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NCT00756470 · ClinicalTrials.gov registry record · Phase 2

Phase II Neoadjuvant in Inflammatory Breast Cancer

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Terminated
Registry status
Phase 2
Development phase
15
Enrollment target

NCT00756470: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00756470 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00756470, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
15 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn how well lapatinib taken alone, followed by taking lapatinib with paclitaxel, and then taking lapatinib with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC75) works to help to control Inflammatory Breast Cancer (IBC). The safety of this drug combination will also be studied.

Primary Outcome

Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy.

Interventions

  • DRUG Cyclophosphamide
  • DRUG 5-Fluorouracil (5-FU)
  • DRUG Paclitaxel
  • DRUG Lapatinib
  • DRUG Epirubicin

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2008-10
Est. Completion 2013-10
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

Why NCT00756470 stopped before completion

NCT00756470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

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

NCT00756470 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00756470 about?

NCT00756470 is a clinical study titled "Phase II Neoadjuvant in Inflammatory Breast Cancer". The goal of this clinical research study is to learn how well lapatinib taken alone, followed by taking lapatinib with paclitaxel, and then taking lapatinib with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC75) works to help to control Inflammatory Breast Cancer (IBC). The safety of this dru...

What is the current status of trial NCT00756470?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2008-10. Estimated completion is 2013-10.

What interventions are being tested in trial NCT00756470?

The interventions under investigation include: Cyclophosphamide (DRUG), 5-Fluorouracil (5-FU) (DRUG), Paclitaxel (DRUG), Lapatinib (DRUG), Epirubicin (DRUG).

Who is sponsoring clinical trial NCT00756470?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00756470's enrollment target sits among peer trials

15 1919th of 2000 higher than 60 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 NCT00756470, the US trial registry maintained by the National Library of Medicine. NCT00756470 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.