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NSABP B-51/RTOG 1304 (Breast Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if participants with cancer cells in the lymph nodes (at the same time that the breast cancer is diagnosed) and have chemotherapy before surgery that clears the cancer cells from the lymph nodes.

What is the Condition Being Studied?

Breast cancer with cancer cells in the lymph nodes at the time of diagnosis which clear after chemotherapy and surgery

Who Can Participate in the Study?

Adult women ages 18 and older who:
- Have completed chemotherapy
- Have had a mastectomy or lumpectomy with all removed lymph nodes cancer
- Have no prior history of cancer or chest radiation therapy
- Are not pregnant or nursing

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have a mammogram or MRI of both your breasts
- Have blood tests to check your blood counts
- Have a blood pregnancy test if you are a woman of childbearing potential
- Be randomized (put into one of two groups by chance like a flip of a coin) after your surgery to one of two groups
-- Group 1: Patients who have had a lumpectomy will receive radiation therapy to the breast.
Patients who have had a mastectomy will not receive radiation therapy
-- Group 2: if you had a lumpectomy, you will receive radiation therapy to your breast and lymph nodes. If you had a mastectomy, you will receive radiation to the area where your breast used to be and to the lymph nodes.
- Continue having mammograms every year until 10 years after you joined the research study

- Be in the study for up to 10 years
- Have a physical exam every 6 months for the first couple of years

Study Details

Full Title
NSABP B-51/RTOG 1304: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
Principal Investigator
Radiation Oncologist
Protocol Number
IRB:PRO00054066
NCT:NCT01872975
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698