Breast CancerNCT06127979
A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Before Surgery
A study testing blood draw in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The researchers are doing this study to look at changes in Ki67 expression after at least 2 weeks of endocrine therapy in people with ER+/HER2- breast cancer undergoing cancer removal surgery. Participants will receive the endocrine therapy before their surgery. 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?
- blood draw
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2024to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 aged ≥18 years with biopsy-proven stage I-III invasive breast cancer that is ER+/HER2-
- Scheduled to undergo upfront surgery
- Eligible for genetic testing in accordance with National Comprehensive Cancer Network guidelines(BRCA2 arm only)
Who cannot join
- History of breast cancer
- Receipt of ET for risk reduction in the previous 3 months
- Stage IV disease at presentation
- Scheduled to undergo neoadjuvant systemic chemotherapy
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Komal Jhaveri, MD contact
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Minna Lee, MD, 646-888-6898
About this study
Official title: Differential Changes in Ki67 Between Carriers and Noncarriers of BRCA2 Mutations With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-negative Breast Cancer Treated With Preoperative Endocrine Therapy
The researchers are doing this study to look at changes in Ki67 expression after at least 2 weeks of endocrine therapy in people with ER+/HER2- breast cancer undergoing cancer removal surgery. Participants will receive the endocrine therapy before their surgery. The researchers will look at how changes in Ki67 expression compare between participants who are carriers of the BRCA2 mutation and participants who are noncarriers of the BRCA2 mutation.
- Conditions
- Breast Cancer
- Being tested
- blood draw
- Keywords
- Ki67 Expression, BRCA2 mutation, ER+/HER2-, endocrine therapy, 23-311
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawOther
blood draw
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer | Experimental | All study patients will receive standard ET for at least 2 weeks. In accordance with the standard of care, postmenopausal women will receive AI ( 1mg daily tablet, letrozole 2.5mg daily tablet, or exemestane 25mg daily tablet which will be followed by standard of care surgical treatment. Surgical tumor tissue will be obtained at the time of surgery and will be assessed for Ki67; a portion of this specimen will be snap-frozen for future analysis. In collaboration with the surgical team, Oncotype can be sent on this research biopsy after pathology assessment. This will enable the patient to receive the Oncotype result and to gain knowledge on the recommendation for adjuvant chemotherapy about 4-6 weeks earlier than our normal workflow. However, if a patient is receiving a clinically indicated, standard of care biopsy after enrolling on this trial, the necessary research samples may be collected during this procedure to avoid an additional research-specific procedure. Receives: Other: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the change in Ki67
The change in Ki67 expression on immunohistochemical staining from baseline to at least 2 weeks of ET will be assessed.
Measured: baseline to at least 2 weeks of endocrine therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start30 Aug 2024
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
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 Memorial Sloan Kettering Cancer 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minna Lee, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127979
- Sponsor's protocol ID
- 23-311
- Status last verified
- Oct 2026
- First submitted
- 6 Nov 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Changes in Ki67 Between Carriers and Noncarriers of BRCA2 Mutations With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-negative Breast Cancer Treated With Preoperative Endocrine Therapy
- ClinicalTrials.gov ID
- NCT06127979
- Acronym / sponsor ID
- 23-311
- Conditions
- Breast Cancer
- Keywords
- Ki67 Expression, BRCA2 mutation, ER+/HER2-, endocrine therapy, 23-311
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 13 Nov 2023 (actual)
- 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.
The researchers are doing this study to look at changes in Ki67 expression after at least 2 weeks of endocrine therapy in people with ER+/HER2- breast cancer undergoing cancer removal surgery. Participants will receive the endocrine therapy before their surgery. The researchers will look at how changes in Ki67 expression compare between participants who are carriers of the BRCA2 mutation and participants who are noncarriers of the BRCA2 mutation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | Experimental | Other: blood drawAll study patients will receive standard ET for at least 2 weeks. In accordance with the standard of care, postmenopausal women will receive AI ( 1mg daily tablet, letrozole 2.5mg daily tablet, or exemestane 25mg daily tablet which will be followed by standard of care surgical treatment. Surgical tumor tissue will be obtained at the time of surgery and will be assessed for Ki67; a portion of this specimen will be snap-frozen for future analysis. In collaboration with the surgical team, Oncotype can be sent on this research biopsy after pathology assessment. This will enable the patient to receive the Oncotype result and to gain knowledge on the recommendation for adjuvant chemotherapy about 4-6 weeks earlier than our normal workflow. However, if a patient is receiving a clinically indicated, standard of care biopsy after enrolling on this trial, the necessary research samples may be collected during this procedure to avoid an additional research-specific procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women aged ≥18 years with biopsy-proven stage I-III invasive breast cancer that is ER+/HER2-
- Scheduled to undergo upfront surgery
- Eligible for genetic testing in accordance with National Comprehensive Cancer Network guidelines(BRCA2 arm only)
Key exclusion criteria (5 listed)
- History of breast cancer
- Receipt of ET for risk reduction in the previous 3 months
- Stage IV disease at presentation
- Scheduled to undergo neoadjuvant systemic chemotherapy
- Pregnant
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 |
|---|---|---|
| blood drawblood draw | Other | Breast Cancer |
Primary outcome
assess the change in Ki67
Time frame: baseline to at least 2 weeks of endocrine therapy
The change in Ki67 expression on immunohistochemical staining from baseline to at least 2 weeks of ET will be assessed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Komal Jhaveri, MD contact
Minna Lee, MD principal investigator
Memorial Sloan Kettering Cancer 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 blood draw in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minna Lee, MD (646-888-6898, leem15@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the change in Ki67 (time frame: baseline to at least 2 weeks of endocrine therapy). 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 13 Oct 2026.