Content-Length: 16781 | pFad | http://app.mc.uky.edu/mcctrials/doctor/chambers/nci-cirb-nrg-br003
| Protocol No. | NCI-CIRB-NRG-BR003 |
| Title | Adjuvant Chemotherapy +/- Carboplatin for Invasive Breast Cancer |
| NCT Number | NCT02488967 (Click to open a new window to clinicaltrials.gov) |
| Principal Investigator | Chambers, Mara |
| Cancer Types | Breast Cancer; Breast Cancer Team |
| Phase | Phase III |
| 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), the overall survival (OS), the breast cancer-free survival (BCFS), the recurrence-free interval (RFI), paclitaxel will improve the recurrence-free interval, paclitaxel will improve the distant recurrence-free interval (DRFI) and paclitaxel administered concurrently with carboplatin compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer; 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; To determine if germline BRCA status is associated with benefit in IDFS or OS from the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel in patients with operable node-positive or high-risk node-negative triple-negative breast cancer; To determine if the addition of carboplatin will improve the RFI among the homologous recombination (HR) deficient patients as determined by the homologous recombination deficiency (HRD) score; To determine whether the efficacy of carboplatin on RFI in HR-deficient patients differs from that in patients who are not HR-deficient and To collect tissue and blood samples at several occasions for future biomarkers development in predicting risk of breast cancer recurrence in patients with operable node-positive or high-risk node-negative triple-negative breast cancer treated with doxorubicin/cyclophosphamide followed by paclitaxel with or without carboplatin and predicting benefit from the addition of carboplatin among these patients. |
| Age Group | Adult |
| Therapies Involved | Cytotoxic Chemotherapy |
| Drugs Involved | Adria (doxorubicin); Adriamycin (doxorubicin); Adriamycin PFS (doxorubicin); Adriamycin RDF (doxorubicin); Cytoxan (cyclophosphamide); Onxol (paclitaxel); Paraplatin (carboplatin); Rubex (doxorubicin); Taxol (paclitaxel); carboplatin; cyclophosphamide; doxorubicin; paclitaxel |
| Status | Closed |
| Eligibility | 1.The trial is open to female and male patients. 2.Age ≥ 18 years. 3.The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination. 4.All of the staging criteria must be met. 5.The tumor must meet the listed criteria. 6.The tumor must have been determined to be ER-and PgR-negative assessed by current ASCO/CAP Guidelines. 7.The patient must have undergone either a mastectomy or lumpectomy. 8.For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. 9.For patients who undergo mastectomy, the margins must be free of residual gross tumor. 10.The patient must have completed one of the listed procedures for evaluation of pathologic nodal status. 11.The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days. 12.Patients must meet adequate organ functions. 13.LVEF assessment must be performed within 90 days prior to randomization. |
Fetched URL: http://app.mc.uky.edu/mcctrials/doctor/chambers/nci-cirb-nrg-br003
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