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NCT01004172 · ClinicalTrials.gov registry record · Phase 2

Carboplatin and Bevacizumab for Progressive Breast Cancer Brain Metastases

A Phase 2 study, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 2
Development phase
38
Enrollment target

NCT01004172: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.

NCT01004172 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01004172, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target

Study Summary

The purpose of this research study is to determine how well the combination of bevacizumab and carboplatin works in treating breast cancer that has spread to the brain. Bevacizumab is an antibody (a protein that attacks a foreign substance in the body) that is made in the laboratory. Bevacizumab works differently from the way chemotherapy drugs work. Usually chemotherapy drugs attack fast growing cancer cells in the body. Bevacizumab works to slow or stop the growth of cells in cancer tumors by decreasing the blood supply to the tumors. When the blood supply is decreased, the tumors don't get the oxygen and nutrients they need to grow. Carboplatin is in a class of drugs known as platinum-containing compounds and has been approved for use in the treatment of ovarian cancer. Information from other research studies suggests that the combination of bevacizumab with carboplatin may be effective in treating breast cancer.

Primary Outcome

CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows: CNS complete response (CR) is achieved if all of the following are satisfied: * Complete resolution of all measurable (\>= 1 cm in longest dimension \[LD\]) and non-measurable brain metastases * No new CNS lesions (defined as any new lesion \>= 6 mm in LD) * Stable or decreasing steroid dose * No new/progressive tumor-related neurologic signs or symptoms * No progression of e

Interventions

  • DRUG carboplatin
  • DRUG bevacizumab
  • DRUG herceptin

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2009-11
Est. Completion 2017-02
Phase Phase 2
Dana-Farber Cancer Institute

781 total trials

What the finished NCT01004172 record still lists

NCT01004172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 3 interventions - of which carboplatin is the first listed.

NCT01004172 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01004172 about?

NCT01004172 is a clinical study titled "Carboplatin and Bevacizumab for Progressive Breast Cancer Brain Metastases". The purpose of this research study is to determine how well the combination of bevacizumab and carboplatin works in treating breast cancer that has spread to the brain. Bevacizumab is an antibody (a protein that attacks a foreign substance in the body) that is made in the laboratory. Bevacizumab wor...

What is the current status of trial NCT01004172?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2009-11. Estimated completion is 2017-02.

What interventions are being tested in trial NCT01004172?

The interventions under investigation include: carboplatin (DRUG), bevacizumab (DRUG), herceptin (DRUG).

Who is sponsoring clinical trial NCT01004172?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01004172's enrollment target sits among peer trials

38 1467th of 2000 higher than 517 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 NCT01004172, the US trial registry maintained by the National Library of Medicine. NCT01004172 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.