma
12/23
10/25
PATINA, NCT02947685 / 2017-000419-17: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

Hourglass Jan 2023 - Dec 2023 : From PATINA trial in combination with anti-HER2 therapy and endocrine therapy for HER2+ metastatic breast cancer
Active, not recruiting
3
496
Europe, US, RoW
palbociclib, Ibrance, trastuzumab, Herceptin, pertuzumab, Perjeta, letrozole, Femara, Anastrozole, Arimidex, Exemestane, Aromasin, Fulvestrant, Faslodex
Alliance Foundation Trials, LLC., Pfizer, German Breast Group, Fondazione Michelangelo, PrECOG, LLC., Breast Cancer Trials, Australia and New Zealand, Syneos Health, SOLTI Breast Cancer Research Group, UNICANCER
HER-2 Positive Breast Cancer, Estrogen Receptor Positive Breast Cancer
07/24
07/26
NCT05429684: Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer

Recruiting
3
120
RoW
Trastuzumab, herceptin；Inetetamab, Pertuzumab, Perjeta, Nab paclitaxel, Abraxane, Pyrotinib, SHR-1258, Capecitabine, T-DM1, Trastuzumab Emtansine, Everolimus, RAD001, CDK4/6 inhibitor, Palbociclib；, AI, Letrozole, Anti-PD-1 monoclonal antibody, Sintilimab
First Affiliated Hospital Xi'an Jiaotong University
HER2+ Breast Cancer
02/24
02/24
EvoPAR-BR01, NCT06380751: Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

Not yet recruiting
3
500
Canada
Saruparib (AZD5305), Camizestrant, Abemaciclib, Ribociclib, Palbociclib, Fulvestrant, Letrozole, Anastrozole, Exemestane
AstraZeneca
Advanced Breast Cancer
03/29
07/30
POLAR, NCT03820830 / 2018-003553-19: Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer

Recruiting
3
400
Europe
Palbociclib 125mg, Ibrance, PD-0332991, Standard endocrine therapy
ETOP IBCSG Partners Foundation, Pfizer
Breast Cancer Recurrent
07/24
11/26
VIKTORIA-1, NCT05501886: Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer

Recruiting
3
701
Europe, Canada, US, RoW
Gedatolisib, PF-05212384, PKI-587, Palbociclib, IBRANCE, PD-0332991, Fulvestrant, Faslodex, Alpelisib, Piqray, Vijoice, BYL719
Celcuity, Inc.
Breast Cancer
09/24
09/26
NCT06377852: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

Not yet recruiting
3
500
NA
Palbociclib, Ribociclib
American Society of Clinical Oncology, Patient-Centered Outcomes Research Institute
Metastatic Breast Cancer
08/28
09/28
SERENA-6, NCT04964934 / 2021-000546-17: Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression

Recruiting
3
300
Europe, Canada, Japan, US, RoW
AZD9833, AZD9833 Placebo, Anastrozole, Anastrozole placebo, Letrozole, Letrozole placebo, Palbociclib, Abemaciclib, Luteinizing hormone-releasing hormone (LHRH) agonist, Ribociclib
AstraZeneca
ER-Positive HER2-Negative Breast Cancer
04/25
11/27
NCT04546009 / 2020-000119-66: A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

Active, not recruiting
3
992
Europe, Canada, Japan, US, RoW
Giredestrant, GDC-9545, RO7197597, RG6171, Giredestrant-matched Placebo, Letrozole, Letrozole-matched Placebo, Palbociclib, LHRH Agonist
Hoffmann-La Roche
Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
03/25
03/27
PATHWAY, NCT03423199: PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY

Active, not recruiting
3
180
Japan, RoW
Palbociclib, PD-0332991, Placebo, Tamoxifen, Goserelin
National Cancer Center, Japan, Pfizer, Korean Cancer Study Group
Breast Neoplasms
09/25
09/25
VIKTORIA-1, NCT05486143: Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer

Recruiting
3
701
US, RoW
Gedatolisib, PF-05212384, PKI-587, Palbociclib, IBRANCE, PD-0332991, Fulvestrant, Faslodex, Alpelisib, Piqray, Vijoice, BYL719
Celcuity, Inc.
Breast Cancer
09/25
09/26
HARMONIA, NCT05207709: Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype

Recruiting
3
456
Europe, US
Ribociclib + Letrozole OR Fulvestrant, Palbociclib + Letrozole OR Fulvestrant, Paclitaxel +/- Tislelizumab
SOLTI Breast Cancer Research Group, Novartis, Alliance Foundation Trials, LLC.
Metastatic Breast Cancer
03/26
03/27
NCT06065748: A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Recruiting
3
1050
Europe, Canada, US, RoW
Giredestrant, RO7197597, RG6171, GDC-9545, Fulvestrant, Abemaciclib, Palbociclib, Ribociclib, LHRH Agonist, FoundationOne Liquid CDx Assay (F1LCDx), F1LCDx
Hoffmann-La Roche
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
07/26
12/28
CAPItello-292, NCT04862663: Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer

Checkmark Progression-free survival data from CAPItello-292 trial in combination with Faslodex in patients with hormone receptor positive, human epidermal growth factor receptor 2 low or negative locally advanced or metastatic breast cancer
Oct 2022 - Oct 2022: Progression-free survival data from CAPItello-292 trial in combination with Faslodex in patients with hormone receptor positive, human epidermal growth factor receptor 2 low or negative locally advanced or metastatic breast cancer
Recruiting
3
895
Europe, Canada, Japan, US, RoW
Capivasertib, Fulvestrant, Palbociclib, Ribociclib, Abemaciclib
AstraZeneca
Locally Advanced (Inoperable) or Metastatic Breast Cancer
11/27
08/29
SERENA-4, NCT04711252 / 2020-002276-12: 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
3
1370
Europe, Canada, Japan, US, RoW
AZD9833, Anastrozole, Anastrozole placebo, AZD9833 placebo, Palbociclib, Luteinizing hormone-releasing hormone (LHRH) agonist
AstraZeneca
ER-Positive HER2-Negative Breast Cancer
08/26
02/29
NCT04966481: 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
3
81
US
Palbociclib, Ibrance, Cetuximab, Erbitux
Washington University School of Medicine, Pfizer, The Joseph Sanchez Foundation
HPV-unrelated Head and Neck Squamous Cell Carcinoma
02/27
02/27
VERITAC-3, NCT05909397: A Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer

Active, not recruiting
3
1180
Europe, Japan, US, RoW
ARV-471 (PF-07850327), Vepdegestrant, Palbociclib, IBRANCE®, Letrozole, FEMARA®
Pfizer, Arvinas Estrogen Receptor, Inc.
Breast Cancer
08/28
07/30
INAVO120, NCT04191499 / 2019-002455-42: A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

Active, not recruiting
2/3
325
Europe, Canada, US, RoW
Inavolisib, GDC-0077, Placebo, Palbociclib, Fulvestrant
Hoffmann-La Roche
Breast Cancer
09/23
09/30

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