Phase II study of palbociclib plus fulvestrant versus placebo plus fulvestrant for pre-treated patients with ER+/HER2- metastatic breast cancer.
Disease site: Breast cancer
Treatment modality: Systemic therapy
Status: In follow-up
PYTHIA is a phase II, international, multicentre, randomised, placebo-controlled, double-blind trial to assess the efficacy of the combination of palbociclib with fulvestrant versus placebo with fulvestrant for the treatment of post-menopausal women with metastatic or locally advanced breast cancer, whose disease has progressed while receiving previous hormone therapy.
This trial is open to participants enrolled in the AURORA study only. In total 120 women from four countries are expected to take part. In the UK, 25 patients will be recruited over a 2 year period. Participants will be randomised to one of two treatment groups:
- Palbociclib plus fulvestrant; or
- Placebo plus fulvestrant.
Participants will continue to receive trial treatment until disease progression or unacceptable toxicity and will be followed up for a maximum of 12 months from the end of trial treatment.
UK Coordinating Investigator: Dr Gianfilippo Bertelli (Abertawe Bro Morgannwg University Health Board)
ICR-CTSU Scientific Lead: Professor Judith Bliss
Trial management contact: [email protected]
ClinicalTrials.gov identifier: NCT02536742
Sponsor: International Breast Cancer Study Group (IBCSG)
View PYTHIA on the National Institute for Health Research website: NIHR - Be Part Of Research
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