- Herceptin, 2 mg/kg IV every week or 6 mg/kg IV every 3 weeks
- Pertuzumab, 840 mg IV day 1, then 420 mg every 3 weeks.
The study took place in two stages according to a modified Simon design, with the primary endpoints of:
- objective response rate
- clinical benefit rate
and secondary endpoints of:
- time to response
- duration of response
- time to progression
- progression-free survival
Results from the first stage were presented at ASCO last year.(3)
No patients withdrew from the trial with treatment-related or cardiac adverse events and the treatment was well-tolerated.
CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) is a Phase III randomised, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of pertuzumab, Herceptin and chemotherapy versus Herceptin and chemotherapy in previously untreated HER2-positive metastatic breast cancer.
CLEOPATRA is currently recruiting in 19 countries (Argentina, Brazil, China, Costa Rica, Finland, France, Germany, Hong Kong, Italy, Korea, Mexico, Philippines, Poland, Russia, Singapore, Spain, Thailand, UK and the US).
About Herceptin (trastuzumab)
Herceptin is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. It has demonstrated efficacy in treating both early and advanced (metastatic) breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2-positive breast cancer.
Herceptin received approval for use in the European Union for advanced (metastatic) HER2-positive breast cancer in 2000, and for early HER2-positive breast cancer in 2006. In the advanced setting, Herceptin is now approved for use as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, as first-line therapy in combination with docetaxel, and as a single agent in third-line therapy. It is also approved for use in combination with an aromatase inhibitor for the treatment of post-menopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer. In the early setting, Herceptin is approved for use following standard (adjuvant) chemotherapy.
Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat more than 450,000 HER2-positive breast cancer patients worldwide.