The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer

Johns Hopkins University30 enrolled

Overview

The investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer.

Breast cancer is among the most common malignancies in women in the United States. Over the years breast cancer management have dramatically developed from the extensive surgical approach toward the breast conservative approach. This was mainly due to the introduction of chemotherapy and hormonal therapy. Hormonal therapy in particular has been shown to improve the oncological outcomes of the breast cancer. However, while this is well documented in the clinical outcomes. Little is known in regards what happens on the genetic level. As such in this study the investigators would like to study the genetic and molecular outcomes that results after a short term neoadjuvant hormonal therapy on patients with breast cancer. The hypothesis of this study is that short-term, preoperative hormonal treatment will induce genetic changes associated with reduced proliferation, including lower Ki67 expression, and changes in Estrogen Receptor (ER) and Progesterone Receptor (PR) expression. The data from such investigation will be very helpful in advancing the individualized care to women with breast cancer.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Tamoxifen CitrateDRUG

10mg administered daily. Patients take this drug for 2-6 weeks

LetrozoleDRUG

2.5mg is administered daily. Patients take this drug for 2-6 weeks

ExemestaneDRUG

25mg is administered daily. Patients take this drug for 2-6 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion criteria * Treatment-naïve, histologically confirmed invasive ductal breast cancer between stages 1 to 3. * Co-enrollment in the FLEX Registry * Estrogen Receptor Positive (ER+) Progesterone Receptor Positive (PR+) confirmed hormone receptor status measured by immunohistochemistry (IHC) * Patients should understand patients' condition and be able to give informed consent to participate Exclusion criteria * History of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer. * Allergic reactions/hypersensitivity to tamoxifen, letrozole, or exemestane or any of the ingredients of these drugs. * Any contraindication to hormonal therapy, such as history of thromboembolic disease or uterine cancer. * Patients without invasive disease (stage 0) * Patients with metastatic breast cancer(stageIV) * Patients that are Human Epidermal Growth Factor 2+(HER2+) by IHC/Fluorescence in situ hybridization (FISH).

Locations (1)

Johns Hopkins Bayview Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)

This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.

Time frame: Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy

Secondary Outcomes

Number of Participants With Low or High Score in MammaPrint

Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence).

Time frame: Baseline and at Time of surgery (up to 6 weeks)

Median Percent of Tissue ER Positive

Median percent of tissue ER positive in matched tissue measured by Immunohistochemistry (IHC)

Time frame: Baseline and at Time of surgery (up to 6 weeks)

Median Percent of Tissue PR Positive

Median percent of tissue PR positive in matched tissue measured by Immunohistochemistry (IHC)

Time frame: Baseline and at Time of surgery (up to 6 weeks)

Data from ClinicalTrials.gov

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