Page 11 - Delaware Medical Journal - April 2018

CANCER CLINICAL TRIAL
PROTOCOL OF THE MONTH
NRG-BR003: 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
Primary Objective:
•To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the invasive disease-free survival (IDFS) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer.
Secondary Objectives:
•To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the overall survival (OS) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer.
•will improve the breast cancer-free survival (BCFS) •will improve the recurrence-free interval (RFI)
•will improve the distant recurrence-free interval (DRFI) •compared the toxicity
Eligibility Criteria:
• Male or female ≥18 years of age, ECOG Performance Status of 0 or 1.
• 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:
• By pathologic evaluation, primary tumor must be pT1-3;
• By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b. • If pN0, tumor must be > 3.0 cm.
The tumor must have been determined to be HER2-negative as follows:
• Immunohistochemistry (IHC) 0-1+; or
• IHC 2+ and ISH non-amplified with a ratio of HER2 to 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.
• The patient must have completed evaluation of pathologic nodal status.
• The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy.
• The interval between the last surgery for breast cancer and randomization must be no more than 60 days.
• Adequate hematologic, hepatic, alkaline phosphatase and renal functions within 6 weeks prior to randomization. • LVEF assessment must be must be ≥ 50% and performed within 90 days prior to randomization.
Treatment:
Chemotherapy regimen for Arm 1
AC Weekly Paclitaxel (WP): Doxorubicin (A) 60 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV every 2 weeks for 4 cycles (dose-dense schedule) followed by paclitaxel 80 mg/m2 IV weekly for 12 doses.
Chemotherapy regimen for Arm 2
AC Weekly Paclitaxel (WP): Doxorubicin (A) 60 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV every 2 weeks for 4 cycles (dose-dense schedule) followed by paclitaxel 80 mg/m2 IV weekly for 12 doses plus Carboplatin AUC of 5 IV every 3 weeks for 4 cycles.
For information regarding clinical trials or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
Del Med J | April 2018 | Vol. 90 | No. 4 107