Phase II study of lapatinib in combination with vinorelbine in patients with HER2 positive recurrent or metastatic breast cancer: a multicentric Turkish Oncology Group (TOG) trial.
BACKGROUND
The aim of this explorative phase II study was to evaluate the activity and safety of lapatinib in combination with intravenous vinorelbine in women with HER2 positive metastatic or recurrent breast cancer.


METHODS
Twenty-nine patients were enrolled. The primary objectives were response and clinical benefit (CB) rates, secondary objectives were toxicity, response duration and progression free survival. Patients received 1250 mg oral lapatinib continuously once daily and intravenous vinorelbine 20-25 mg/m(2) on days 1 and 8, every 3 weeks.


RESULTS
Although 25 patients were evaluable for response, according to intend to treat analysis of 28 patients; 14% had confirmed partial response (PR) and 36% had stable disease more than 24 weeks with a CB rate of 50%. Sixty four percent of the patients suffered from grade 3-4 hematologic and 18% from grade 3 extra-hematologic toxicities.


CONCLUSION
The results of this trial provide evidence to further investigate the potential of this combination for patients unsuitable for trastuzumab or who become refractory to trastuzumab.
['Saip|P|P|', 'Eralp|Y|Y|', 'Sen|F|F|', 'Karaca|H|H|', 'Ozkan|M|M|', 'Cetin|B|B|', 'Benekli|M|M|', 'Kucukoner|M|M|', 'Isikdogan|A|A|', 'Un|O|O|', 'Basaran|G|G|', 'Onur|H|H|']
D000328:Adult D000368:Aged D000971:Antineoplastic Combined Chemotherapy Protocols D001943:Breast Neoplasms D018572:Disease-Free Survival D005260:Female D006801:Humans D057194:Intention to Treat Analysis D000077341:Lapatinib D008875:Middle Aged D009362:Neoplasm Metastasis D009364:Neoplasm Recurrence, Local D011799:Quinazolines D018719:Receptor, ErbB-2 D013997:Time Factors D014421:Turkey D014747:Vinblastine D000077235:Vinorelbine
Lapatinib Vinorelbine HER2 positive Metastatic breast cancer