NCT03154749

DCb (Docetaxel/Carboplatin) Versus EC-D (Epirubicin/Cyclophosphamide Followed by Docetaxe) as Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer

Neoadjuvant Docetaxel + Carboplatin Versus Epirubicin+Cyclophosphamide Followed by Docetaxel in Triple-Negative, Early-Stage Breast Cancer (NeoCART): Study Protocol for a Multicenter, Randomized Controlled, Open-Label, Phase 2 Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe)	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).

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-05-16
• Last updated: 2022-09-01

Locations

1 site across 1 country: China