Breast CancerPhase 2NCT00661531
Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy
A Phase 2 study testing Estrace and Anastrozole in people with Breast Cancer and Cancer of the Breast, run by Georgetown University at 3 sites in United States.
Trial summary
This trial seeks to confirm the response rate for estrace treatment in a patients with hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine therapies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer of the Breast, Neoplasms, Breast
- What is being tested?
- Estrace and Anastrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2008to Jun 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 confirmed estrogen and/or progesterone receptor-positive breast cancer metastatic breast cancer
- Clinically determined evaluable disease
- Post-menopausal woman
- Previous clinical benefit from prior anti-estrogen therapies and subsequent failure of at least 2 prior endocrine therapies.
- May have had chemotherapy for adjuvant \&/or metastatic disease.
- May have had radiation therapy but not to the only site of disease.
- Ecog performance status </= 2.
- Life expectancy of > 6 months
Who cannot join
- Chemotherapy or radiotherapy within 1 week of beginning treatment in the clinical trial
- Brain metastasis
- Prior history of or active thrombophlebitis, deep venous thrombosis or pulmonary embolus
- Current vaginal bleeding
- Hypercalcemia or hypocalcemia
- History of or active hepatic adenoma
- No other malignancies within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Cooper Cancer Institute
Voorhees Township, New Jersey, 08043
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057
About this study
Official title: A Single Arm Phase II Study of Pharmacologic Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
This trial seeks to confirm the response rate for estrace treatment in a patients with hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine therapies.
Read the detailed description
Prior to the current standard of care utilizing estrogen deprivation or antiestrogen therapy to treat hormonally sensitive breast cancers, treatment with pharmacologic doses of estrogen was a common technique used to treat post-menopausal women with hormone sensitive metastatic disease that resulted in durable responses with regression of disease. A randomized trial comparing tamoxifen and pharmacologic doses of estrogen demonstrated similar rates of response with long-term follow-up data confirming a survival benefit for those treated with the estrogen preparation. Additional data has shown that post-menopausal women with hormonally sensitive tumors that have progressed on prior endocrine therapies responded to treatment with pharmacologic doses of estrogen. These data, coupled with pre-clinical data that postmenopausal levels of estrogen can be used to cause apoptosis (programmed cell death within the tumor) and tumor regression in exhaustively treated endocrine resistant disease form the rationale for the proposed clinical trial. This trial seeks to confirm the response rate for estrace treatment in a patient population heavily pre-treated with modern endocrine therapies.
- Conditions
- Breast Cancer, Cancer of the Breast, Neoplasms, Breast
- Being tested
- Estrace, Anastrozole
- Keywords
- Breast cancer, Metastatic breast cancer, ER positive breast cancer, Hormonal therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstraceDrug
Estrace 10 mg three times daily will be administered for 3 months.
AnastrozoleDrug
Also called Arimidex
After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment
| Study group | Role | What they receive |
|---|---|---|
| Estrace & Anastrozole | Experimental | Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered Receives: Drug: Estrace; Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression free survival is defined as the time from assignment of treatment to the time of disease progression or death from any cause
Measured: 6 months
Secondary outcomes (1)
Response Rate
Response rate was defined per RECIST version 1.0. In this study, response rate was defined as including patients with either a complete response (complete disappearance of all target lesions with changes confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met) or a partial response (at least 30% decrease in the sum of the longest diameter of the target lesions)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Poor accrual
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudine Isaacs, M.D., Principal investigator, Lombardi Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661531
- Sponsor's protocol ID
- FER-BR-030
- Other IDs
- W81XWH-06-1-0590
- Status last verified
- Nov 2015
- First submitted
- 17 Apr 2008
- Last updated
- 12 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Study of Pharmacologic Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
- ClinicalTrials.gov ID
- NCT00661531
- Acronym / sponsor ID
- FER-BR-030
- Conditions
- Breast Cancer, Cancer of the Breast, Neoplasms, Breast
- Keywords
- Breast cancer, Metastatic breast cancer, ER positive breast cancer, Hormonal therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Apr 2008 (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.
This trial seeks to confirm the response rate for estrace treatment in a patients with hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine therapies.
Detailed description
Prior to the current standard of care utilizing estrogen deprivation or antiestrogen therapy to treat hormonally sensitive breast cancers, treatment with pharmacologic doses of estrogen was a common technique used to treat post-menopausal women with hormone sensitive metastatic disease that resulted in durable responses with regression of disease. A randomized trial comparing tamoxifen and pharmacologic doses of estrogen demonstrated similar rates of response with long-term follow-up data confirming a survival benefit for those treated with the estrogen preparation. Additional data has shown that post-menopausal women with hormonally sensitive tumors that have progressed on prior endocrine therapies responded to treatment with pharmacologic doses of estrogen. These data, coupled with pre-clinical data that postmenopausal levels of estrogen can be used to cause apoptosis (programmed cell death within the tumor) and tumor regression in exhaustively treated endocrine resistant disease form the rationale for the proposed clinical trial. This trial seeks to confirm the response rate for estrace treatment in a patient population heavily pre-treated with modern endocrine therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Estrace & Anastrozole | Experimental | Drug: Estrace, Drug: AnastrozoleEstrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed estrogen and/or progesterone receptor-positive breast cancer metastatic breast cancer
- Clinically determined evaluable disease
- Post-menopausal woman
- Previous clinical benefit from prior anti-estrogen therapies and subsequent failure of at least 2 prior endocrine therapies.
- May have had chemotherapy for adjuvant \&/or metastatic disease.
Key exclusion criteria (7 listed)
- Chemotherapy or radiotherapy within 1 week of beginning treatment in the clinical trial
- Brain metastasis
- Prior history of or active thrombophlebitis, deep venous thrombosis or pulmonary embolus
- Current vaginal bleeding
- Hypercalcemia or hypocalcemia
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 |
|---|---|---|
| EstraceEstrace 10 mg three times daily will be administered for 3 months. | Drug | Estrace & Anastrozole |
| AnastrozoleAlso: ArimidexAfter 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment | Drug | Estrace & Anastrozole |
Primary outcome
Progression Free Survival
Time frame: 6 months
Progression free survival is defined as the time from assignment of treatment to the time of disease progression or death from any cause
1 secondary outcome
Response Rate
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Claudine Isaacs, M.D. principal investigator
Lombardi Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Estrace and Anastrozole in people with Breast Cancer and Cancer of the Breast, run by Georgetown University at 3 sites 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 8 inclusion and 7 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 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Progression Free Survival (time frame: 6 months). 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 12 Apr 2017.