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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129216
• Other study ID #: IRB00130428
• Status: Completed
• Phase: Phase 2
• Start date: February 20, 2019
• Est. completion date: November 10, 2022

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 10, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tamoxifen Citrate
10mg administered daily. Patients take this drug for 2-6 weeks
• Letrozole
2.5mg is administered daily. Patients take this drug for 2-6 weeks
• Exemestane
25mg is administered daily. Patients take this drug for 2-6 weeks.

Diagnostic Test:
• Blueprint
studies the genomics of the tumor and tumor behavior
• Mammaprint
studies the genomics of the tumor

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Agendia

Country where clinical trial is conducted

United States, 

References & Publications (1)

Suman VJ, Ellis MJ, Ma CX. The ALTERNATE trial: assessing a biomarker driven strategy for the treatment of post-menopausal women with ER+/Her2- invasive breast cancer. Chin Clin Oncol. 2015 Sep;4(3):34. doi: 10.3978/j.issn.2304-3865.2015.09.01. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy
Secondary	Number of Participants With Low or High Score in MammaPrint	Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence).	Baseline and at Time of surgery (up to 6 weeks)
Secondary	Median Percent of Tissue ER Positive	Median percent of tissue ER positive in matched tissue measured by Immunohistochemistry (IHC)	Baseline and at Time of surgery (up to 6 weeks)
Secondary	Median Percent of Tissue PR Positive	Median percent of tissue PR positive in matched tissue measured by Immunohistochemistry (IHC)	Baseline and at Time of surgery (up to 6 weeks)