Study Summary
This trial will compare the effectiveness of two different treatments for breast cancer. One treatment will be Fulvestrant plus Enza, and the other will be Fulvestrant by itself. The trial will last for four months, and will involve postmenopausal women with locally advanced breast cancer.
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 16 weeks
16 Weeks
Androgen Receptor (AR) expression
Correlate PEPI score and Progression-free survival, Clinical Benefit Rate, and Overall Response Rate
Document the number of patients in both treatment arms separately who have a PEPI score equal to 0 at post treatment
Progression-free survival (PFS)
16 weeks
Clinical Benefit Rate
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Anastrozole
13%Fatigue
11%Nausea
11%Arthralgia
8%Musculoskeletal pain
7%Hot flush
6%Back pain
5%Constipation
5%Cough
5%Diarrhoea
4%Vomiting
4%Dyspnoea
3%Urinary tract infection
1%Hypercalcaemia
1%Dizziness
1%General Physical Health Deterioration
1%Urinary Tract Infection
1%Humerus Fracture
1%Pericardial Effusion
1%Vertigo
1%Pain
1%Chest Pain
1%Muscular Weakness
1%Pneumonia
Trial Design
2 Treatment Groups
Fulvestrant With Enzalutamide
1 of 2
Fulvestrant Without Enzalutamide
1 of 2
Experimental Treatment
Non-Treatment Group
61 Total Participants · 2 Treatment Groups
Primary Treatment: Fulvestrant · Has Placebo Group · Phase 2
Fulvestrant With EnzalutamideExperimental Group · 2 Interventions: Enzalutamide, Fulvestrant · Intervention Types: Drug, Drug
Fulvestrant Without Enzalutamide
Drug
PlaceboComparator Group · 1 Intervention: Fulvestrant · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved
Fulvestrant
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,594 Previous Clinical Trials
1,927,335 Total Patients Enrolled
24 Trials studying Breast Cancer
5,423 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
779 Previous Clinical Trials
202,499 Total Patients Enrolled
35 Trials studying Breast Cancer
3,382 Patients Enrolled for Breast Cancer
Anthony D Elias, MDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Breast Cancer
32 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18 - 101 · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be at least 18 years old to buy cigarettes.
I was planning on getting surgery from a local doctor.
is required
A stage of at least T2 or greater is required.
If you are postmenopausal, or if you are pre- or perimenopausal, then you will need to have concurrent ovarian suppression.
If the total bilirubin is less than 1.5 times the upper limit of normal (ULN) at the screening visit, then it is most likely not due to a malignant tumor
I am not on anticoagulants.
Can swallow the study medication and comply with the study requirements.
, no RBC transfusions
At the screening visit, the ANC was more than 1000/uL and the platelets were more than 75,000/uL
patients have a much better prognosis than those with ER- Her2+ breast cancer
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Conditions
Cancer Related
Treatments