Higher Dose Fulvestrant for Breast Cancer

Not currently recruiting at 5 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Anticancer, Anticoagulants, Estrogen, others

Disqualifiers: Life-threatening metastasis, Chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: Unknown

Duration: Until disease progression or serious side effects

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a higher dose of fulvestrant (also known as Faslodex) can improve outcomes for women with hormone receptor-positive metastatic breast cancer. Fulvestrant has already proven effective, but researchers believe a higher dose might enhance its efficacy. Women with metastatic breast cancer that cannot be cured by standard treatments, and who have hormone-sensitive tumors, may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop certain medications before joining. You must stop any endocrine therapy for advanced disease, systemic chemotherapy within the last 4 weeks, and trastuzumab or biologic therapy within the last 2 weeks. Long-term anticoagulant therapy with warfarin and estrogen replacement therapy within 6 months are also not allowed.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that fulvestrant is generally safe and well-tolerated by patients. Studies have demonstrated that the usual 500 mg dose effectively treats hormone receptor-positive metastatic breast cancer. In these studies, patients did not report major safety concerns with this dose.

This trial will use a higher dose of fulvestrant to evaluate its efficacy. Although this higher dose is experimental, existing data on the 500 mg dose suggests that fulvestrant is a safe treatment overall. It is important to note that this is a Phase 2 trial, with the main goal of learning more about the safety of this higher dose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Fulvestrant is unique because it is being tested at a higher dose of 500mg to treat breast cancer. Unlike other treatments that typically use lower doses, this higher dose aims to improve its effectiveness by more aggressively blocking estrogen receptors, which are often involved in the growth of breast cancer cells. Researchers are excited about this approach because it could potentially offer better outcomes for patients who have not responded well to standard doses of fulvestrant or other hormonal therapies.

What is the effectiveness track record for Fulvestrant in treating breast cancer?

Studies have shown that taking 500 mg of fulvestrant can significantly extend the time patients with hormone receptor-positive metastatic breast cancer live without disease progression. In this trial, participants will receive a 500 mg dose of fulvestrant. The CONFIRM study found that 500 mg of fulvestrant was more effective than a 250 mg dose. Real-world data supports this, showing that patients lived about 16.6 months without disease progression. The FALCON trial confirmed these findings, demonstrating significant improvement with the 500 mg dose. These results suggest that higher doses of fulvestrant could lead to better outcomes for patients. ^{2 3 6 7 8}

Who Is on the Research Team?

Steven Come, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for postmenopausal women with hormone-sensitive breast cancer that has spread and can't be cured by surgery or radiation. They should have a good performance status, meaning they're fairly active and self-sufficient. Women who've had certain previous treatments are eligible if enough time has passed since those treatments.

Inclusion Criteria

My cancer responds to hormone therapy.

I am female.

My breast cancer is spreading and cannot be cured with surgery or radiation.

Exclusion Criteria

I am not receiving any other cancer treatments.

I have not had Trastuzumab or similar treatments in the last 2 weeks.

I have not had extensive radiation therapy in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Fulvestrant is administered by intramuscular injection on day 1, day 15, and day 29, then every 28 days thereafter

Until disease progression or serious side effects

In-person visits on each treatment date

Follow-up

Participants are monitored for safety and effectiveness after treatment

First 2 years: every 3 months; Years 2-5: every 6 months; Annually after 5 years

In-person visits as per schedule

What Are the Treatments Tested in This Trial?

Interventions

• Fulvestrant

Trial Overview

The study is testing whether a higher dose of Fulvestrant (500mg) will be more effective in treating metastatic breast cancer than the doses used before. The drug targets hormone receptors to slow down or stop cancer growth.

How Is the Trial Designed?

Group I: single Experimental Treatment 1 Intervention

fulvestrant 500mg

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?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Lowell General Hospital

Collaborator

Trials

11

Recruited

7,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

University of Maryland Greenebaum Cancer Center

Collaborator

Trials

15

Recruited

430+

South Shore Hospital

Collaborator

Trials

13

Recruited

10,800+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3906991/

Final Overall Survival: Fulvestrant 500mg vs 250mg in the ...

The initial results showed that fulvestrant 500mg was associated with a statistically significant increase in progression-free survival (PFS) ...

2.

nature.com

nature.com/articles/s41598-021-83622-1

Real-world data of fulvestrant as first-line treatment ...

Fulvestrant showed superior efficacy in terms of progression-free survival (PFS, 16.6 months; 95% confidence interval, 95% CI 13.8–21.0 months) ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9984913/

Retrospective Evaluation of Fulvestrant Efficacy and ...

In the literature, the CONFIRM study reported that the efficacy of 500 mg fulvestrant was higher than 250 mg, and the subsequent phase II FIRST ...

4.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.24.00994

Final Overall Survival in the Phase III FALCON Trial

In 2016, FALCON met its primary end point, demonstrating significant improvement in progression-free survival (PFS) with fulvestrant 500 mg ...

5.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1201622

Combination Anastrozole and Fulvestrant in Metastatic ...

A study comparing low-dose fulvestrant with tamoxifen did not show a between-group difference in progression-free survival or overall survival, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8391338/

Efficacy of Fulvestrant in Women with Hormone-Resistant ...

Our results show that women with clinical benefit from fulvestrant, who received post-fulvestrant chemotherapy, or had non-visceral disease, had better survival ...

7.

astrazeneca-us.com

astrazeneca-us.com/media/press-releases/2022/capivasertib-plus-faslodex-fulvestrant-reduced-the-risk-of-disease-progression-or-death-by-40-versus-faslodex-in-advanced-hr-positive-breast-cancer-12082022.html

Capivasertib plus FASLODEX® (fulvestrant) reduced the ...

Results showed capivasertib in combination with FASLODEX demonstrated a 40% reduction in the risk of disease progression or death versus placebo plus FASLODEX.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6464820/

Fulvestrant for hormone‐sensitive metastatic breast cancer

Our review demonstrates that fulvestrant is a safe and effective systemic therapy and can be considered as a valid option in the sequence of treatments for ...