Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer (PARSIFAL)
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| ClinicalTrials.gov Identifier: NCT02491983 |
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Recruitment Status :
Completed
First Posted : July 8, 2015
Last Update Posted : January 19, 2023
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Sponsor:
MedSIR
Information provided by (Responsible Party):
MedSIR
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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 |
| 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 Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm A
Combination of Palbociclib and Letrozole
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Drug: Palbociclib
Other Name: PD-0332991 Drug: Letrozole Other Name: Femara |
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Experimental: Arm B
Combination of Palbociclib and Fulvestrant
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Drug: Palbociclib
Other Name: PD-0332991 Drug: Fulvestrant Other Name: Faslodex |
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 ]CTCAE v5
- 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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
- 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:
- ER or HER2 unknown disease
- HER2 positive disease based on local laboratory results
- Locally advanced breast cancer candidate for a radical treatment
- Prior (neo)adjuvant endocrine treatment with DFI ≤ 12-months from completion of treatment.
- Patients with rapidly progressive visceral disease or visceral crisis.
- Major surgery within 4 weeks of start of study drug
- Patients with an active, bleeding diathesis
- Serious concomitant systemic disorder incompatible with the study
- Are unable to swallow tablets
- Chronic daily treatment with corticosteroids with a dose of ≥ 10mg/day methylprednisolone equivalent
- Known active uncontrolled or symptomatic CNS metastases
- Known hypersensitivity to letrozole, fulvestrant or any of their excipients, or to any PD-0332991 excipients
- 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
- 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 ClinicalTrials.gov identifier (NCT number): NCT02491983
Locations
Show 48 study locations
Sponsors and Collaborators
MedSIR
Investigators
| Principal Investigator: | Antonio Llombart, MD | MedSIR |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | MedSIR |
| ClinicalTrials.gov 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:
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metastatic breast cancer Endocrine receptors positive HER-2 negative |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Letrozole Fulvestrant Palbociclib 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 |