Study study type
PathologyT1T0Patientssample sizesROB Results

la/mBC - HR-positive - 1st line (L1) breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 1st line (L1)

versus fulvestrant
lapatinib plus fulvestrant
CALGB 40302, 2014
  NCT00390455		RCTla/mBC - HR-positive - 1st line (L1)lapatinib plus fulvestrantplacebo plus fulvestrantPostmenauposal women with stage III or IV HR-positive BC (Er and/or PR positive). Originally with HER2-positive, then an amendment to include tumors regardless of HER2 status. Patients had one or two prior endocrine treatments for at least 3 months without tumor progression in either the adjuvant or metastatic setting.-/-NA
 suggested
  • inconclusive 4 % increase in progression or deaths (PFS) (PE)
versus letrozole
lapatinib plus letrozole
EGF30008 (HER2-positive), 2009
  NCT00073528		RCTla/mBC - HR-positive - 1st line (L1)lapatinib plus letrozoleplacebo plus letrozolePostmenopausal women with histologically confirmed stage IIIB/IIIC or IV, with HR positive. No prior therapy for advanced/metastatic BC was allowed, bu prior (neo)adjuvant antiestrogen therapy was allowed.111 / 108NA
 conclusif
  • demonstrated 29 % decrease in progression or deaths (PFS) (PE)
  • statistically significant 60 % decrease in CBR
  • statistically significant 60 % decrease in objective responses (ORR)
Adding lapatinib to letrozole improve significantly PFS for patients with HR-positive and HER2-positive breast cancer
EGF30008 (all population), 2009
  NCT00073528		RCTla/mBC - HR-positive - 1st line (L1)lapatinib plus letrozoleplacebo plus letrozolePostmenopausal women with histologically confirmed stage IIIB/IIIC or IV, with HR positive. No prior therapy for advanced/metastatic BC was allowed, bu prior (neo)adjuvant antiestrogen therapy was allowed.642 / 644NA
 conclusif
  • demonstrated 14 % decrease in progression or deaths (PFS) (PE)

 

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