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NCT01194869 · ClinicalTrials.gov registry record · Phase 2

Preoperative Trial of Sorafenib in Combination With Cisplatin Followed by Paclitaxel for Early Stage Breast Cancer

A Phase 2 study, sponsored by Emory University.

Terminated
Registry status
Phase 2
Development phase
25
Enrollment target

NCT01194869: Clinical Trial Phase 2 study, sponsored by Emory University.

NCT01194869 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01194869, a Phase 2 study, was terminated before completion, sponsored by Emory University.

TERMINATED
Registry status
Phase 2
Development phase
25 participants
Enrollment target

Study Summary

The purpose of this study is to identify new treatment regimens with better response rates and to find out if the combination of cisplatin and sorafenib followed by paclitaxel and sorafenib can shrink the size of your breast tumor and allow you to preserve your breast. Sorafenib is a newer drug that targets blood vessel formation and may help the chemotherapy work better. Additionally, by receiving chemotherapy before surgery, we will be able to determine if your cancer is responsive to chemotherapy.

Primary Outcome

Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.

Interventions

  • DRUG Cisplatin
  • DRUG Paclitaxel
  • DRUG Sorafenib

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2010-06
Est. Completion 2015-06
Phase Phase 2
Emory University

1,208 total trials

Why NCT01194869 stopped before completion

NCT01194869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).

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

NCT01194869 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01194869 about?

NCT01194869 is a clinical study titled "Preoperative Trial of Sorafenib in Combination With Cisplatin Followed by Paclitaxel for Early Stage Breast Cancer". The purpose of this study is to identify new treatment regimens with better response rates and to find out if the combination of cisplatin and sorafenib followed by paclitaxel and sorafenib can shrink the size of your breast tumor and allow you to preserve your breast. Sorafenib is a newer drug that...

What is the current status of trial NCT01194869?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2010-06. Estimated completion is 2015-06.

What interventions are being tested in trial NCT01194869?

The interventions under investigation include: Cisplatin (DRUG), Paclitaxel (DRUG), Sorafenib (DRUG).

Who is sponsoring clinical trial NCT01194869?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01194869's enrollment target sits among peer trials

25 1719th of 2000 higher than 245 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 NCT01194869, the US trial registry maintained by the National Library of Medicine. NCT01194869 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.