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NCT01276704 · ClinicalTrials.gov registry record · Phase 2

Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer

A Phase 2 study, sponsored by Carol Fabian, MD.

Terminated
Registry status
Phase 2
Development phase
180
Enrollment target

NCT01276704: Clinical Trial Phase 2 study, sponsored by Carol Fabian, MD.

NCT01276704 is a Phase 2 study that was terminated before completion, run by Carol Fabian, MD. The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01276704, a Phase 2 study, was terminated before completion, sponsored by Carol Fabian, MD.

TERMINATED
Registry status
Phase 2
Development phase
180 participants
Enrollment target

Study Summary

The investigators will study the effect of 12 months of SDG (Brevail) vs placebo on women at increased risk for development of breast cancer.

Primary Outcome

Change over the course of study in the percent of breast epithelial cells expressing the proliferation marker Ki- 67/MIB-1 in hyperplastic benign breast tissue acquired by random periareolar fine needle aspiration pre-study and post-study.

Interventions

  • DRUG Placebo
  • DRUG secoisolariciresinol

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2011-01
Est. Completion 2017-07
Phase Phase 2
Carol Fabian, MD

14 total trials

Why NCT01276704 stopped before completion

NCT01276704 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01276704 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01276704 about?

NCT01276704 is a clinical study titled "Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer". The investigators will study the effect of 12 months of SDG (Brevail) vs placebo on women at increased risk for development of breast cancer.

What is the current status of trial NCT01276704?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2011-01. Estimated completion is 2017-07.

What interventions are being tested in trial NCT01276704?

The interventions under investigation include: Placebo (DRUG), secoisolariciresinol (DRUG).

Who is sponsoring clinical trial NCT01276704?

This trial is sponsored by Carol Fabian, MD, which has 14 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01276704's enrollment target sits among peer trials

180 365th of 2000 higher than 1,610 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01276704, the US trial registry maintained by the National Library of Medicine. NCT01276704 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.