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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.
Verified May 2016 by MedSIR
Sponsor:
MedSIR
Information provided by (Responsible Party):
MedSIR
ClinicalTrials.gov Identifier:
NCT02491983
First received: June 29, 2015
Last updated: May 10, 2016
Last verified: May 2016
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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
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
Hide Study Locations
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 |
Hide Study Locations
Locations
| Czech Republic | |
| MedSIR investigative site | Not yet recruiting |
| Olomouc, Czech Republic, 77600 | |
| MedSIR investigative site | Not yet recruiting |
| Prague, Czech Republic, 12000 | |
| MedSIR investigative site | Not yet recruiting |
| Prague, Czech Republic, 15006 | |
| France | |
| MedSIR investigative site | Recruiting |
| Paris, France, 75005 | |
| MedSIR investigative site | Recruiting |
| Paris, France, 75015 | |
| MedSIR investigative site | Recruiting |
| Paris, France, 75020 | |
| MedSIR investigative site | Not yet recruiting |
| Strasbourg, France, 67065 | |
| MedSIR investigative site | Recruiting |
| Toulouse, France, 31059 | |
| Germany | |
| MedSIR investigative site | Not yet recruiting |
| Dessau, Germany, 06847 | |
| MedSIR investigative site | Recruiting |
| Heidelberg, Germany, 69120 | |
| Italy | |
| MedSIR investigative site | Not yet recruiting |
| Brindisi, Italy, 72021 | |
| MedSIR investigative site | Not yet recruiting |
| Cagliari, Italy, 09134 | |
| MedSIR investigative site | Not yet recruiting |
| Cremona, Italy, 26100 | |
| MedSIR investigative site | Recruiting |
| Milan, Italy, 20133 | |
| MedSIR investigative site | Not yet recruiting |
| Milan, Italy, 20141 | |
| MedSIR investigative site | Not yet recruiting |
| Modena, Italy, 41124 | |
| MedSIR investigative site | Not yet recruiting |
| Monza, Italy, 20052 | |
| MedSIR investigative site | Not yet recruiting |
| Piacenza, Italy | |
| MedSIR investigative site | Not yet recruiting |
| Torino, Italy, 10126 | |
| Russian Federation | |
| MedSIR investigative site | Not yet recruiting |
| Moscow, Russian Federation, 115478 | |
| MedSIR investigative site | Not yet recruiting |
| Moscow, Russian Federation, 125284 | |
| MedSIR investigative site | Not yet recruiting |
| St Petersburg, Russian Federation, 197758 | |
| MedSIR investigative site | Not yet recruiting |
| Yaroslavl, Russian Federation, 150040 | |
| Saudi Arabia | |
| MedSIR investigative site | Not yet recruiting |
| Jaddah, Saudi Arabia, 21423 | |
| MedSIR investigative site | Not yet recruiting |
| Riyadh, Saudi Arabia, 14611 | |
| Spain | |
| MedSIR investigative site | Recruiting |
| Barcelona, Spain, 08003 | |
| MedSIR investigative site | Recruiting |
| Barcelona, Spain, 08035 | |
| MedSIR investigative site | Recruiting |
| Barcelona, Spain, 08908 | |
| MedSIR investigative site | Not yet recruiting |
| Bilbao, Spain, 48013 | |
| MedSIR investigative site | Recruiting |
| Castellón, Spain, 12002 | |
| MedSIR investigative site | Recruiting |
| Cordoba, Spain, 14004 | |
| MedSIR investigative site | Recruiting |
| Cáceres, Spain, 10003 | |
| MedSIR investigative site | Recruiting |
| Girona, Spain, 17007 | |
| MedSIR investigative site | Recruiting |
| Huelva, Spain, 21005 | |
| MedSIR investigative site | Recruiting |
| Madrid, Spain, 28046 | |
| MedSIR investigative site | Recruiting |
| Oviedo, Spain, 33011 | |
| MedSIR investigative site | Not yet recruiting |
| Pamplona, Spain, 31008 | |
| MedSIR investigative site | Recruiting |
| Santiago de Compostela, Spain, 15706 | |
| MedSIR investigative site | Recruiting |
| Sevilla, Spain, 41013 | |
| MedSIR investigative site | Recruiting |
| Tarragona, Spain, 43005 | |
| MedSIR investigative site | Recruiting |
| Valencia, Spain, 46009 | |
| MedSIR investigative site B | Recruiting |
| Zaragoza, Spain, 50009 | |
| MedSIR investigative site | Recruiting |
| Zaragoza, Spain, 50009 | |
| United Arab Emirates | |
| MedSIR investigative site | Not yet recruiting |
| Dubai, United Arab Emirates | |
| United Kingdom | |
| MedSIR investigative site | Not yet recruiting |
| Bath, United Kingdom, BA1 3NG | |
| MedSIR investigative site | Recruiting |
| Cornwall, United Kingdom, TR1 3LQ | |
| MedSIR investigative site | Recruiting |
| London, United Kingdom, EC1M 6BQ | |
| MedSIR investigative site | Not yet recruiting |
| Manchester, United Kingdom, M20 4 BX | |
| MedSIR investigative site | Not yet recruiting |
| Nottingham, United Kingdom, NG5 1PB | |
| MedSIR investigative site | Not yet recruiting |
| Romford, United Kingdom, RM7 0AG | |
| MedSIR investigative site | Recruiting |
| Swansea, United Kingdom, SA2 8QA | |
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