NCT07483307 A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer
| NCT ID | NCT07483307 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2026-03-13 |
| Primary Completion | 2030-03-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 176 participants in total. It began in 2026-03-13 with a primary completion date of 2030-03-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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).
Eligibility Criteria
Inclusion Criteria: * 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: 1. ER+: Positive for ER staining as indicated by ≥10% immunoreactive tumor nuclei. 2. 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. Exclusion Criteria: * 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.
Contact & Investigator
Anita SKCCSC(P Mamtani, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT07483307 clinical trial?
This trial is open to female participants only, aged 50 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07483307 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07483307 currently recruiting?
Yes, NCT07483307 is actively recruiting participants. Contact the research team at mamtana1@mskcc.org for enrollment information.
Where is the NCT07483307 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT07483307 clinical trial?
NCT07483307 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Anita SKCCSC(P Mamtani, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 176 participants.
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