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)

This study is currently recruiting participants.

See

Contacts and Locations

Verified May 2016 by MedSIR

Sponsor:

Information provided by (Responsible Party):

MedSIR

ClinicalTrials.gov Identifier:

NCT02491983

First received: June 29, 2015

Last updated: May 10, 2016

Last verified: May 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

June 29, 2015

Last Updated Date

May 10, 2016

Start Date ^ICMJE

August 2015

Estimated Primary Completion Date

July 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Complete list of historical versions of study NCT02491983 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Breast Cancer

Intervention ^ICMJE

Drug: Palbociclib
Drug: Letrozole
Drug: Fulvestrant

Study Arms

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

Recruiting

Estimated Enrollment ^ICMJE

304

Estimated Completion Date

July 2018

Estimated Primary Completion Date

July 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Confirmed diagnosis of HR+/HER2- breast cancer

Post-menopausal status

No prior chemotherapy line in the metastatic setting

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

Eastern Cooperative Oncology Group (ECOG) PS 0-1

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

Exclusion Criteria:

Confirmed diagnosis of HER2 positive disease

Patients with rapidly progressive visceral disease or visceral crisis.

Locally advanced breast cancer candidate for a radical treatment.

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

Major surgery within 4 weeks of start of study drug

Serious concomitant systemic disorder incompatible with the study

Known active uncontrolled or symptomatic CNS metastases

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Alicia Garcia-Sanz, PhD

+34 93 221 41 35

alicia.garcia@medsir.org

Listed Location Countries ^ICMJE

Czech Republic, France, Germany, Italy, Russian Federation, Saudi Arabia, Spain, United Arab Emirates, United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02491983

Other Study ID Numbers ^ICMJE

MedOPP67

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

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

May 2016

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

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