Breast CancerPhase 2NCT00146601
Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
A Phase 2 study testing Fulvestrant in people with Breast Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
The purpose of this study is to test the effectiveness and safety of fulvestrant in premenopausal women with advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fulvestrant
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2004to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 invasive breast cancer, with stage IV disease.
- Tumors must be positive for estrogen receptors, progesterone receptors, or both.
- Patients must be premenopausal.
- Prior anti-estrogen therapy (with or without ovarian suppression)
- Platelet count > 100,000/mm3
- Age older than 18 years
- ECOG performance status 0-2
Who cannot join
- Hormonal treatment for metastatic disease
- Pregnant or breast-feeding women
- Postmenopausal
- Concurrent hormonal therapy or chemotherapy
- Prior fulvestrant therapy
- More than three prior chemotherapy regimens for metastatic disease
Show all 9Show fewer
- Concurrent, long-term anticoagulation therapy
- Severe, uncontrolled intercurrent illness
- History of hypersensitivity to castor oil
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
Lowell General Hospital
Lowell, Massachusetts, 01854
About this study
Official title: A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
The purpose of this study is to test the effectiveness and safety of fulvestrant in premenopausal women with advanced breast cancer.
Read the detailed description
Patients will receive an injection of fulvestrant on first day of treatment and then again 2 weeks later and again 2 weeks after that. Then patients will receive injections every 4 weeks.
Routine blood tests will be performed each time an injection is given.
Patients will be required to complete a hot flash diary, recording the number and severity of hot flashes they experience on a daily basis.
After every 12 weeks of treatment, patients' disease will be assessed by x-rays or scans. If there is no disease progression, the patient will continue to receive injections every 4 weeks with reassessment every 8 weeks.
Patients will continue to receive treatment as long as there is no disease progression or serious side effects.
- Conditions
- Breast Cancer
- Being tested
- Fulvestrant
- Keywords
- Fulvestrant, Advanced breast cancer, Invasive breast cancer, Stage IV Breast Cancer, Hormone Receptor-Positive 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.
FulvestrantDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the clinical benefit and response rate of hormone receptor-positive metastatic breast cancer previously treated with anti-estrogen therapy in premenopausal women to treatment with fulvestrant
Secondary outcomes (1)
To determine the safety, time-to-progression, and duration of response for this patient population
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Lowell General Hospital, Brigham and Women's Hospital
- Investigators
- Craig A. Bunnell, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146601
- Sponsor's protocol ID
- 04-075
- Status last verified
- Dec 2007
- First submitted
- 6 Sep 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00146601
- Acronym / sponsor ID
- 04-075
- Conditions
- Breast Cancer
- Keywords
- Fulvestrant, Advanced breast cancer, Invasive breast cancer, Stage IV Breast Cancer, Hormone Receptor-Positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Lowell General Hospital, Brigham and Women's Hospital
- Study start
- Jun 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
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 test the effectiveness and safety of fulvestrant in premenopausal women with advanced breast cancer.
Detailed description
Patients will receive an injection of fulvestrant on first day of treatment and then again 2 weeks later and again 2 weeks after that. Then patients will receive injections every 4 weeks.
Routine blood tests will be performed each time an injection is given.
Patients will be required to complete a hot flash diary, recording the number and severity of hot flashes they experience on a daily basis.
After every 12 weeks of treatment, patients' disease will be assessed by x-rays or scans. If there is no disease progression, the patient will continue to receive injections every 4 weeks with reassessment every 8 weeks.
Patients will continue to receive treatment as long as there is no disease progression or serious side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed invasive breast cancer, with stage IV disease.
- Tumors must be positive for estrogen receptors, progesterone receptors, or both.
- Patients must be premenopausal.
- Prior anti-estrogen therapy (with or without ovarian suppression)
- Platelet count > 100,000/mm3
Key exclusion criteria (9 listed)
- Hormonal treatment for metastatic disease
- Pregnant or breast-feeding women
- Postmenopausal
- Concurrent hormonal therapy or chemotherapy
- Prior fulvestrant therapy
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 |
|---|---|---|
| Fulvestrant | Drug | – |
Primary outcome
To examine the clinical benefit and response rate of hormone receptor-positive metastatic breast cancer previously treated with anti-estrogen therapy in premenopausal women to treatment with fulvestrant
1 secondary outcome
To determine the safety, time-to-progression, and duration of response for this patient population
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
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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.
Craig A. Bunnell, MD principal investigator
Dana-Farber Cancer Institute
4 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 Fulvestrant in people with Breast Cancer, run by Dana-Farber Cancer Institute at 4 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To examine the clinical benefit and response rate of hormone receptor-positive metastatic breast cancer previously treated with anti-estrogen therapy in premenopausal women to treatment with fulvestrant. 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 21 Dec 2007.