BIG4-11 BO25126 Pertuzumab & Herceptin in Adjuvant Breast Cancer
Research type
Research Study
Full title
A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placeboversus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer
IRAS ID
69715
Contact name
Caroline Michie
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2010-022902-41
Duration of Study in the UK
12 years, 7 months, 0 days
Research summary
Breast cancer is the most common cancer in women and the second most common cause
of cancer-related death in women worldwide. About 18% of breast cancers overexpress HER2 receptors and have a poor prognosis when treated with standard chemotherapy treatments. The development of trastuzumab in the 1990’s provided patients who had HER2−overexpressing breast cancer with a better outcome. However, despite improvements in survival that have been demonstrated following treatment with trastuzumab in early breast cancer, patients still remain at significant risk of their cancer recurring during the initial years following treatment. Considerable scope therefore remains to build on the successes demonstrated thus far and to increase further the numbers of patients alive and disease-free after adjuvant treatment for HER2-positive early breast cancer.Pertuzumab is a monoclonal antibody and, like trastuzumab, binds to the HER2 receptor on breast cancer cells. Pertuzumab has been shown to increase the level of activity seen with trastuzumab when used to treat HER2 overexpressing tumours.
This study has been designed to investigate the efficacy and safety of combining pertuzumab with trastuzumab and standard approved chemotherapy regimens as treatment for patients with HER2-overexpressing early breast cancer.
The planned, maximum, targeted treatment period is 52 weeks. Once this is complete all patients will continue to be followed up until approximately 10 years after the randomisation date of the last patient, irrespective of their treatment arm, even if the assigned treatment is discontinued permanently. For this reason, some patients will be followed for more than 10 years (due to the 27 month projected recruitment period).
A total of 3806 patients will take part in the study from all over the world.
REC name
Scotland B REC
REC reference
11/SS/0018
Date of REC Opinion
26 Sep 2011
REC opinion
Further Information Favourable Opinion