PARSIFAL I
Research type
Research Study
Full 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.
IRAS ID
173029
Contact name
Sally Burtles
Contact email
Sponsor organisation
Medica Scientia Innovation Research (MedSIR)
Eudract number
2014-004698-17
Clinicaltrials.gov Identifier
ESMES009, CRO Trial Code (TFS)
Duration of Study in the UK
3 years, 0 months, days
Research summary
The PARSIFAL study is designed to assess the effect and safety of palbociclibin in combinations with two different endocrine treatments in patients with ER+, HER negative locally advanced or metastatic breast cancer.
Patients will be randomized into one of two group. Arm A (Palbociclib+Letrozole) is the comparator arm as this combination has been assessed as effective in previous clinical trials; Arm B (Palbociclib+Fulvestrant) is the experimental arm.
Patients will continue to receive their assigned treatment until any of the below occur:
- The worsening of the disease
- Hypersensitivity to study drug
- Death and/or withdrawal of consent.Afterwards, patients will enter a treatment follow-up period during which survival and new anti-cancer therapy information will be collected every 6 months . The treatment follow-up period will continue up to 12 months after last patient randomization.
Subjects considered to be eligible comprises of postmenopausal women with ER positive and HER2 negative locally advanced or metastatic breast cancer that have not received any therapy for the metastatic disease. Subjects have to provide written informed consent, passed screening assessments and comply with inclusion/exclusion criteria.
Before starting the study, patients will have a screening visit and will be asked about their health and medical history. They will be physically examined and vital signs will be measured.
During the study, assessments will be performed every 12 weeks (±7 days) from the date of randomisation up to end of the study follow-up period. Tumour assessments will be performed using RECIST guidelines v.1.1. These guidelines describe a standard approach to solid tumors measurement and definitions per objective assessments and change in tumor size for use in adult and paediatric cancer clinical trials.
The primary endpoint for this study is defined as the time from randomization to death or disease progression, assessed by the investigator as per RECIST guidelines v1.1 at 52 weeks.
REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/1055
Date of REC Opinion
5 Aug 2015
REC opinion
Further Information Favourable Opinion