A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Ca… (NCT03962647) | Clinical Trial Compass
CompletedEarly Phase 1
A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer
United States31 participantsStarted 2019-07-08
Plain-language summary
This is a neoadjuvant study to determine the feasibility and tolerability of 2 weeks of a very low carbohydrate ketogenic diet in combination with letrozole for patients with early stage operable ER+disease.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* All participants must provide written informed consent.
* Patients must have histologically confirmed primary invasive mammary carcinoma
* The tumor must be estrogen receptor positive
* The tumor must be HER2 negative (negative IHC or FISH)
* The primary tumor size must be at least 2 mm in size.
* Patients must be post-menopausal defined by any of the following:
* Subjects at least 55 years of age.
* Subjects younger than 55 years of age and amenorrheic for at least 12 months or serum follicle-stimulating hormone (FSH) levels and estradiol levels in the post-menopausal range by local lab criteria
* Subjects with history of bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 months.
* Patients must have clinical stage I, II, or III invasive mammary carcinoma planning to undergo surgical treatment with either segmental resection or total mastectomy.
* Patients must have BMI \>= 30.
* A core biopsy from the time of diagnosis must be available.
* Mammogram or ultrasound required prior to screening
* Patients must have adequate organ function based on the following laboratory parameters:
* Serum creatinine \<= 1.5x ULN
* SGOT, SGPT \<= 4x ULN (unless known steatohepatitis)
* Serum albumin \>= 2.0 g/dL
* Total serum bilirubin \<= 1.5x ULN (or \<= 3x ULN if known Gilbert's syndrome)
Exclusion Criteria:
Patients with locally advanced disease who are candidates for other preoperative (chemo)therapy at the …