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Doxorubicin or Epirubicin and Cyclophosphamide in Treating Older Women With Invasive Breast Cancer

NCT00516425 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2013-08-07

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, epirubicin, 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 combination chemotherapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving doxorubicin or epirubicin together with cyclophosphamide is more effective than observation in treating older women with invasive breast cancer.

PURPOSE: This randomized phase III trial is studying doxorubicin or epirubicin and cyclophosphamide to see how well they work compared with observation in treating older women with invasive breast cancer.

Conditions

Interventions

BIOLOGICAL

pegfilgrastim

DRUG

cyclophosphamide

DRUG

doxorubicin hydrochloride

DRUG

epirubicin hydrochloride

GENETIC

proteomic profiling

OTHER

diagnostic laboratory biomarker analysis

OTHER

matrix-assisted laser desorption/ionization time of flight mass spectrometry

OTHER

pharmacological study

OTHER

surface-enhanced laser desorption/ionization-time of flight mass spectrometry

PROCEDURE

adjuvant therapy

Sponsors & Collaborators

  • Charing Cross Hospital

    lead OTHER

Principal Investigators

  • Robert C.F. Leonard, MD, BS, MB · Charing Cross Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00516425 on ClinicalTrials.gov