RATIONALE: To compare efficacy, toxicity and quality of life of the sequential administration of Her alone followed, at PD, by the combination with Chemotherapy (Arm A) vs. the upfront combination of Her and Chemotherapy (Arm B) in patients with advanced/metastatic breast cancer. PURPOSE: Trial SAKK 22/99 addresses clinically relevant and currently unresolved questions regarding the optimal use of Herceptin in the treatment of patients with advanced/metastatic breast cancer.
In advanced HER2+ breast cancer the impact of combining Trastuzumab (T) and chemotherapy (chemo) versus T alone followed by the addition of chemo at disease progression has not been properly studied. The trial compared efficacy, toxicity and quality of life of sequential administration of T followed, at progression, by combination with chemo (T\>TChemo) versus the upfront combination of T and chemo (TChemo) in patients with HER2+ advanced breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
175
Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks; at time of progression add chemotherapy
Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks, and chemotherapy
European Institute of Oncology
Milan, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, Italy
Time to progression on combined HerChemo (TTPHerChemo)
Time frame: 8 weeks
Response rate
Time frame: 8 weeks
Time to first progression
Time frame: 8 weeks
Time to treatment failure
Time frame: 8 weeks
Overall survival
Time frame: 8 weeks
Adverse events
Time frame: 8 weeks
Predictive value of serum HER2/neu ECD levels on clinical outcome
Time frame: 8 weeks
Conversion rate of estrogen receptor status
Time frame: 8 weeks
Association of immunoprofiles of erbB-1, erbB-2, erbB-3 and erbB-4 with clinical outcome
Time frame: 8 weeks
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...and 7 more locations