Phase 2 N=30 Basic Science

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT04129216 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcome: Primary: Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC) — -3.6; -5.1; -4.2 Change in percentage expression of ki 67

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Tamoxifen Citrate (Drug); Letrozole (Drug); Exemestane (Drug); Blueprint (Diagnostic_test); Mammaprint (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Percent Expression of Ki67 Measured by Immunohistochemistry (IHC)	-3.6; -5.1; -4.2	—
SECONDARY Number of Participants With Low or High Score in MammaPrint	5; 7; 5; 5; 3; 5	—
SECONDARY Median Percent of Tissue ER Positive	98; 93; 95; 95; 95; 95	—
SECONDARY Median Percent of Tissue PR Positive	97; 33; 83; 90; 0; 7	—

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.

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04129216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.