Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
Active Date:
March 10, 2016
IRB Number:
BR-003
Condition/Disease:
Breast Cancer
Lead Researcher:
Amaryllis Gil, MD
Location:
Edward Cancer Center - Naperville
Purpose:
This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.
Sponsor: NRG Oncology
https://clinicaltrials.gov/ct2/show/NCT02488967?term=br-003&rank=2
Eligibility:
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
Primary tumor must be pT1-3, no T4 tumors including inflammatory breast cancer
Ipsilateral nodes must be pN0, pN1, pN2a, pN2b, pN3a, or pN3b
If pN0, tumor must be > 3.0 cm
No metastatic disease
No current or previous invasive breast cancer
No previous therapy with anthracyclines or taxanes for any malignancy
The tumor must have been determined to be human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor (ER)- negative, and progesterone receptor (PgR)-negative
The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy
For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS)
For patients who undergo mastectomy, the margins must be free of residual gross tumor
The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days
No conditions that would prohibit administration of corticosteroids
No chronic daily treatment with corticosteroids with a dose of >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)
Time Commitment:
10 years
Status:
Accepting Participants
Current Trial Type:
Interventional
Phase:
III
Contact Name:
Kathy Seymour, BSN
Phone:
630-646-6075
Fax:
630-646-6110
Alternate Phone:
630-646-6072