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

• Status: Recruiting
• Trial end date: 2021-11-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Agendia
• Treatments: Exemestane; Letrozole; Tamoxifen

Criteria

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).