D699BC00001 - Ph. III Study for Metastatic Breast Cancer in Women

• Research type

  Research Study

• Full title

  A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEXTM) 500 mg with Anastrozole (ARIMIDEXTM) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy (FALCON)

• IRAS ID

  108451

• Contact name

  John Forsyth Russell Robertson

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2011-006326-24

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a clinical trial (known as FALCON) comparing the efficacy and tolerability of two approved drugs fulvestrant(known as FASLODEX) with anastrozole(known as ARIMIDEX)and will be carried out at selected UK hospitals or clinics until February 2018. Treatment will be administered to Postmenopausal women with breast cancer in the form of two injections (Fulvestrant), during a series of planned visits, or orally as a single daily tablet (anastrozole). Dummy drugs (Placebo) will also be given in conjunction with the drug treatments. A series of tests (eg blood,tumour tissue and radiation) will be performed throughout treatment to monitor the patient's progress. Treatment will continue until it is deemed to be of no further benefit to the patient. The patient will be offered the option to provide an additional tumour tissue sample. The phase 2 study (FIRST) indicated that Fulvestrant 500mg was more efficacious than Anastrozole 1mg. However, as a phase 2 trial this was not sufficient to change practice. If these findings are confirmed, in this phase 3 trial (FALCON) then this would supply the evidence needed to change current practice. Given the Phase 2 results it seems very unlikely the patients receiving Fulvestrant 500mg would be disadvantaged compared to the current standard which is Anastrozole 1mg. This research will contribute to the understanding of cancer and it is hoped will lead to improvements in treatment.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  12/EM/0280

• Date of REC Opinion

  7 Nov 2012

• REC opinion

  Further Information Favourable Opinion