Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women
A Randomised, Double-Blind, Parallel-Group, Multicentre Study Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Postmenopausal Women With ER+ Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
1 other identifier
interventional
249
1 country
15
Brief Summary
The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant with the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed a prior endocrine treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
Started Mar 2011
Shorter than P25 for phase_3 breast-cancer
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2011
CompletedFirst Posted
Study publicly available on registry
February 21, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
April 24, 2015
CompletedApril 24, 2015
April 1, 2015
3 years
February 17, 2011
March 12, 2015
April 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions, or death (by any cause in the absence of progression). The primary analysis for PFS was the log rank test stratified by last endocrine therapy received prior to fulvestrant (AO vs. AI). The treatment effect was estimated using the HR of 500 mg fulvestrant to 250 mg fulvestrant together with the corresponding 95% CI and p value.
36 months
Secondary Outcomes (4)
Objective Response Rate
36 months
Clinical Benefit Rate
36 months
Duration of Response
36 months
Duration of Clinical Benefit
36 months
Study Arms (2)
Fulvestrant 500mg
EXPERIMENTALFulvestrant 500mg (2 syringes of Fulvestrant 250mg), Fulvestrant 500 mg i.m. every 28 (+/- 3) days plus an additional 500 mg on day 14 (+/-3) of first month only
Fulvestrant 250mg
ACTIVE COMPARATORFulvestrant 250mg (1 syringe of fulvestrant 250mg + 1 syringe matching placebo), Fulvestrant 250 mg and matching placebo i.m. every 28 (+/- 3) days plus an additional 2 placebo syringes on day 14 (+/-3) of first month only
Interventions
Fulvestrant was supplied as a castor oil based solution in clear neutral glass pre-filled syringes. Each syringe will contain 250 mg of fulvestrant in 5 ml.
Matching placebo was supplied as a castor oil based solution in clear neutral glass prefilled syringes. Each syringe will contain 5 ml.
Eligibility Criteria
You may qualify if:
- Postmenopausal women defined as a woman who has stopped having menstrual periods
- 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
- Oestrogen-receptor positive tumour
- Written informed consent to participate in the trial
You may not qualify if:
- Treatment with an investigational or non-approved drug within one month
- An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
- A history of allergies to any active or inactive ingredients of fulvestrant (i.e. castor oil)
- Treatment with more than one regimen of chemotherapy for advanced breast cancer
- Treatment with more than one regimen of hormonal treatment for advanced breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (15)
Research Site
Beijing, China
Research Site
Chongqing, China
Research Site
Dalian, China
Research Site
Guangzhou, China
Research Site
Hangzhou, China
Research Site
Harbin, China
Research Site
Hefei, China
Research Site
Jiangsu, China
Research Site
Kunming, China
Research Site
Nanning, China
Research Site
Shandong, China
Research Site
Shanghai, China
Research Site
Shijiazhuang, China
Research Site
Taiyuan, China
Research Site
Tianjin, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
China CONFIRM Study was planned as a bridge study to the CONFIRM Study and therefore was not formally powered to detect a statistically significant difference between two treatment groups.
Results Point of Contact
- Title
- Guofei Dai
- Organization
- AstraZeneca China
Study Officials
- PRINCIPAL INVESTIGATOR
Zefei Jiang
307 Hospital of PLA
- STUDY DIRECTOR
Yuri E Rukazenkov
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2011
First Posted
February 21, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
April 24, 2015
Results First Posted
April 24, 2015
Record last verified: 2015-04