Tina J. Hieken, M.D.

This study aims to create a registry for primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of SN-negative melanoma patients.

The purpose of this study is to identify biomarker(s) and/or algorithms incorporating baseline patient clinical, tumor, blood and microbiome data to guide selection of the optimal neoadjuvant regimen for patients with clinical stage III melanoma. Specifically, identify a robust pre-treatment marker that predicts a high rate of major pathologic response to the least toxic neoadjuvant immunotherapy regimen, e.g. anti-PD-1 monotherapy or similar low toxicity regimen.

This randomized phase III trial has several primary objectives. One primary objective is to compare the efficacy of 3 different endocrine therapies, the estrogen receptor down regulator fulvestrant and the aromatase inhibitor anastrozole, either alone or in combination, in reducing cancer growth before surgery (neoadjuvant) in postmenopausal women with clinical stage II-III estrogen receptor positive and HER2 negative breast cancer. Another primary objective is to evaluate whether patients who achieved a modified PEPI (Preoperative Endocrine Prognostic Index) score of 0, defined by tumor size <5 cm, N0, Ki67<2.7% (by central testing), at surgery post 6 months of neoadjuvant endocrine therapy predict excellent long term outcome, for whom chemotherapy is unnecessary.

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes.

PURPOSE: This phase II trial is studying how well letrozole works in treating women with ductal carcinoma in situ.

The purpose of this study is to compare the effectiveness of fulvestrant to anastrozole or tamoxifen in treating invasive lobular breast cancer, by measuring the level of the biomarker Ki67 found in tumor tissue before and then after treatment.

The purpose of this study is to see if having different kinds of bacteria genes in breast tissue may be connected to the risk of getting breast cancer.