Letrozole for HER2-Negative Breast Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Emory University Hospital/Winship Cancer Institute, Atlanta, GA
HER2-Negative Breast Carcinoma+7 More
Letrozole - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This early phase I trial tests whether letrozole with simvastatin works better than letrozole alone to stop tumor cell proliferation in patients with stage I-III hormone receptor positive, HER2 negative invasive breast cancer. Letrozole and simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The addition of simvastatin to letrozole may be more effective at stopping the growth of cancer cells than letrozole alone.

Eligible Conditions

  • HER2-Negative Breast Carcinoma
  • Anatomic Stage 1 Breast Cancer AJCC v8
  • Hormone Receptor-Positive Breast Carcinoma
  • Anatomic Stage III Breast Cancer AJCC v8
  • Invasive Breast Carcinoma
  • Anatomic Stage II Breast Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for HER2-Negative Breast Carcinoma

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Through study completion, an average of 1 year

Day 14
Mean percentage change in Ki-67
Year 1
Change in the level of the following immune biomarkers: Percentage of CD8+ T cells, percentage of FOXp3 Treg cells, ratio of CD8+/Treg ratio
Changes in HMG-CoA reductase immunohistochemistry (IHC) expression in the tumor tissue
Changes in the level of immune activation in the blood using blood-based biomarkers (CRP, IL-6, IL-10, TGF-beta, TNF-alpha)
Changes in total cholesterol levels in the blood
Response per Ki-67
Day 30
Incidence of adverse events
Patient-Reported Outcomes Measurement Information System (PROMIS) for pain

Trial Safety

Safety Progress

1 of 3

Other trials for HER2-Negative Breast Carcinoma

Trial Design

2 Treatment Groups

Arm II (letrozole)
1 of 2
Arm I (letrozole, simvastatin)
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Letrozole · No Placebo Group · Phase < 1

Arm I (letrozole, simvastatin)Experimental Group · 2 Interventions: Simvastatin, Letrozole · Intervention Types: Drug, Drug
Arm II (letrozole)
Drug
ActiveComparator Group · 1 Intervention: Letrozole · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Simvastatin
2012
Completed Phase 4
~1270
Letrozole
2005
Completed Phase 4
~4490

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Trial Background

Ruth Sacks, Principal Investigator
Principal Investigator
Emory University
Closest Location: Emory University Hospital/Winship Cancer Institute · Atlanta, GA
Photo of Atlanta  1Photo of Atlanta  2Photo of Atlanta  3
2013First Recorded Clinical Trial
2 TrialsResearching HER2-Negative Breast Carcinoma
48 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
HER2 is positive if tested by local laboratory assessment.
You have HER2 non-amplified (ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell) IHC
You have a Ki-67 IHC expression of ≥ 10% on tumor tissue.
You are post-menopausal.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.