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

Last updated: April 11, 2024
Sponsor: Johns Hopkins University
Overall Status: Completed

Phase

2

Condition

Breast Cancer

Cancer

Treatment

Tamoxifen Citrate

Blueprint

Letrozole

Clinical Study ID

NCT04129216
IRB00130428
  • Ages 18-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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).

Study Design

Total Participants: 30
Treatment Group(s): 5
Primary Treatment: Tamoxifen Citrate
Phase: 2
Study Start date:
February 20, 2019
Estimated Completion Date:
November 10, 2022

Study Description

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.

Connect with a study center

  • Johns Hopkins Bayview Hospital

    Baltimore, Maryland 21224
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.