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NSABP B-51

Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery

Status:

Recruiting | Phase III

Official Title:

Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall 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

Study Purpose:

To determine whether or not radiation therapy to the lymph nodes is better at keeping breast cancer from returning for patients whose lymph nodes were positive for cancer cells before their chemotherapy (and surgery), but are negative for cancer cells after their chemotherapy.

Interventions:   

  • Radiation Therapy (high energy x-rays to kill cancer cells)
  • Lab Biomarker Analysis
  • Quality of Life questionnaires
  • ARM I: For patients who have had a lumpectomy – Radiation to the whole breast only. For patients who have had a mastectomy – No radiation therapy.
  • ARM II: For patients who have had a lumpectomy – Radiation therapy to the whole breast and lymph nodes. For patients who have had a mastectomy – Radiation therapy to the chest wall and lymph nodes.

After completion of study therapy, patients are followed up every 6 months for 2 years, then annually thereafter.

Key Participation Requirements:

Gender:

Female

Age:

19 years and older

Diagnosis:

Breast Cancer with lymph nodes positive for cancer cells (lymph node positivity must be proven with a biopsy before starting chemotherapy)

Eligibility:

All marker statuses accepted.

Patients must have received chemotherapy before surgery (a minimum of 8 weeks).

Patients’ lymph nodes must be negative for cancer cells at the time of surgery.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

NSABP B-51

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!