TEXAS – Roche recently announced results from the NEOSPHERE trial, a Phase II neoadjuvant study evaluating the effect of a novel combination regimen of pertuzumab and trastuzumab plus chemotherapy in women with early-stage HER2-positive breast cancer.
The data, presented at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), showed that the two antibodies plus the chemotherapy drug given in the neoadjuvant setting prior to surgery significantly improved the rate of complete tumor disappearance in the breast.
“The findings of the NEOSPHERE study suggested that this new approach was effective for early HER2-positive breast cancer,” said Prof. Luca Gianni, principal investigator of the study and director of Medical Oncology at the National Cancer Institute in Milan, Italy.
“The combination of pertuzumab and trastuzumab plus chemotherapy had a substantial effect on HER2-positive breast cancer tumors after just four cycles (12 weeks) of neoadjuvant use,” Gianni added.
The combination of pertuzumab and trastuzumab plus docetaxel was not associated with a significant increase in side effects or cardiac risk compared to trastuzumab and chemotherapy.
Most common severe side effects were neutropenia (low white blood cell count), fever that was associated with neutropenia and diarrhea.
“We are committed to developing new medicine that make a difference for people living with cancer and to advancing personalized treatments,” said Hal Barron, head of global development and chief medical officer at Roche.
“The clinical data presented today (at SABCS) add to the body of evidence that this novel targeted regimen plus chemotherapy may improve outcomes in women with HER2-positive breast cancer,” Barron said.
Based on these findings, Roche plans to initiate a Phase III study in HER2-positive early (adjuvant) breast cancer in 2011.
In addition, CLEOPATRA, a Phase III study evaluating the efficacy and safety profile of pertuzumab and trastuzumab plus chemotherapy as a first-line regimen in patients with HER2-positive metastatic breast cancer, completed enrolment in Q2 2010 and results are expected by the end of 2011.