NSABP B-51: A 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 ID
STU 062013-024

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
J Susan Armstrong
214-645-4673
susan.armstrong@utsouthwestern.edu

Principal Investigator
Ann Leitch

Summary

arm 1
(Groups 1a and 1B)
no Regional nodal XRT
* Group 1a Lumpectomy: no regional nodal XRT with WBi
* Group 1B Mastectomy: no regional nodal XRT and no chestwall XRT

arm 2
(Groups 2a and 2B)
Regional nodal XRT
* Group 2a Lumpectomy: Regional nodal XRT with WBi
* Group 2B Mastectomy: Regional nodal XRT and chestwall XRT

* Patients will be randomized to one of the following:
* arm 1
[?]Radiation therapy for Group 1a
Whole breast irradiation + boost
[?]no radiation therapy for Group 1B
* arm 2
[?]Radiation therapy for Group 2a
Whole breast irradiation + boost and regional nodal irradiation
[?]Radiation therapy for Group 2B
Chest wall and regional nodal irradiation

Participant Eligibility

The patient must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
The patient must be female.
The patient must be >= 18 years old.
The patient must have an ECOG performance status of 0 or 1.
Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy). Clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, MRI, PET scan, or PET/CT scan.
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. Documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted.
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 (http://www.asco.org).
Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy according to the current ASCO/CAP Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer (http://www.asco.org). Patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible.
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 before randomization. (If treatment delays occur, chemotherapy must be completed within 14 weeks.) The dose and schedule of the adjuvant chemotherapy are at the investigator's discretion. Note: It is preferred that all intended chemotherapy be administered in the neoadjuvant setting.
Patients with HER2-positive tumors must have received neoadjuvant trastuzumab or other anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.
At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer. Acceptable procedures for assessment of axillary nodal status at the time of surgery include:

* axillary node dissection; sentinel node biopsy alone; or sentinel node biopsy followed by axillary node dissection. Note: Patients are eligible whether there is residual invasive carcinoma in the surgical breast specimen or whether there is evidence of pathologic complete response.
[Patients who are found to be pathologically node-positive at the time of surgery, based on sentinel node biopsy alone, are candidates for A011202, a study developed by the Alliance in Oncology, an NCI Cooperative Group. If A011202 is open at the investigator's institution, patients should be approached about participating in the A011202 study. (Note: A011202 is open at UTSW and Dr. Marilyn Leitch is the PI.)]
Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible.
Patient who have undergone either a total mastectomy or a lumpectomy are eligible.
For patients who undergo lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS as determined by the local pathologist. Additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)
For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor.
The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 56 days. Also, if adjuvant chemotherapy was
administered, the interval between the last chemotherapy treatment and randomization must be no more than 56 days.
The patient must have recovered from surgery with the incision completely healed and no signs of infection.
If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved.