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Recommendations for use of Trastuzumab (Herceptin®)

Details of trials or studies

TRASTUZUMAB IN EARLY BREAST CANCER

Table 1: Details of trials in early breast cancer
TRIAL TRASTUZUMAB SEQUENCE CONTROL REGIMEN DURATION OF TREATMENT MEDIAN FOLLOW-UP (months) REF
FinHer concurrent with docetaxel or vinorelbine followed by FEC docetaxel or vinorelbine followed by FEC LD: 4 mg/kg; SD: 2 mg/kg weekly 9 weeks 36 5
HERA sequential after completion of neoadjuvant or adjuvant chemo-therapy various chemo-therapy LD: 8 mg/kg; SD: 6 mg/kg 3-weekly 1v2 years 12 7, 8
NSABP-B31 after AC then concurrently with paclitaxel* AC followed by paclitaxel LD: 4 mg/kg; SD: 2 mg/kg weekly 1 year 29 6
NCCTG-N9831 after AC then concurrently with paclitaxel, or sequentially following paclitaxel* AC followed by paclitaxel LD: 4 mg/kg; SD: 2 mg/kg weekly 1 year 18 6
BCIRG-006 (abstract only) after AC with docetaxel or with docetaxel and carboplatin* AC followed by docetaxel with A LD: not reported; SD: not reported weekly 1 year 23 4
Buzdar after paclitaxel then concurrently with FEC neoadjuvant* paclitaxel followed by FEC SD: 2 mg/kg weekly 24 weeks 20 9

A= doxorubicin; C=cyclophosphamide; E= epirubicin; F= fluorouracil; LD=loading dose; RT=radiotherapy; SD=subsequent dose; *= trastuzumab concurrent with radiotherapy; = prior to radiotherapy; = after radiotherapy

TRASTUZUMAB IN METASTATIC BREAST CANCER

Table 2: Details of trials in metastatic breast cancer
TRIAL TRASTUZUMAB SEQUENCE CONTROL REGIMEN DURATION OF TREAT-MENT MEDIAN FOLLOW-UP (months) REF
Slamon concurrent with doxorubicin or epirubicin plus C or paclitaxel (if received prior anthracycline) doxorubin or epirubicin plus C or paclitaxel (if received prior anthracycline) LD: 4 mg/kg; SD: 2 mg/kg weekly until disease progression 30 12
M77001 concurrent with docetaxel docetaxel LD: 4 mg/kg; SD: 2 mg/kg weekly until disease progression not reported 11
Vogel Trastuzumab as monotherapy trial compared two doses of trastuzumab LD: 4 mg/kg; SD: 2 mg/kg weekly vs LD: 8 mg/kg; SD: 4 mg/kg weekly until disease progression not reported 14, 15
Gasparini (abstract only) concurrent with paclitaxel paclitaxel LD: 4 mg/kg; SD 2 mg/kg weekly not reported not reported 10
BCIRG 007 (abstract only) concurrent with docetaxel concurrent trastuzumab with docetaxel and carboplatin LD: 4 mg/kg; SD: 2 mg/kg weekly then 6mg/kg 3-weekly until disease progression or unacceptable toxicity not reported 13
CALGB 9840 (abstract only) concurrent with paclitaxel paclitaxel LD: 4 mg/kg; SD: 2 mg/kg weekly until disease progression or unacceptable toxicity not reported 16

C=cyclophosphamide; LD=loading dose; SD=subsequent dose

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