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Clinical trials for Palbociclib

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44356   clinical trials with a EudraCT protocol, of which   7382   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    77 result(s) found for: Palbociclib. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2020-002276-12 Sponsor Protocol Number: D8532C00001 Start Date*: 2021-04-07
    Sponsor Name:AstraZeneca AB
    Full Title: SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) plus Palbociclib versus Anastrozole plus Palbociclib for the Treatment of Patients with Estrogen Recepto...
    Medical condition: Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) SK (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) DE (Trial now transitioned) AT (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) BG (Trial now transitioned) NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001824-33 Sponsor Protocol Number: EFC15935 Start Date*: 2020-10-19
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: A randomized, multicenter, double-blind phase 3 study of SAR439859 plus palbociclib versus letrozole plus palbociclib for the treatment of patients with ER (+), HER2 (-) breast cancer who have not ...
    Medical condition: ER (+), HER2 (-) breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028997 Neoplasm malignant PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (GB - no longer in EU/EEA) NL (Prematurely Ended) PT (Prematurely Ended) HU (Prematurely Ended) BE (Completed) PL (Prematurely Ended) FI (Completed) CZ (Completed) AT (Prematurely Ended) BG (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000119-66 Sponsor Protocol Number: BO41843 Start Date*: 2020-11-06
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMBINED WITH PALBOCICLIB COMPARED WITH LETROZOLE COMBINED WITH PALBOCICLI...
    Medical condition: First line of treatment for Estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070575 Estrogen receptor positive breast cancer LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070577 Oestrogen receptor positive breast cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10083232 HER2 negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) DE (Trial now transitioned) PL (Trial now transitioned) GB (GB - no longer in EU/EEA) FR (Trial now transitioned) AT (Trial now transitioned) PT (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004698-17 Sponsor Protocol Number: MedOPP067 Start Date*: 2015-05-07
    Sponsor Name:Medica Scientia Innovation Research (MedSIR)
    Full Title: A randomized, multicenter, open-label, phase II trial to evaluate the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with HER2 negative, ER+ metastatic ...
    Medical condition: Metastatic breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) GB (GB - no longer in EU/EEA) IT (Completed) DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2016-004660-19 Sponsor Protocol Number: NCT-2016-415 Start Date*: 2017-11-22
    Sponsor Name:University Hospital Heidelberg
    Full Title: CDK4/6 inhibition in locally advanced/metastatic chordoma
    Medical condition: Patients with locally advanced or metastatic chordoma refractory to treatment with tyrosine kinase inhibitors.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008747 Chordoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004032-29 Sponsor Protocol Number: M18CYP Start Date*: 2019-01-23
    Sponsor Name:Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
    Full Title: Effect of the moderate CYP3A4-inhibitor erythromycin on the pharmacokinetics of palbociclib
    Medical condition: Patients for whom palbociclib is standard of care (breast cancer)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-002455-42 Sponsor Protocol Number: WO41554 Start Date*: 2020-08-21
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS PALBOCICLIB AND FULVESTRANT VERSUS PLACEBO PLUS PALBOCICLIB AND FULVESTRANT IN ...
    Medical condition: Breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned) PT (Trial now transitioned) GB (GB - no longer in EU/EEA) DK (Completed) HU (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003444-25 Sponsor Protocol Number: A5481092 Start Date*: 2022-05-15
    Sponsor Name:Pfizer Inc.
    Full Title: PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE® ) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REF...
    Medical condition: recurrent/refractory Ewing sarcoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10015560 Ewing's sarcoma PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) SK (Trial now transitioned) HU (Prematurely Ended) PL (Prematurely Ended) BG (Prematurely Ended) FR (Trial now transitioned) DE (Ongoing) ES (Ongoing) CZ (Trial now transitioned) NL (Prematurely Ended) BE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-003320-30 Sponsor Protocol Number: D2270C00020 Start Date*: 2016-01-05
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase I/II Multicenter Study of the Combination of AZD2014 and Palbociclib on a background of Hormonal Therapy in Patients with Locally Advanced/Metastatic Estrogen Receptor Positive Breast Cance...
    Medical condition: Locally advanced or metastatic estrogen receptor positive breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2017-002781-48 Sponsor Protocol Number: MedOPP068 Start Date*: 2019-02-08
    Sponsor Name:Medica Scientia Innovation Research (MedSIR)
    Full Title: INTERNATIONAL, MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF CONTINUATION OF PALBOCICLIB IN COMBINATION WITH SECOND-LINE ENDOCRINE THERAPY IN H...
