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

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ClinicalTrials.gov Identifier: NCT00274469
Recruitment Status : Completed
First Posted : January 11, 2006
Results First Posted : August 12, 2009
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: fulvestrant Drug: anastrozole Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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. ]
    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 :
  1. 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. ]
    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.

  2. 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. ]
    Time from randomization until earlier of disease progression or death

  3. 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. ]
    Time from randomization until earlier of progression or death measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.

  4. 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. ]
    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.



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Ages Eligible for Study:   45 Years to 100 Years   (Adult, Senior)
Sexes 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274469


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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00274469     History of Changes
Other Study ID Numbers: D6995C00006
FIRST
First Posted: January 11, 2006    Key Record Dates
Results First Posted: August 12, 2009
Last Update Posted: March 13, 2017
Last Verified: February 2017

Keywords provided by AstraZeneca:
oncology
cancer
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Anastrozole
Estradiol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action