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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00274469
First received: January 10, 2006
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: fulvestrant
Drug: anastrozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Clinical Benefit Rate [ Time Frame: Each patient was assessed for Clinical Benefit from the sequence of RECIST (Response Evaluation Criteria In Solid Tumours) scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization. ] [ Designated as safety issue: No ]
    A Clinical Benefit (CB) responder is defined as a patient having a best overall response ofCR, PR or SD provided SD (or better) was present ≥ 154 days from randomization (ie SD ≥ 24weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.


Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization. ] [ Designated as safety issue: No ]
    An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CRif she had overall response of CR or PR on one visit and met the confirmation criteria perRECIST. ORR is defined as percentage of patients with objective response.

  • Time to Progression [ Time Frame: RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008. ] [ Designated as safety issue: No ]
    Time from randomization until earlier of disease progression or death

  • Duration of Response [ Time Frame: RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008. ] [ Designated as safety issue: No ]
    Time from randomization until earlier of progression or death measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.

  • Duration of Clinical Benefit [ Time Frame: RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008. ] [ Designated as safety issue: No ]
    Time from randomization until earlier of disease progression or death measured only in those patients who achieved clinical benefit.Time from randomization until earlier of disease progression or death measured only in those patients who achieved clinical benefit.


Enrollment: 233
Study Start Date: February 2006
Study Completion Date: July 2014
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fulvestrant
Drug: fulvestrant
500 mg intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Active Comparator: 2
Anastrozole
Drug: anastrozole
1 mg oral tablet
Other Names:
  • Arimidex
  • ZD1033

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274469

  Show 37 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Faslodex Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00274469     History of Changes
Other Study ID Numbers: D6995C00006, FIRST
Study First Received: January 10, 2006
Results First Received: January 27, 2009
Last Updated: August 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
oncology
cancer
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014