Trial Information

NSABP B-47 Phase III Randomized Study of Adjuvant Chemotherapy With Versus Without Trastuzumab in Women With Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer

To determine whether the addition of trastuzumab to chemotherapy (TC or AC→WP) improves invasive disease-free survival (IDFS) in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed.

Patient Inclusion Criteria:

Age ≥ 18 years
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
All of the following staging criteria (according to the 7th edition of the AJCC Cancer Staging Manual) must be met:
1. By pathologic evaluation, primary tumor must be pT1-3
2. By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b

If pN0, one of the following criteria must be met:
1. pT2 and estrogen receptor (ER) negative and progesterone receptor (PgR) negative
2. pT2 and ER positive (PgR status may be positive or negative) and either grade 3 histology or Oncotype DX® Recurrence Score of = 25
3. pT3 regardless of hormone-receptor status, histologic grade, and Oncotype DX® Recurrence Score

Patient Exclusion Criteria:

None of the following allowed:

No T4 tumors including inflammatory breast cancer
No definitive clinical or radiologic evidence of metastatic disease Note: Chest imaging (mandatory for all patients) and other imaging (if required) must have been performed within 90 days prior to randomization]
No synchronous or previous contralateral invasive breast cancer (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)
No previous ipsilateral invasive breast cancer or ipsilateral DCIS (patients with synchronous or previous ipsilateral LCIS are eligible)

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071
Email: janeen.bazan@shermanhospital.org

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Research Center Information: Sherman Health

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