EORTC 75111
Research type
Research Study
Full title
Pertuzumab + trastuzumab (PH) versus PH plus metronomic chemotherapy (PHM) in the elderly HER2+ metastatic breast cancer population who may continue on T-DM1 alone following disease progression while on PH / PHM: an open-label multicentre randomized phase II selection trial of the EORTC Elderly Task Force and Breast Cancer Group
IRAS ID
126320
Contact name
Nick Preston
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Eudract number
2011-006342-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 17 days
Research summary
Research Summary
There is little information about the benefits of chemotherapy for the treatment of breast cancer in elderly patients. The decision to treat is based on the treating doctor’s preference, based in part on the patients' fitness for the treatment, rather than evidence, and doctors disagree whether the known benefits of the drugs on younger patients outweigh the effects of toxicity of the drugs on quality of life in frail elderly patients. This trial aims to increase the knowledge of the optimal treatment of breast cancer in elderly patients with metastatic breast cancer.
This trial will compare progression free survival in 2 groups of 40 patients with metastatic HER2-positive breast cancer aged over 70 (the trial will include patients over 60 if they have certain functional restrictions). Patients will be allocated into groups randomly. Both groups will receive Pertuzumab and trastuzumab (Herceptin®) but one group will also receive metronomic chemotherapy (repetitive, low doses of Cyclophosphamide, taken daily). Additionally, the trial aims to select promising treatments for further investigation in phase III trials. Patients will continue on these treatments until disease progression, until they refuse treatment or until drug toxicity becomes unacceptable. After disease progression, patients will be given the opportunity to receive Trastuzumab-DM1 (T-DM1), a drug recently approved in the EU for the treatment of patients with advanced HER2 positive breast cancer.
This trial includes the option for participants to donate blood samples for translational research. Blood samples will be taken on 4 occasions, at the same time as blood is taken for routine testing, and sent to the laboratory for investigations into whether biomarkers might predict toxicity, treatment tolerability and general outcome in elderly patients. Participants will also be asked to consent to the use of any remaining blood for future, unplanned, research on the condition that the future research has received approval from a Research Ethics Committee.
Summary of Results
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-pertuzumab-trastuzumab-and-cyclophosphamide-for-older-people-with-advanced-breast-cancer#undefined
REC name
West of Scotland REC 1
REC reference
14/WS/1107
Date of REC Opinion
22 Dec 2014
REC opinion
Further Information Favourable Opinion