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
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison in the Change of Proliferation Index Between Fulvestrant and Tamoxifen in Cyclin D1 +, Estrogen Receptor + Breast Cancer
- ClinicalTrials.gov ID
- NCT02936206
- Acronym / sponsor ID
- GCO 16-1470
- Conditions
- Breast Cancer
- Keywords
- proliferation Index, Tamoxifen, Fulvestrant, cyclinD1, Breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual rate
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Oct 2016
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 19 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fulvestrant | Experimental | Drug: Fulvestrant750 mg injection in 3 divided doses |
| Tamoxifen | Active comparator | Drug: Tamoxifen20mg orally |
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)
- 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
- Tumor size at least 5 mm with planned primary surgery at Mount Sinai
Key exclusion criteria (11 listed)
- 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
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: Faslodexfulvestrant 750 mg (three 5 ml injections slowly over 1-2 mn per injection in the buttocks) on day 1 only | Drug | Fulvestrant |
| TamoxifenAlso: Nolvadex14 days of treatment with tamoxifen 20mg orally each day | Drug | Tamoxifen |
Primary outcome
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.
6 secondary outcomes
Change in Estrogen Receptor Level
Time frame: baseline and 2 weeks
Change in Progesterone Receptor Level
Time frame: baseline and 2 weeks
Incidence of Tamoxifen-resistance Gene Expression
Time frame: 2 weeks
Incidence of Fulvestrant-sensitivity Gene Expression
Time frame: 2 weeks
Drug Dose Level
Time frame: 2 weeks
Percentage of Cells Staining Positive Within the Breast Tumor
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Amy Tiersten, MD principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 11 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 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 19 May 2021). 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?
Change in Ki67 Cell Percentage (time frame: baseline and 2 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 19 May 2021.