WO29217 - Neo-adjuvant Pertuzumab in Breast Cancer
Research type
Research Study
Full title
A MultiCenter, MultiNational, Phase II Study to Evaluate Pertuzumab in Combination with Trastuzumab and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients with HER2-Positive, Locally Advance, Inflammatory or Early-Stage Breast Cancer
IRAS ID
154256
Contact name
Mark Verrill
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2014-000156-28
Research summary
Breast cancer is the most common form of cancer in women. Approximately 20% of breast cancers over-express a receptor called HER2. These HER2-positive breast cancers were found to have a poorer prognosis. This finding lead to the development of two treatments called trastuzumab and pertuzumab, both of which are used to treat HER2-positive breast cancer.
Improving the initial treatment of breast cancer whilst it is still confined to the breast and regional lymph nodes offers a chance of potentially curing the disease, as well as delaying recurrence and death in those patients who are not cured. Treatment given before surgery is called “Neoadjuvant” therapy and treatment given after surgery is called “adjuvant” therapy. Promising results have been reported for combinations of pertuzumab, trastuzumab and chemotherapy when given in the neoadjuvant setting. A range of different chemotherapy treatments have previously been tested, however more data on different chemotherapy treatments is needed.
This study aims to investigate the safety and effectiveness of two different chemotherapy treatments when given in combination with pertuzumab and trastuzumab for patients with newly diagnosed breast cancer that has not spread to other parts of the body.
In this study, all patients will receive chemotherapy and trastuzumab before surgery (neoadjuvant), and all patients will receive trastuzumab after surgery (adjuvant). This is considered standard treatment. In addition, all patients will receive pertuzumab before and after surgery (along with the trastuzumab). The two neoadjuvant chemotherapy regimens used in this study are as follows:
Cohort A – doxorubicin + cyclophosphamide, followed by paclitaxel
Cohort B – 5-fluorouracil, epirubicin + cyclophosphamide, followed by docetaxel
The choice of chemotherapy regimen is made by the Investigator according to their standard practice.
Patients will receive treatment in the study for approximately 14 months after which they will be required to attend for follow-up visits. These follow-up visits will continue until the last patient who enters the study has been followed up for 5 years. This means that the total length of the study for patients could be up to 7 years.
This study is a global study and will involve approximately 10 UK centers.
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/1356
Date of REC Opinion
15 Sep 2014
REC opinion
Further Information Favourable Opinion