Treatment trial for patients who have been diagnosed with node-positive or high-risk node-negative triple-negative invasive breast cancer

Study ID: NRG BR003

A randomized phase 3 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

This trial is examining treatment protocols for those patients with a specific type of invasive breast cancer. There are two arms to this trial. Patients in Arm 1 will receive the medication doxorubicin hydrochloride intravenously over 15 minutes  and cyclophosphamide intravenously over 30 minutes on day one. The treatment repeats every two weeks for four courses as long as there is no disease progression or toxicity. Patients in Arm 1 then receive the medication paclitaxel intravenously over 60 minutes on day one. Treatment repeats weekly for 12 courses as long as there is no disease progression or toxicity.

Patients in Arm 2 will receive doxorubicin hydrochloride and cyclophosphamide, then paclitaxel intravenously over 60 minutes on days one, eight and 15, and carboplatin intravenously over 30–60 minutes on day one. Treatment repeats every three weeks for four courses as long as there is no disease progression or toxicity.

Treatment:

  • Arm I (AC-->WP): Doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day one. Treatment repeats every two weeks for four courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 60 minutes on day one. Treatment repeats weekly for 12 courses in the absence of disease progression or unacceptable toxicity.
  • Arm 2 (Experimental) (AC-->WP + carboplatin): Doxorubicin hydrochloride & cyclophosphamide, then paclitaxel IV over 60 minutes on days one, eight and 15 and carboplatin IV over 30–60 minutes on day one. Treatment repeats every three weeks for four courses in the absence of disease progression or unacceptable toxicity.

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.

Additional schema information (PDF)

Inclusion Snapshot

You must have been diagnosed via histologic examination with invasive adenocarcinoma of the breast

Contact Information

Lankenau Institute for Medical Research trial