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Anastrozole for Breast Cancer

Phase 2
Waitlist Available
Led By Tufia C Haddad
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to swallow oral medication
Adjuvant radiation therapy, if needed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 weeks
Awards & highlights

Study Summary

This trial is testing anastrozole and letrozole to see if they can help treat stage I-III breast cancer patients and prevent cancer from recurring.

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You can swallow pills or tablets.
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If necessary, you have received radiation therapy after surgery.
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You may need chemotherapy before or after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Estrogen suppression rate
Incidence of adverse events
Secondary outcome measures
Distribution of estrone (E1) and estradiol (E2) concentrations

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538
10%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anastrozole
Letrozole

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (anastrozole, letrozole)Experimental Treatment2 Interventions
Patients receive anastrozole PO QD for 56-70 days (8-10 weeks). Patients with E1 >= 1.3 pg/ml and E2 >= 0.5 pg/ml continue to receive anastrozole PO QD for another 56-70 days (8-10 weeks). Patients then receive letrozole PO QD for 8-10 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anastrozole
2019
Completed Phase 4
~10090
Letrozole
2002
Completed Phase 4
~3240

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,757,890 Total Patients Enrolled
83 Trials studying Breast Cancer
14,036 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,485 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Tufia C HaddadPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
83 Total Patients Enrolled

Media Library

Anastrozole Clinical Trial Eligibility Overview. Trial Name: NCT04294225 — Phase 2
Breast Cancer Research Study Groups: Treatment (anastrozole, letrozole)
Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT04294225 — Phase 2
Anastrozole 2023 Treatment Timeline for Medical Study. Trial Name: NCT04294225 — Phase 2
Breast Cancer Patient Testimony for trial: Trial Name: NCT04294225 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are Anastrozole's common applications in medication?

"Anastrozole is often used as part of a tamoxifen treatment plan that lasts two to three years. Additionally, it can be given to postmenopausal women and those with early-stage breast cancer that has spread beyond the milk ducts."

Answered by AI

Are there any dangers associated with Anastrozole?

"Since Anastrozole is in Phase 2 clinical trials, there is not yet data supporting its efficacy. However, it has been deemed safe enough to progress to this stage of testing, so our team gives it a score of 2."

Answered by AI

Are there other examples in which Anastrozole has been used in research?

"As of now,185 active clinical studies are investigating Anastrozole with 49 of them being in Phase 3. Although a concentration of these trials for Anastrozole is based in San Francisco, CA, there are 13,838 total locations running trials for this medication."

Answered by AI

Are we still enrolling people in this experiment?

"This study, which is currently recruiting participants, was originally posted on April 28th 2020. The last edit to the posting was made on May 31st 2022."

Answered by AI

How many test subjects are taking part in this clinical trial?

"This study requires 29 eligible patients that meet the set inclusion criteria. The trial is being conducted at multiple locations, such as Mayo Clinic in Jacksonville, Florida and Mayo Clinic in Scottsdale, Arizona."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What site did they apply to?
Mayo Clinic in Arizona
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

I am ready to be on an AI and want to help doctors discover what medication works best.
PatientReceived 1 prior treatment
I want to help doctors learn more about what works best for treatment. I live close by too!
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Mayo Clinic in Arizona: < 48 hours
Average response time
  • < 2 Days
~33 spots leftby Mar 2025