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PARSIFAL: Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer

Sponsor
MedSIR (Other)
Overall Status
Completed
CT.gov ID
NCT02491983
Collaborator
(none)
486
Enrollment
48
Locations
2
Arms
53
Actual Duration (Months)
10.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Patients will be stratified by site of disease (visceral vs. non-visceral) and by onset of metastatic disease diagnose (patients metastatic de novo versus non de novo).

Study Design

Study Type:
Interventional
Actual Enrollment :
486 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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 Breast Cancer
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A

Combination of Palbociclib and Letrozole

Drug: Palbociclib
Other Names:
  • PD-0332991

    • Drug: Letrozole
    Other Names:
  • Femara

    		•
    Experimental: Arm B

    Combination of Palbociclib and Fulvestrant

    Drug: Palbociclib
    Other Names:
  • PD-0332991

    • Drug: Fulvestrant
    Other Names:
  • Faslodex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 1-year Progression Free Survival [Baseline up to 52 weeks after last patient entry]

      Percentage of patients who are alive and without evidence of tumor progression at 52 weeks of study entry.

    Secondary Outcome Measures

    1. Grade 3/4 adverse events, SAEs, deaths and discontinuations • [Baseline up to 52 weeks after last patient entry]

      CTCAE v5

    2. Time To Progression (TTP) [Baseline up to 52 weeks after last patient entry]

      Time from randomization to disease progression

    3. Overall Survival (OS) [Baseline up to 52 weeks after last patient entry]

      Time from date of randomization to date of death due to any cause

    4. Clinical Benefit Rate [Baseline up to 52 weeks after last patient entry]

      Percentage of patients who experience a CR, PR or stable disease (for at least 24 weeks) and assessed by modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria.

    5. Overall Response Rate [Baseline up to 52 weeks after last patient entry]

      proportion of patients with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy

    2. Confirmed diagnosis of HR+/HER2- breast cancer

    3. Post-menopausal status

    4. No prior chemotherapy line in the metastatic setting

    5. Measurable disease defined by RECIST version 1.1, or non-measurable disease

    6. Eastern Cooperative Oncology Group (ECOG) PS 0-1

    7. Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures

    8. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCICTCAE version 4.0 Grade equal or minor than 1

    Exclusion Criteria:

    1. ER or HER2 unknown disease

    2. HER2 positive disease based on local laboratory results

    3. Locally advanced breast cancer candidate for a radical treatment

    4. Prior (neo)adjuvant endocrine treatment with DFI ≤ 12-months from completion of treatment.

    5. Patients with rapidly progressive visceral disease or visceral crisis.

    6. Major surgery within 4 weeks of start of study drug

    7. Patients with an active, bleeding diathesis

    8. Serious concomitant systemic disorder incompatible with the study

    9. Are unable to swallow tablets

    10. Chronic daily treatment with corticosteroids with a dose of ≥ 10mg/day methylprednisolone equivalent

    11. Known active uncontrolled or symptomatic CNS metastases

    12. Known hypersensitivity to letrozole, fulvestrant or any of their excipients, or to any PD-0332991 excipients

    13. QTc > 480 msec on basal assessments, personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes

    14. Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MedSIR investigative site Olomouc Czechia 77600
    2 MedSIR investigative site Prague Czechia 12000
    3 MedSIR investigative site Prague Czechia 15006
    4 MedSIR investigative site Paris France 75005
    5 MedSIR investigative site Paris France 75015
    6 MedSIR investigative site Paris France 75020
    7 MedSIR investigative site Strasbourg France 67065
    8 MedSIR investigative site Toulouse France 31059
    9 MedSIR investigative site Dessau Germany 06847
    10 MedSIR investigative site Heidelberg Germany 69120
    11 MedSIR investigative site Brindisi Italy 72021
    12 MedSIR investigative site Cagliari Italy 09134
    13 MedSIR investigative site Cremona Italy 26100
    14 MedSIR investigative site Milan Italy 20133
    15 MedSIR investigative site Milan Italy 20141
    16 MedSIR investigative site Modena Italy 41124
    17 MedSIR investigative site Monza Italy 20052
    18 MedSIR investigative site Piacenza Italy
    19 MedSIR investigative site Torino Italy 10126
    20 MedSIR investigative site Moscow Russian Federation 115478
    21 MedSIR investigative site Moscow Russian Federation 125284
    22 MedSIR investigative site Saint Petersburg Russian Federation 197758
    23 MedSIR investigative site Yaroslavl Russian Federation 150040
    24 MedSIR investigative site Barcelona Spain 08003
    25 MedSIR investigative site Barcelona Spain 08035
    26 MedSIR investigative site Barcelona Spain 08908
    27 MedSIR investigative site Bilbao Spain 48013
    28 MedSIR investigative site Castelló Spain 12002
    29 MedSIR investigative site Cordoba Spain 14004
    30 MedSIR investigative site Cáceres Spain 10003
    31 MedSIR investigative site Girona Spain 17007
    32 MedSIR investigative site Huelva Spain 21005
    33 MedSIR investigative site Madrid Spain 28046
    34 MedSIR investigative site Oviedo Spain 33011
    35 MedSIR investigative site Pamplona Spain 31008
    36 MedSIR investigative site Santiago de Compostela Spain 15706
    37 MedSIR investigative site Sevilla Spain 41013
    38 MedSIR investigative site Tarragona Spain 43005
    39 MedSIR investigative site Valencia Spain 46009
    40 MedSIR investigative site B Zaragoza Spain 50009
    41 MedSIR investigative site Zaragoza Spain 50009
    42 MedSIR investigative site Bath United Kingdom BA1 3NG
    43 MedSIR investigative site London United Kingdom EC1M 6BQ
    44 MedSIR investigative site Manchester United Kingdom M20 4 BX
    45 MedSIR investigative site Nottingham United Kingdom NG5 1PB
    46 MedSIR investigative site Romford United Kingdom RM7 0AG
    47 MedSIR investigative site Swansea United Kingdom SA2 8QA
    48 MedSIR investigative site Truro United Kingdom TR1 3LQ

    Sponsors and Collaborators

    • MedSIR

    Investigators

    • Principal Investigator: Antonio Llombart, MD, MedSIR

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MedSIR
    ClinicalTrials.gov Identifier:
    NCT02491983
    Other Study ID Numbers:
    • MedOPP067
    • 2014-004698-17
    First Posted:
    Jul 8, 2015
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Keywords provided by MedSIR
    metastatic breast cancer
    Endocrine receptors positive
    HER-2 negative
    Additional relevant MeSH terms:
    Breast Neoplasms
    Letrozole
    Fulvestrant
    Palbociclib

    Study Results

    No Results Posted as of Jun 21, 2022