Treatment trial for certain patients diagnosed with early-stage breast cancer

Study ID: NSABP B-51 / RTOG 1304

Randomized phase 3 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

This trial is for patients who have been diagnosed with specific types of early-stage breast cancer, notably T1-3, N1 cancer. (Patients whose primary tumor has been deemed HER2-positive or HER-2 negative are also eligible.) Patients must have already undergone at least 8 weeks of standard chemotherapy.

The goal of this trial is to compare radiation therapy (RT) to the breast, chest wall and lymph nodes (known as comprehensive radiation) to standard RT to the breast. It is not yet known whether comprehensive RT is more effective than standard RT in treating patients with early-stage breast cancer.

Patients must have previously undergone chemotherapy and surgery for their breast cancer.

All patients receive systemic therapy as planned. Patients are also grouped into two study arms, each with two groups.

  • Arm1/Group 1A: Lumpectomy patients undergo whole breast RT once daily for 5 days for 5 weeks, followed by an RT boost to the lumpectomy cavity once daily 5 days for 1.5 weeks
  • Arm1/Group 2A: Mastectomy patients do not undergo RT
  • Arm 2/Group 2A: Lumpectomy patients undergo regional nodal RT with whole breast RT 5 days for 5 weeks, followed by an RT boost to the lumpectomy cavity 5 days for 1.5 weeks
  • Arm 2/Group 2B: Mastectomy patients undergo regional nodal RT 5 days for 5 weeks

Patients must agree to undergo follow-up evaluation at 6,12,18 and 24 months, and then annually for 8 years.

Eligibility criteria:

  • Patients must have been diagnosed with T1-3, N1 breast cancer. Patients whose primary tumor has been deemed HER2-positive or HER-2 negative are eligible.
  • Patients must have had ER analysis performed on the primary breast tumor before neoadjuvant therapy according to current ASCO/CAP Guideline Recommendations for hormone receptor testing. If negative for ER, assessment of PgR must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing.
  • Patients with pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma). Patients may not have had documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy).

Study and treatment:

All patients receive systemic therapy as planned.

Patients are randomized to 1 of 2 treatments arms, each of which has two study groups.

  • Arm1/Group 1A: Lumpectomy patients undergo whole breast RT using IMRT or 3D-CRT once daily for 5 days for 5 weeks, followed by RT boost to the lumpectomy cavity once daily 5 days for 1.5 weeks.
  • Arm1/Group 2A: Mastectomy patients do not undergo RT.
  • Arm 2/Group 2A: Lumpectomy patients undergo regional nodal RT with whole breast RT using IMRT or 3D-CRT 5 days for 5 weeks, followed by RT boost to the lumpectomy cavity 5 days for 1.5 weeks.
  • Arm 2/Group 2B: Mastectomy patients undergo regional nodal RT using IMRT or 3D-CRT 5 days for 5 weeks.

Follow up at 6,12,18 and 24 months, and then yearly for 8 years.

Additional schema information (PDF)

Inclusion Snapshot

  • Must have been diagnosed with a specific type of early-stage breast cancer
  • Must have already completed a minimum of 8 weeks of standard chemotherapy consisting of an anthracycline and/or taxane-based regimen
  • Must be willing to undergo radiation therapy and follow-up evaluation

Contact Information

Lankenau Institute for Medical Research trial

Physician Investigator(s)