Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 28 for:    MedSIR
Previous Study | Return to List | Next Study

Study to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Locally Advanced or Metastatic Breast Cancer (PARSIFAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02491983
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
MedSIR

Tracking Information
First Submitted Date  ICMJE June 29, 2015
First Posted Date  ICMJE July 8, 2015
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
1-year Progression Free Survival [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
  • Grade 3/4 adverse events, SAEs, deaths and discontinuations • [ Time Frame: Baseline up to 52 weeks after last patient entry ]
  • Time To Progression (TTP) [ Time Frame: Baseline up to 52 weeks after last patient entry ]
    Time from randomization to disease progression
  • Overall Survival (OS) [ Time Frame: Baseline up to 52 weeks after last patient entry ]
    Time from date of randomization to date of death due to any cause
  • Clinical Benefit Rate [ Time Frame: 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.
  • Overall Response Rate [ Time Frame: 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Locally Advanced or Metastatic Breast Cancer
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: Palbociclib
    Other Name: PD-0332991
  • Drug: Fulvestrant
    Other Name: Faslodex
  • Drug: Letrozole
    Other Name: Femara
Study Arms  ICMJE
  • Active Comparator: Arm A
    Combination of Palbociclib and Letrozole
    Interventions:
    • Drug: Palbociclib
    • Drug: Letrozole
  • Experimental: Arm B
    Combination of Palbociclib and Fulvestrant
    Interventions:
    • Drug: Palbociclib
    • Drug: Fulvestrant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2017)
486
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2015)
304
Actual Study Completion Date  ICMJE January 2020
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   France,   Germany,   Italy,   Russian Federation,   Spain,   United Kingdom
Removed Location Countries Czech Republic,   Saudi Arabia,   United Arab Emirates
 
Administrative Information
NCT Number  ICMJE NCT02491983
Other Study ID Numbers  ICMJE MedOPP067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedSIR
Study Sponsor  ICMJE MedSIR
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio Llombart, MD MedSIR
PRS Account MedSIR
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP