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Therapeutic Areas: Oncology | Obstetrics/Gynecology (Women’s Health) | Family Medicine
Disease Category: Breast Cancer
Location: United States, NJ

Clinical Trial Details

Overview

Research Study Summary

Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

Purpose

Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. 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. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.

This randomized phase III trial is trying to find out the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25.

Eligibility criteria include the following:

  • 18-75 years old
  • Estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor
  • HER2/neu negative tumor
  • Has undergone surgery to remove the tumor within the past 3 months
  • No previous chemotherapy or radiation therapy for this cancer

For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

To Learn more
Phase

3

Gender

Female

Age

18 to 75 Years

Overall Status

Recruiting

Facility Type

N/A

Contact

Thomas Rakowski, MD/ Cheryl Parish, Principal Investigator/Manager, Oncology Clinical Trials
The Valley Hospital/Valley Health System
Office of Clinical Trials, Oncology
One Valley Health Plaza
Paramus, NJ 07652
Phone: 201-634-5792

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Research Center Information: The Valley Hospital/Valley Health System

CW ID: 137325

Date Last Changed: July 25, 2013


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