Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05464810
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Letrozole — DRUG
    Given PO
  • Simvastatin — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Sep 2, 2022
Status verified
May 2025
Primary completion
Apr 15, 2026
Completion
Apr 15, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (letrozole, simvastatin)
    Patients receive letrozole PO QD and simvastatin PO QD for 14 days in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm II (letrozole)
    Patients receive letrozole PO QD for 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Mean percentage change in Ki-67 [ Time Frame: From pre-surgical baseline to 14 days following preoperative therapy ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Jody Ewing
[email protected]
678-843-7029
Ruth L. Sacks, MD (PRINCIPAL_INVESTIGATOR)
Emory University Hospital MidtownAtlantaGeorgia30308
Carlos E. Aguilera
[email protected]
404-778-4982
Ruth L. Sacks, MD (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Ashley Trumbull
[email protected]
404-778-3969
Ruth L. Sacks, MD (PRINCIPAL_INVESTIGATOR)
Grady Healthcare SystemAtlantaGeorgia30303
Ruth Sacks, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GAGrady Healthcare System· Atlanta, GA

Related Studies