PURPOSE: @entity4381 ( @entity5921 ) is a @entity1568 -containing @entity5520 that induces osteoclast apoptosis and inhibits bone resorption by inhibiting the mevalonate pathway. Its benefit for the prevention of @entity532 due to bone @entity3 has been established. However, the antitumor efficacy of @entity5921 , although suggested by multiple preclinical and clinical studies, has not yet been clinically proven. We performed the present randomized Phase 2 trial to investigate the antitumor effect of @entity5921 with chemotherapy (CT). METHODS: Asian @entity1 with @entity1722 -negative @entity0 were randomly assigned to either the CT or CT+ @entity5921 (CTZ) group. One hundred and eighty-eight @entity1 were randomized to either the CT group (n = 95) or the CTZ group (n = 93) from March 2010 to April 2012, and 180 @entity1 were assessed. All @entity1 received four cycles of FEC100 ( @entity1487 500 mg/m2, @entity1259 100 mg/m2, and @entity786 500 mg/m2), followed by 12 cycles of @entity1311 at 80 mg/m2 weekly. @entity5921 (4 mg) was administered three to four times weekly for 7 weeks to the @entity1 in the CTZ group. The primary endpoint was the pathological complete response (pCR) rate, which was defined as no invasive @entity5 in the breast tissue specimen. Safety was assessed in all @entity1 who received at least one dose of the study drug. RESULTS: This randomized controlled trial indicated that the rates of pCR in CTZ group (14.8%) was doubled to CT group (7.7%), respectively (one-sided chi-square test, p = 0.068), though the additional efficacy of @entity4381 was not demonstrated statistically. The pCR rate in postmenopausal @entity1 was 18.4% and 5.1% in the CTZ and CT groups, respectively (one-sided Fisher's exact test, p = 0.071), and that in @entity1 with triple-negative @entity0 was 35.3% and 11.8% in the CTZ and CT groups, respectively (one-sided Fisher's exact test, p = 0.112). Thus the addition of @entity5921 to neoadjuvant CT has potential anticancer benefits in postmenopausal @entity1 and @entity1 with triple-negative @entity0 . Further investigation is warranted. TRIAL REGISTRATION: University Hospital Medical Information Network. UMIN000003261.

Randomized Controlled Trial of @entity4381 plus Chemotherapy versus Chemotherapy Alone as Neoadjuvant Treatment of @entity1722 -Negative Primary XXXX (JONIE Study).

@entity5921 :: ('CHEBI:46557', 'Chemical') :: ['ZOL'] @entity1 :: ('9606', 'Species') :: ['patients'] @entity1568 :: ('MESH:D009584', 'Chemical') :: ['nitrogen'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer', 'invasive breast cancer'] @entity5 :: ('MESH:D009369', 'Disease') :: ['cancer'] @entity1259 :: ('MESH:D015251', 'Chemical') :: ['epirubicin'] @entity532 :: ('MESH:D003925', 'Disease') :: ['skeletal complications'] @entity786 :: ('MESH:D003520', 'Chemical') :: ['cyclophosphamide'] @entity1311 :: ('MESH:D017239', 'Chemical') :: ['paclitaxel'] @entity5520 :: ('D004164', 'Chemical') :: ['bisphosphonate'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['fluorouracil'] @entity3 :: ('MESH:D009362', 'Disease') :: ['metastases'] @entity4381 :: ('MESH:C088658', 'Chemical') :: ['zoledronic acid', 'Zoledronic acid'] @entity1722 :: ('2064', 'Gene') :: ['HER2']
@entity0 :: (MESH:D001943,Disease) :: ['Breast Cancer']
