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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04129216
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Collaborator:
Agendia
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Tamoxifen Citrate Drug: Letrozole Drug: Exemestane Diagnostic Test: Blueprint Diagnostic Test: Mammaprint Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : November 26, 2020
Estimated Study Completion Date : November 26, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tamoxifen arm
for premenopausal patients
Drug: Tamoxifen Citrate
10mg administered daily. Patients take this drug for 2-6 weeks
Other Name: 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
Drug: Letrozole
2.5mg is administered daily. Patients take this drug for 2-6 weeks
Other Name: Femara

Diagnostic Test: Blueprint
studies the genomics of the tumor and tumor behavior

Diagnostic Test: Mammaprint
studies the genomics of the tumor

Experimental: Exemestane arm
for postmenopausal patients
Drug: Exemestane
25mg is administered daily. Patients take this drug for 2-6 weeks.
Other Name: Aromasin

Diagnostic Test: Blueprint
studies the genomics of the tumor and tumor behavior

Diagnostic Test: Mammaprint
studies the genomics of the tumor




Primary Outcome Measures :
  1. Change in percent expression of Ki67 measured by immunohistochemistry (IHC) [ Time Frame: Baseline and at Time of surgery, up to 6 weeks ]
    This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.

  2. Change in percent expression of Ki67 measured by single-gene read out [ Time Frame: Baseline and at Time of surgery, up to 6 weeks ]
    This is a measure of tumor proliferation, and will be determined at baseline and at time of surgery.


Secondary Outcome Measures :
  1. Change in the Mammaprint risk score [ 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).

  2. Change in percent ER expression as measured by IHC [ Time Frame: Baseline and at Time of surgery, up to 6 weeks ]
    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.

  3. Change in percent ER expression as measured by single-gene read out [ Time Frame: Baseline and at Time of surgery, up to 6 weeks ]
    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.

  4. Change in percent PR expression as measured by IHC [ Time Frame: Baseline and at Time of surgery, up to 6 weeks ]
    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.

  5. Change in percent PR expression as measured by single-gene read out [ Time Frame: Baseline and at Time of surgery, up to 6 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129216


Contacts
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Contact: Mehran Habibi, MD 4105501226 mhabibi2@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Bayview Hospital Recruiting
Baltimore, Maryland, United States, 21224
Contact: Mehran Habibi, MD    410-550-1226    mhabibi2@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Agendia
Investigators
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Principal Investigator: Mehran Habibi, MD Johns Hopkins Bayview

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04129216    
Other Study ID Numbers: IRB00130428
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Johns Hopkins University:
breast cancer
genomic assay
hormone therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Letrozole
Exemestane
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents