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NCT Number: NCT04129216

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Bayview Hospital

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

tamoxifen citrate

Drug

10mg administered daily. Patients take this drug for 2-6 weeks

Other names: Soltamox

letrozole

Drug

2.5mg is administered daily. Patients take this drug for 2-6 weeks

Other names: Femara

Exemestane

Drug

25mg is administered daily. Patients take this drug for 2-6 weeks.

Other names: Aromasin

Blueprint

Diagnostic Test

studies the genomics of the tumor and tumor behavior

Mammaprint

Diagnostic Test

studies the genomics of the tumor

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Agendia

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 16, 2019
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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