Clinical trial NCT00944918: Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)
Official title: A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal Aromatase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Progression-free Survival
Keywords: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-23
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the breast.
* Metastatic disease must be measurable or evaluable
* Relapsed or progressed during prior treatment with single-agent NSAI, meeting either of the following criteria:
* NSAI given as adjuvant therapy that lasted ≥ 12 months OR
* Achieved an objective CR, PR, or SD that that lasted ≥ 6 months after prior 1st-line
* Female postmenopausal patients

Exclusion Criteria:

* Hormone receptor status1. ER -ve and PgR NK2. ER-ve and PgR -ve3. ER NK
* Prescribed Tamoxifen for metastatic disease
* Rapidly progressive visceral disease
* Patients with malignancies within the last 5 years.

Primary outcomes:
measure: Progression-free survival
timeFrame: every 3 months during treatment and, at time of discontinuation from treatment
Secondary outcomes:
measure: Objective complete response (CR) and partial response (PR) rate
timeFrame: every 3 months during treatment and, at time of discontinuation from treatment
measure: Duration of response
timeFrame: every 3 months during treatment and, at time of discontinuation from treatment
measure: Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate
timeFrame: every 3 months during treatment and, at time of discontinuation from treatment
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Professor(Samsung Medical Center)
name: Young-Huck Im
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM; SoFEA investigators. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol. 2013 Sep;14(10):989-98. doi: 10.1016/S1470-2045(13)70322-X. Epub 2013 Jul 29.