Insulin-like growth factor-I inhibition with pasireotide decreases cell proliferation and increases apoptosis in pre-malignant lesions of the breast: a phase 1 proof of principle trial

What Was Tested

The paper reports a study of Somatostatin and Pasireotide, published as a clinical trial, phase i.

NCT01372644 Trial date: July 1, 2007.

Who Took Part

The abstract describes 13 women taking part.

By PubMed's age tags, the people studied were middle-aged adults, women only.

In total, 13 women with core breast biopsies diagnostic of atypical hyperplasia (AH) were treated for 10 days with pasireotide, a somatostatin analog which uniquely inhibits IGF-I action in the mammary gland.

They then had excision biopsies. 12 patients also had proliferative lesions and one a ductal carcinoma in situ (DCIS).

How the Study Was Run

The methods mention a period of 10 days.

Primary outcomes were changes in cell proliferation and apoptosis after treatment.

Expression of estrogen receptor (ER), progesterone receptor (PR), and phosphorylated Insulin-like growth factor I receptor (IGF-1R), protein kinase B (AKT) and extracellular signal-regulated kinases 1/2 (ERK1/2) were also assessed.

Hyperglycemia and other side effects were carefully monitored.

What Was Measured

The subject headings attached to it are Apoptosis, Breast, Breast Neoplasms, Carcinoma in Situ, Carcinoma, Intraductal, Noninfiltrating, Cell Proliferation and Hyperplasia.

What This Means in Plain Language

This is a clinical trial, phase i of Somatostatin and Pasireotide in 13 women over 10 days.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Its findings take up roughly 8 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2014 (Breast cancer research : BCR), a journal based in England.

More context: the Somatostatin compound page and the Pasireotide compound page, all human trials.