The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Tamoxifen arm
for premenopausal patients
Intervention: Tamoxifen Citrate (Drug)
Tamoxifen arm
for premenopausal patients
Intervention: Blueprint (Diagnostic Test)
Tamoxifen arm
for premenopausal patients
Intervention: Mammaprint (Diagnostic Test)
Letrozole arm
for postmenopausal patients
Intervention: Letrozole (Drug)
Letrozole arm
for postmenopausal patients
Intervention: Blueprint (Diagnostic Test)
Letrozole arm
for postmenopausal patients
Intervention: Mammaprint (Diagnostic Test)
Exemestane arm
for postmenopausal patients
Intervention: Exemestane (Drug)
Exemestane arm
for postmenopausal patients
Intervention: Blueprint (Diagnostic Test)
Exemestane arm
for postmenopausal patients
Intervention: Mammaprint (Diagnostic Test)
Outcomes
Primary Outcomes
Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)
Time Frame: 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 Outcomes
- Median Percent of Tissue PR Positive(Baseline and at Time of surgery (up to 6 weeks))
- Median Percent of Tissue ER Positive(Baseline and at Time of surgery (up to 6 weeks))
- Number of Participants With Low or High Score in MammaPrint(Baseline and at Time of surgery (up to 6 weeks))