DCb (Docetaxel/Carboplatin) Versus EC-D (Epirubicin/Cyclophosphamide Followed by Docetaxe) as Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer
Condition: Triple-Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Both DCb (docetaxel/carboplatin) and EC followed by D (epirubicin/cyclophosphamide followed
      by docetaxe) regimens as Neoadjuvant Treatment for Triple-Negative Breast Cancer have been
      recommended by NCCN guideline. It is unknown which regimen is better. This study is to
      evaluate the efficacy and safety of DCb (docetaxel/carboplatin) and EC followed by
      D(epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment in
      Triple-Negative breast cancer. The endpoint of pathologic complete response is used as a
      surrogate marker for survival. Safety and tolerability assessed by number of grade 4
      toxicities and hospitalizations.
    

Detailed description: 
      Triple negative breast cancer (TNBC) is a subtype lacking estrogen receptor (ER),
      progesterone receptor (PR) and human epidermal growth factor receptor type 2 (HER2)
      amplification. TNBC accounts for 15-20% of all invasive breast cancer. Although PARP
      inhibitors and immunotherapy may play a role in the treatment of early TNBC, the mainstay of
      treatment for TNBC is cytotoxic chemotherapy. However, despite its sensitivity to
      chemotherapy, TNBC is still associated with a poor prognosis.

      TNBC is usually recommended for neoadjuvant therapy. The benefits of neoadjuvant therapy
      include reducing the size of the tumor to suit breast conserving surgery, avoiding axillary
      lymph node dissection, making inoperable tumors operable, and obtaining an in vivo evaluation
      of the tumor's chemosensitivity. Taxane- and anthracycline-based neoadjuvant regimens have
      become a standard treatment for TNBC, and patients have been proved to have better event-free
      survival (EFS) and overall survival (OS) who achieve a pathologic complete response (pCR)
      after neoadjuvant chemotherapy1.

      Carboplatin attack cancer cells by inducing double-stranded DNA breaks, and TNBC may be
      sensitive to carboplatin2. Previous studies have shown that adding carboplatin to neoadjuvant
      chemotherapy regimens significantly improved pCR rate in TNBC patients3, 4.

      Due to the long-term cardiotoxicity caused by anthracycline, several studies have explored
      the efficacy of neoadjuvant paclitaxel plus carboplatin regimens in TNBC and have achieved
      satisfactory pCR rates, but there are still controversies5. However, there is no study making
      comparisons between the combination of taxanes and carboplatin without anthracycline and the
      standard neoadjuvant regimens. Whether the combination of taxanes and carboplatin without
      anthracycline can achieve better efficacy while reducing adverse reactions still needs to be
      explored.

      The NeoCART study was designed to compare the efficacy and safety of docetaxel plus
      carboplatin with standard neoadjuvant chemotherapy in TNBC.
    

Intervention name(s): DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe)
Intervention type(s): Drug
Intervention description(s): All eligible patients were randomly assigned at a 1:1 ratio to the experimental arm (docetaxel (75 mg/m2 administered intravenously every 3 weeks) plus carboplatin (AUC 6 mg/mL per min, intravenously every 3 weeks) for six cycles) or the standard treatment arm (epirubicin (90 mg/m2) plus cyclophosphamide (600 mg/m2), both administered intravenously every 3 weeks for four cycles, followed by docetaxel (100 mg/m2) administered intravenously every 3 weeks for four cycles).
Intervention MeSH terms: Cyclophosphamide; Carboplatin; Docetaxel; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoadjuvant chemotherapy; Triple-Negative Breast Cancer