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

Recruiting Early Phase 1 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Emory University · Other
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About This Trial
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 ef…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age \>= 18 years * Biopsy proven hormone receptor positive, HER2 negative stage I-III invasive breast cancer * Estrogen receptor (ER) and/or progesterone receptor (PR) positivity are defined as \>= 10% of cells expressing hormonal receptors via IHC analysis * HER2 negativ…
Contacts

Ruth L. Sacks, MD

404-778-1345

ruth.lauren.sacks@emory.edu

CONTACT