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HERCEPTIN (trastuzumab), monoclonal antibody - Treatment of HER2+ early breast cancer

ONCOLOGY - Investigation
Opinions on drugs - Posted on Sep 28 2016

Reason for request

Re-assessment of the actual benefit and the improvement in actual benefit

Substantial improvement as ADJUVANT

Minor improvement as NEOADJUVANT


  • HERCEPTIN has Marketing Authorisation in the treatment of adult patients with HER2+ early breast cancer:

     - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiation therapy (if applicable);

     - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel,

     - in combination with adjuvant chemotherapy combining docetaxel and carboplatin,

     - in combination with neoadjuvant chemotherapy followed by adjuvant HERCEPTIN therapy, in patients with locally advanced (including inflammatory) disease or tumours measuring more than 2 cm in diameter.

  • In adjuvant treatment of HER2+ breast cancer, new data confirm the benefit of adding trastuzumab to chemotherapy in terms of disease-free survival and overall survival.
  • In neoadjuvant treatment of HER2+ breast cancer, trastuzumab, in combination with chemotherapy, has not always demonstrated gain in overall survival. However, its use may improve access to breast-conserving surgery.

Actual benefit



Improvement in actual benefit

II (important)


IV (mineur)
V (absence)

Therapeutic use


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