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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Tamoxifen Citrate; Drug: Letrozole; Drug: Exemestane; Diagnostic Test: Blueprint; Diagnostic Test: Mammaprint

• Registration Number: NCT04129216
• Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-02-20
• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-16
• Primary Completion: 2022-11-10
• Study Completion: 2022-11-10
• Results First Submitted: 2023-11-10
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Results First Posted: 2024-05-07
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamoxifen arm	Tamoxifen Citrate	for premenopausal patients
Letrozole arm	Blueprint	for postmenopausal patients
Tamoxifen arm	Mammaprint	for premenopausal patients
Exemestane arm	Mammaprint	for postmenopausal patients
Tamoxifen arm	Blueprint	for premenopausal patients
Letrozole arm	Mammaprint	for postmenopausal patients
Exemestane arm	Blueprint	for postmenopausal patients
Letrozole arm	Letrozole	for postmenopausal patients
Exemestane arm	Exemestane	for postmenopausal patients

Primary Outcome Measures

Name	Time	Method
Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)	Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy	This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.

Secondary Outcome Measures

Name	Time	Method
Median Percent of Tissue ER Positive	Baseline and at Time of surgery (up to 6 weeks)	Median percent of tissue ER positive in matched tissue measured by Immunohistochemistry (IHC)
Median Percent of Tissue PR Positive	Baseline and at Time of surgery (up to 6 weeks)	Median percent of tissue PR positive in matched tissue measured by Immunohistochemistry (IHC)
Number of Participants With Low or High Score in MammaPrint	Baseline and at Time of surgery (up to 6 weeks)	Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence).

Trial Locations

Locations (1)

Johns Hopkins Bayview Hospital; 🇺🇸 Baltimore, Maryland, United States