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NCT00503750 · ClinicalTrials.gov registry record · Phase 2

Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™)

A Phase 2 study of Breast Cancer, sponsored by Emory University.

Completed
Registry status
Phase 2
Development phase
27
Enrollment target
2
Study locations

NCT00503750: Completed Phase 2 study of Breast Cancer, sponsored by Emory University.

NCT00503750 is a Phase 2 study of Breast Cancer that has completed, run by Emory University. The registered enrollment target is 27 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% 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

NCT00503750, a Phase 2 study of Breast Cancer, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 2
Development phase
27 participants
Enrollment target
2
Study locations

Study Summary

This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor 2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.

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. Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response.

Conditions Studied

Interventions

  • DRUG Vinorelbine
  • DRUG Pre operativeTrastuzumab
  • DRUG ABI-007 (Abraxane)

Study Locations (2)

Georgia

  • Piedmont Hospital Research Institute - Atlanta
  • Emory University Winship Cancer Institute - Atlanta

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2008-04
Est. Completion 2011-07
Phase Phase 2
Emory University

1,208 total trials

What the finished NCT00503750 record still lists

NCT00503750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Vinorelbine is the first listed.

NCT00503750 reports a single indexed study location in Georgia.

Frequently Asked Questions

What is clinical trial NCT00503750 about?

NCT00503750 is a clinical study titled "Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™)". This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor 2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.

What is the current status of trial NCT00503750?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2008-04. Estimated completion is 2011-07.

What conditions does trial NCT00503750 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00503750?

The interventions under investigation include: Vinorelbine (DRUG), Pre operativeTrastuzumab (DRUG), ABI-007 (Abraxane) (DRUG).

Who is sponsoring clinical trial NCT00503750?

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

Where is trial NCT00503750 being conducted?

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

Similar trials for Breast Cancer

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 NCT00503750's enrollment target sits among peer trials

27 1019th of 1224 higher than 198 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer 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 NCT00503750, the US trial registry maintained by the National Library of Medicine. NCT00503750 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.