PASIPHAE
Research type
Research Study
Full title
A Phase 2, international, multicenter, open-labeled, randomised trial of palbociclib and fulvestrant versus standard oral capecitabine in patients with hormone receptor positive / HER2 negative advanced breast cancer and documented endocrine resistance (PASIPHAE)
IRAS ID
238918
Contact name
Iain MacPherson
Contact email
Sponsor organisation
Karolinska University Hospital
Eudract number
2016-002893-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Patients will be invited to take part in this research study because they have ER+/HER2- advanced breast cancer. This is breast cancer with greater than normal amounts of oestrogen receptors (ER “positive” or ER+) but normal amounts of HER2 receptors on the surface of their breast cancer cells (HER2 “normal” or “negative” or HER2-). Advanced breast cancer is breast cancer which has either reappeared following treatment (known as recurrent or locally advanced), or spread to another part of the body (known as metastatic breast cancer).
Previous studies have shown that patients with ER+/HER2- breast cancer may do better when a new drug called palbociclib is given in combination with hormone therapy compared to giving standard hormone therapy alone. In this study we are aiming to investigate the anti-tumour activity (how well the treatment works) and tolerability (how severe any side effects are) of the combination of palbociclib with the hormone therapy fulvestrant compared to standard chemotherapy in women with this type of advanced breast cancer.
As well as testing how well new treatments work, it is important that doctors find out how treatments affect patients’ wellbeing. To investigate this, doctors design questionnaires to ask people about how they are feeling and what side effects they are having from the cancer and the treatment. These are called quality of life questionnaires and these will also be examined in this study.
The study is also being carried out to look at factors in tumour tissue and blood to see if this can predict the effect of the different drug treatments which may help in selecting the best treatment for individual patients in the future. Because breast cancer is a disease in which the recurring tumour does not always have the same characteristics as the original breast tumour, we always try, if possible to obtain a sample of tumour recurrence. Such sampling may be done in different ways, sometimes with a direct core needle biopsy of tumour recurrence, while in other cases, it may be necessary to use a CT scan or ultrasound to guide the biopsy process. The purpose of the sampling is to ensure that the tumour is a relapse of breast cancer and to examine tumour characteristics while considering treatment options.REC name
West of Scotland REC 1
REC reference
19/WS/0049
Date of REC Opinion
8 Apr 2019
REC opinion
Favourable Opinion