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Antiandrogen
Enzalutamide + Exemestane for Advanced Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to 3 years
Awards & highlights
Study Summary
This trial will test if a combination of drugs is safe and effective for patients with advanced breast cancer.
Who is the study for?
This trial is for postmenopausal women with advanced breast cancer that's ER+, PgR+, or both, and HER-2 normal. They can have had up to one hormone therapy and one chemotherapy before. Participants must be in good physical condition (ECOG status of 0 or 1) and not have a history of seizures, severe diseases, recent radiation therapy, major surgery, or certain drug treatments.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining enzalutamide with exemestane versus placebo with exemestane in treating advanced breast cancer. It aims to see if this combination helps patients better than the standard treatment alone.See study design
What are the potential side effects?
Possible side effects include reactions related to hormones since enzalutamide affects hormone receptors. There may also be typical chemotherapy-related side effects like fatigue, nausea, skin changes, bone pain, hot flashes from hormonal manipulation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
Secondary outcome measures
Best Objective Response Rate
Clinical Benefit Rate-24 (CBR-24)
Concentration Versus Time Summary of Enzalutamide
+6 moreOther outcome measures
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)
Number of Participants With Clinically Significant Laboratory Abnormalities
+6 moreSide effects data
From 2017 Phase 4 trial • 215 Patients • NCT0211658234%
Fatigue
25%
Decreased appetite
18%
Asthenia
17%
Back pain
16%
Arthralgia
15%
Nausea
13%
Bone pain
13%
Diarrhoea
13%
Constipation
12%
Pain in extremity
12%
Weight decreased
11%
Anaemia
11%
Musculoskeletal pain
9%
Hypertension
8%
Oedema peripheral
7%
Dizziness
7%
Haematuria
6%
Insomnia
6%
Hot flush
6%
Malignant neoplasm progression
6%
Muscular weakness
5%
General physical health deterioration
5%
Vomiting
5%
Dyspnoea
3%
Spinal cord compression
2%
Renal failure acute
2%
Pneumonia
2%
Pulmonary embolism
1%
Cardiac failure
1%
Pyrexia
1%
Urinary tract infection
1%
Lower respiratory tract infection
1%
Neutropenia
1%
Metastases to central nervous system
1%
Lung disorder
1%
Renal failure
1%
Osteoarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enzalutamide Total
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Enzalutamide & exemestaneExperimental Treatment2 Interventions
Enzalutamide 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.
Group II: Placebo & exemestaneActive Control2 Interventions
Placebo 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
exemestane
2005
Completed Phase 4
~27080
Enzalutamide
2014
Completed Phase 4
~2760
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,575 Previous Clinical Trials
10,922,854 Total Patients Enrolled
111 Trials studying Breast Cancer
35,618 Patients Enrolled for Breast Cancer
Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
10,995 Total Patients Enrolled
2 Trials studying Breast Cancer
50 Patients Enrolled for Breast Cancer
Astellas Pharma IncIndustry Sponsor
692 Previous Clinical Trials
232,172 Total Patients Enrolled
6 Trials studying Breast Cancer
261 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a sample of your breast tumor preserved in a specific way, with a report from a pathologist.You are currently taking any medication that affects the production of male hormones or targets the male hormone receptor.You have had a seizure before or have a condition that could make you more likely to have a seizure.You currently have a gastrointestinal (stomach and intestine) problem that is not under control.You should be in good enough health to carry out everyday activities or be active for at least half of your waking hours.You have a visible sign of disease that can be measured, such as a tumor that can be seen on a scan. If you have advanced breast cancer and your only visible signs of the disease are in your bones or skin, you can still participate.You have had a bad reaction to exemestane in the past.You have gone through menopause.You have only had one hormone therapy and one chemotherapy treatment for your condition.You currently have or have had cancer spread to your brain.You haven't taken certain medications like estrogen, androgen, or systemic radionuclides in the 14 days before starting the study.You have a serious heart condition.You have advanced breast cancer that tests positive for estrogen and/or progesterone receptors and negative for HER-2.You had another type of cancer within the last 5 years before joining the study.You have taken exemestane for metastatic cancer within the last 28 days. If you took exemestane for a different type of cancer and it came back more than a year after you stopped taking the medication, you are eligible.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo & exemestane
- Group 2: Enzalutamide & exemestane
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can people with the required qualifications join this trial at this time?
"No, this particular clinical trial is not recruiting at the moment. The most recent update on clinicaltrials.gov was on April 26th, 2022 and it stated that the trial is no longer looking for candidates. Although this may be the case, there are 2,860 other trials that are still recruiting participants."
Answered by AI
What are some other Enzalutamide-based clinical trials that have already been completed?
"There are a total of 162 trials registered on clinicaltrials.gov that involve Enzalutamide. 53 of those are currently ongoing, andPhase 3. The primary trial location is Duarte, California; however, there are 13376 different centres whereEnzalutamide studies are being conducted."
Answered by AI
What are some common indications for Enzalutamide?
"Enzalutamide can help manage the symptoms of postmenopause, as well as advance directives and castration."
Answered by AI
Could you please explain the risks of taking Enzalutamide?
"Enzalutamide is a Phase 2 medication, meaning that while there is some evidence pointing to its safety, there is none yet for efficacy. Our team gives it a score of 2."
Answered by AI
How many individuals are chosen to participate in this clinical trial?
"This study has finished recruiting patients. The trial was first posted on December 13th, 2013 and was updated for the last time on April 26th, 20212. However, there are currently 2698 trials actively recruiting patients with breast cancer and 162 trials for Enzalutamide that are looking for participants."
Answered by AI
How many hospitals are participating in this research?
"Patients can be enrolled at locations such as ATTN-Research Pharmacist in Englewood, Colorado, University of Colorado Cancer Center - Anschutz Cancer Pavilion in Altamonte Springs, Indiana, and Investigational Drug Services in Aurora, Illinois. In total, there are 79 sites where patients can participate."
Answered by AI
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