Fulvestrant for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast CancerFulvestrant - Drug
Eligibility
18 - 101
Female
What conditions do you have?
Select

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

1 of 3

Similar Trials

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

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

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
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT00256698) in the Anastrozole ARM group. Side effects include: Fatigue with 13%, Nausea with 11%, Arthralgia with 11%, Musculoskeletal pain with 8%, Hot flush with 7%.

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: Drug
Treatment
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