DCb (Docetaxel/Carboplatin) Versus EC-D (Epirubicin/Cyclophosphamide Followed by Docetaxe) as Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer
- Conditions
- Triple-Negative Breast Cancer
- Interventions
- Registration Number
- NCT03154749
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 93
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DCb DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe) Docetaxel (75 mg/m2 administered intravenously every 3 weeks) and carboplatin (area under the concentration-time curve \[AUC\] 6, intravenously every 3 weeks) for six cycles EC-D DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe) 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
- Primary Outcome Measures
Name Time Method PCR Up to approximately 27-30 weeks Local evaluation of pCR defined as the absence of any residual invasive cancer of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/is, ypN0 in the current AJCC staging system)
- Secondary Outcome Measures
Name Time Method OS Up to approximately 36 months defined as the time from randomization to death from any cause
Breast-conserving surgery rate Up to approximately 27-30 weeks defined as the proportion of patients who achieved breast-conserving surgery out of the intent-to-treat (ITT) population of patients without inflammatory breast cancer
EFS Up to approximately 36 months defined as time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral \[invasive or non-invasive\]), or death from any cause
Adverse events Up to approximately 27-30 weeks Incidence, type, and severity of all adverse events (including serious adverse events) based on NCI CTCAE, v4.0.
Trial Locations
- Locations (1)
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China