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

October 22, 2024 updated by: MedSIR

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

486

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Olomouc, Czechia, 77600
        • MedSIR Investigative Site
      • Prague, Czechia, 12000
        • MedSIR Investigative Site
      • Prague, Czechia, 15006
        • MedSIR Investigative Site
  • France
      • Paris, France, 75005
        • MedSIR Investigative Site
      • Paris, France, 75015
        • MedSIR Investigative Site
      • Paris, France, 75020
        • MedSIR Investigative Site
      • Strasbourg, France, 67065
        • MedSIR Investigative Site
      • Toulouse, France, 31059
        • MedSIR Investigative Site
  • Germany
      • Dessau, Germany, 06847
        • MedSIR Investigative Site
      • Heidelberg, Germany, 69120
        • MedSIR Investigative Site
  • Italy
      • Brindisi, Italy, 72021
        • MedSIR Investigative Site
      • Cagliari, Italy, 09134
        • MedSIR Investigative Site
      • Cremona, Italy, 26100
        • MedSIR Investigative Site
      • Milan, Italy, 20133
        • MedSIR Investigative Site
      • Milan, Italy, 20141
        • MedSIR Investigative Site
      • Modena, Italy, 41124
        • MedSIR Investigative Site
      • Monza, Italy, 20052
        • MedSIR Investigative Site
      • Piacenza, Italy
        • MedSIR Investigative Site
      • Torino, Italy, 10126
        • MedSIR Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • MedSIR Investigative Site
      • Moscow, Russian Federation, 125284
        • MedSIR Investigative Site
      • Saint Petersburg, Russian Federation, 197758
        • MedSIR Investigative Site
      • Yaroslavl, Russian Federation, 150040
        • MedSIR Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • MedSIR Investigative Site
      • Barcelona, Spain, 08003
        • MedSIR Investigative Site
      • Barcelona, Spain, 08908
        • MedSIR Investigative Site
      • Bilbao, Spain, 48013
        • MedSIR Investigative Site
      • Castelló, Spain, 12002
        • MedSIR Investigative Site
      • Cordoba, Spain, 14004
        • MedSIR Investigative Site
      • Cáceres, Spain, 10003
        • MedSIR Investigative Site
      • Girona, Spain, 17007
        • MedSIR Investigative Site
      • Huelva, Spain, 21005
        • MedSIR Investigative Site
      • Madrid, Spain, 28046
        • MedSIR Investigative Site
      • Oviedo, Spain, 33011
        • MedSIR Investigative Site
      • Pamplona, Spain, 31008
        • MedSIR Investigative Site
      • Santiago de Compostela, Spain, 15706
        • MedSIR Investigative Site
      • Sevilla, Spain, 41013
        • MedSIR Investigative Site
      • Tarragona, Spain, 43005
        • MedSIR Investigative Site
      • Valencia, Spain, 46009
        • MedSIR Investigative Site
      • Zaragoza, Spain, 50009
        • MedSIR investigative site B
      • Zaragoza, Spain, 50009
        • MedSIR Investigative Site
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • MedSIR Investigative Site
      • London, United Kingdom, EC1M 6BQ
        • MedSIR Investigative Site
      • Manchester, United Kingdom, M20 4 BX
        • MedSIR Investigative Site
      • Nottingham, United Kingdom, NG5 1PB
        • MedSIR Investigative Site
      • Romford, United Kingdom, RM7 0AG
        • MedSIR Investigative Site
      • Swansea, United Kingdom, SA2 8QA
        • MedSIR Investigative Site
      • Truro, United Kingdom, TR1 3LQ
        • MedSIR Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year Progression Free Survival
Time Frame: One year
Percentage of patients who are alive and without evidence of tumor progression (defined using RECIST v1.1)
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations •
Time Frame: Through study completion. From baseline up to 51 months.
Grade 3/4 adverse events, SAEs, deaths and discontinuations following the CTCAE v5 criteria
Through study completion. From baseline up to 51 months.
Time To Progression (TTP)
Time Frame: Through study completion. From baseline up to 51 months.
Time from randomization to disease progression
Through study completion. From baseline up to 51 months.
Overall Survival (OS)
Time Frame: Through study completion. From baseline up to 51 months.
Time from date of randomization to date of death due to any cause
Through study completion. From baseline up to 51 months.
Clinical Benefit Rate
Time Frame: Through study completion. From baseline up to 51 months.
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.
Through study completion. From baseline up to 51 months.
Overall Response Rate
Time Frame: Through study completion. From baseline up to 51 months.
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)
Through study completion. From baseline up to 51 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedSIR

Investigators

  • Principal Investigator: Antonio Llombart, MD, MedSIR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

July 3, 2015

First Posted (Estimated)

July 8, 2015

Study Record Updates

Last Update Posted (Actual)

December 9, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedOPP067
  • 2014-004698-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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