Fulvestrant Doses for Breast Cancer
(CONFIRM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two different doses of Fulvestrant (also known as Faslodex), a treatment for breast cancer. It targets postmenopausal women whose estrogen receptor-positive breast cancer has grown despite previous hormone therapy. The goal is to determine if the new 500 mg dose is more effective than the standard 250 mg dose. Women who have stopped having menstrual periods and experienced cancer progression after hormone treatments like tamoxifen might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you've taken an investigational or non-approved drug within the last month.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Fulvestrant is approved by the FDA for treating a type of advanced breast cancer known as HR+ (hormone receptor positive), HER2- (human epidermal growth factor receptor 2 negative). This approval indicates it is generally considered safe for use.
A review of medical records from 171 patients with advanced breast cancer treated with Fulvestrant found it was generally well-tolerated. However, some patients experienced side effects, such as pain at the injection site, nausea, and tiredness. These side effects are common with many cancer treatments.
Overall, existing evidence suggests that Fulvestrant is a safe option for those with advanced breast cancer, but like any medication, it may cause some side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using Fulvestrant for breast cancer because it offers a different approach compared to the current standard treatments, which often involve surgery, chemotherapy, or hormone therapy. Fulvestrant is unique because it specifically targets and degrades the estrogen receptor, a key player in many breast cancers, potentially reducing the cancer's ability to grow. Unlike other hormone therapies that might block these receptors, Fulvestrant breaks them down entirely, which could lead to more effective control of the cancer. The trial is particularly intriguing because it compares two doses, 500 mg and 250 mg, to see which is more effective, offering insights that could optimize treatment further.
What evidence suggests that Fulvestrant might be an effective treatment for advanced breast cancer?
Research has shown that Fulvestrant effectively treats advanced hormone receptor-positive breast cancer. This trial will compare two doses of Fulvestrant: 500 mg and 250 mg. The CONFIRM study found that a 500 mg dose of Fulvestrant delayed cancer progression more effectively than a 250 mg dose. Real-world data supports this finding, showing that individuals treated with Fulvestrant had a median time of 14.6 months before cancer progression. In the FALCON trial, the 500 mg dose also significantly improved the time before cancer worsened. Overall, Fulvestrant has proven effective in both early and later stages of hormone-resistant breast cancer.678910
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Fulvestrant 500 mg or 250 mg for advanced breast cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
Survival Follow-up
Overall survival is monitored until data cut-off for the survival extension
What Are the Treatments Tested in This Trial?
Interventions
- Fulvestrant
Fulvestrant is already approved in European Union, United States, Canada, Japan for the following indications:
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
- Hormone receptor-positive metastatic breast cancer
- Locally advanced breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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