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Enzalutamide for Early Stage Breast Cancer
Phase 2
Waitlist Available
Led By Tiffany Traina, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0 or 1.
Stage 1, 2 or 3 invasive breast cancer which is triple negative. Triple negative breast cancer is defined as ER <1%, PR <1% and HER2 0 or 1+ or FISH not amplified if IHC 2+.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing whether a year of treatment with the drug enzalutamide can help treat early stage triple negative breast cancer that is positive for the androgen receptor.
Who is the study for?
This trial is for women aged 18 or older with early stage, AR(+) triple negative breast cancer. Participants must have completed any previous treatments at least 4 weeks prior and resolved most side effects. They should be able to take oral medication, not breastfeeding, agree to use dual contraception methods during the study and for three months after. Exclusions include severe diseases, certain blood count levels, absorption disorders, allergies to capsule ingredients, metastatic cancer history or conditions that may cause seizures.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Enzalutamide as an additional treatment (adjuvant therapy) over a year for patients with early stage AR(+) triple negative breast cancer. The goal is to see if this anti-androgen drug can help prevent cancer recurrence in these patients who have already undergone initial treatment like surgery or chemotherapy.See study design
What are the potential side effects?
Enzalutamide may cause fatigue, back pain, hot flashes, joint pain or swelling; it can also affect mood causing anxiety or depression. There's a risk of high blood pressure and rare but serious side effects like seizures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My breast cancer is early stage and lacks ER, PR, and HER2 receptors.
Select...
It's been over 4 weeks since my last cancer treatment and any side effects are mild, except for hair loss.
Select...
My breast cancer is early stage and lacks ER, PR, and HER2 receptors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The treatment discontinuation rate of enzalutamide in the adherent population
Side 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
1Treatment groups
Experimental Treatment
Group I: EnzalutamideExperimental Treatment2 Interventions
160mg orally as daily continuous dosing for 52 weeks. Patients will be seen for protocol visits every 4 weeks (+/- 2 week window) for the first 12 weeks followed by every 12 weeks (+/- 2 week window) to complete 52 weeks. An assessment will also be performed at 52 weeks (+ 4 week window).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
assessment
2010
N/A
~7950
Find a Location
Who is running the clinical trial?
Astellas Pharma IncIndustry Sponsor
691 Previous Clinical Trials
232,164 Total Patients Enrolled
6 Trials studying Breast Cancer
458 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,572 Total Patients Enrolled
202 Trials studying Breast Cancer
81,087 Patients Enrolled for Breast Cancer
Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
11,192 Total Patients Enrolled
2 Trials studying Breast Cancer
247 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer has spread to other parts of my body.I am fully active or can carry out light work.I can swallow pills and follow study rules.I am a woman aged 18 or older.I am a woman over 18 and agree to participate in the study.My breast cancer is early stage and lacks ER, PR, and HER2 receptors.I may or may not have had chemotherapy for my breast cancer before.It's been over 4 weeks since my last cancer treatment and any side effects are mild, except for hair loss.I finished my breast cancer treatment within the last 6 months.I haven't had another invasive cancer except for non-dangerous skin cancers or very early stage cancers in the last 5 years.My kidney function is below the normal range.I am eligible for treatment for my early stage breast cancer.My cancer tests positive for androgen receptors.I have a stomach or bowel problem that affects how my body absorbs food.I am allergic to specific ingredients in the medication's capsule.My breast cancer is early stage and lacks ER, PR, and HER2 receptors.I can have AR testing while receiving other cancer treatments.Your bilirubin levels are too high, or your AST or ALT levels are too high.I have a history of seizures or conditions that could lead to seizures.Your white blood cell count, platelet count, or hemoglobin level is too low.
Research Study Groups:
This trial has the following groups:- Group 1: Enzalutamide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Has Enzalutamide been given the stamp of approval by the FDA?
"The safety of enzalutamide was rated a 2 as this Phase 2 trial has some data indicating its security but no evidence that it is effective."
Answered by AI
What is the scope of enrolment for this research trial?
"Unfortunately, this research project is not presently enrolling new participants. The trial was initially published on May 19th 2016 and its details were most recently updated in April 26th 2022. For those looking for other studies related to breast cancer, there are currently 2,666 active clinical trials recruiting individuals with the condition; 98 of these involve Enzalutamide therapy specifically."
Answered by AI
How many locales provide access to this clinical trial?
"Presently, this medical trial is being administered from 12 sites located in Allentown, Uniondale, New york and other nearby areas. To minimize necessary travel for participants, it is paramount to select the site closest to you."
Answered by AI
Are any additional participants being accepted for this research endeavor?
"Data hosted on clinicaltrials.gov suggests that, as of April 26th 2022 this trial is not actively seeking candidates. This investigation was initially posted in May 2016 and has since been inactive; however there are many other studies recruiting patients at this time - 2764 to be exact."
Answered by AI
What other research has been conducted with regards to the efficacy of Enzalutamide?
"Currently, there are 98 medical trials underway that investigate Enzalutamide. Of these studies, 30 have progressed to Phase 3 of the trial process. Germantown in Tennessee is home to most of these experiments; however, 5740 other locations across the world also host research on this drug treatment."
Answered by AI
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