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

April 11, 2024 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tamoxifen arm
for premenopausal patients
Drug: Tamoxifen Citrate
10mg administered daily. Patients take this drug for 2-6 weeks
Other Names:
  • Soltamox
Diagnostic test: Blueprint
studies the genomics of the tumor and tumor behavior
Diagnostic test: Mammaprint
studies the genomics of the tumor
Experimental: Letrozole arm
for postmenopausal patients
Diagnostic test: Blueprint
studies the genomics of the tumor and tumor behavior
Diagnostic test: Mammaprint
studies the genomics of the tumor
Drug: Letrozole
2.5mg is administered daily. Patients take this drug for 2-6 weeks
Other Names:
  • Femara
Experimental: Exemestane arm
for postmenopausal patients
Diagnostic test: Blueprint
studies the genomics of the tumor and tumor behavior
Diagnostic test: Mammaprint
studies the genomics of the tumor
Drug: Exemestane
25mg is administered daily. Patients take this drug for 2-6 weeks.
Other Names:
  • Aromasin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Agendia

Investigators

  • Principal Investigator: Mehran Habibi, MD, Johns Hopkins Bayview

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2019

Primary Completion (Actual)

November 10, 2022

Study Completion (Actual)

November 10, 2022

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00130428

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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