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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

FALCON Trial 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.Check my eligibility
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.See study design
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.

FALCON Trial 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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline recist 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
Secondary outcome measures
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 more

FALCON 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)

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,262 Previous Clinical Trials
288,594,780 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer
Matthew Ellis, DMPrincipal InvestigatorWashington University School of Medicine, USA
Shankar S, MDStudy DirectorAstraZeneca

Media Library

Anastrozole (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01602380 — Phase 3
Breast Cancer Research Study Groups: faslodex+placebo, arimidex +placebo
Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT01602380 — Phase 3
Anastrozole (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01602380 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For whom is this trial looking for participants?

"Eligible participants for this trial must have a diagnosis of breast cancer and be between 18-130 years old. The study is looking to enroll 462 individuals."

Answered by AI

How many study participants are being enrolled in this research?

"This study has already completed recruitment and is no longer seeking participants. The trial was initially posted on October 17th, 2012 and was last updated on October 31st, 2022. However, there are still 2357 trials actively searching for patients with breast cancer and 189 studies for faslodex 500mg still looking for participants."

Answered by AI

Does the age limit for this trial extend to those who are not yet 85 years old?

"According to the eligibility requirements, patients aged 18 to 130 can apply to participate in this trial. There are currently 68 studies underway for patients under 18 and 2456 for seniors."

Answered by AI

Could faslodex 500mg lead to any adverse effects for patients?

"There is some data supporting faslodex 500mg's efficacy and multiple rounds of data supporting its safety, so it received a score of 3."

Answered by AI

What are faslodex 500mg's main purposes?

"The brca1 gene is most often treated with faslodex 500mg. However, faslodex 500mg is also effective against other conditions, like breast cancer, malignant neoplasms, and pik3ca gene mutation."

Answered by AI

Would you like to participate in this research project?

"Data from clinicaltrials.gov suggests that this study is no longer recruiting patients. This specific trial was first posted on October 17th, 2012 and was last edited on October 31st, 2022. Although this particular study is not enrolling patients, there are 2546 other clinical trials with open recruitment at this time."

Answered by AI

Are there other faslodex 500mg clinical trials that have been completed?

"As of now, 189 clinical trials are underway to research faslodex 500mg with 49 of those trials in Phase 3. Most of the faslodex 500mg research is taking place in Correggio, RE, but there are 11777 total locations running trials for faslodex 500mg."

Answered by AI

Could you tell me how many different hospitals this clinical trial is taking place in?

"To limit the burden of travel on participants, this study is recruiting from 19 sites that are based in or near major cities including Montgomery, Savannah and Saint Louis."

Answered by AI
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~37 spots leftby Apr 2025