Researchers seek 880 men and women with metastatic breast cancer who have a primary tumor still in the breast for a study designed to find out if removing it lengthens survival. The primary tumor is the first tumor in the breast. Cancer cells from the primary tumor can spread to other parts of the body, causing metastatic disease.
Background and Goals
When treating metastatic breast cancer, doctors usually wait to remove the primary tumor or treat it with radiation therapy until it causes symptoms including pain, significantly swollen lymph nodes or breaks through the skin. When used to ease these kinds of side effects, surgery, radiation therapy, or both, are called palliative therapy, because they lessen the discomfort caused by the cancer.
Some researchers believe removing the primary tumor before these symptoms begin may result in fewer negative side effects and might improve overall survival, the length of time from the start of treatment to death from any cause.
This study will assess rates of overall survival among those with the primary tumor removed early compared with those receiving standard palliative therapy. The trial team will also collect data on:
- health-related quality of life, or how satisfied participants are with their lives in relation to the cancer
- the number of circulating tumor cells present at 6 months, and
- the length of time to the development of chest wall disease
Circulating tumor cells are tumor cells found traveling in the bloodstream. Chest wall disease is breast cancer that spreads to the chest wall, the part of the body that protects your heart, lungs, liver and other organs.
Participants will be randomly assigned to one of two treatment groups.
- Group 1 will have standard palliative therapy when the primary tumor starts to cause symptoms
- Group 2 will have lumpectomy followed by radiation therapy, or mastectomy, before symptoms start. For participants who have mastectomy, radiation therapy may also be recommended.
All participants may be asked to give blood and tumor tissue samples to be used in future studies. So changes in quality of life can be assessed by researchers, people taking part in the trial will fill out an initial survey before beginning study treatment. They will also complete surveys a few times during the trial. Participants will be followed-up for 5 years.
You may be eligible for this study if you
- are 18 years of age or older and have metastatic breast cancer with a primary tumor confirmed by needle biopsy
- are medically able to have a full mastectomy
- finished at least 16, but no more than 32, weeks of systemic therapy (chemotherapy or hormonal therapy)
- had no disease progression while on systemic therapy
- know your hormonal status
For more information or to find out if you qualify, talk to your doctor about trial NCT01242800 on ClinicalTrials.gov.
This trial is being held in 411 locations in the United States, Canada, Israel, Saudi Arabia and South Africa. For a full list of locations and contact information, visit ClinicalTrials.gov.