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Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced 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. Identifier: NCT02491983
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : January 19, 2023
Information provided by (Responsible Party):

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
Metastatic Breast Cancer Drug: Palbociclib Drug: Fulvestrant Drug: Letrozole 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).

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Study Type : Interventional  (Clinical Trial)
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 : August 2015
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Arm A
Combination of Palbociclib and Letrozole
Drug: Palbociclib
Other Name: PD-0332991

Drug: Letrozole
Other Name: Femara

Experimental: Arm B
Combination of Palbociclib and Fulvestrant
Drug: Palbociclib
Other Name: PD-0332991

Drug: Fulvestrant
Other Name: Faslodex

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Grade 3/4 adverse events, SAEs, deaths and discontinuations • [ Time Frame: Baseline up to 52 weeks after last patient entry ]
    CTCAE v5

  2. Time To Progression (TTP) [ Time Frame: Baseline up to 52 weeks after last patient entry ]
    Time from randomization to disease progression

  3. 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

  4. 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.

  5. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02491983

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Sponsors and Collaborators
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Principal Investigator: Antonio Llombart, MD MedSIR
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: MedSIR Identifier: NCT02491983    
Other Study ID Numbers: MedOPP067
2014-004698-17 ( EudraCT Number )
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: June 2022
Keywords provided by MedSIR:
metastatic breast cancer
Endocrine receptors positive
HER-2 negative
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Protein Kinase Inhibitors