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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
486

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedSIR

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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