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.

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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

Purpose

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	Intervention	Phase
Metastatic Breast Cancer	Drug: Palbociclib Drug: Letrozole Drug: Fulvestrant	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Letrozole Fulvestrant Palbociclib

U.S. FDA Resources

Further study details as provided by MedSIR:

Primary Outcome Measures:

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:

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)


Estimated Enrollment:	304
Study Start Date:	August 2015
Estimated Study Completion Date:	July 2018
Estimated Primary Completion Date:	July 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm A Combination of Palbociclib and Letrozole	Drug: Palbociclib Drug: Letrozole
Experimental: Arm B Combination of Palbociclib and Fulvestrant	Drug: Palbociclib Drug: Fulvestrant

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02491983

Contacts


Contact: Alicia Garcia-Sanz, PhD	+34 93 221 41 35	alicia.garcia@medsir.org

Show 51 Study Locations

Sponsors and Collaborators

MedSIR

Investigators


Principal Investigator:	Antonio Llombart, MD	MedSIR

More Information


Responsible Party:	MedSIR
ClinicalTrials.gov Identifier:	NCT02491983 History of Changes
Other Study ID Numbers:	MedOPP67
Study First Received:	June 29, 2015
Last Updated:	May 10, 2016

Keywords provided by MedSIR:


metastatic breast cancer Endocrine receptors positive HER-2 negative

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Letrozole Fulvestrant Palbociclib Estradiol 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 Estrogens Hormones Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 14, 2017

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