Page 12 - Delaware Medical Journal - April 2016
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CANCER CLINICAL TRIAL
NCI 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
The objectives of the trial are:
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:
1. To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the overall survival (OS), breast cancer free survival (BCFS), recurrence-free interval (RFI), and/or distant recurrence free interval (DRFI) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer.
2. To determine the toxicity of doxorubicin/cyclophosphamide followed by paclitaxel administered concurrently with carboplatin compared to the toxicity of doxorubicin/cyclophosphamide followed by paclitaxel alone.
3. chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel .
4.
5.
6. To collect tissue and blood samples at several occasions for future biomarker development.
Eligibilty:
Female and male patients with unilateral invasive adenocarcinoma of the breast on histologic examination having undergone a mastectomy or lumpectomy with negative margins within the preceding 60 days
Tumor must be Her2 Negative, ER/PR negative
Must have had sentinel lymphadenectomy or axillary lymphadenectomy
No evidence of metastatic disease
Adequate organ function
May not have had previous ipsilateral, contralateral, or synchronous invasive breast cancer
May not have cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the
treatment regimens
Treatment:
Eligible patients will be randomized to receive either Arm 1 or Arm2
Chemotherapy regimen for Arm 1
Doxorubicin (A) 60 mg/m2 IV + Cyclophosphamide (C) 600 mg/m2 IV every 2 weeks for 4 cycles
Paclitaxel 80 mg/m2 IV weekly for 12 doses.
Chemotherapy regimen for Arm 2
Doxorubicin (A) 60 mg/m2 IV + Cyclophosphamide (C) 600 mg/m2 IV every 2 weeks for 4 cycles
Paclitaxel 80 mg/m2 IV weekly for 12 doses plus Carboplatin AUC of 5 IV every 3 weeks for 4 cycles.
The Delaware Cancer Treatment Program (DCTP) provides medical insurance coverage to uninsured Delawareans for the treatment of cancer. Call 302-7441040 for more information.
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
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Del Med J | April 2016 | Vol. 88
| No. 4
