search
Back to results

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

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tamoxifen Citrate
Letrozole
Exemestane
Blueprint
Mammaprint
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer focused on measuring breast cancer, genomic assay, hormone therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Johns Hopkins Bayview Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Tamoxifen arm

Letrozole arm

Exemestane arm

Arm Description

for premenopausal patients

for postmenopausal patients

for postmenopausal patients

Outcomes

Primary Outcome Measures

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.
Change in percent expression of Ki67 measured by single-gene read out
This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.

Secondary Outcome Measures

Change in the Mammaprint risk report
Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence).
Change in percent ER expression as measured by IHC
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.
Change in percent ER expression as measured by single-gene read out
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.
Change in percent PR expression as measured by IHC
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.
Change in percent PR expression as measured by single-gene read out
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.

Full Information

First Posted
May 17, 2019
Last Updated
November 11, 2022
Sponsor
Johns Hopkins University
Collaborators
Agendia
search

1. Study Identification

Unique Protocol Identification Number
NCT04129216
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
November 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Agendia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, genomic assay, hormone therapy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients will start the hormone therapy before surgery; the investigators look for the genomic profiles of the tumor before and after chemotherapy
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tamoxifen arm
Arm Type
Experimental
Arm Description
for premenopausal patients
Arm Title
Letrozole arm
Arm Type
Experimental
Arm Description
for postmenopausal patients
Arm Title
Exemestane arm
Arm Type
Experimental
Arm Description
for postmenopausal patients
Intervention Type
Drug
Intervention Name(s)
Tamoxifen Citrate
Other Intervention Name(s)
Soltamox
Intervention Description
10mg administered daily. Patients take this drug for 2-6 weeks
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara
Intervention Description
2.5mg is administered daily. Patients take this drug for 2-6 weeks
Intervention Type
Drug
Intervention Name(s)
Exemestane
Other Intervention Name(s)
Aromasin
Intervention Description
25mg is administered daily. Patients take this drug for 2-6 weeks.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blueprint
Intervention Description
studies the genomics of the tumor and tumor behavior
Intervention Type
Diagnostic Test
Intervention Name(s)
Mammaprint
Intervention Description
studies the genomics of the tumor
Primary Outcome Measure Information:
Title
Change in percent expression of Ki67 measured by immunohistochemistry (IHC)
Description
This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.
Time Frame
Baseline and at Time of surgery, up to 6 weeks
Title
Change in percent expression of Ki67 measured by single-gene read out
Description
This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.
Time Frame
Baseline and at Time of surgery, up to 6 weeks
Secondary Outcome Measure Information:
Title
Change in the Mammaprint risk report
Description
Mammaprint risk score is binary (high risk of recurrence or low risk of recurrence).
Time Frame
Baseline and at Time of surgery, up to 6 weeks
Title
Change in percent ER expression as measured by IHC
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.
Time Frame
Baseline and at Time of surgery, up to 6 weeks
Title
Change in percent ER expression as measured by single-gene read out
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.
Time Frame
Baseline and at Time of surgery, up to 6 weeks
Title
Change in percent PR expression as measured by IHC
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.
Time Frame
Baseline and at Time of surgery, up to 6 weeks
Title
Change in percent PR expression as measured by single-gene read out
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.
Time Frame
Baseline and at Time of surgery, up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehran Habibi, MD
Organizational Affiliation
Johns Hopkins Bayview
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs