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Hormone Therapy

Fulvestrant Doses for Breast Cancer (CONFIRM Trial)

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
Postmenopausal women defined as a woman who has stopped having menstrual periods
Must not have
Treatment with more than one regimen of chemotherapy for advanced breast cancer
A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recist tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether a higher dose of Fulvestrant is more effective than the standard dose in treating advanced breast cancer in postmenopausal women who have failed other hormone therapies.

Who is the study for?
This trial is for postmenopausal women with estrogen receptor positive advanced breast cancer that has worsened after anti-estrogen treatments like tamoxifen. Participants must be willing to provide consent and have no serious illnesses or allergies to Faslodex ingredients.
What is being tested?
The study compares the effectiveness of a new, higher dose (500 mg) of Fulvestrant against the standard dose (250 mg) in patients whose breast cancer has progressed despite previous endocrine therapy.
What are the potential side effects?
Fulvestrant can cause side effects such as nausea, injection site pain, muscle or joint pain, and fatigue. Allergic reactions are possible but only in those sensitive to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer grew despite hormone therapy like tamoxifen.
Select...
I have stopped having menstrual periods.
Select...
My cancer is sensitive to hormones.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had more than one type of chemotherapy for advanced breast cancer.
Select...
I am allergic to Faslodex or its components, like castor oil.
Select...
I have had more than one type of hormone therapy for advanced breast cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recist(response evaluation criteria in solid tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and recist(response evaluation criteria in solid tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Progression (TTP)
Secondary study objectives
Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study
Clinical Benefit Rate (CBR)
Duration of Clinical Benefit (DoCB)
+4 more

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507
63%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Headache
17%
Mucositis
17%
Diarrhea
16%
Weight gain
15%
Vomiting
13%
Hypothermia
13%
Arthralgia
12%
Anorexia
12%
Alopecia
11%
Anemia
11%
Cough
11%
Upper respiratory infection
10%
Obesity
10%
Flu like symptoms
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Dizziness
7%
Dyspepsia
7%
Hot flashes
7%
Bone pain
7%
Pruritus
5%
Pain
5%
Dysgeusia
3%
Abdominal pain
3%
Respiratory infection
3%
Nail disorder
1%
Spinal cord compression
1%
Heart failure
1%
Pleural effusion
1%
Ascites
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Dislocation of hip
1%
Renal failure
1%
Bronchial infection
1%
Urinary tract infection
1%
Thromboembolic event
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Osteonecrosis of jaw
1%
Cholecystitis acute
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
Fulvestrant 250 mg
Group II: 1Experimental Treatment1 Intervention
Fulvestrant 500 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3790

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,122,336 Total Patients Enrolled
176 Trials studying Breast Cancer
1,244,337 Patients Enrolled for Breast Cancer
Faslodex Medical Science Director, MDStudy DirectorAstraZeneca

Media Library

Fulvestrant (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00099437 — Phase 3
Breast Cancer Research Study Groups: 1, 2
Breast Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT00099437 — Phase 3
Fulvestrant (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00099437 — Phase 3
~35 spots leftby Dec 2025
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