PHERGain
Research type
Research Study
Full title
Chemotherapy-free trastuzumab and pertuzumab in HER2-positive breast cancer: FDG-PET response-adapted strategy. The PHERGain study
IRAS ID
226230
Contact name
Peter Schmid
Contact email
Sponsor organisation
Medica Scientia Innovation Research (MEDSIR)
Eudract number
2016-002676-27
Duration of Study in the UK
4 years, 5 months, 2 days
Research summary
This is a multicenter, open-label, randomized phase II clinical trial for the chemotherapy-free treatment (trastuzumab and pertuzumab) of HER2-positive breast cancer using an FDG-PET (fluorodeoxglucose-positron emission tomography) response-adapted strategy.
Significant antitumor activity of the dual HER2 blockade with trastuzumab and pertuzumab has been reported during neoadjuvant treatment (early stage, prior to the main treatment such as surgery).
Non-invasive imaging tools such as 18F-FDG PET/CT, that could guide the response to this early stage therapy are of particular interest. Early metabolic evaluation using 18F-FDG PET/CT might help to recognize patients with an increased probability of a pathologic complete response (pCR) and an excellent outcome with a chemotherapy-free treatment strategy based on the dual HER2 blockade with trastuzumab and pertuzumab.
This randomized, open-label phase II study will assess the efficacy of the combination of trastuzumab and pertuzumab, ± endocrine therapy according to hormone receptor (HR) status, as exclusive neoadjuvant and adjuvant treatment in patients with HER2-positive breast cancer through a FDG-PET response-adapted strategy.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/1715
Date of REC Opinion
28 Nov 2017
REC opinion
Further Information Favourable Opinion