Clinical Trials /

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

NCT04129216

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.

Related Conditions:
  • Breast Invasive Ductal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • Breast Cancer

Interventions

DrugSynonymsArms
Tamoxifen CitrateSoltamoxTamoxifen arm
LetrozoleFemaraLetrozole arm
ExemestaneAromasinExemestane 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

NameTypeDescriptionInterventions
Tamoxifen armExperimentalfor premenopausal patients
  • Tamoxifen Citrate
Letrozole armExperimentalfor postmenopausal patients
  • Letrozole
Exemestane armExperimentalfor postmenopausal patients
  • Exemestane

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 score
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

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