This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin. The primary objective of the trial is to evaluate of the efficacy and safety of weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer. The primary endpoint of the study is to to assess Pathological complete response rate(pCR)using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).. The total number of patients to be included in this study is 60 patients. The duration of the study, from first patient visit to last patient visit will be approximately 19 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1. Patients will receive this as a single-agent for the first twelve weeks, then followed by epirubicin in combination with cyclophosphamide. Drug: Epirubicin 90 mg/m² given IV Drug: Cyclophosphamide 600 mg/m² given IV
Cancer Hospital/ Institute, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGThe primary endpoint is pathological complete remission (pCR)
Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens.
Time frame: 2 months
The second endpoint includes the objective response rate (ORR)
The second endpoint ORR composed of tumor response classifications of complete response (CR) and partial response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases.
Time frame: 2 months
Breast conserving surgery(BCS) rate
Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable.
Time frame: 2 months
Adverse events (AE)
Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly.
Time frame: 2 months
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