Breast CarcinomaPhase 2NCT00183963
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
A Phase 2 study testing Tamoxifen and Fulvestrant in people with Breast Carcinoma, run by University of Southern California at 1 site in United States.
Trial summary
The subjects in this trial have been diagnosed as having a pre-cancerous disease of the breast called ductal carcinoma in situ (DCIS). This condition is associated with the development of breast cancer in up to 50% of cases. The subjects are being asked to participate in this research study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Tamoxifen and Fulvestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jun 2008
- 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
- Postmenopausal women with newly diagnosed DCIS. Women will be considered to be in menopause if they fall into one of the following groups:
- Age > 60
- Age > 45 with amenorrhea > 1 year with intact uterus
- Status post bilateral oophorectomies
- FSH/estradiol levels in postmenopausal range for the institution
- DCIS must have been diagnosed with a minimally invasive biopsy technique, such as a vacuum-assisted large core tool (Mammotome) or an equivalent method.
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- There must be available tissue from the diagnostic biopsy to perform molecular markers.
- Baseline mammogram within 8 weeks of study entry.
- Serum creatinine less than or equal to 2.0 mg/dl.
- Total bilirubin less than or equal to 2.0 upper limit of normal (ULN), transaminases (SGOT and/or SGPT) and alkaline phosphatase may be up to 2.5 x institutional upper limit of normal (ULN), AGC greater than or equal to 1500, platelets greater than or equal to 100,000, Hemoglobin greater than or equal to 8.0 g/dl
- Peripheral neuropathy grade 0-1.
- No prior therapy for DCIS.
- SWOG performance status of less than or equal to 1
- All patients must provide informed written consent
Who cannot join
- Prior hormonal therapy (antiestrogens, estrogen, SERM's, progestins, or aromatase inhibitors) within 6 months of study entry.
- Underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment.
- History of DVT or Pulmonary Embolism
Trial locations and contacts
1 site in 1 country.
United States1 site
Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
The subjects in this trial have been diagnosed as having a pre-cancerous disease of the breast called ductal carcinoma in situ (DCIS). This condition is associated with the development of breast cancer in up to 50% of cases.
The subjects are being asked to participate in this research study. They are being offered voluntary admission to this study to test the effects of a new investigational drug called Fulvestrant (Faslodex). This drug is approved by the United States Food and Drug Administration (FDA) for the treatment of advanced breast cancer but has not been approved for the treatment of DCIS. However, the FDA has given permission for the drug to be tested in this study. The purpose of this study is to find out if Fulvestrant has any effect on the subject's precancerous changes by comparing samples taken before and after receiving Fulvestrant.
- Conditions
- Breast Carcinoma
- Being tested
- Tamoxifen, 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.
TamoxifenDrug
20mg
FulvestrantDrug
250mg
FulvestrantDrug
500 mg IM
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Active comparator | Tamoxifen 20 mg Receives: Drug: Tamoxifen |
| 3 | Active comparator | Fulvestrant 250mg Receives: Drug: Fulvestrant |
| 4 | Active comparator | Fulvestrant 500mg IM Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment
Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment.
Measured: 6 months after treatment of last patient enrolled
Secondary outcomes (1)
Number of Participants With Changes in Mammographic Density
The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.
Measured: 6 months after treatment of last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startAug 2006
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Insufficient 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 CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Dennis Holmes, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183963
- Sponsor's protocol ID
- 1B-03-7
- Status last verified
- May 2014
- First submitted
- 12 Sep 2005
- Last updated
- 22 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
- ClinicalTrials.gov ID
- NCT00183963
- Acronym / sponsor ID
- 1B-03-7
- Conditions
- Breast Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Aug 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 6 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The subjects in this trial have been diagnosed as having a pre-cancerous disease of the breast called ductal carcinoma in situ (DCIS). This condition is associated with the development of breast cancer in up to 50% of cases.
The subjects are being asked to participate in this research study. They are being offered voluntary admission to this study to test the effects of a new investigational drug called Fulvestrant (Faslodex). This drug is approved by the United States Food and Drug Administration (FDA) for the treatment of advanced breast cancer but has not been approved for the treatment of DCIS. However, the FDA has given permission for the drug to be tested in this study. The purpose of this study is to find out if Fulvestrant has any effect on the subject's precancerous changes by comparing samples taken before and after receiving Fulvestrant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Active comparator | Drug: TamoxifenTamoxifen 20 mg |
| 3 | Active comparator | Drug: FulvestrantFulvestrant 250mg |
| 4 | Active comparator | Drug: FulvestrantFulvestrant 500mg IM |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Postmenopausal women with newly diagnosed DCIS. Women will be considered to be in menopause if they fall into one of the following groups:
- DCIS must have been diagnosed with a minimally invasive biopsy technique, such as a vacuum-assisted large core tool (Mammotome) or an equivalent method.
- There must be available tissue from the diagnostic biopsy to perform molecular markers.
- Baseline mammogram within 8 weeks of study entry.
- Serum creatinine less than or equal to 2.0 mg/dl.
Key exclusion criteria (3 listed)
- Prior hormonal therapy (antiestrogens, estrogen, SERM's, progestins, or aromatase inhibitors) within 6 months of study entry.
- Underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment.
- History of DVT or Pulmonary Embolism
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 |
|---|---|---|
| Tamoxifen20mg | Drug | 2 |
| Fulvestrant250mg | Drug | 3 |
| Fulvestrant500 mg IM | Drug | 4 |
Primary outcome
Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment
Time frame: 6 months after treatment of last patient enrolled
Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment.
1 secondary outcome
Number of Participants With Changes in Mammographic Density
Time frame: 6 months after treatment of last patient enrolled
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
- 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.
Dennis Holmes principal investigator
University of Southern California
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 Tamoxifen and Fulvestrant in people with Breast Carcinoma, run by University of Southern California 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 14 inclusion and 3 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 22 May 2014. 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 6 Dec 2012). 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?
Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment (time frame: 6 months after treatment of last patient enrolled). 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 2014; AzTrials last refreshed its copy on 6 Nov 2026.