Breast CancerPhase 1NCT02936206
Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant.
A Phase 1 study testing Fulvestrant and Tamoxifen in people with Breast Cancer, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial summary
The purpose of this study is to microscopically examine breast cancer cells of pre-menopausal and post-menopausal women before and after exposure to one of the two commonly used breast cancer drugs, tamoxifen or fulvestrant. 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 and Tamoxifen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2016to 1 May 2020
- Phase
- Phase 1
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
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the study treatment regimen and follow-up, must be obtained and documented according to the local regulatory requirements
- Adult women greater than 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- New diagnosis of invasive cyclin D1 +, ER+, PR +/-, Her2- breast cancer
- Cyclin D1 positive as defined as a total immunohistochemical score of 5 or greater
- Hormone receptor positive as defined as ≥ 10% positive stained cells
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- HER2-normal (IHC score 0-1 or FISH negative [in-situ hybridization (ISH) ratio <= 2.0 status])
- Tumor size at least 5 mm with planned primary surgery at Mount Sinai
- A negative urine dipstick pregnancy test
Who cannot join
- Estrogen receptor negative invasive breast carcinoma as defined as less than 10% stained cells
- Prior antiestrogen therapy
- Tumor size less than 5 mm
- Prior diagnosis of thrombosis or known hypercoagulable state
- Known history of bleeding diathesis
- Known liver disease
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- Prior treatment with neoadjuvant therapy
- Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema).
- Current severe or uncontrolled systemic disease
- Pregnancy or lactation period. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices) during study treatment.
- Prior malignancy (including invasive or ductal in-situ breast cancer) within 5 years prior to randomization, except curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mount Sinai West
New York, New York, 10019
Mount Sinai St. Luke's
New York, New York, 10025
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Comparison in the Change of Proliferation Index Between Fulvestrant and Tamoxifen in Cyclin D1 +, Estrogen Receptor + Breast Cancer
The purpose of this study is to microscopically examine breast cancer cells of pre-menopausal and post-menopausal women before and after exposure to one of the two commonly used breast cancer drugs, tamoxifen or fulvestrant.
Read the detailed description
The researchers hypothesize that the cyclinD1-interactome can be used to orient the use of fulvestrant in premenopausal and postmenopausal women. To test this hypothesis, the researchers propose a pre-surgical randomized clinical trial of tamoxifen vs fulvestrant in the window between breast cancer diagnosis on core biopsy and definitive surgery. Women with ER/cyclinD1 positive tumors will be eligible. Response to tamoxifen or fulvestrant will be evaluated using standard proliferation index as well as gene expression signatures obtained in pre-clinical models of tamoxifen resistance and sensitivity to fulvestrant. In addition, the researchers propose to use cutting edge new technology allowing ex-vivo expansion of primary culture from only a few cancer cells obtained by fine needle biopsy. The researchers propose to compare the response of these primary cells to patient response. If successful, the impact of this work can support the expansion of use of fulvestrant to not only postmenopausal women but premenopausal women as well. In addition, it may serve as a proof of principle to maximize the use of biopsy material to predict treatment response
- Conditions
- Breast Cancer
- Being tested
- Fulvestrant, Tamoxifen
- Keywords
- proliferation Index, Tamoxifen, Fulvestrant, cyclinD1, 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
Also called Faslodex
fulvestrant 750 mg (three 5 ml injections slowly over 1-2 mn per injection in the buttocks) on day 1 only
TamoxifenDrug
Also called Nolvadex
14 days of treatment with tamoxifen 20mg orally each day
| Study group | Role | What they receive |
|---|---|---|
| Fulvestrant | Experimental | 750 mg injection in 3 divided doses Receives: Drug: Fulvestrant |
| Tamoxifen | Active comparator | 20mg orally Receives: Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ki67 Cell Percentage
The change in proliferation index as measured by the percentage of cells staining for Ki67 at 2 weeks as compared on baseline.
Measured: baseline and 2 weeks
Secondary outcomes (6)
Change in Estrogen Receptor Level
The change in estrogen receptor level at 2 weeks as compared to baseline.
Measured: baseline and 2 weeks
Change in Progesterone Receptor Level
The change in progesterone receptor level at 2 weeks as compared to baseline.
Measured: baseline and 2 weeks
Incidence of Tamoxifen-resistance Gene Expression
Number of tamoxifen-resistance gene expression signature observed in patients with cyclinD1 overexpressing breast cancers.
Measured: 2 weeks
Incidence of Fulvestrant-sensitivity Gene Expression
Number of fulvestrant-sensitivity gene expression signature observed in patients with cyclinD1 overexpressing breast cancers.
Measured: 2 weeks
Drug Dose Level
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.
Measured: 2 weeks
Percentage of Cells Staining Positive Within the Breast Tumor
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion1 May 2020
- Study completion1 May 2020
Why it stopped: low accrual rate
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 CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Amy Tiersten, Icahn School of Medicine at Mount Sinai
- Investigators
- Amy Tiersten, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936206
- Sponsor's protocol ID
- GCO 16-1470
- Status last verified
- Apr 2021
- First submitted
- 14 Oct 2016
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No