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Hormone Therapy
Fulvestrant vs Anastrozole for Breast Cancer (FALCON Trial)
Phase 3
Waitlist Available
Led By Matthew Ellis, DM
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline recist 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial will compare the effects of two different hormone treatments, Fulvestrant and Anastrozole, on disease progression in women with breast cancer that has spread to other parts of the body.
Who is the study for?
This trial is for postmenopausal women aged 60 or above with breast cancer that's either locally advanced or metastatic, and who haven't had hormonal treatment before. They should have a positive hormone receptor status and can have had one chemotherapy line if there's still disease progression.
What is being tested?
The study compares the effects of two drugs on breast cancer: Fulvestrant (FASLODEX) at 500mg versus Anastrozole (ARIMIDEX) at 1mg. It aims to see which drug better slows down disease progression in patients who haven't received prior hormonal therapy.
What are the potential side effects?
Possible side effects include hot flashes, joint pain, nausea, fatigue, bone pain for Arimidex; and injection site reactions, headache, back pain, fatigue for Faslodex. Each patient may experience side effects differently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline recist 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline recist 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
Secondary study objectives
Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment
Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events
Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)
+5 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: faslodex+placeboExperimental Treatment2 Interventions
Blinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets
Group II: arimidex +placeboActive Control2 Interventions
Blinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg)
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,194 Total Patients Enrolled
175 Trials studying Breast Cancer
1,243,071 Patients Enrolled for Breast Cancer
Matthew Ellis, DMPrincipal InvestigatorWashington University School of Medicine, USA
Shankar S, MDStudy DirectorAstraZeneca
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received hormone therapy for breast cancer.My cancer has spread to other parts of my body and is life-threatening.I have advanced or metastatic cancer and have had only one chemotherapy treatment.I am a postmenopausal woman, either by surgery, age, or natural causes.I have at least one tumor that can be measured and monitored over time.My cancer has not severely affected my liver, brain, or lungs.I have not had any cancer other than breast cancer, skin cancer, or cervical cancer in the last 3 years.I am a woman over 60 with breast cancer that is hormone receptor positive.I haven't had radiation therapy in the last 28 days, except for bone pain treatment.I've had only one round of chemotherapy for breast cancer, and it was over 28 days ago.
Research Study Groups:
This trial has the following groups:- Group 1: faslodex+placebo
- Group 2: arimidex +placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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