BACKGROUND: Preclinical data suggest that @entity470 ( @entity470 ) inhibitors (e.g. @entity4562 ) can delay endocrine resistance in @entity0 . A double-blind, placebo-controlled, phase II trial investigated whether adding @entity4562 (G) to @entity13558 (A) would improve outcome in @entity0 ( @entity0 ). METHODS: Postmenopausal pre-treated @entity5282 -positive  @entity0 @entity1 (locally recurrent or metastatic) were 1:1 randomized to A (1  mg/d) plus G 250  mg/d or plus placebo (P). @entity1 who had prior treatment with an aromatase inhibitor in metastatic setting or with trastuzumab, anti- @entity470 or anti-VEGF agents were excluded. Treatment was given until disease progression, unacceptable @entity137 or @entity1 withdrawal. Progression-free survival (PFS) rate at 1 year was assessed according to Response Evaluation Criteria in Solid Tumours, version 1.0. RESULTS: Of 108 planned @entity1 , 71 were recruited (36 in A/G and 35 in A/P). The trial closed prematurely due to slow recruitment; 31 @entity1 had prior chemotherapy and 53 prior endocrine therapy (all except one received @entity440 ); 60% in adjuvant and 16% in metastatic setting received @entity440 ; 59 @entity1 had @entity66 . Median follow-up was 18 months. PFS rate at 1 year was 35% for A/G and 32% for A/P arm. Objective responses were six (22%) in the A/G and nine (28%) in the A/P arm. Median duration of response was 13.8 and 18.6 months in the A/G and A/P arms, respectively. Fatigue (35%), @entity294 (31%), @entity1910 (32%), dry skin (27%), and @entity4841 / @entity925 (27%) were the commonest adverse events in the A/G arm. CONCLUSIONS: This phase II study, although prematurely closed, did not show a signal that adding G to A improves PFS at 1 year and its use is not supported. @entity344 were more pronounced with G resulting in premature therapy interruption in almost 1 in 3 @entity1 (ClinicalTrials.gov number, NCT00066378).

A European Organisation for Research and Treatment of Cancer randomized, double-blind, placebo-controlled, multicentre phase II trial of @entity13558 in combination with @entity4562 or placebo in @entity5282 -positive XXXX (NCT00066378).

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer', 'advanced breast cancer', 'ABC'] @entity4562 :: ('MESH:C419708', 'Chemical') :: ['gefitinib'] @entity440 :: ('MESH:D013629', 'Chemical') :: ['tamoxifen'] @entity470 :: ('1956', 'Gene') :: ['EGFR', 'epidermal growth factor receptor'] @entity66 :: ('MESH:D004194', 'Disease') :: ['visceral disease'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhoea'] @entity1910 :: ('MESH:D005076', 'Disease') :: ['rash'] @entity344 :: ('MESH:D005767', 'Disease') :: ['Gastrointestinal and skin toxicities'] @entity13558 :: ('MESH:C090450', 'Chemical') :: ['anastrozole'] @entity4841 :: ('MESH:D018771', 'Disease') :: ['arthralgia'] @entity925 :: ('MESH:D063806', 'Disease') :: ['myalgia'] @entity5282 :: ('3164', 'Gene') :: ['hormone receptor']
@entity0 :: (MESH:D001943,Disease) :: ['advanced breast cancer']
