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NCT00429572 · ClinicalTrials.gov registry record · Phase 2

Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer

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

Completed
Registry status
Phase 2
Development phase
19
Enrollment target

NCT00429572: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00429572 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00429572, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
19 participants
Enrollment target

Study Summary

Primary Objectives: 1. To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC) transplantation in patients with recurrent or metastatic breast cancer. 2. To determine the success rate (complete remission without severe toxicity or death) at 100 days after the transplant and long-term progression free survival (PFS) rate. 3. To examine the graft vs. breast cancer effect of allogeneic PBPC transplantation.

Primary Outcome

Best response recorded from start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria of Complete Response: disappearance of all disease/symptoms \> 4 weeks; Partial response, \> 50% reduction in sum of products of diameters of each measurable lesion for more than 4 weeks; Stable Disease, no change in tumor size; and Progressive Disease, appearance of new lesions or \> 25% increase in sum of products of diameters of any measurable lesions.

Interventions

  • DRUG Fludarabine
  • DRUG Melphalan
  • PROCEDURE Stem Cell Infusion

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 1998-01
Est. Completion 2008-05
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00429572 record still lists

NCT00429572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

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

NCT00429572 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00429572 about?

NCT00429572 is a clinical study titled "Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer". Primary Objectives: 1. To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC) transplantation in patients with recurrent or metastatic breast cancer. 2. To determine the success rate (complete remission without severe toxicity or death) at 100 days after the transplant...

What is the current status of trial NCT00429572?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 1998-01. Estimated completion is 2008-05.

What interventions are being tested in trial NCT00429572?

The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Stem Cell Infusion (PROCEDURE).

Who is sponsoring clinical trial NCT00429572?

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 NCT00429572's enrollment target sits among peer trials

19 1894th of 2000 higher than 103 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 NCT00429572, the US trial registry maintained by the National Library of Medicine. NCT00429572 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.