Breast Cancer, ER+ Breast Cancer, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, Lobular Breast Carcinoma
Conditions
Keywords
Breast Cancer, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, ER+ Breast Cancer, 26-095, Memorial Sloan Kettering Cancer Center, Lobular Breast Cancer
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).
Interventions
The endocrine therapy used for the NET in this study will be anastrozole, letrozole, exemestane, or tamoxifen.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of positive surgical margins after breast cancer surgery | 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. |
Countries
United States
Contacts
CONTACTAnita Mamtani, MD
CONTACTGeorge Plitas, MD
PRINCIPAL_INVESTIGATORAnita SKCCSC(P Mamtani, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed