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Adjuvant Trial Combining Bevacizumab with Trastuzumab

Track 30

DR LOVE: Mark, what do we know in terms of trials evaluating trastuzumab and bevacizumab together, as is being tested in the BETH trial?

DR PEGRAM: An interim analysis of our ongoing Phase II trial of bevacizumab in combination with trastuzumab as first-line treatment for HER2-positive metastatic breast cancer was presented previously at San Antonio (Pegram 2006; [2.2]). Among the 37 evaluable patients, the overall response rate was 54 percent, which we thought was a fairly robust efficacy signal for an all-biologic combination.

2.2

Some concern arose regarding cardiac safety. One patient receiving the combination developed congestive heart failure, and a number of asymptomatic declines in ejection fraction were recorded among those 37 patients. However, I hasten to add that an ascertainment bias is possible in this data set in that it represents the most heavily screened patient population treated with trastuzumab to date.

We evaluated ejection fractions at baseline and closely each month thereafter. Cardiac safety will continue to be monitored closely as the project moves forward into the randomized trials. The BETH trial will now evaluate this in the adjuvant setting (1.2).

 

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Adjuvant Chemotherapy for Patients with HER2-Negative Disease

Adjuvant Systemic Therapy for Patients with HER2-Positive Disease

Adjuvant Therapy for Elderly Patients with HER2-Positive Disease

Adjuvant Trial Evaluating Trastuzumab and/or Lapatinib in HER2-Positive Disease
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Role of Bevacizumab for Patients with HER2-Negative Metastatic Disease

Adjuvant Trial Combining Bevacizumab with Trastuzumab

Optimizing First-Line Systemic Therapy for Patients with ER-Positive, HER2-Positive Metastatic Disease
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