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Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers

NCT00941330 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-04-10

Study results available
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Summary

The patients are being asked to take part in this study because they have a hormone receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their doctor has told them that they have an option to receive chemotherapy or hormonal therapy before surgery. The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane can shrink the size of their breast tumor and allow them to preserve the breast or have less extensive surgery on their breast.

Conditions

Interventions

DRUG

Exemestane

25 mg daily by mouth for 6 to 12 months.

DRUG

Docetaxel

Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).

DRUG

Cytoxan

Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Elisavet Paplomata, MD · Emory University Winship Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00941330 on ClinicalTrials.gov