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Protocol No. RTOG1304

Principal Investigator Anderson, Bethany

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title 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

Objective The main purpose of this clinical trial is to study women like you who have cancer cells in the lymph nodes at the time that the breast cancer is diagnosed and have chemotherapy before surgery that clears the cancer cells from the lymph nodes. This study asks 1) if, after lumpectomy, radiation to the breast and lymph nodes will be better than radiation only to the breast at keeping breast cancer from returning, and 2) if, after mastectomy, radiation to the area where the breast used to be and to the lymph nodes is better than no radiation at keeping breast cancer from returning. This study also asks whether giving radiation as described above will help women live longer.

Description You will be "randomized" to one of the study arms described below. Randomization means that you are put into a study arm by chance. A computer program will place you in one of two study arms. Neither you nor your doctor can choose the study arm you will be in. You will have an equal chance of being placed in either study arm. If you are in Arm 1 and had a lumpectomy, you will receive radiation to your breast. If you had a mastectomy, you will not receive radiation therapy. If you are in Arm 2 and 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. You will begin your radiation therapy within 12 weeks after your surgery or after chemotherapy if you received it after surgery.Click here for more info

Key Eligibility
  • Patients must be female.
  • Patients must have clinically T 1-3, N1 breast cancer at the time of diagnosis before neoadjuvant therapy.
  • Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma). The FNA or core needle biopsy can be performed either by palpation or by image guidance.
  • Patient must have completed a minimum of 12 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen.
  • For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed.
  • Patients with HER2-positive tumors must have received neoadjuvant trastuzumab or other anti-HER2 therapy.
  • At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer.
  • Patients must not have any evidence of metastatic disease.

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions Johnson Creek, UW Cancer Center; Swedish American Hospital, Rockford ; UW Hospital and Clinics