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Enzalutamide for Triple Negative Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Triple Negative Breast CancerEnzalutamide - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial will test if a new medication, enzalutamide, is safe and effective for treating patients with advanced breast cancer who express the androgen receptor, but not the estrogen or progesterone receptor, and are not Her2 amplified.

Eligible Conditions
  • Triple Negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Predose on Day 1 (Baseline), Week 9 and Week 17

Week 87
Number of Participants With Change From Baseline in Laboratory Parameters Grades by 2 or More Grades
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Number of Participants With Grade 3 or Higher Adverse Events
Number of Participants With Study Drug Discontinuation Due to Adverse Events
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Week 87
Percentage of Participants With Best Objective Response: Evaluable Population
Percentage of Participants With Best Objective Response: ITT Population
Progression-Free Survival (PFS): Evaluable Population
Progression-Free Survival: ITT Population
Week 17
Trough Plasma Concentration of Enzalutamide and Its Metabolite
Week 16
Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population
Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population
Week 24
Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population
Percentage of Participants With Clinical Benefit at Week 24: ITT Population

Trial Safety

Safety Progress

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

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1
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Side Effects for

Enzalutamide Total
34%Fatigue
25%Decreased appetite
18%Asthenia
17%Back pain
16%Arthralgia
15%Nausea
13%Constipation
13%Bone pain
13%Diarrhoea
12%Weight decreased
12%Pain in extremity
11%Musculoskeletal pain
11%Anaemia
9%Hypertension
8%Oedema peripheral
7%Haematuria
7%Dizziness
6%Malignant neoplasm progression
6%Muscular weakness
6%Insomnia
6%Hot flush
5%General physical health deterioration
5%Vomiting
5%Dyspnoea
3%Spinal cord compression
2%Pulmonary embolism
2%Pneumonia
2%Renal failure acute
1%Cardiac failure
1%Lower respiratory tract infection
1%Urinary tract infection
1%Metastases to central nervous system
1%Lung disorder
1%Renal failure
1%Neutropenia
1%Pyrexia
1%Osteoarthritis
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT02116582) in the Enzalutamide Total ARM group. Side effects include: Fatigue with 34%, Decreased appetite with 25%, Asthenia with 18%, Back pain with 17%, Arthralgia with 16%.

Trial Design

1 Treatment Group

Enzalutamide
1 of 1

Experimental Treatment

118 Total Participants · 1 Treatment Group

Primary Treatment: Enzalutamide · No Placebo Group · Phase 2

Enzalutamide
Drug
Experimental Group · 1 Intervention: Enzalutamide · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: predose on day 1 (baseline), week 9 and week 17

Who is running the clinical trial?

Astellas Pharma IncIndustry Sponsor
679 Previous Clinical Trials
213,185 Total Patients Enrolled
PfizerLead Sponsor
4,304 Previous Clinical Trials
7,094,661 Total Patients Enrolled
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.Industry Sponsor
20 Previous Clinical Trials
9,763 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy ChairPfizer
3,277 Previous Clinical Trials
4,804,552 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

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You have a performance status of 0 or 1.
References

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