Female Breast CancerPhase 2NCT01083641
Estrogen for Triple Negative Breast Cancer
A Phase 2 study testing Estradiol in people with Female Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of Estradiol treatment for advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study will also use tumor tissue from your original diagnosis or from a biopsy you may have had for your cancer to look at hormone receptors in the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Breast Cancer
- What is being tested?
- Estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically or cytologically confirmed breast cancer which is metastatic.
- A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from either a prior biopsy of the primary tumor or a metastatic site. .
- Primary tumor or metastatic biopsy lacking estrogen and progesterone receptor and Her2 negative
- Patients must have measurable disease.
- Eastern Cooperative Oncology Group performance status 0-1.
- Patients with bone metastasis at baseline must agree to treatment with intravenous bisphosphonates
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- Subjects may have had 0-4 lines of prior systemic chemotherapy or targeted therapy regimens administered for treatment of their metastatic breast cancer.
- Age >18 years
- Life expectancy of greater than 3 months.
- Patients must have adequate organ and marrow function as defined below:
Who cannot join
- systemic chemotherapies, targeted therapies or radiotherapy for their cancer within 2 weeks prior to entering the study
- Patients receiving any other investigational agents for breast cancer treatment.
- Patients with known brain metastases are excluded 3.2.4 History of allergic reactions attributed to compounds of similar chemical or biologic composition to estradiol.
- Patients with any condition of the gastrointestinal tract that is expected to result in an inability to take oral medication
- Dysfunctional or post-menopausal vaginal bleeding.
- Uncontrolled hypercalcemia/hypocalcemia
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- Prior history of or active thrombophlebitis, cerebral vascular accident, myocardial infarction, deep venous thrombosis or pulmonary embolism.
- History of or active hepatic adenoma.
- Uncontrolled intercurrent illness
- Pregnant women are excluded from this study
- Patients with bone metastasis are excluded if they are unable to receive intravenous bisphosphonate therapy due to the risk for developing hypercalcemia.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: A Phase II Study of High Dose Estradiol in Metastatic Triple Negative Breast Cancer
The purpose of this study is to determine the effectiveness of Estradiol treatment for advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study will also use tumor tissue from your original diagnosis or from a biopsy you may have had for your cancer to look at hormone receptors in the lab. The tissue left over from your previous surgery or a previous biopsy will be used for research tests to check whether a different estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen work better.
- Conditions
- Female Breast Cancer
- Being tested
- Estradiol
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
10mg oral three times daily
| Study group | Role | What they receive |
|---|---|---|
| Estrogen Therapy | Experimental | Estrogen therapy Receives: Drug: Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Tumor Objective Response (OR) Rates
OR=complete response (CR) + partial response (PR) as defined by RECIST version 1.1, where CR=disappearance of all target lesions, and PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to 4 years
Secondary outcomes (3)
Clinical Benefit (CB)
Defined as complete response, partial response, or stable disease at > 16 weeks
Measured: Up to 4 years
Progression-free Survival (PFS)
Measured: Up to 4 years
Median Overall Survival (OS)
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2013
- Study completionMar 2015
Why it stopped: did not meet efficacy goals after interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Female Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kari B Wisinski, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083641
- Sponsor's protocol ID
- CO09711
- Other IDs
- H-2009-0172, NCI-2011-00618, A534260, SMPH\MEDICINE\HEM-ONC, P30CA014520
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2010
- Last updated
- 9 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of High Dose Estradiol in Metastatic Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01083641
- Acronym / sponsor ID
- CO09711
- Conditions
- Female Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: did not meet efficacy goals after interim analysis
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Posted 7 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of Estradiol treatment for advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study will also use tumor tissue from your original diagnosis or from a biopsy you may have had for your cancer to look at hormone receptors in the lab. The tissue left over from your previous surgery or a previous biopsy will be used for research tests to check whether a different estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen work better.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Estrogen Therapy | Experimental | Drug: EstradiolEstrogen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histologically or cytologically confirmed breast cancer which is metastatic.
- A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from either a prior biopsy of the primary tumor or a metastatic site. .
- Primary tumor or metastatic biopsy lacking estrogen and progesterone receptor and Her2 negative
- Patients must have measurable disease.
- Eastern Cooperative Oncology Group performance status 0-1.
Key exclusion criteria (11 listed)
- systemic chemotherapies, targeted therapies or radiotherapy for their cancer within 2 weeks prior to entering the study
- Patients receiving any other investigational agents for breast cancer treatment.
- Patients with known brain metastases are excluded 3.2.4 History of allergic reactions attributed to compounds of similar chemical or biologic composition to estradiol.
- Patients with any condition of the gastrointestinal tract that is expected to result in an inability to take oral medication
- Dysfunctional or post-menopausal vaginal bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol10mg oral three times daily | Drug | Estrogen Therapy |
Primary outcome
Determine Tumor Objective Response (OR) Rates
Time frame: Up to 4 years
OR=complete response (CR) + partial response (PR) as defined by RECIST version 1.1, where CR=disappearance of all target lesions, and PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
3 secondary outcomes
Clinical Benefit (CB)
Time frame: Up to 4 years
Progression-free Survival (PFS)
Time frame: Up to 4 years
Median Overall Survival (OS)
Time frame: Up to 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari B Wisinski, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Estradiol in people with Female Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Tumor Objective Response (OR) Rates (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.