Description:
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.
Title
- Brief Title: The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
- Official Title: The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
IRB00130428
- NCT ID:
NCT04129216
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Tamoxifen Citrate | Soltamox | Tamoxifen arm |
| Letrozole | Femara | Letrozole arm |
| Exemestane | Aromasin | Exemestane arm |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Tamoxifen arm | Experimental | for premenopausal patients | |
| Letrozole arm | Experimental | for postmenopausal patients | |
| Exemestane arm | Experimental | for postmenopausal patients | |
Eligibility 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).
| Maximum Eligible Age: | 90 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Change in percent expression of Ki67 measured by immunohistochemistry (IHC) |
| Time Frame: | Baseline and at Time of surgery, up to 6 weeks |
| Safety Issue: | |
| Description: | This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery. |
Secondary Outcome Measures
| Measure: | Change in the Mammaprint risk report |
| Time Frame: | Baseline and at Time of surgery, up to 6 weeks |
| Safety Issue: | |
| Description: | Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence). |
| Measure: | Change in percent ER expression as measured by IHC |
| Time Frame: | Baseline and at Time of surgery, up to 6 weeks |
| Safety Issue: | |
| Description: | Units for Estrogen Receptor protein expression are percent based. >10 percent is positive, <1 percent is negative. 1-10 percent is weakly positive or focally positive. |
| Measure: | Change in percent ER expression as measured by single-gene read out |
| Time Frame: | Baseline and at Time of surgery, up to 6 weeks |
| Safety Issue: | |
| Description: | Units for Estrogen Receptor protein expression are percent based. >10 percent is positive, <1 percent is negative. 1-10 percent is weakly positive or focally positive. |
| Measure: | Change in percent PR expression as measured by IHC |
| Time Frame: | Baseline and at Time of surgery, up to 6 weeks |
| Safety Issue: | |
| Description: | Units for Progesterone Receptor protein expression are percent based. >10 percent is positive, <1 percent is negative. 1-10 percent is weakly positive or focally positive. |
| Measure: | Change in percent PR expression as measured by single-gene read out |
| Time Frame: | Baseline and at Time of surgery, up to 6 weeks |
| Safety Issue: | |
| Description: | Units for Progesterone Receptor protein expression are percent based. >10 percent is positive, <1 percent is negative. 1-10 percent is weakly positive or focally positive. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Johns Hopkins University |
Trial Keywords
- breast cancer
- genomic assay
- hormone therapy
Last Updated
December 17, 2020
