Clinical trial · Interventional
A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer
Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study
NCT07483307CI-TRIAL-00113544recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| ER+ Breast Cancer | — | UNRESOLVED | — |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| HER2 Negative Breast Carcinoma | HER2-Negative Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lobular Breast Carcinoma | Breast Lobular Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant endocrine therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with ER+/HER2- Breast Cancer
- description
- Participants will be postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC, ER+/HER2- subtype
- interventionNames
- Drug: Neoadjuvant endocrine therapy
Primary outcomes (1)
- measure
- Rate of positive surgical margins after breast cancer surgery
- timeFrame
- up to 3 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.