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NCT01038804 · ClinicalTrials.gov registry record · Phase 2

A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer

A Phase 2 study, sponsored by Astellas Pharma.

Completed
Registry status
Phase 2
Development phase
101
Enrollment target

NCT01038804: Completed Phase 2 study, sponsored by Astellas Pharma.

NCT01038804 is a Phase 2 study that has completed, run by Astellas Pharma. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01038804, a Phase 2 study, has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 2
Development phase
101 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.

Interventions

  • DRUG Docetaxel
  • DRUG YM155

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2009-12
Est. Completion 2013-06
Phase Phase 2
Astellas Pharma

165 total trials

What the finished NCT01038804 record still lists

NCT01038804 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).

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

NCT01038804 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01038804 about?

NCT01038804 is a clinical study titled "A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer". The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.

What is the current status of trial NCT01038804?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2009-12. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01038804?

The interventions under investigation include: Docetaxel (DRUG), YM155 (DRUG).

Who is sponsoring clinical trial NCT01038804?

This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01038804's enrollment target sits among peer trials

101 672nd of 2000 higher than 1,329 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 NCT01038804, the US trial registry maintained by the National Library of Medicine. NCT01038804 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.