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NCT00520975 · ClinicalTrials.gov registry record · Phase 3

Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU

A Phase 3 study, sponsored by National Cancer Institute (NCI).

Terminated
Registry status
Phase 3
Development phase
96
Enrollment target

NCT00520975: Clinical Trial Phase 3 study, sponsored by National Cancer Institute (NCI).

NCT00520975 is a Phase 3 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 96 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00520975, a Phase 3 study, was terminated before completion, sponsored by National Cancer Institute (NCI).

TERMINATED
Registry status
Phase 3
Development phase
96 participants
Enrollment target

Study Summary

This randomized phase III trial studies first-line chemotherapy and trastuzumab to compare how well they work when given with or without bevacizumab in treating patients with breast cancer that overexpresses human epidermal growth factor receptor 2 (HER-2/NEU) and has spread to other areas of the body. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether giving first-line chemotherapy together with trastuzumab is more effective with or without bevacizumab in treating patients with metastatic breast cancer that overexpresses HER-2/NEU.

Primary Outcome

Progression-free survival (PFS) was defined as time from date of randomization to first disease progression, new second breast primaries, or to death from any cause, whichever occurred first, otherwise cases were censored at date last documented to be free of progression. Disease progression was defined using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesi

Interventions

  • DRUG Carboplatin
  • OTHER Placebo
  • DRUG Paclitaxel
  • BIOLOGICAL Bevacizumab
  • BIOLOGICAL Trastuzumab

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2007-11
Est. Completion 2015-10
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

Why NCT00520975 stopped before completion

NCT00520975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.

NCT00520975 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00520975 about?

NCT00520975 is a clinical study titled "Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU". This randomized phase III trial studies first-line chemotherapy and trastuzumab to compare how well they work when given with or without bevacizumab in treating patients with breast cancer that overexpresses human epidermal growth factor receptor 2 (HER-2/NEU) and has spread to other areas of the bo...

What is the current status of trial NCT00520975?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 96 participants. The study started on 2007-11. Estimated completion is 2015-10.

What interventions are being tested in trial NCT00520975?

The interventions under investigation include: Carboplatin (DRUG), Placebo (OTHER), Paclitaxel (DRUG), Bevacizumab (BIOLOGICAL), Trastuzumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00520975?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00520975's enrollment target sits among peer trials

96 1718th of 2000 higher than 282 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00520975, the US trial registry maintained by the National Library of Medicine. NCT00520975 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.