A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer (FIRST)

• ClinicalTrials.gov Identifier: NCT00274469
• Recruitment Status: Completed
• First Posted: January 11, 2006
• Results First Posted: August 12, 2009
• Last Update Posted: September 6, 2019
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Tracking Information

• First Submitted Date: January 10, 2006
• First Posted Date: January 11, 2006
• Results First Submitted Date: January 27, 2009
• Results First Posted Date: August 12, 2009
• Last Update Posted Date: September 6, 2019
• Actual Study Start Date: February 6, 2006
• Actual Primary Completion Date: January 10, 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 2019)

Clinical Benefit Rate [ Time Frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled. ]

A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.

• Original Primary Outcome Measures (submitted: January 10, 2006): The clinical benefit rate will be analysed when all patients have been in the study for 6 months.

Current Secondary Outcome Measures (submitted: August 14, 2019)

• Objective Response Rate [ Time Frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled. ]
  For each patient with measurable disease at baseline, the determination of the overall response for each visit was carried out using a SAS program per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesion (TL) and non-target lesions (NTLs) and no new lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameter of TLs (compared to baseline), no progression of NTLs and no new lesions. Objective response rate is defined as percentage of patients with either CR or PR.
• Time to Progression [ Time Frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled. ]
  Time from randomization until earlier of disease progression or death. Progression was defined according to RECIST: a patient is determined to have progressed if they have progression of target lesions, clear progression of existing non-target lesions, or the appearance of one or more new lesions. Progression of target lesions is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum of LD recorded. Kaplan-Meier estimates of median for each treatment are reported.
• Time to Treatment Failure [ Time Frame: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled. ]
  Time from randomization to treatment discontinuation
• Time to Progression (Investigator Assessed) [ Time Frame: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled. ]
  Time from randomization to disease progression (investigator assessed) or death from any cause. Progression was defined by investigator opinion, as patients did not have formal RECIST visits in the follow-up period after the data cut off for the primary analysis of the study.

• Original Secondary Outcome Measures (submitted: January 10, 2006): Objective response, time to progression, duration of response, duration of clinical benefit and safety will be analysed when all patients have been in the study for 6 months. Response to subsequent therapy and tumour marker levels will also be analysed.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer
• Official Title: A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
• Brief Summary: The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Metastatic Breast Cancer

Intervention

• Drug: fulvestrant
  500 mg intramuscular injection
  Other Names:

  • Faslodex
  • ZD9238
• Drug: anastrozole
  1 mg oral tablet
  Other Names:

  • Arimidex
  • ZD1033

Study Arms

• Experimental: 1
  Fulvestrant
  Intervention: Drug: fulvestrant
• Active Comparator: 2
  Anastrozole
  Intervention: Drug: anastrozole

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 14, 2019): 205
• Original Enrollment (submitted: January 10, 2006): 200
• Actual Study Completion Date: January 13, 2017
• Actual Primary Completion Date: January 10, 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Confirmed hormone receptor positive advanced breast cancer, postmenopausal women

Exclusion Criteria:

• Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 45 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil, Bulgaria, Czechia, France, Italy, Poland, Spain, United Kingdom, United States
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT00274469
• Other Study ID Numbers: D6995C00006; FIRST
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: AstraZeneca
• Original Responsible Party: Not Provided
• Current Study Sponsor: AstraZeneca
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: AstraZeneca Faslodex Medical Science Director, MD; AstraZeneca

• PRS Account: AstraZeneca
• Verification Date: August 2019