Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Octreotide.

It had two arms (groups): Octreotide treatment (experimental) and No Octreotide treatment (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 62 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed written informed consent. Females age \>=18 years old. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy of at least 12 weeks. Able to swallow and retain oral medications.

The full record lists 14 inclusion and 11 exclusion criteria; among the exclusions: concurrent treatment with an investigational agent or concurrent participation in another clinical study; treatment with octreotide within the 3 months prior to randomization; concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy (including an epidermal growth factor receptor (egfr) and/or her2 inhibitor), or hormonal therapy for treatment of cancer.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Octreotide study did not mask who received what.

It started in 2014-12-17 with completion listed for 2017-10-19.

It ran at 17 sites in Russia (8), United Kingdom (4), Poland (3), Czechia (1) and Israel (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion of Subjects Experiencing Diarrhoea of Grade 2 and Above (up to 24 Weeks) (time frame: Up to 24 weeks).

It also tracked 19 secondary outcomes, for example Proportion of Subjects Experiencing Diarrhoea of Grade 3 and Above (up to 24 Weeks), Proportion of Subjects Experiencing Diarrhoea of Any Grade of Severity (up to 24 Weeks), Duration of Diarrhoea of Any Grade of Severity, Time to Onset of the First Episode of Diarrhoea of Any Grade of Severity, Proportion of Subjects Taking Anti-diarrhoeal Medication and Proportion of Subjects Who Had Unscheduled Visits to Healthcare Professionals Due to Diarrhoea.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 62 people.

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

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