Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor

What Was Tested

This registered phase 1, phase 2 trial tested Pasireotide.

This will be a proof of principle clinical trial to evaluate the use of pasireotide (SOM230) in women with ductal carcinoma in situ (DCIS) of the breast.

Unfortunately, treatment with antiestrogens carries potential serious side effects and toxicities that are intolerable to some patients.

It had 1 arm (groups): SOM 230/Pasireotide (experimental).

The registry classes the interventions as drug.

More on the Plan

Unfortunately, treatment with antiestrogens carries potential side effects and toxicities.

The investigators have data that indicate that IGF-I also has direct actions on the breast that are independent of steroid hormones.

One example is that IGF-I has a direct stimulatory effect on mammary development in the absence of E2.

Additionally, IGF-I has effects on ER-negative tumor cell lines that can be reversed by IGF-I inhibition.

Who Took Part

The registry lists 9 actual participants took part.

It was open to women only aged from 21 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 21 years of age and older. Must sign informed consent, witnessed, and dated prior to entry. The participant has breast biopsy consistent with Ductal Carcinoma in situ (DCIS). Performance Status: ECOG 0-1 unless mobility is limited from chronic physical handicap. No clinical evidence of other malignancies (except Basal Cell carcinoma).

The full record lists 11 inclusion and 23 exclusion criteria; among the exclusions: less than 21 years of age; known invasive breast cancer of any type; bilateral prophylactic mastectomy.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Pasireotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-06 with completion listed for 2015-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Cell Proliferation and Apoptosis (time frame: Before and after 20 days of treatment).

It also tracked 2 secondary outcomes, for example Effect of SOM 230 / Pasireotide on Tumor Volume and Tumor Kinetics and Hyperglycemia.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Pasireotide in 9 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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