Breast CancerPhase 2NCT00585507
Efficacy and Safety of 500mg of Fulvestrant
A Phase 2 study testing Fulvestrant in people with Breast Cancer, run by Beth Israel Deaconess Medical Center at 5 sites in United States.
Trial summary
Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic breast cancer. The dose used in studies so far has been well tolerated and may be too low for optimal effectiveness. In this study, a higher dose will be used to see whether an improved outcome will result. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2004to 15 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Female
- 18 years of age or older
- Histologically confirmed adenocarcinoma of the breast progressing local-regional or metastatic disease that is not considered amenable to curative treatment
- Evidence of hormone sensitivity of primary or secondary tumor tissue
- Postmenopausal as defined by criteria listed in protocol
- May have had adjuvant endocrine therapy if discontinued at least 12 months prior to inclusion. Subjects who have had minimal exposure to adjuvant or first line metastatic endocrine treatment during the 12 months prior to study enrollment can be eligible with overall PI and sponsor permission
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- Prior trastuzumab and biologic therapy is allowed, but must be discontinued more than 2 weeks prior to inclusion
- Presence of measurable or evaluable, nonmeasurable, disease. Any x-rays and scans for assessment of measurable disease must be performed with 28 days prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
Who cannot join
- Presence of life-threatening metastatic disease
- Endocrine therapy the advanced disease setting
- Systemic chemotherapy, whether as adjuvant therapy or for advanced disease, within previous 4 weeks
- Trastuzumab or biologic therapy within previous 2 weeks
- Extensive radiation therapy within the last 2 weeks
- Prior adjuvant or neoadjuvant treatment with fulvestrant is not allowed
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- Concomitant anticancer treatments
- Chronic bisphosphonates for hypercalcemia or prevention of bone metastases
- Subjects receiving long-term anticoagulant therapy with warfarin
- Estrogen replacement therapy within 6 months of trial entry
- Previous or current systems malignancy within the past 3 years
- Treatment with non approved or investigational drug within 2 weeks before study entry
- Any evidence of severe or uncontrolled systemic disease
- History of bleeding diathesis
- Any severe concomitant condition which makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the study protocol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hosptial
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Lowell General Hospital
Lowell, Massachusetts, 01854
South Shore Hospital
South Weymouth, Massachusetts, 02190
About this study
Official title: A Phase II Multi-Center Study to Evaluate the Efficacy and Safety of 500mg of Fulvestrant (Faslodex) as a First Line Hormonal Treatment in Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer
Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic breast cancer. The dose used in studies so far has been well tolerated and may be too low for optimal effectiveness. In this study, a higher dose will be used to see whether an improved outcome will result.
Read the detailed description
- Fulvestrant will be administered by intramuscular injection on day 1, day 15 and day 29 and then every 28 days thereafter.
- Participants will have a physical examination and blood work performed on each treatment date. After teh study treatment has been completed, the physical examinations will be done every three months for the first 2 years, every 6 months for years 2-5, and annually after 5 years.
- Participants may remain on study treatment until disease progression or until they experience serious side effects.
- Conditions
- Breast Cancer
- Being tested
- Fulvestrant
- Keywords
- hormone receptor positive breast cancer, Fulvestrant
- 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
Also called Faslodex
500mg into the muscle on days 1, 15 and 29 and then every 28 days thereafter.
| Study group | Role | What they receive |
|---|---|---|
| single | Experimental | fulvestrant 500mg Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the clinical benefit rate for subjects receiving this dose and schedule of fulvestrant.
Secondary outcomes (3)
Overall objective response rate, time to response, duration of response, duration of clinical benefit, and time to progression.
Assessment of adverse events
Measured: 4 years
Assessment of pharmacokinetics of this dose and schedule of fulvestrant.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startApr 2004
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
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 Beth Israel Deaconess Medical CenterThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, Lowell General Hospital, University of Colorado, Denver, University of Maryland Greenebaum Cancer Center, South Shore Hospital
- Responsible party
- Principal investigator, Steven Come, Beth Israel Deaconess Medical Center
- Investigators
- Steven Come, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585507
- Sponsor's protocol ID
- 04-016
- Status last verified
- May 2026
- First submitted
- 22 Dec 2007
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi-Center Study to Evaluate the Efficacy and Safety of 500mg of Fulvestrant (Faslodex) as a First Line Hormonal Treatment in Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00585507
- Acronym / sponsor ID
- 04-016
- Conditions
- Breast Cancer
- Keywords
- hormone receptor positive breast cancer, Fulvestrant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, Lowell General Hospital, University of Colorado, Denver, University of Maryland Greenebaum Cancer Center, South Shore Hospital
- Study start
- Apr 2004 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 3 Jan 2008 (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.
Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic breast cancer. The dose used in studies so far has been well tolerated and may be too low for optimal effectiveness. In this study, a higher dose will be used to see whether an improved outcome will result.
Detailed description
- Fulvestrant will be administered by intramuscular injection on day 1, day 15 and day 29 and then every 28 days thereafter.
- Participants will have a physical examination and blood work performed on each treatment date. After teh study treatment has been completed, the physical examinations will be done every three months for the first 2 years, every 6 months for years 2-5, and annually after 5 years.
- Participants may remain on study treatment until disease progression or until they experience serious side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single | Experimental | Drug: Fulvestrantfulvestrant 500mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- 18 years of age or older
- Histologically confirmed adenocarcinoma of the breast progressing local-regional or metastatic disease that is not considered amenable to curative treatment
- Evidence of hormone sensitivity of primary or secondary tumor tissue
- Postmenopausal as defined by criteria listed in protocol
Key exclusion criteria (15 listed)
- Presence of life-threatening metastatic disease
- Endocrine therapy the advanced disease setting
- Systemic chemotherapy, whether as adjuvant therapy or for advanced disease, within previous 4 weeks
- Trastuzumab or biologic therapy within previous 2 weeks
- Extensive radiation therapy within the last 2 weeks
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 |
|---|---|---|
| FulvestrantAlso: Faslodex500mg into the muscle on days 1, 15 and 29 and then every 28 days thereafter. | Drug | single |
Primary outcome
To assess the clinical benefit rate for subjects receiving this dose and schedule of fulvestrant.
3 secondary outcomes
Overall objective response rate, time to response, duration of response, duration of clinical benefit, and time to progression.
Assessment of adverse events
Time frame: 4 years
Assessment of pharmacokinetics of this dose and schedule of fulvestrant.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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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.
Steven Come, MD principal investigator
Beth Israel Deaconess Medical Center
5 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 Beth Israel Deaconess Medical Center at 5 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 9 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
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 assess the clinical benefit rate for subjects receiving this dose and schedule of 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 22 May 2026.