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

NCT04129216 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: IRB00130428
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; genomic assay; hormone therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and at Time of surgery up to 6 weeks after the start of hormone therapy

Secondary Outcomes (3)

• Number of Participants With Low or High Score in MammaPrint

  Baseline and at Time of surgery (up to 6 weeks)

• Median Percent of Tissue ER Positive

  Baseline and at Time of surgery (up to 6 weeks)

• Median Percent of Tissue PR Positive

  Baseline and at Time of surgery (up to 6 weeks)

Study Arms (3)

Tamoxifen arm

EXPERIMENTAL

for premenopausal patients

Drug: Tamoxifen Citrate; Diagnostic Test: Blueprint; Diagnostic Test: Mammaprint

Letrozole arm

EXPERIMENTAL

for postmenopausal patients

Drug: Letrozole; Diagnostic Test: Blueprint; Diagnostic Test: Mammaprint

Exemestane arm

EXPERIMENTAL

for postmenopausal patients

Drug: Exemestane; Diagnostic Test: Blueprint; Diagnostic Test: Mammaprint

Interventions

Tamoxifen Citrate DRUG

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

Also known as: Soltamox

Tamoxifen arm

Letrozole DRUG

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

Also known as: Femara

Letrozole arm

Exemestane DRUG

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

Also known as: Aromasin

Exemestane arm

Blueprint DIAGNOSTIC_TEST

studies the genomics of the tumor and tumor behavior

Exemestane arm; Letrozole arm; Tamoxifen arm

Mammaprint DIAGNOSTIC_TEST

studies the genomics of the tumor

Exemestane arm; Letrozole arm; Tamoxifen arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• Agendia: collaborator

Study Sites (1)

Johns Hopkins Bayview Hospital

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Suman VJ, Ellis MJ, Ma CX. The ALTERNATE trial: assessing a biomarker driven strategy for the treatment of post-menopausal women with ER+/Her2- invasive breast cancer. Chin Clin Oncol. 2015 Sep;4(3):34. doi: 10.3978/j.issn.2304-3865.2015.09.01.

  PMID: 26408301 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; Letrozole; exemestane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

small number of participants

Results Point of Contact

• Title: Dr. Mehran Habibi
• Organization: Johns Hopkins University

mhabibi2@jhmi.edu

4105505522

Study Officials

• Mehran Habibi, MD

  Johns Hopkins Bayview

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will start the hormone therapy before surgery; the investigators look for the genomic profiles of the tumor before and after chemotherapy

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: October 16, 2019
• Study Start: February 20, 2019
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: May 7, 2024
• Results First Posted: May 7, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)