Table 2.

Clinical trials involving lapatinib in patients with breast cancer

Author	Study phase	Sample size	Cancer	Lapatinib’s place in therapy	Lapatinib regimen	Effi cacy outcomes (% of study population)
Storniolo et al 2005	I	27	Metastatic breast cancer	2nd-line treatment used in combination regimen	750–1500 mg daily plus trastuzumab	Patients receiving lapatinib were noted to have achieved: 6 complete or partial responses (22%), and 10 disease stabilizations (37%)
						Time to progression and overall survival not reported
Blackwell et al 2005	II	81	Metastatic breast cancer	2nd-line treatment used as monotherapy	Not reported	Patients receiving lapatinib were noted to have achieved: 7 complete or partial responses (9%) and 12 disease stabilizations (15%)
						Time to progression and overall survival not reported
Gomez et al 2005	II	13	Advanced or metastatic breast cancer	1st-line treatment used as monotherapy	1500 mg daily or 500 mg twice daily	Patients receiving lapatinib were noted to have achieved: 5 partial responses (39%) and 6 disease stabilizations (46%)
						Time to progression and overall survival not reported
Spector et al 2006	II	17	Relapsed or refractory inflamatory breast cancer	2nd-line treatment used as monotherapy	1500 mg daily	Patients receiving lapatinib were noted to have achieved: 8 complete or partial responses (47%)
						Time to progression and overall survival not reported All responders were overexpressors of Erb2 (11 of the 17 patients)
Geyer et al 2006	III	321	Refractory advanced metastatic breast cancer	2nd-line treatment used in combination regimen	1250 mg daily plus capecitabine 2000 mg/m2 on days 1–14 of 3-week cycle (vs. capecitabine monotherapy)	Patients receiving lapatinib were noted to have achieved: 23 complete or partial responses (15%) Median time to progression significantly favored patients treated with lapatinib and capecitabine (37 weeks) compared to patients treated with only capecitabine (20 weeks)

**Table includes studies that focused on breast cancer.