PYTHIA
Research type
Research Study
Full title
Palbociclib in molecularly characterized ER-positive/HER2-negative metastatic breast cancer: the PYTHIA study A Phase II Study of Palbociclib plus Fulvestrant for pretreated patients with ER+/HER2- Metastatic Breast Cancer
IRAS ID
204319
Contact name
Gianfilippo Bertelli
Contact email
Sponsor organisation
International Breast Cancer Study Group (IBCSG)
Eudract number
2014-005387-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Breast International Group, BIG_14-04; Pfizer Inc., WI198393
Duration of Study in the UK
3 years, 7 months, 1 days
Research summary
The PYTHIA trial is a Phase II trial aiming to discover potentially innovative biomarkers in postmenopausal women with metastatic or locally relapsed breast cancer receiving palbociclib/fulvestrant treatment.
The trial will enroll 120 patients. Enrollment is expected to be completed within 12 months from the activation date. The final trial analysis is expected approximately 30-36 months after the inclusion of the first patient under the amendment.
Three countries (Belgium, Italy and United Kingdom) and a total of 22 centers will participate in PYTHIA trial.Summary of Results
This study was launched in 2015 with the initial aim to demonstrate the superiority of a therapy consisting of two drugs, namely palbociclib and fulvestrant compared to a therapy consisting of placebo plus fulvestrant in postmenopausal women with a certain type of metastatic or locally-relapsed breast cancer. In 2016, the drug palbociclib became commercially available for this indication. Therefore, the study was revised to a single-arm study with only the therapy palbociclib and fulvestrant further investigated. The goal of this revised study was to evaluate potential biomarkers that are associated with the duration of how long patients live without their cancer getting worse.A total of 124 patients were enrolled in the PYTHIA trial. The first results were addressed at a specific marker called serum thymidine kinase activity (sTKa). This marker was measured before and during the treatment and appeared to have a prognostic value on how well patients respond to the treatment. High levels of sTKa before the treatment and incompletely suppressed during the treatment, may help to identify patients with poorer prognosis and primary resistance. However, as the study is limited by the sample size, these data need further validation in larger patient populations.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
17/EM/0360
Date of REC Opinion
8 Dec 2017
REC opinion
Further Information Favourable Opinion