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Phase III Trial Removes Primary Tumor in Metastatic Breast Cancer

Study compares effect of removing primary tumor to standard therapy

Trial Starts: February 2011 Trial Ends: June 2025

Written By Nicole Katze, MA, Writer and Editorial Coordinator
Reviewed By Monica Morrow, MD

This trial is currently seeking participants

A clinical trial seeks 880 participants to test whether removing the  tumor in the breast in ­newly diagnosed metastatic breast cancer helps women who receive systemic therapy to live longer than those who receive systemic therapy alone. Systemic therapy is using medicine like chemotherapy and hormonal therapy to travel through the bloodstream and treat the whole body. 

Local therapies like surgery and radiation only affect the tumor and the area around it, and are not commonly used to treat metastatic breast cancer because the outcome of the disease is believed to be determined by way the cancer outside the breast responds to treatment. In metastatic disease, surgery and radiation are typically used palliatively, to treat pain, tumor growth, or other side effects.

Study Background and Goals 

New research suggests primary breast tumors may seed the growth of tumors in metastatic sites. With better therapies available than in the past, women with metastatic breast cancer are living longer, so symptoms from the tumor in the breast may be more common. Some retrospective studies – studies that analyze medical or lifestyle history – also suggest women live longer when the primary tumor is removed.  

This randomized, open-label study’s main goal is to test the impact of removing the primary breast tumor in women with newly diagnosed metastatic breast cancer against the standard treatment, which does not typically include surgery on the breast unless problems develop. It will also compare participants in the trial arms for health-related quality of life, disease spread to the chest wall and the number of tumor cells in the bloodstream at six months. 

Structure of the Study

Participants will be randomly assigned to one of two arms:

  • In the first arm, participants will receive a standard systemic therapy; surgery, radiation, or both will be used only to relieve symptoms such as pain.
  • In the second arm, participants who have 32 weeks of systemic therapy will afterward undergo lumpectomy or mastectomy to remove the primary breast tumor. Those who have lumpectomy will receive radiation therapy once a day, five days per week. The doctor will determine whether radiation therapy is needed after mastectomy.

After study treatment is complete, participants will be followed for five years.

Eligibility

You may be eligible for this study if you:

  • Are 18 years old or older
  • Have newly diagnosed (not recurrent) stage IV breast cancer with a tumor in the breast that has never been treated
  • Are being treated with systemic therapy and the cancer has not grown for 16 weeks since the start of that therapy; you may still participate if you received therapy that controls the cancer and lasts at least 12 weeks but was discontinued due to side effects
  • Know the cancer’s hormone receptor status

This trial also allows some people to enroll who have brain metastases, had non-invasive breast cancer (DCIS) that did not return, or had invasive cancer more than five years ago. For full details on eligibility, please visit the study site.

Study Locations 

This trial is being held at hundreds of locations throughout the United States, Canada and around the world. For a full listing of locations and local contact information, see trial NCT01242800 on ClinicalTrials.gov.

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer.

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