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Hormone Therapy
Fulvestrant Doses for Breast Cancer (CONFIRM Trial)
Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
Postmenopausal women defined as a woman who has stopped having menstrual periods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recist tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Awards & highlights
CONFIRM Trial Summary
This trial is testing whether a higher dose of Fulvestrant is more effective than the standard dose in treating advanced breast cancer in postmenopausal women who have failed other hormone therapies.
Who is the study for?
This trial is for postmenopausal women with estrogen receptor positive advanced breast cancer that has worsened after anti-estrogen treatments like tamoxifen. Participants must be willing to provide consent and have no serious illnesses or allergies to Faslodex ingredients.Check my eligibility
What is being tested?
The study compares the effectiveness of a new, higher dose (500 mg) of Fulvestrant against the standard dose (250 mg) in patients whose breast cancer has progressed despite previous endocrine therapy.See study design
What are the potential side effects?
Fulvestrant can cause side effects such as nausea, injection site pain, muscle or joint pain, and fatigue. Allergic reactions are possible but only in those sensitive to its components.
CONFIRM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer grew despite hormone therapy like tamoxifen.
Select...
I have stopped having menstrual periods.
Select...
My cancer is sensitive to hormones.
CONFIRM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ recist(response evaluation criteria in solid tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recist(response evaluation criteria in solid tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Progression (TTP)
Secondary outcome measures
Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
Clinical Benefit Rate (CBR)
Duration of Clinical Benefit (DoCB)
+4 moreSide effects data
From 2012 Phase 3 trial • 514 Patients • NCT0025669812%
Arthralgia
11%
Fatigue
9%
Nausea
8%
Hot flush
6%
Constipation
6%
Diarrhoea
5%
Urinary tract infection
5%
Dyspnoea
5%
Vomiting
4%
Cough
4%
Back pain
3%
Musculoskeletal pain
1%
Femur Fracture
1%
Renal Failure
1%
Cardiac Failure
1%
Pulmonary Embolism
1%
Pleural Effusion
1%
Pneumonia
1%
Sepsis
1%
Back Pain
1%
Dizziness
1%
Syncope
1%
Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fulvestrant + Anastrozole
Anastrozole
CONFIRM Trial Design
2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
Fulvestrant 250 mg
Group II: 1Experimental Treatment1 Intervention
Fulvestrant 500 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3690
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,262 Previous Clinical Trials
288,594,506 Total Patients Enrolled
173 Trials studying Breast Cancer
1,245,603 Patients Enrolled for Breast Cancer
Faslodex Medical Science Director, MDStudy DirectorAstraZeneca
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a serious illness that would stop me from following the study's requirements.I have had more than one type of chemotherapy for advanced breast cancer.My breast cancer grew despite hormone therapy like tamoxifen.I need hormone therapy for my condition.I am allergic to Faslodex or its components, like castor oil.I have had more than one type of hormone therapy for advanced breast cancer.I have stopped having menstrual periods.My cancer is sensitive to hormones.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other ongoing Fulvestrant trials?
"As of now, there are one hundred and forty clinical trials underway for fulvestrant. A third of those studies are in their third and final phase. Most of the research for fulvestrant is centered in Shanghai, but there are five thousand eight hundred and thirty-six different locations running trials for this medication."
Answered by AI
What is Fulvestrant's current standing with the FDA?
"Fulvestrant is a phase 3 clinical trial medication, so it has received a 3 for safety. This means that there is data supporting its efficacy and multiple rounds of data supporting its safety."
Answered by AI
Are adolescents able to participate in this research project?
"According to the inclusion criteria, eligible participants for this clinical trial must be aged 45 to 130. In comparison, there are 78 clinical trials for people under 18 and 2730 for those over 65."
Answered by AI
For what purpose is Fulvestrant most commonly prescribed?
"Fulvestrant is most often used to treat patients who have already undergone endocrine therapy. Additionally, it is sometimes used as a treatment for different conditions like disease, breast, and pik3ca gene mutation."
Answered by AI
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