Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)

• ClinicalTrials.gov Identifier: NCT00944918
• Recruitment Status: Completed
• First Posted: July 23, 2009
• Last Update Posted: August 29, 2011
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Tracking Information

• First Submitted Date: July 22, 2009
• First Posted Date: July 23, 2009
• Last Update Posted Date: August 29, 2011
• Study Start Date: December 2008
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 23, 2009): Progression-free survival [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ]
• Original Primary Outcome Measures (submitted: July 22, 2009): Progression-free survival [ Time Frame: Per RECIST schedule ]

Current Secondary Outcome Measures (submitted: July 23, 2009)

• Objective complete response (CR) and partial response (PR) rate [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ]
• Duration of response [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ]
• Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ]

Original Secondary Outcome Measures (submitted: July 22, 2009)

• Objective complete response (CR) and partial response (PR) rate [ Time Frame: Per RECIST schedule ]
• Duration of response [ Time Frame: Per RECIST schedule ]
• Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate [ Time Frame: Per RECIST schedule ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Progression-free Survival

Intervention

• Drug: fulvestrant
  Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
  Other Name: Faslodex
• Drug: anastrozole
  Tablet, oral, once daily until disease progression.
  Other Name: Arimidex
• Drug: exemestane
  Tablet, oral, once daily until disease progression.
  Other Name: Aromasin

Study Arms

• Experimental: 1
  fulvestrant and anastrozole
  Interventions:

  • Drug: fulvestrant
  • Drug: anastrozole
• Experimental: 2
  fulvestrant and placebo
  Intervention: Drug: fulvestrant
• Active Comparator: 3
  exemestane alone
  Intervention: Drug: exemestane

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 3, 2011): 25
• Original Estimated Enrollment (submitted: July 22, 2009): 36
• Actual Study Completion Date: June 2011
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT00944918
• Other Study ID Numbers: 9238UK/0005
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: AstraZeneca
• Original Responsible Party: Bahn, JoonWoo, MD, AstraZeneca Pharmaceuticals
• Current Study Sponsor: AstraZeneca
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Young-Huck Im; Professor(Samsung Medical Center)

• PRS Account: AstraZeneca
• Verification Date: August 2011