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NCT03324425 · ClinicalTrials.gov registry record · Phase 2

Simvastatin Plus Dual Anti-HER2 Therapy for Metastatic Breast Cancer

A Phase 2 study of Breast Cancer Stage IV, sponsored by Baylor Breast Care Center.

Active
Registry status
Phase 2
Development phase
5
Enrollment target
2
Study locations

NCT03324425: Active Phase 2 study of Breast Cancer Stage IV, sponsored by Baylor Breast Care Center.

NCT03324425 is a Phase 2 study of Breast Cancer Stage IV that is active but no longer recruiting, run by Baylor Breast Care Center. The registered enrollment target is 5 participants, below the 51-participant average among 10 other Breast Cancer Stage IV trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03324425, a Phase 2 study of Breast Cancer Stage IV, is active but no longer recruiting, sponsored by Baylor Breast Care Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
5 participants
Enrollment target
2
Study locations

Study Summary

This study recruits patients with metastatic breast cancer who have progressed on their current regimen of dual anti-HER2 therapy. This study evaluates whether or not the addition of simvastatin to the dual anti-HER2 therapy regimen helps make the tumor respond to the anti-HER2 therapy again. All participants will receive simvastatin in combination with their current anti-HER2 therapy regimen.

Primary Outcome

Objective response is defined as complete response or partial response, according to RECIST criteria.

Conditions Studied

Interventions

  • DRUG Simvastatin 80mg

Study Locations (2)

Texas

  • Harris Health System - Smith Clinic - Houston
  • O'Quinn Medical Tower - McNair Campus; Dan L Duncan Comprehensive Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2020-03-04
Est. Completion 2030-12
Phase Phase 2
Baylor Breast Care Center

15 total trials

What the registry record for NCT03324425 still lists

NCT03324425 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 51-participant average among 10 other Breast Cancer Stage IV trials with a reported enrollment target (90% lower).

The record links to 1 condition, with Breast Cancer Stage IV appearing as the primary indexed condition, and to 1 intervention - of which Simvastatin 80mg is the first listed.

NCT03324425 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT03324425 about?

NCT03324425 is a clinical study titled "Simvastatin Plus Dual Anti-HER2 Therapy for Metastatic Breast Cancer". This study recruits patients with metastatic breast cancer who have progressed on their current regimen of dual anti-HER2 therapy. This study evaluates whether or not the addition of simvastatin to the dual anti-HER2 therapy regimen helps make the tumor respond to the anti-HER2 therapy again. All pa...

What is the current status of trial NCT03324425?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2020-03-04. Estimated completion is 2030-12.

What conditions does trial NCT03324425 study?

This clinical trial studies the following conditions: Breast Cancer Stage IV.

What interventions are being tested in trial NCT03324425?

The interventions under investigation include: Simvastatin 80mg (DRUG).

Who is sponsoring clinical trial NCT03324425?

This trial is sponsored by Baylor Breast Care Center, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03324425 being conducted?

This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer Stage IV

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03324425's enrollment target sits among peer trials

5 11th of 10 the lowest of 10 other Breast Cancer Stage IV trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer Stage IV 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 NCT03324425, the US trial registry maintained by the National Library of Medicine. NCT03324425 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.