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NCT00470301 · ClinicalTrials.gov registry record · Phase 1

Tipifarnib and Combination Chemotherapy in Treating Patients With Stage II or Stage III Breast Cancer

A Phase 1 study of Breast Cancer and Stage II Breast Cancer, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
60
Enrollment target
7
Study locations

NCT00470301: Completed Phase 1 study of Breast Cancer and Stage II Breast Cancer, sponsored by National Cancer Institute (NCI).

NCT00470301 is a Phase 1 study of Breast Cancer and Stage II Breast Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00470301, a Phase 1 study of Breast Cancer and Stage II Breast Cancer, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target
7
Study locations

Study Summary

Tipifarnib may stop the growth of breast cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with combination chemotherapy may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of tipifarnib when given together with combination chemotherapy and to see how well they work in treating patients with stage II or stage III breast cancer.

Primary Outcome

An increase in the breast pCR from 15% (anticipated for chemotherapy alone) to 35% would be considered promising.

Interventions

  • DRUG cyclophosphamide
  • DRUG doxorubicin
  • DRUG paclitaxel
  • DRUG tipifarnib

Study Locations (7)

New York

  • Mount Sinai Medical Center - New York
  • Columbia University Medical Center - New York
  • Weill Medical College of Cornell University - New York
  • Albert Einstein College of Medicine - The Bronx
  • Montefiore Medical Center - The Bronx

Florida

  • H. Lee Moffitt Cancer Center and Research Institute - Tampa

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2007-04
Est. Completion 2013-09
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00470301 record still lists

NCT00470301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).

The record links to 6 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which cyclophosphamide is the first listed.

NCT00470301 lists 7 locations in 3 states (New York, Florida, Texas).

Frequently Asked Questions

What is clinical trial NCT00470301 about?

NCT00470301 is a clinical study titled "Tipifarnib and Combination Chemotherapy in Treating Patients With Stage II or Stage III Breast Cancer". Tipifarnib may stop the growth of breast cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killi...

What is the current status of trial NCT00470301?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2007-04. Estimated completion is 2013-09.

What conditions does trial NCT00470301 study?

This clinical trial studies the following conditions: Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer.

What interventions are being tested in trial NCT00470301?

The interventions under investigation include: cyclophosphamide (DRUG), doxorubicin (DRUG), paclitaxel (DRUG), tipifarnib (DRUG).

Who is sponsoring clinical trial NCT00470301?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00470301 being conducted?

This trial has 7 study locations across Florida, New York, Texas. 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 NCT00470301's enrollment target sits among peer trials

60 736th of 1224 higher than 468 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 NCT00470301, the US trial registry maintained by the National Library of Medicine. NCT00470301 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.