736 Participants Needed

Fulvestrant Doses for Breast Cancer

(CONFIRM Trial)

Recruiting at 98 trial locations
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must be taking: Hormonal treatments
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.

Who Is on the Research Team?

FM

Faslodex Medical Science Director, MD

Principal Investigator

AstraZeneca

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My breast cancer grew despite hormone therapy like tamoxifen.
I need hormone therapy for my condition.
I have stopped having menstrual periods.
See 2 more

Exclusion Criteria

Treatment with an investigational or non-approved drug within one month
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.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fulvestrant 500 mg or 250 mg for advanced breast cancer

24 weeks
Visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months
RECIST assessments every 12 weeks

Survival Follow-up

Overall survival is monitored until data cut-off for the survival extension

Up to 80 months

What Are the Treatments Tested in This Trial?

Interventions

  • Fulvestrant
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
Group II: 1Experimental Treatment1 Intervention

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

🇪🇺
Approved in European Union as Faslodex for:
🇺🇸
Approved in United States as Faslodex for:
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Approved in Canada as Faslodex for:
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Approved in Japan as Faslodex for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

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