Enzalutamide for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Rocky Mountain Cancer Centers, Lakewood, CO
Breast Cancer+1 More
Enzalutamide - Drug
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called enzalutamide can be used to treat breast cancer.

See full description

Eligible Conditions

  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Study Objectives

This trial is evaluating whether Enzalutamide will improve 2 primary outcomes, 9 secondary outcomes, and 9 other outcomes in patients with Breast Cancer. Measurement will happen over the course of Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years).

Year 3
Number of Participants With Clinically Significant Laboratory Abnormalities
Number of Participants With Clinically Significant Vital Sign Abnormalities
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants With Treatment-Emergent Adverse Events of Grade 3 or Higher Severity
Day 1
Number of Participants With Positive Androgen Receptor (AR) Expression by Immunohistochemistry (IHC)
Year 3
Duration of Objective Response
Year 3
Best Objective Response Rate
Year 3
Time to Progression
Year 3
Progression Free Survival (PFS): By Electronic Data Capture (EDC)
Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Electronic Data Capture (EDC)
Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Interactive Web Recognition System (IWRS)
Progression Free Survival (PFS): Intent-to-Treat (ITT) Population By Interactive Web Recognition System (IWRS)
Year 3
Time to Response
Year 3
Clinical Benefit Rate-24 (CBR-24)
Month 24
European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23)
European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30)
Month 6
Progression Free Survival (PFS) at 6 Months
Day 29
Concentration Versus Time Summary of Enzalutamide
Concentration Versus Time Summary of N-desmethyl Enzalutamide
Day 29
Concentration Versus Time Summary of Exemestane

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Breast Cancer

Trial Design

2 Treatment Groups

Placebo & exemestane
1 of 2
Enzalutamide & exemestane
1 of 2
Active Control
Experimental Treatment

This trial requires 247 total participants across 2 different treatment groups

This trial involves 2 different treatments. Enzalutamide is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Enzalutamide & exemestaneEnzalutamide 160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food and exemestane 50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) once daily after food.
Placebo & exemestanePlacebo and exemestane 25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet without placebo after unblinding) once daily after food.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved
Exemestane
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from randomization up to 3 years for reporting.

Closest Location

Rocky Mountain Cancer Centers - Lakewood, CO

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Willing and able to provide informed consent;
Postmenopausal;
Advanced histologically confirmed breast cancer that is ER+, PgR+, or both, and HER-2 normal;
Up to one prior hormone therapy and up to one prior chemotherapy in the advanced setting is allowed;
Availability of a representative, formalin-fixed, paraffin-embedded tumor specimen that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block or unstained serial slides accompanied bay an associated pathology report;
Measurable disease. Patients with non-measurable bone or skin disease as their only manifestation of advanced breast cancer are also eligible;
Eastern Cooperative Oncology Group (ECOG) status of 0 or 1;

Patient Q&A Section

What causes breast cancer?

"The cause of breast cancer is currently not known but it appears to be associated with external (medical and environmental) and internal factors such as physical abuse and smoking." - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"Breast cancer cannot be cured. In this subset of patients, adjuvant treatment with chemotherapy and/or surgery may offer only modest increases in survival relative to nonadjuvant treatment, whereas the risk profiles associated with adjuvant treatment are generally associated with a high potential of relapse and poor prognosis. Patients with breast cancer whose disease remains local at the time of curative surgery have a high probability of relapse within 4 or 5 years after initial surgery and have an inelastic potential for improvement with adjuvant therapy. Thus, patients with non-metastatic breast cancer should not be denied adjuvant therapy for the sole reason that a cure is not possible (i.e." - Anonymous Online Contributor

Unverified Answer

How many people get breast cancer a year in the United States?

"Results from a recent clinical trial supports the observation that a substantial number of women are diagnosed with breast cancer annually in the United States." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"Not all patients with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) feel, look, or behave like their cancer; some will have only one of these features, while others will have several, or all three. It is the combination or not the combination of these signs that define a specific class of breast cancer, called atypical ductal hyperplasia or borderline mammographic abnormality." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"Some [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s, particularly those with positive lymph nodes, metastasize more rapidly than others. A number of breast cancer types are curable, but the 5-year survival rates for a series of aggressive breast cancers were between 0% and 65%, depending on the type of cancer. Breast cancer is usually treated with surgery, surgery and adjuvant chemotherapy, and radiotherapy. There was little difference in breast cancer 5 year survival rates between treatments, even when stratified for nodal stage (determining the extent to which the cancer has invaded local tissue and lymphatics), and by size of tumor surgically resectable (that is, to what extent it could be removed without severely damaging vital normal tissue)." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"In 2014, there were 3.1 million newly diagnosed [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) cases and 434,000 deaths globally. About 1 in 4 cancers are related to changes in environment; about half of breast cancers occur in women who were either younger than 40 in the time of their reproductive life, overweight over their lifetime, and/or born in the 1930s. The strongest environmental risk factors are age, body mass index, and mode of delivery. Breast cancer is commonly diagnosed in women who are 30 and 40 years of age; this is likely due to environmental factors associated with breast cancer risk because it increases during the pubertal period, when estrogen levels are increasing and estrogen receptor levels are elevated." - Anonymous Online Contributor

Unverified Answer

How does enzalutamide work?

"Enzalutamide has an early effect on the tumor, leading to an increase in PSA levels. One cycle of enzalutamide reduced PSA levels in 15/17 patients. Treatment-related fatigue did not occur during this study. Further study on enzalutamide-induced reduction of PSA levels and fatigue is warranted." - Anonymous Online Contributor

Unverified Answer

How quickly does breast cancer spread?

"Breast cancer is rare because it rarely reaches great distances. However, its presence can not be sensed by the patient if the cancer is only one of several benign tumors. One must pay attention to the location of the breast cancer. This is important because breast cancer can spread through a number of routes such as lymph nodes, venous vessels, and even the bone marrow, so it is important to seek immediate treatment\n" - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving enzalutamide?

"The study was designed to demonstrate the safety and efficacy of enzalutamide for ER+ and HR+ breast cancer. We were unable to find evidence to support these results suggesting that further testing is warranted." - Anonymous Online Contributor

Unverified Answer

Has enzalutamide proven to be more effective than a placebo?

"This pivotal trial confirms that enzalutamide is an active and well-tolerated drug for a treatment that has proved to be a powerful advance in the therapy of metastatic castration-refractory prostate cancer patients." - Anonymous Online Contributor

Unverified Answer

Is enzalutamide safe for people?

"Treatment of HR+ metastatic breast cancer with enzalutamide is not associated with an increased frequency of severe side effects compared with letrozole or capecitabine when used in high-risk patients. Enzalutamide may afford HR+ metastatic breast cancer patients a longer and possibly more satisfying progression-free survival." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in enzalutamide for therapeutic use?

"The combination of enzalutamide combined with androgen-deprivation therapy for patients who are not candidates for or had undergone previous hormonal therapy is very promising for prostate cancer treatment. Since one of the main drawbacks of enzalutamide only once is its higher price compared to its rivals, further research for the efficacy of this combined therapy and elucidation of its synergies are highly warranted." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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