Breast CancerNCT00126464
Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast
A study testing fulvestrant, tamoxifen citrate and conventional surgery in people with Breast Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving fulvestrant or tamoxifen before surgery may be an effective treatment for breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- fulvestrant, tamoxifen citrate and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to not given
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed ductal carcinoma in situ (DCIS) of the breast
- T0 disease
- Newly diagnosed disease by minimally invasive biopsy (e.g., a vacuum-assisted large core tool [mammotome] or an equivalent method)
- Biopsy tissue available for molecular marker analysis
- Baseline mammography performed within the past 8 weeks
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- Postmenopausal
Sex
- Female
Menopausal status
- Postmenopausal, as defined by 1 of the following:
- Age ≥ 60
- Age ≥ 45 AND amenorrheic for > 1 year with uterus intact
- Underwent bilateral oophorectomy
- Follicle-stimulating hormone and estradiol levels in postmenopausal range
Performance status
- SWOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL
Hepatic
- SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 2.0 times ULN
Renal
- Creatinine ≤ 2.0 mg/dL
Cardiovascular
- No history of deep vein thrombosis
Pulmonary
- No history of pulmonary embolism
Other
- Negative pregnancy test (if clinically indicated)
- No peripheral neuropathy > grade 1
- No underlying medical, psychiatric, or social condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- More than 6 months since prior hormonal therapy, including any of the following:
- Antiestrogens
- Estrogen
- Selective estrogen-receptor modulators
- Progestins
- Aromatase inhibitors
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior therapy for DCIS
Trial locations and contacts
1 site in 1 country.
United States1 site
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving fulvestrant or tamoxifen before surgery may be an effective treatment for breast cancer.
PURPOSE: This randomized clinical trial is studying how well giving fulvestrant or tamoxifen works in treating postmenopausal women who are undergoing surgery for ductal carcinoma in situ of the breast.
Read the detailed description
OBJECTIVES:
Primary
- Determine, preliminarily, the efficacy of neoadjuvant fulvestrant, in terms of molecular changes in markers of the estrogen pathway, cell proliferation and apoptosis, and the epidermal growth factor pathway, in postmenopausal women with newly diagnosed ductal carcinoma in situ of the breast.
Secondary
- Determine the toxicity profile of fulvestrant in these patients.
OUTLINE: This is a randomized, placebo-controlled, pilot, multicenter study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral placebo once daily on days 1-21.
- Arm II: Patients receive oral tamoxifen once daily on days 1-21.
- Arm III: Patients receive fulvestrant intramuscularly (IM) on day 1.
- Arm IV: Patients receive fulvestrant IM as in arm III but at a higher dose. In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. All patients undergo surgical resection of the tumor on approximately day 21.
PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- fulvestrant, tamoxifen citrate, conventional surgery, neoadjuvant therapy
- Keywords
- ductal breast carcinoma in situ, breast cancer in situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fulvestrantDrug
tamoxifen citrateDrug
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks
Secondary outcomes (1)
Mammographic breast density as measured by the Madena method at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2005 (estimated)
- Study startNov 2004
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 Cedars-Sinai 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Agustin Garcia, MD, Study chair, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126464
- Sponsor's protocol ID
- CDR0000430705
- Other IDs
- CSMC-00000244, CSMC-4415/CR00000244, ZENECA-CSMC-00000244, CSMC-1B-03-7
- Status last verified
- Jul 2006
- First submitted
- 2 Aug 2005
- Last updated
- 6 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. 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 (Faslodex) in Breast Ductal Carcinoma (DCIS)
- ClinicalTrials.gov ID
- NCT00126464
- Acronym / sponsor ID
- CDR0000430705
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma in situ, breast cancer in situ
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Nov 2004
- First posted
- 4 Aug 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.
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving fulvestrant or tamoxifen before surgery may be an effective treatment for breast cancer.
PURPOSE: This randomized clinical trial is studying how well giving fulvestrant or tamoxifen works in treating postmenopausal women who are undergoing surgery for ductal carcinoma in situ of the breast.
Detailed description
OBJECTIVES:
Primary
- Determine, preliminarily, the efficacy of neoadjuvant fulvestrant, in terms of molecular changes in markers of the estrogen pathway, cell proliferation and apoptosis, and the epidermal growth factor pathway, in postmenopausal women with newly diagnosed ductal carcinoma in situ of the breast.
Secondary
- Determine the toxicity profile of fulvestrant in these patients.
OUTLINE: This is a randomized, placebo-controlled, pilot, multicenter study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral placebo once daily on days 1-21.
- Arm II: Patients receive oral tamoxifen once daily on days 1-21.
- Arm III: Patients receive fulvestrant intramuscularly (IM) on day 1.
- Arm IV: Patients receive fulvestrant IM as in arm III but at a higher dose. In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. All patients undergo surgical resection of the tumor on approximately day 21.
PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 | – |
| tamoxifen citrate | Drug | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
Primary outcome
Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks
1 secondary outcome
Mammographic breast density as measured by the Madena method at 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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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.
Agustin Garcia, MD study chair
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fulvestrant, tamoxifen citrate and conventional surgery in people with Breast Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2013. 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.
Are results available for this study?
Results are not available in the source record.
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?
Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks. 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 6 Nov 2013.