A European Organisation for Research and Treatment of Cancer randomized, double-blind, placebo-controlled, multicentre phase II trial of anastrozole in combination with gefitinib or placebo in hormone receptor-positive advanced breast cancer (NCT00066378)

2016 ◽  
Vol 53 ◽  
pp. 144-154 ◽  
Author(s):  
Konstantinos Tryfonidis ◽  
Gul Basaran ◽  
Jan Bogaerts ◽  
Marc Debled ◽  
Luc Dirix ◽  
...  
2016 ◽  
Vol 12 (02) ◽  
pp. 79
Author(s):  
Karen A Gelmon ◽  

New treatments are needed urgently for advanced cancer of the breast, in which the most common subtype is hormone receptorpositive breast cancer. In the randomised, double-blind, multicentre phase III trial, Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naïve advanced breast cancer (FALCON), a statistically significant 21% reduction in the risk of disease progression or death was reported in women with hormone receptor-positive advanced breast cancer who had been treated with fulvestrant compared with those who had received anastrozole. Women in this study had not received prior hormone therapy. Access to the treatment and the mechanisms for funding need to be facilitated in a timely fashion. Ongoing studies are awaited to help define the optimal sequence of therapy for women with hormone receptor-positive advanced breast cancer.


2010 ◽  
Vol 28 (25) ◽  
pp. 3917-3921 ◽  
Author(s):  
Robert. W. Carlson ◽  
Richard Theriault ◽  
Christine M. Schurman ◽  
Edgardo Rivera ◽  
Cathie T. Chung ◽  
...  

Purpose To explore the antitumor activity of the aromatase inhibitor, anastrozole, in the treatment of premenopausal women with hormone receptor–positive, metastatic breast cancer who have been rendered functionally postmenopausal with the use of the luteinizing hormone-releasing hormone agonist, goserelin. Patients and Methods Premenopausal women with estrogen and/or progesterone receptor–positive, metastatic or recurrent breast cancer were enrolled in this prospective, single-arm, multicenter phase II trial. Patients were treated with goserelin 3.6 mg subcutaneous monthly and began anastrozole 1-mg daily 21 days after the first injection of goserelin. Patients continued on treatment until disease progression or unacceptable toxicity. Results Thirty-five patients were enrolled of which 32 were evaluable for response and toxicity. Estradiol suppression was assessed, with mean estradiol levels of 18.7 pg/mL at 3 months and 14.8 pg/mL at 6 months. One participant (3.1%) experienced a complete response, 11 (34.4%) experienced partial response, and 11 (34.4%) experienced stable disease for 6 months or longer for a clinical benefit rate of 71.9%. Median time to progression was 8.3 months (range, 2.1 to 63+) and median survival was not been reached (range, 11.1 to 63+). The most common adverse events were fatigue (50%), arthralgias (53%), and hot flashes (59%). There were no grade 4 to 5 toxicities. Conclusion The combination of goserelin plus anastrozole has substantial antitumor activity in the treatment of premenopausal women with hormone receptor–positive metastatic breast cancer.


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