Reason for request

Extension of Inclusion and

No clinical benefit demonstrated in the second-line treatment of locally advanced or metastatic breast cancer in patients in whom the disease has progressed, compared with the existing therapeutic strategy

 Minor improvement in the treatment confirmed in third-line and later line of treatment of locally advanced or metastatic breast cancer that has progressed

 

  • HALAVEN now has Marketing Authorisation in the treatment of locally advanced or metastatic breast cancer in patients in whom the disease has progressed after at least one chemotherapy protocol for the treatment of the advanced stage. The previous treatment, in the adjuvant or metastatic situation, must have included an anthracycline and a taxane, unless the patient cannot be given these treatments.
  • In second-line treatment in a phase III study, no improvement in overall survival or in progression-free survival by comparison with XELODA (capecitabine) was demonstrated.

Clinical Benefit

Substantial

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Clinical Added Value

minor

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no clinical added value

Therapeutic use

-

-

 

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