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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04129216

Run by

Johns Hopkins University

People needed

30

Starts

2019-02-20

Expected to finish

2022-11-10

Last updated by the study team

2024-05-07

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Johns Hopkins Bayview Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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