Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant.
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|ClinicalTrials.gov Identifier: NCT02936206|
Recruitment Status : Terminated (low accrual rate)
First Posted : October 18, 2016
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Fulvestrant Drug: Tamoxifen||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison in the Change of Proliferation Index Between Fulvestrant and Tamoxifen in Cyclin D1 +, Estrogen Receptor + Breast Cancer|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||May 1, 2020|
|Actual Study Completion Date :||May 1, 2020|
750 mg injection in 3 divided doses
fulvestrant 750 mg (three 5 ml injections slowly over 1-2 mn per injection in the buttocks) on day 1 only
Other Name: Faslodex
Active Comparator: Tamoxifen
14 days of treatment with tamoxifen 20mg orally each day
Other Name: Nolvadex
- Change in Ki67 cell percentage [ Time Frame: baseline and 2 weeks ]The change in proliferation index as measured by the percentage of cells staining for Ki67 at 2 weeks as compared on baseline.
- Change in estrogen receptor level [ Time Frame: baseline and 2 weeks ]The change in estrogen receptor level at 2 weeks as compared to baseline.
- Change in progesterone receptor level [ Time Frame: baseline and 2 weeks ]The change in progesterone receptor level at 2 weeks as compared to baseline.
- Incidence of tamoxifen-resistance gene expression [ Time Frame: 2 weeks ]Number of tamoxifen-resistance gene expression signature observed in patients with cyclinD1 overexpressing breast cancers.
- Incidence of fulvestrant-sensitivity gene expression [ Time Frame: 2 weeks ]Number of fulvestrant-sensitivity gene expression signature observed in patients with cyclinD1 overexpressing breast cancers.
- drug dose level [ Time Frame: 2 weeks ]For samples that are available for culture in vivo, proliferation assay to test whether the cells derived from individual patients respond the same as the tumor in vivo in the same patient.
- Percentage of cells staining positive within the breast tumor [ Time Frame: 2 weeks ]Differential treatment effect for pre and post menopausal subjects assessed by the mean change in levels (expressed as a percentage of cells staining positive within the breast tumor) of ER (and PR) between pre-treatment and post-treatment stratified by menopausal status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936206
|United States, New York|
|Mount Sinai West|
|New York, New York, United States, 10019|
|Mount Sinai St. Luke's|
|New York, New York, United States, 10025|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Amy Tiersten, MD||Icahn School of Medicine at Mount Sinai|