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NCT00182793 · ClinicalTrials.gov registry record · Phase 2

Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer

A Phase 2 study, sponsored by City of Hope Medical Center.

Completed
Registry status
Phase 2
Development phase
32
Enrollment target

NCT00182793: Completed Phase 2 study, sponsored by City of Hope Medical Center.

NCT00182793 is a Phase 2 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00182793, a Phase 2 study, has completed, sponsored by City of Hope Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
32 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy works in treating patients with stage III or stage IV breast cancer.

Primary Outcome

Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. Whenever possible, relapses should be documented histologically.

Interventions

  • DRUG carboplatin
  • DRUG cyclophosphamide
  • BIOLOGICAL trastuzumab
  • DRUG melphalan
  • DRUG thiotepa

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2005-07
Est. Completion 2014-10
Phase Phase 2
City of Hope Medical Center

582 total trials

What the finished NCT00182793 record still lists

NCT00182793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).

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

NCT00182793 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00182793 about?

NCT00182793 is a clinical study titled "Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer". RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and sprea...

What is the current status of trial NCT00182793?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2005-07. Estimated completion is 2014-10.

What interventions are being tested in trial NCT00182793?

The interventions under investigation include: carboplatin (DRUG), cyclophosphamide (DRUG), trastuzumab (BIOLOGICAL), melphalan (DRUG), thiotepa (DRUG).

Who is sponsoring clinical trial NCT00182793?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00182793's enrollment target sits among peer trials

32 1563rd of 2000 higher than 423 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 NCT00182793, the US trial registry maintained by the National Library of Medicine. NCT00182793 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.