This randomized early phase I trial studies the effect of omega-3 fatty acid and/or letrozole on hormone levels in obese patients with newly diagnosed estrogen receptor positive breast cancer before surgery. Anti-inflammatory fish oils, called omega-3 fatty acids, are a type of fat obtained in the diet and involved in immunity and may block the effect of obesity on estrogen and tumor regrowth by blocking the production of estrogen to prevent the regrowth of breast cancer and reduce swelling and inflammation from substances produced in the body. Estrogen can cause the growth of breast cancer cells. Letrozole may help fight breast cancer by lowering the amount of estrogen made by the body. It is not yet known whether omega-3 fatty acid or letrozole alone, or the combination of both is better in reducing hormone levels in obese patients with estrogen receptor positive breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02538484.
PRIMARY OBJECTIVES:
I. Assess the impact of dietary omega-3 free fatty acids (FFA) or pharmacological letrozole aromatase inhibitor on:
Ia. Patient serum-induced expression of prostaglandin E2 (PGE2) and aromatase by neoplastic mammary epithelial cells.
Ib. Circulating levels of pro-inflammatory cytokines (i.e. interleukin [IL]-6, tumor necrosis factor-alpha [TNF-alpha], insulin-like growth factor [IGF]-1), steroids (i.e. estrogen and testosterone) and lipids (omega-6 and omega-3 polyunsaturated fatty acids [PUFAs]).
Ic. Wound healing complication rate.
Id. Seroma.
Ie. Hematoma.
If. Delayed wound healing (3+ days).
Ig. Partial Areola necrosis.
Ih. Complete areola necrosis.
Ig. Other.
Ih. Surgical site infection rate.
Ii. Blood loss during surgical intervention.
Ij. Superficial surgical site infection (SSI).
Ik. Deep incisional SSI.
Il. Organ/space SSI.
Im. None.
In. other.
SECONDARY OBJECTIVE:
I. Correlation for body mass index impact on response to cyclooxygenase (COX)2 inhibition.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive letrozole orally (PO) once daily (QD) for 30 days.
ARM II: Patients receive omega-3 fatty acids PO twice daily (BID) for 30 days.
ARM III: Patients receive letrozole PO QD and omega 3 fatty acids PO BID for 30 days.
In all arms, patients with a minimum exposure of 14 days of treatment undergo surgery.
After completion of study, patients are followed up at 2 weeks.
Lead OrganizationCancer Therapy and Research Center at The UT Health Science Center at San Antonio
Principal InvestigatorAndrew Jacob Brenner
