Phase III Trial Removes Primary Tumor in Metastatic Breast Cancer

Featured Clinical Trials
June 4, 2013
By: 
Nicole Katze, MA, Editor and Manager, Content Development
Reviewed By: 
Monica Morrow, MD

Study compares effect of removing primary tumorinfo-icon to standard therapyinfo-icon

This trial is currently seeking participants

A clinical trialinfo-icon seeks 880 participants to test whether removing the  tumorinfo-icon in the breast in ­newly diagnosed metastaticinfo-icon breast cancer helps women who receive systemic therapyinfo-icon to live longer than those who receive systemic therapy alone. Systemic therapyis using medicineinfo-icon like chemotherapyinfo-icon and hormonal therapyinfo-icon to travel through the bloodstream and treat the whole body. 

Local therapies like surgeryinfo-icon and radiationinfo-icon only affect the tumor and the area around it, and are not commonly used to treat metastatic breast cancer because the outcomeinfo-icon 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 lifeinfo-icon, disease spread to the chest wallinfo-icon 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 lumpectomyinfo-icon or mastectomyinfo-icon to remove the primary breast tumor. Those who have lumpectomy will receive radiation therapyinfo-icon 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 cancerinfo-icon 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 therapyinfo-icon; 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 receptorinfo-icon status

This trial also allows some people to enroll who have brain metastases, had non-invasive breast cancerinfo-icon (DCISinfo-icon) that did not return, or had invasive cancerinfo-icon 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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