A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg (FINDER I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00305448
First received: March 20, 2006
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.


Condition Intervention Phase
Advanced Breast Cancer
Metastatic Breast Cancer
Drug: Fulvestrant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008) ] [ 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 CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.

    Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization



Secondary Outcome Measures:
  • Time to Progression (TTP) [ Time Frame: every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008) ] [ Designated as safety issue: No ]
    Time (in days) from randomization until objective disease progression or death (in the absence of objective progression). RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 19th March 2008.

  • Duration of Response (DoR) [ Time Frame: RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008. ] [ Designated as safety issue: No ]
    Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.

  • Clinical Benefit Rate (CBR) [ Time Frame: every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008. ] [ Designated as safety issue: No ]
    A Clinical Benefit (CB) responder is defined as a patient having a best overall response of Complete response (CR), Partial Response (PR) or Stable disease (SD) provided SD (or better) was present = 154 days from randomization (ie SD = 24 weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.

  • Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    The measure of dispersion for mean population clearance is based on the estimated inter-individual variance

  • Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes


Enrollment: 143
Study Start Date: March 2006
Study Completion Date: February 2012
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fulvestrant 250 mg intramuscular injection
Drug: Fulvestrant
250 intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Experimental: 2
Fulvestrant 250mg (Plus 250mg Loading Regimen)
Drug: Fulvestrant
250 intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Experimental: 3
Fulvestrant 500 mg
Drug: Fulvestrant
500 mg intramuscular injection

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
  • Requiring hormonal treatment
  • Postmenopausal women defined as a woman who has stopped having menstrual periods

Exclusion Criteria:

  • Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer
  • Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
  • An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
  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: NCT00305448

Locations
Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Asahi, Chiba, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Kitakyushu, Fukuoka, Japan
Research Site
Kurume, Fukuoka, Japan
Research Site
Daito, Fukushima, Japan
Research Site
Koriyama, Fukushima, Japan
Research Site
Ota, Gunma, Japan
Research Site
Fukuyama, Hiroshima, Japan
Research Site
Kure, Hiroshima, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Amagasaki, Hyogo, Japan
Research Site
Matsubaracho, Kagoshima, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Kurashiki, Okayama, Japan
Research Site
Izumisano, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Suita, Osaka, Japan
Research Site
Ina, Saitama, Japan
Research Site
Moroyama, Saitama, Japan
Research Site
Shimotsuke, Tochigi, Japan
Research Site
Chuo, Tokyo, Japan
Research Site
Koto-ku, Tokyo, Japan
Research Site
Chiba, Japan
Research Site
Fukuoka, Japan
Research Site
Hiroshima, Japan
Research Site
Kawasaki, Japan
Research Site
Kumamoto, Japan
Research Site
Niigata, Japan
Research Site
Oita, Japan
Research Site
Osaka, Japan
Research Site
Shizuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Japan Medical Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00305448     History of Changes
Other Study ID Numbers: D6997C00004, FINDER I
Study First Received: March 20, 2006
Results First Received: March 17, 2009
Last Updated: February 14, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
oncology
cancer
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Estrogens
Hormones

ClinicalTrials.gov processed this record on August 28, 2014