Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations

Plain-language guide to NCT00700778: not phased interventional trial of hCG (human chorionic gonadotropin), 2 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00700778
Phase: not phased
Status: terminated early
Start: 2008-07
Completion (planned or actual): 2014-03
Participants: 2 (actual)
Design: na, open label (everyone knows who gets what), prevention
Conditions studied: BRCA1 Mutation; Breast Cancer
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around hCG (human chorionic gonadotropin).

It had 1 arm (groups): Recombinant human chorionic gonadotropin (experimental).

Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.

The registry classes the interventions as biological, genetic, other and procedure.

More on the Plan

OUTLINE: Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly.

Treatment continues weekly for 90 days in the absence of unacceptable toxicity.

Benign breast tissue specimens are collected by core needle biopsy at baseline, day 90, and day 270.

Tissue samples are analyzed by cytopathology for epithelial normality, Ki67 immunohistochemical staining for cell proliferation, cDNA microarray for gene expression, and serum studies for hormone levels and biomarker determinations.

Who Took Part

Enrollment: 2 actual participants took part.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: Asymptomatic women who have a deleterious mutation on the BRCA1 gene. Normal, no complaints, no evidence of disease. Nulliparous, never pregnant (G0P0). No known brain metastases. Hormone receptor status not specified.

The full record lists 35 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

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

It started in 2008-07 with completion listed for 2014-03.

It ran at 3 sites in United States (2) and Austria (1).

Its stated primary purpose is prevention.

What This Means in Plain Language

Put simply, this is a not phased trial of hCG (human chorionic gonadotropin) in 2 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 hCG (human chorionic gonadotropin) compound page, all human trials.

Our Notes on the Compound

hCG (human chorionic gonadotropin): An LH analog that drives Leydig-cell testosterone production.

hCG (human chorionic gonadotropin) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.