Enzalutamide for Breast Cancer

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

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.

Eligible Conditions
  • Breast Cancer
  • Early Stage

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 3 years

3 years
The treatment discontinuation rate of enzalutamide in the adherent population

Trial Safety

Safety Progress

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

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

50 Total Participants · 1 Treatment Group

Primary Treatment: Enzalutamide · No Placebo Group · Phase 2

EnzalutamideExperimental Group · 2 Interventions: Enzalutamide, assessment · Intervention Types: Drug, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved
assessment
2010
N/A
~2270

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
11,192 Total Patients Enrolled
2 Trials studying Breast Cancer
247 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,358 Total Patients Enrolled
192 Trials studying Breast Cancer
93,774 Patients Enrolled for Breast Cancer
Astellas Pharma IncIndustry Sponsor
679 Previous Clinical Trials
213,253 Total Patients Enrolled
6 Trials studying Breast Cancer
589 Patients Enrolled for Breast Cancer
Tiffany Traina, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
455 Total Patients Enrolled
5 Trials studying Breast Cancer
455 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to provide informed consent
The assessment of AR expression is not limited to participation in Step 1.
Patients are eligible to participate within 6 months of completion of therapy for their breast cancer
You have no or mild symptoms of cancer.
Patients who are undergoing adjuvant therapy should be tested for the presence of ARs.
Breast cancer patients who have received chemotherapy for the treatment of this disease are eligible for this study.