The combination therapy of @entity632 and trastuzumab has been proven to be highly effective for @entity0 ( @entity0 ) @entity1 with @entity1722 over-expressing @entity5 . However, this regimen is characterized by frequent @entity1370 , occurring in 27% of all treated @entity1 and aggravating when the two substances are given concurrently. Pegylated liposomal @entity632 (PLD) as a single agent reduces significantly @entity1370 and maintains efficacy compared to conventional @entity632 . This prospective open labeled, multicenter phase II study assessed the potential @entity1370 and efficacy of PLD and trastuzumab as first and second line combination therapy in @entity1722 over-expressing @entity0 @entity1 . @entity1 with @entity1722 over-expressing, measurable @entity0 with a baseline left ventricular ejection fraction (LVEF) > or =50% were treated with @entity6066 40 mg/m(2) every 4 weeks for 6 up to 9 cycles and weekly trastuzumab (4 mg/kg loading dose, then 2 mg/kg). @entity1370 was defined as the appearance of clinical signs or symptoms of @entity712 in combination with a decrease in LVEF < or =44% or > or =10 units below the normal value of 50% in the obligatory, subsequently performed transthoracic echocardiography. Due to conflicting interests, the planned accrual goal of 30 @entity1 was not reached. Finally 16 @entity1 were enrolled. Ten @entity1 presented with more than one metastatic site and six of them were in second-line therapy. The median LVEF in the study cohort was 66.1 +/- 8.68% at baseline, 62.7 +/- 5.11% after 6 cycles of therapy, 64.4 +/- 7.61% at the first follow up and did not change significantly (61.0 +/- 5.56% even at the 5th follow-up). Six out of 12 assessable @entity1 (50.0%) demonstrated a clinical benefit and after a median follow-up of 15.4 months a median progression free survival of 9.67 and a median overall survival of 16.23 months. Non-cardiac side effects were mild with only 3 CTC grade 3 events of 247 treatment cycles (1.2%) and no grade 4 @entity137 . The combination of PLD and trastuzumab in @entity1 with @entity1722 over-expressing @entity0 is a safe, feasible and effective therapy. However, cardiac function should be monitored at close intervals. Due to the promising clinical response rates and mild @entity137 profile in this prognostically unfavorable group, this combination therapy should be evaluated in larger studies.

Pegylated liposomal @entity632 and trastuzumab as 1st and 2nd line therapy in @entity1722 /neu positive XXXX : a multicenter phase II trial.

@entity632 :: ('MESH:D004317', 'Chemical') :: ['doxorubicin'] @entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity712 :: ('MESH:D006333', 'Disease') :: ['congestive heart failure'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity0 :: ('MESH:D001943', 'Disease') :: ['metastatic breast cancer', 'MBC'] @entity6066 :: ('MESH:C041277', 'Chemical') :: ['PLD'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumors'] @entity1370 :: ('MESH:D066126', 'Disease') :: ['Cardiotoxicity', 'cardiotoxicity', 'cardiac toxicity'] @entity1722 :: ('2064', 'Gene') :: ['Her2', 'Her2/neu']
@entity0 :: (MESH:D001943,Disease) :: ['metastatic breast cancer']