    Medical condition: Hormone receptor-positive/HER2-negative Advanced Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) DE (Completed) SI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004231-12 Sponsor Protocol Number: NL20151001 Start Date*: 2016-08-08
    Sponsor Name:University Medical Center Groningen
    Full Title: Early identification of patients who benefit from palbociclib in addition to letrozole
    Medical condition: estrogen receptor positive metastatic breast cancer patients eligible for palbociclib plus letrozole treatment
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-003647-34 Sponsor Protocol Number: AMLSG23-14/Palbo-AL-1 Start Date*: 2015-05-19
    Sponsor Name:University Hospital Ulm
    Full Title: Phase Ib/IIa study of palbociclib in MLL-rearranged acute leukemias
    Medical condition: Acute myeloid leukemia Acute lymphoblastic leukemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001072-11 Sponsor Protocol Number: CO41012 Start Date*: 2019-08-21
    Sponsor Name:Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    Full Title: A PHASE IB/III STUDY OF IPATASERTIB PLUS PALBOCICLIB AND FULVESTRANT VERSUS PLACEBO PLUS PALBOCICLIB AND FULVESTRANT IN HORMONE RECEPTOR POSITIVE AND HER2 NEGATIVE LOCALLY ADVANCED UNRESECTABLE OR ...
    Medical condition: Hormone receptor (HR)-positive/HER2-negative locally advanced unresectable or metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    20.0 100000004864 10072740 Locally advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-001334-34 Sponsor Protocol Number: CA209-7A8 Start Date*: 2020-12-10
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Randomized, Non-comparative Neoadjuvant Phase II Study in Patients with ER+/HER2- Breast Cancer >= 2 cm with Safety Run-in, Assessing Nivolumab + Abemaciclib or Palbociclib + Anastrozole
    Medical condition: ER+/HER2- Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070577 Oestrogen receptor positive breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) DE (Prematurely Ended) BE (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001007-16 Sponsor Protocol Number: WO42133 Start Date*: 2020-10-15
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A RANDOMIZED, MULTICENTER, OPEN-LABEL, TWO-ARM, PHASE II, NEOADJUVANT STUDY EVALUATING THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF GDC-9545 PLUS PALBOCICLIB COMPARED WITH ANASTROZOLE PLUS PALBOCI...
    Medical condition: Estrogen Receptor (ER)-Positive and HER2-Negative Untreated Early Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070575 Estrogen receptor positive breast cancer LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070577 Oestrogen receptor positive breast cancer LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10083232 HER2 negative breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Completed) PL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002553-30 Sponsor Protocol Number: EORTC-1745-ETF-BCG Start Date*: 2018-11-28
    Sponsor Name:European Organisation for research and treatment of Cancer
    Full Title: A Phase II study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS with high-risk ER+/HER2- early breast cance (APPALACHES)
    Medical condition: Localized ER+ breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070575 Estrogen receptor positive breast cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070577 Oestrogen receptor positive breast cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006290 Breast and nipple neoplasms malignant HLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006291 Breast neoplasms malignant and unspecified (incl nipple) HLGT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    Population Age: Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned) GB (GB - no longer in EU/EEA) PL (Trial now transitioned) SE (Completed) ES (Ongoing) DE (Trial now transitioned) PT (Trial now transitioned) IT (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2018-000157-41 Sponsor Protocol Number: UoL001343 Start Date*: 2019-06-07
    Sponsor Name:The University of Liverpool
    Full Title: NEO21-RS: A phase II randomised study of the cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with oestrogen suppression therapy versus oestrogen suppression therapy alone as neoadj...
    Medical condition: ER-positive, HER2-negative breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070577 Oestrogen receptor positive breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-003892-31 Sponsor Protocol Number: MedOPP089 Start Date*: 2017-03-23
    Sponsor Name:Medica Scientia Innovation Research (MedSIR)
    Full Title: A multicenter, international, non-controlled, phase II trial to identify the molecular mechanisms of resistance and sensitivity to palbociclib re-challenge upon progression to a palbociclib combina...
    Medical condition: Patients with hormone receptor (HR)-positive/HER2-negative locally advanced or metastatic breast cancer (mBC). Second/third-line of endocrine treatment.
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-000879-24 Sponsor Protocol Number: IJB-BC-NEORHEA-2016 Start Date*: 2017-03-23
    Sponsor Name:Institut Jules Bordet
    Full Title: Neoadjuvant Biomarker ResearcH Study of Palbociclib Combined with Endocrine Therapy in Estrogen Receptor Positive/ HER2 Negative Breast CAncer
    Medical condition: Primary breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10006192 Breast cancer NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-005181-30 Sponsor Protocol Number: AFT-05/ABCSG-42/BIG_14-03 Start Date*: 2015-07-09
    Sponsor Name:ABCSG GmbH
    Full Title: PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor...
    Medical condition: To determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer.
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) ES (Ongoing) IE (Trial now transitioned) HU (Trial now transitioned) PT (Trial now transitioned) DE (Trial now transitioned) SE (Trial now transitioned) NL (Trial now transitioned) BE (Trial now transitioned) PL (Trial now transitioned) GB (GB - no longer in EU/EEA) IT (Trial now transitioned)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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