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Trial Tests Hormonal Therapy With and Without Chemo for Early-Stage, Invasive Breast Cancer

The trial team seeks to find out whether giving chemotherapy with hormonal therapy can better prevent the growth of cancer than hormonal therapy alone

January 30, 2014

Written By Josh Fernandez, Writer and Web Content Coordinator
Reviewed By Virginia Kaklamani, MD, DSc

Researchers seek women diagnosed with invasive, early-stage, hormone-positive breast cancer to enroll in a phase III study. The trial will assess whether giving chemotherapy in addition to hormonal therapy better stops the growth of the cancer than hormonal therapy alone.

Background 

Hormone-positive breast cancers grow because the cancer cells are fueled by the hormones estrogen and progesterone. Medicines that treat these cancers include tamoxifen, which blocks the effects of estrogen on breast tissue, and aromatase inhibitors (AIs), which lessen the amount of estrogen the body makes by stopping the enzyme aromatase from changing other hormones into estrogen. AIs include anastrozole, letrozole and exemstane.

While hormonal therapies play a central role in treating estrogen- and progesterone receptor-positive breast cancers, it is unknown whether chemotherapy can help improve a patient’s outcome when added to hormonal therapy. 

Goals of the Study

The primary goal of the trial team is to assess the impact of hormonal therapies alone versus hormonal therapies with chemotherapy on invasive disease-free survival, defined as the time from random assignment to one of the treatment groups until

  • a local, regional or distant recurrence, or return of the breast cancer
  • a new invasive primary breast cancer develops
  • death from any cause

Other goals of the researchers include finding out the impact of both treatments on:

  • overall survival, the time from random assignment to a treatment group until death from any cause
  • distant disease-free survival, the time from random assignment to a treatment group until the cancer returns in a distant organ, until a new invasive primary breast cancer develops, or until death from any cause
  • local disease-free interval, the time from random assignment to a treatment group until the breast cancer returns locally — in the remaining breast, skin, or chest wall — or regionally, in the nearby lymph nodes or collarbone

The trial team will also assess for any serious side effects of the treatment.

Study Structure

To be eligible to participate, you must receive the Oncotype DX breast cancer assay. This test examines a sample of the tumor removed at your surgery and predicts risk of recurrence, or the cancer returning after treatment, as well as whether you will benefit from chemotherapy after surgery. 

The Oncotype DX test studies the behavior of a group of genes from the tumor sample and assigns a numbered score between 0 and 100, showing the likelihood of the cancer recurring. There are three common interpretations based on previous studies: a score lower than 18 means a low risk of cancer recurrence, a score between 18 and 31 means an intermediate risk of cancer recurrence and a score greater than 31 means a high risk of the cancer returning. 

Study investigators seek women who have a score of 25 or lower. If your score is in that range, you are able to take part in the trial, assuming other eligibility criteria have been met.

Participants in the study receive one of two courses of treatment:

  • Chemotherapy followed by an aromatase inhibitor (anastrozole, exemestane or letrozole), tamoxifen, or both, for 5 to 10 years 
  • One of the three aromatase inhibitors, tamoxifen, or both for 5 to 10 years 

If the disease worsens or the side effects become too difficult for the patient, treatment can be stopped.

Eligibility

You are able to take part in this study if you are a woman who is 18 years of age or older and 

  • are diagnosed with invasive breast cancer that is hormone receptor-positive
  • have HER2-negative breast cancer
  • have no more than three known positive lymph nodes
  • do not have inflammatory or metastatic breast cancer
  • have had a lumpectomy with planned radiation therapy or total mastectomy
  • have undergone or are willing to undergo Oncotype DX screening
  • are able to receive a taxane- or anthracycline-based chemotherapy
  • were not treated with chemotherapy or hormonal therapy for breast cancer in the past
  • are not pregnant or nursing

Visit the study’s listing on ClinicalTrials.gov to learn more about eligibility. 

Study Locations

This study is being conducted in more than 1,000 locations. 

To enroll in a study location near you or to learn more about this study visit the ClinicalTrials.gov listing.

Denver, CO  ·  September 13, 2014

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