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

Must not be taking: Investigational drugs

Disqualifiers: Serious disease, Allergies, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 24 weeks

736 Participants Needed

Trial Summary

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.

Research Team

Faslodex Medical Science Director, MD

Principal Investigator

AstraZeneca

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: 2 Experimental Treatment 1 Intervention

Fulvestrant 250 mg

Group II: 1 Experimental Treatment 1 Intervention

Fulvestrant 500 mg

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

Approved in European Union as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Approved in United States as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Approved in Canada as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Approved in Japan as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

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