Breast CancerPhase 2NCT07483307
A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer
A Phase 2 study testing Neoadjuvant endocrine therapy in people with Breast Cancer and HER2-negative Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to look at how effective neoadjuvant (before surgery) endocrine therapy (NET) is in participants with invasive lobular carcinoma (ILC) who have breast-conserving surgery (BCS). Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma
- What is being tested?
- Neoadjuvant endocrine therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Mar 2026to 13 Mar 2030
- Phase
- Phase 2
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent by participant or legally authorized representative
- Postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC who opt to undergo and are medically fit to undergo BCS at enrollment.
- Tumors of the ER+/HER2- subtype, defined as:
- ER+: Positive for ER staining as indicated by ≥10% immunoreactive tumor nuclei.
- HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay.
Who cannot join
- Patients with prior ipsilateral breast cancer.
- Patients with advanced regional disease (cN2/cN3) or stage 4 disease.
- Patients who would benefit from neoadjuvant chemotherapy, per the treating medical oncologist.
- Patients who are not candidates for definitive breast surgery (inoperable or stage 4 disease).
- Patients with gadolinium allergy, precluding the use of breast MRI.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Anita Mamtani, MD, 646-888-6864
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Anita Mamtani, MD, 646-888-6864
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Anita Mamtani, MD, 646-888-6864
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Anita Mamtani, MD, 646-888-6864
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Anita Mamtani, MD, 646-888-6864
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Anita Mamtani, MD, 646-888-6864
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Anita Mamtani, MD, 646-888-6864
About this study
Official title: Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study
The purpose of this study is to look at how effective neoadjuvant (before surgery) endocrine therapy (NET) is in participants with invasive lobular carcinoma (ILC) who have breast-conserving surgery (BCS). The main purpose of the study is to see if NET reduces the chance of having cancer cells at the edges of tissue removed during surgery (positive margins).
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, ER+ Breast Cancer, Lobular Breast Carcinoma
- Being tested
- Neoadjuvant endocrine therapy
- Keywords
- Breast Cancer, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, ER+ Breast Cancer, 26-095, Memorial Sloan Kettering Cancer Center, Lobular Breast Cancer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant endocrine therapyDrug
Also called NET
The endocrine therapy used for the NET in this study will be anastrozole, letrozole, exemestane, or tamoxifen.
| Study group | Role | What they receive |
|---|---|---|
| Participants with ER+/HER2- Breast Cancer | Experimental | Participants will be postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC, ER+/HER2- subtype Receives: Drug: Neoadjuvant endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of positive surgical margins after breast cancer surgery
To prospectively evaluate rates of positive surgical margins after initial breast cancer surgery/BCS among postmenopausal women with cT2-3 N0-1 ER+/HER2- ILC who have undergone a course of NET.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start13 Mar 2026
- Primary completion13 Mar 2030 (estimated)
- Study completion13 Mar 2030 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita SKCCSC(P Mamtani, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483307
- Sponsor's protocol ID
- 26-095
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- 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 following one year after publication and for up to 36 months later. 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study
- ClinicalTrials.gov ID
- NCT07483307
- Acronym / sponsor ID
- 26-095
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, ER+ Breast Cancer, Lobular Breast Carcinoma
- Keywords
- Breast Cancer, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, ER+ Breast Cancer, 26-095, Memorial Sloan Kettering Cancer Center, Lobular Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 13 Mar 2030 (estimated)
- Study completion
- 13 Mar 2030 (estimated)
- First posted
- 19 Mar 2026 (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 purpose of this study is to look at how effective neoadjuvant (before surgery) endocrine therapy (NET) is in participants with invasive lobular carcinoma (ILC) who have breast-conserving surgery (BCS). The main purpose of the study is to see if NET reduces the chance of having cancer cells at the edges of tissue removed during surgery (positive margins).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with ER+/HER2- Breast Cancer | Experimental | Drug: Neoadjuvant endocrine therapyParticipants will be postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC, ER+/HER2- subtype |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent by participant or legally authorized representative
- Postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC who opt to undergo and are medically fit to undergo BCS at enrollment.
- Tumors of the ER+/HER2- subtype, defined as:
Key exclusion criteria (5 listed)
- Patients with prior ipsilateral breast cancer.
- Patients with advanced regional disease (cN2/cN3) or stage 4 disease.
- Patients who would benefit from neoadjuvant chemotherapy, per the treating medical oncologist.
- Patients who are not candidates for definitive breast surgery (inoperable or stage 4 disease).
- Patients with gadolinium allergy, precluding the use of breast MRI.
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 |
|---|---|---|
| Neoadjuvant endocrine therapyAlso: NETThe endocrine therapy used for the NET in this study will be anastrozole, letrozole, exemestane, or tamoxifen. | Drug | Participants with ER+/HER2- Breast Cancer |
Primary outcome
Rate of positive surgical margins after breast cancer surgery
Time frame: up to 3 months
To prospectively evaluate rates of positive surgical margins after initial breast cancer surgery/BCS among postmenopausal women with cT2-3 N0-1 ER+/HER2- ILC who have undergone a course of NET.
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 4 Jun 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 following one year after publication and for up to 36 months later. 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.
Anita SKCCSC(P Mamtani, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant endocrine therapy in people with Breast Cancer and HER2-negative Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 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 5 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Anita Mamtani, MD (646-888-6864, mamtana1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of positive surgical margins after breast cancer surgery (time frame: up to 3 months). 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 4 Jun 2026.