Borstkanker Onderzoek Groep
S. Sleijfer
A.E. van Leeuwen-Stok
IKNL locatie Amsterdam, Trialbureau PO Box 9236 1006 AE Amsterdam Email amsterdam.trialbureau@iknl.nl Tel 020 3462544 Fax 088 – 234 6011
SMS-Oncology
Funding by KWF
Randomization: Arm A: trastuzumab, bevacizumab with paclitaxel. Arm B: trastuzumab, bevacizumab, followed by the combination of trastuzumab, bevacizumab and paclitaxel at progression
Primary objective: To establish whether concomitant therapy of trastuzumab, bevacizumab with paclitaxel (regimen A) and/or trastuzumab and bevacizumab followed by the combination of trastuzumab, bevacizumab, and paclitaxel at progression (regimen B) deserves to be further studied.
Primary endpoint:
Secondary endpoints: To evaluate:
Pre- and postmenopausal patients with locally recurrent breast cancer that cannot be treated with curative intent by local treatment (surgery, radiotherapy +/- hyperthermia) or metastatic HER2 positive breast cancer. Patients with HER2 positive MBC who have received trastuzumab in the adjuvant setting are allowed to be enrolled, provided they received at least 10 months of therapy with trastuzumab and ≥ 6 months has elapsed since last adjuvant administration of trastuzumab. Patients with HER2 positive MBC who have received a taxane in the adjuvant setting are allowed to be enrolled, provided ≥6 months had elapsed since last adjuvant administration of taxane and taxane-related toxicity is resolved to less than grade 2.
