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Benefits of Herceptin in subsequent lines of therapy for metastatic breast cancer
 

Herceptin has been shown to deliver high response rates in further lines of MBC.


H0649g 

In the multicentre H0649g study, patients who had progressed after at least one line of chemotherapy in metastatic disease achieved an objective response rate of 15% with Herceptin monotherapy.1

 

Table 3.4  Efficacy of Herceptin monotherapy in second-line metastatic breast cancer (H0649g).1

 

 H0649g trial design

 

Herceptin treatment beyond disease progression may also improve overall survival relative to initial Herceptin-based therapy only.

 

GBG-26

This is the first Phase III randomised clinical trial to have demonstrated the benefits of continuing Herceptin treatment beyond disease progression on prior Herceptin-based therapy. 

Table 3.5 Continued therapy with Herceptin plus Xeloda improves outcomes compared with discontinuation of Herceptin in the GBG-26 trial2

 


Continuation of Herceptin beyond disease progression nearly doubled the objective response rate and significantly prolonged time to progression by almost 3 months – an improvement of 46%.2 This impressive efficacy was achieved without any unexpected grade 3/4 toxicities or treatment-related deaths.

GBG-26 trial design

 

EGF104900

This Phase III trial evaluated the efficacy and safety of Herceptin combined with lapatinib in patients with HER2-positive MBC who had progressed on Herceptin-based treatment for metastatic disease.

 

Table 3.6 Herceptin in combination with lapatinib improves outcomes when compared with lapatinib alone3

 

 

Combining Herceptin with lapatinib significantly improved median progression-free survival. This clear benefit was observed in patients who had received a median of three prior Herceptin-containing regimens.

EGF104900 trial design

 
References
 
  1. Cobleigh S et al. J Clin Oncol 1999: 17 (9); 2639-2648.
  2. von Minckwitz G et al. J Clin Oncol 2008: 26 (May 20 Suppl); abs 1025.
  3. O’Shaughnessy J et al. J Clin Oncol 2008: 26 (May 20 Suppl); abs 1015.

EU approval and labelling information

Herceptin is approved for the treatment of women with early and metastatic HER2-positive breast cancer and patients with HER2-positive metastatic gastric cancer.

More

Roche Clinical Trials Database

In 2005 Roche launched an electronic clinical trial registry and results database. To learn more about the Herceptin trials, please visit

http://www.roche-trials.com/