Fulvestrant vs Anastrozole for Breast Cancer
(FALCON Trial)

Recruiting in Palo Alto (17 mi)

+103 other locations

Overseen byMatthew Ellis, DM

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.

Eligibility Criteria

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.

Inclusion Criteria

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.

+1 more

Exclusion Criteria

I have received hormone therapy for breast cancer.

My cancer has spread to other parts of my body and is life-threatening.

My cancer has not severely affected my liver, brain, or lungs.

+3 more

Participant Groups

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.

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)

Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Arimidex for:

Breast cancer
Early breast cancer in postmenopausal women

🇺🇸 Approved in United States as Arimidex for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer

🇨🇦 Approved in Canada as Arimidex for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer

🇯🇵 Approved in Japan as Arimidex for: