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Hormone Therapy

Fulvestrant + Enzalutamide for Breast Cancer

Phase 2

Waitlist Available

Led By Anthony D Elias, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not on anticoagulants

ER+ Her2- breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial will compare the effectiveness of two different treatments for breast cancer. One treatment will be Fulvestrant plus Enza, and the other will be Fulvestrant by itself. The trial will last for four months, and will involve postmenopausal women with locally advanced breast cancer.

Who is the study for?

This trial is for postmenopausal women with advanced ER+/Her2- breast cancer who are planning surgery after treatment. Participants must be willing to donate blood and tissue, have no history of seizures or brain metastases, not use systemic estrogens/androgens (vaginal estrogens allowed), and meet certain health criteria like normal organ function tests.Check my eligibility

What is being tested?

The study compares the effectiveness of two treatments: Fulvestrant alone versus Fulvestrant combined with Enzalutamide in patients before surgery. It's a phase II trial where participants are randomly assigned to one of the two groups to see which works better.See study design

What are the potential side effects?

Potential side effects include those common to hormone therapies such as hot flashes, fatigue, joint pain, and mood swings. Enzalutamide may also cause issues like high blood pressure, dizziness or falls due to its action on androgen receptors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not taking blood thinners.

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My breast cancer is estrogen receptor positive and HER2 negative.

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My cancer is at least stage T2 or more advanced.

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I am scheduled for surgery in a specific area.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

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I am postmenopausal or will undergo ovarian suppression if not.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients With a PEPI Score Equal to Zero at Post Treatment

Secondary outcome measures

Androgen Receptor (AR) Expression

Correlation Between PEPI Score and Disease-free Survival, Clinical Benefit Rate, and Overall Response Rate

Disease-free Survival

Side effects data

From 2012 Phase 3 trial • 514 Patients • NCT00256698

12%

Arthralgia

11%

Fatigue

Nausea

Hot flush

Constipation

Diarrhoea

Urinary tract infection

Dyspnoea

Vomiting

Cough

Back pain

Musculoskeletal pain

Femur Fracture

Cardiac Failure

Pulmonary Embolism

Renal Failure

Pleural Effusion

Pneumonia

Sepsis

Back Pain

Dizziness

Syncope

Infection

100%

80%

60%

40%

20%

Study treatment Arm

Fulvestrant + Anastrozole

Anastrozole

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Fulvestrant With EnzalutamideExperimental Treatment2 Interventions

500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC), plus160mg of Enzalutamide will be given daily.

Group II: Fulvestrant Without EnzalutamidePlacebo Group1 Intervention

500 mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~2760

Fulvestrant

2011

Completed Phase 3

~3690

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,487 Total Patients Enrolled

26 Trials studying Breast Cancer

6,452 Patients Enrolled for Breast Cancer

United States Department of DefenseFED

861 Previous Clinical Trials

227,133 Total Patients Enrolled

36 Trials studying Breast Cancer

3,405 Patients Enrolled for Breast Cancer

Anthony D Elias, MDPrincipal InvestigatorUniversity of Colorado, Denver

1 Previous Clinical Trials

32 Total Patients Enrolled

1 Trials studying Breast Cancer

32 Patients Enrolled for Breast Cancer

Media Library

Fulvestrant (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02955394 — Phase 2

Breast Cancer Research Study Groups: Fulvestrant Without Enzalutamide, Fulvestrant With Enzalutamide

Breast Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT02955394 — Phase 2

Fulvestrant (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02955394 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any severe side-effects associated with Fulvestrant?

"Since this is a phase 2 trial, meaning that there is only anecdotal evidence for its safety, our team at Power has given Fulvestrant a score of 2."

Answered by AI

How many people can join this clinical trial at most?

"Unfortunately, this study is not currently taking applications. However, it was open from September 21st 2017 until February 22nd 2022. If you are interested in other studies, 2698 are actively recruiting patients with breast cancer and 241 are recruiting patients specifically for Fulvestrant trials."

Answered by AI

Are there any other case studies that compare Fulvestrant with other treatments?

"Currently, there are 241 global clinical trials testing the efficacy of Fulvestrant. 63 of those studies are in Phase 3. However, most research locations for Fulvestrant (11588) are based in Shanghai, China."

Answered by AI

What conditions does Fulvestrant typically treat?

"Fulvestrant is a medication that's used to target the pik3ca gene mutation. It's also been shown to be effective in treating malignant neoplasms, disease progression, and castration-resistant conditions."

Answered by AI

Can adults aged 45 and up participate in this experiment?

"This trial, which includes patients aged 18 to 101 years old, is one of 80 such clinical trials for minors and 2839 for senior citizens."

Answered by AI

Who does this clinical trial require in order to be successful?

"The researchers conducting this study are recruiting 61 patients that meet the following criteria: must have breast cancer, be between 18-101 years old, and not currently taking anticoagulants. Additionally, participants must either be postmenopausal or planning to suppress their ovaries if they are pre- or peri- menopausal."

Answered by AI

Are people with the qualifying factors currently able to enroll in this experiment?

"The clinicaltrials.gov website indicates that this study has completed recruitment as of February 22nd, 2022. This specific trial was first posted on September 21st, 2017 and had a total duration of 4 years and 5 months. There are many other trials (2939 to be exact) that are still recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer

2017. "Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02955394.

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