Therapeutic Estradiol for Breast Cancer

UCSF Medical Center-Mission Bay, San Francisco, CA
Breast Cancer+12 More ConditionsTherapeutic Estradiol - Biological

Study Summary

This trial is studying how well estradiol works in treating patients with a certain type of breast cancer that has spread.

Eligible Conditions
  • Triple Negative Breast Cancer
  • Breast Cancer
  • Stage III Breast Cancer
  • Stage IV Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Metastatic Triple-Negative Breast Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 5 years

5 years
Changes in phospho-ERbeta, cystatins 1, 2, 4 and 5, phospho-Smad2/3 and Ki-67
Incidence of adverse events
Tumor response rate among those patients with measurable disease
6 months
Clinical benefit rate
Baseline up to cycle 1
Changes in serum cystatin levels in response to treatment
Year 5
Overall survival distribution
Year 5
Progression free survival (PFS) distribution

Trial Safety

Phase-Based Safety

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

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Treatment (estradiol)
1 of 1

Experimental Treatment

38 Total Participants · 1 Treatment Group

Primary Treatment: Therapeutic Estradiol · No Placebo Group · Phase 2

Treatment (estradiol)Experimental Group · 5 Interventions: Computed Tomography, Magnetic Resonance Imaging, Biopsy, Positron Emission Tomography, Therapeutic Estradiol · Intervention Types: Procedure, Procedure, Procedure, Procedure, Biological
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
Completed Phase 2
Magnetic Resonance Imaging
Completed Phase 3
Completed Phase 4
Positron Emission Tomography
Completed Phase 2

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,235,360 Total Patients Enrolled
932 Trials studying Breast Cancer
1,541,944 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,008 Previous Clinical Trials
3,513,431 Total Patients Enrolled
85 Trials studying Breast Cancer
17,187 Patients Enrolled for Breast Cancer
Matthew P GoetzPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
343 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Are there long-term risks associated with taking Therapeutic Estradiol?

"Power's team has rated the safety of Therapeutic Estradiol as a 2. This is due to it being in Phase 2 clinical trials, where there is evidence of safety but not yet efficacy." - Anonymous Online Contributor

Unverified Answer

Are participants being recruited for this clinical research at present?

"That is correct.if you visit, you'll see that the most recent update to this study was on 8/31/2022. The trial is seeking 38 individuals who are willing to participate at 14 different locations." - Anonymous Online Contributor

Unverified Answer

In how many different geographical areas is this trial taking place?

"Presently, this trial is being conducted in 14 different centres. These locations include Jacksonville, Chicago and Bronx as well other surrounding areas. If you are interested in enrolling, it would be beneficial to choose the site closest to your residence to cut down on commute times." - Anonymous Online Contributor

Unverified Answer

How many people are helping to test this new medication?

"Yes, the data on indicates that this study is looking for participants. The trial was first posted on 8/28/2019 and was last updated on 8/31/2022. 38 patients need to be recruited from 14 different sites." - Anonymous Online Contributor

Unverified Answer

Do you know of any other times when Therapeutic Estradiol has been studied?

"Estradiol's therapeutic effects were first investigated in 1996 at the National Institutes of Health Clinical Center. To date, there have been a total of 351 completed trials worldwide. There are currently 52 live clinical trials, with a significant portion taking place in Jacksonville, Florida." - Anonymous Online Contributor

Unverified Answer

What are the benefits of taking Therapeutic Estradiol?

"Therapeutic Estradiol is most commonly used to treat amenorrhea, or the absence of a menstrual period, in women who have not had one in the last 6 months. However, it can also be helpful for managing other conditions like hypoestrogenism, menopausal vasomotor symptoms, and breast cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.