Clinical Trial of the Week: Treatment trial for patients diagnosed with node-positive or high-risk node-negative, triple-negative invasive breast cancer

By Donna Loyle, communications specialist, LIMR

Study #BR003 is a randomized phase III trial of adjuvant therapy comparing doxorubicin plus cyclophosphamide followed by weekly paclitaxel with or without carboplatin for node-positive or high-risk node-negative, triple-negative invasive breast cancer.

There are two treatment arms:

  • Arm I: doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 courses. Patients then receive paclitaxel IV over 60 minutes on day 1. Treatment repeats weekly for 12 courses.
  • Arm 2 (experimental): doxorubicin hydrochloride and cyclophosphamide. Then paclitaxel IV over 60 minutes on days 1, 8 and 15. Carboplatin IV over 30–60 minutes on day 1. Treatment repeats every 3 weeks for 4 courses.

Inclusion criteria: Patient’s primary tumor must be pT1-3. Ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b (if pN0, tumor must be > 3.0 cm)

EGFR 2 (HER2)-negative tumor as follows:

  • Immunohistochemistry (IHC) 0-1+, or
  • IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to centromere enumerator probe 17 (CEP17) < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells, or
  • ISH non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells

Lumpectomy margins must be histologically free of invasive tumor and DCIS.

Mastectomy margins must be free of residual gross tumor; patients with microscopic positive margins are eligible as long as post-mastectomy radiation therapy of the chest wall will be administered.

This trial is available at all Main Line Health acute care hospitals. The principal investigators are Albert DeNittis, MD, and Paul Gilman, MD. More information is available here: https://www.mainlinehealth.org/research/clinical-trials/nrg-br003

 

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