Vall d’Hebron leads international study to test a new treatment approach for metastatic HER2-positive breast cancer

Recently published in the Journal of Clinical Oncology, results of an early phase I-II study, led by the Vall d’Hebron University Hospital and the Vall d’Hebron Institute of Oncology (VHIO), have spurred an international phase III trial. This study, currently under way, could lead to the approval of a new treatment approach for patients with advanced HER2-positive breast cancer.

Barcelona, 23 October 2014
. A study recently published in the Journal of Clinical Oncology shows the combination of two drugs, neratinib plus capecitabine, to be effective in patients with metastatic HER2-positive breast cancer who progressed to other previous line therapies. This newly proposed combination of Neratinib, a potent inhibitor of tumoral activity, with the chemotherapy drug capecitabine, has an additional advantage in that the two can be administered orally. This combination offers a new treatment option for patients with advanced HER2-positive breast cancer who have become resistant to prior treatment with trastuzumab, lapatinib or other anti-HER2 agents, and represents a potential third line therapy for these patients.

The study shows that 63% of patients enrolled responded to the treatment; of whom 64% had not previously received lapatinib (a drug administered as second-line treatment for these patients), while 57% of them had. Patient progression free survival was 40 weeks in the first group and 36 weeks in the second. These results are comparatively better than other drug combinations that have been tested in patients with advanced cancer who did not respond well to first line therapies.

Positive results from this trial, led by VHIO´s Breast Cancer & Melanoma Group, have given rise to an international phase III study, currently under way, to directly compare the results of the neratinib plus capecitabine combination with lapatinib plus capecitabine (the latter therapy already approved in this setting), for patients with this type of advanced breast cancer. If the results prove positive, commercialization of this agent as a new standard treatment for patients with advanced HER2-positive breast cancer could be possible within three years.

This international phase III study is co-led by Cristina Saura, Medical Oncologist of VHIO´s Breast Cancer & Melanoma Group, headed by Javier Cortés, and José Baselga, Physician-in-Chief at the Memorial Sloan Kettering Cancer Center (MSKCC), New York, as Co-Principal Investigator. Cristina Saura affirms that “the positive clinical results from the preliminary studies led by Vall d’Hebron have spurred a phase III study. We hope that the results will be positive and lead to the approval of a new drug that could change the standard treatment of advanced HER2-positive breast cancer, a type of cancer that affects around 10-15% of patients with breast cancer”.

New targeted therapies against HER2-positive breast cancer, a highly aggressive type of cancer

Approximately 10-15% of women with breast cancer are positive for HER2, an oncogene that plays an important role in the development and most aggressive progression of breast cancer with poorer prognosis. Over recent years, therapies (trastuzumab, lapatinib, pertuzumab and TDM-1) that have been developed against this oncogene (anti-HER2), represent an important advancement in the treatment of this type of breast cancer. However, there are still some patients who do not respond to these therapies, the majority of whom ultimately develop mechanisms of resistence. It is therefore critical to focus continued research on developing new anti-HER2 strategies for patients whose disease has progressed.


For more information please contact:

Amanda Wren, Director of Communication, Vall d´Hebron Institute of Oncology (VHIO), Tel.: +34 934893021, Mobile: +34 609207886, Email:

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