scholarly journals Neoadjuvant docetaxel plus carboplatin vs epirubicin plus cyclophosphamide followed by docetaxel in triple‐negative , early‐stage breast cancer ( NeoCART ): Results from a multicenter, randomized controlled, open‐label phase II trial

2021 ◽  
Author(s):  
Liulu Zhang ◽  
Zhi‐Yong Wu ◽  
Jie Li ◽  
Ying Lin ◽  
Zhenzhen Liu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase Ii ◽  
Triple Negative ◽  
Phase Ii Trial ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Open Label ◽  
Randomized Controlled ◽  
Open Label Phase

scholarly journals Neoadjuvant Docetaxel plus Carboplatin Versus Epirubicin plus Cyclophosphamide Followed by Docetaxel in Triple-negative, Early-stage Breast Cancer (NeoCART): Results from a Multicenter, Randomized Controlled, Open-label Phase II Trial

2021 ◽  
Author(s):  
Liulu Zhang ◽  
Zhiyong Wu ◽  
Jie Li ◽  
Ying Lin ◽  
Zhenzhen Liu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Triple Negative ◽  
Early Stage ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Open Label ◽  
Randomized Controlled ◽  
End Point ◽  
Open Label Phase

Abstract Background: Previous studies have shown that the addition of carboplatin to neoadjuvant chemotherapy regimens improved the pathologic complete response (pCR) rate in patients suffering from triple-negative breast cancer (TNBC). However, no studies have assessed the effects of the combination of docetaxel and carboplatin without anthracycline with taxane- and anthracycline-based regimens.Methods: The NeoCART study was designed as a multicenter, randomized controlled, open-label, phase 2 trial to assess the efficacy and safety of docetaxel combined with carboplatin with taxane- and anthracycline-based neoadjuvant chemotherapy in untreated stage II-III TNBC. All eligible patients were randomly assigned, at a 1:1 ratio, to the experimental DCb group (docetaxel plus carboplatin for six cycles) or the EC-D group (epirubicin plus cyclophosphamide followed by docetaxel). In both groups, pCR (ypT0/is ypN0) was evaluated as the primary outcome.Results: Between September 1, 2016, and December 31, 2019, 93 patients from 6 participating centers were randomly assigned, and 88 patients were evaluated for the primary end-point (44 patients in the DCb group and 44 patients in the EC-D group). In the primary end point analysis, 27 patients in the DCb group achieved a pCR (61.4%, 95% CI 47.0-75.8), and 17 patients in the EC-D group achieved a pCR (38·6%, 95% CI 24.3-53.0); with a difference of 22.8% (odds ratio 2.52, 95% CI 2.4-43.1; p non-inferiority=0.004), non-inferiority was met, and the DCb regimen was confirmed as superior to the EC-D regimen (p=0.044, superiority margin of 5%). At the end of the 37-month median follow-up period, overall survival and event-free rates were equivalent in both groups. The grade 3/4 adverse events in the DCb group included anemia (4.5%), thrombocytopenia (2.3%), neutropenia (2.3%) and an increased alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ratio (2.3%).Conclusions: Compared with the taxane- and anthracycline-based regimen, the pCR rate of DCb was higher in TNBC patients.Trial registration: ClinicalTrials.gov, NCT03154749. Registered 12 May 2017 - Retrospectively registered, https://clinicaltrials.gov/

Adjuvant docetaxel and cyclophosphamide plus trastuzumab in patients with HER2 -amplified early stage breast cancer: a single-group, open-label, phase 2 study

2013 ◽  
Vol 14 (11) ◽  
pp. 1121-1128 ◽  
Author(s):  
Stephen E Jones ◽  
Rufus Collea ◽  
Devchand Paul ◽  
Scot Sedlacek ◽  
Anne M Favret ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Phase 2 ◽  
Single Group ◽  
Open Label ◽  
Phase 2 Study ◽  
Open Label Phase

scholarly journals Efficacy and safety of camrelizumab combined with apatinib in advanced triple-negative breast cancer: an open-label phase II trial

2020 ◽  
Vol 8 (1) ◽  
pp. e000696
Author(s):  
Jieqiong Liu ◽  
Qiang Liu ◽  
Ying Li ◽  
Qian Li ◽  
Fengxi Su ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase Ii ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Phase Ii Trial ◽  
Objective Response ◽  
Therapeutic Effects ◽  
Open Label ◽  
Programmed Death ◽  
Continuous Dosing

BackgroundPrevious trials showed that antiangiogenesis or anti-programmed death protein 1/programmed death ligand 1 (PD-1/PD-L1) monotherapy only showed marginal effect in triple-negative breast cancer (TNBC). Preclinical studies demonstrated that antiangiogenic therapy could sensitize breast cancer to PD-1/PD-L1 blockade via reprogramming tumor microenvironment. Combinational treatment of checkpoint blockade and antiangiogenesis for TNBC has not been reported.MethodsPatients with advanced TNBC with less than three lines of systemic therapy were enrolled in an open-label, non-comparative, two-arm, phase II trial at Sun Yat-sen Memorial Hospital. Camrelizumab (intravenously every 2 weeks) with apatinib orally at either continuous dosing (d1–d14) or intermittent dosing (d1–d7) was given until disease progression or unacceptable toxicities. Primary endpoint was objective response rate (ORR).ResultsFrom January 2018 to April 2019, 40 patients were enrolled, including 10 in the apatinib intermittent dosing cohort and 30 in the apatinib continuous dosing cohort. The ORR was 43.3% (13 of 30) in the continuous dosing cohort, while no objective response was observed in the intermittent dosing cohort. The disease control rate was 63.3% (19 of 30) in the apatinib continuous dosing cohort, and 40.0% (4 of 10) in the apatinib intermittent dosing cohort, respectively. The median progression-free survival (PFS) was 3.7 (95% CI 2.0 to 6.4) months and 1.9 (95% CI 1.8 to 3.7) months in the continuous dosing and intermittent dosing cohort, respectively. In the continuous dosing cohort, the median PFS of patients with partial response (8.3 months, 95% CI 5.9 to not reached) was significantly longer than that of patients with stable disease/progressive disease/not evaluable (2.0 months, 95% CI 1.7 to 3.0). The most common adverse events (AEs) included elevated aspartate aminotransferase/alanine aminotransferase and hand-foot syndrome. Overall, 26.7% and 20.0% of patients experienced grade ≥3 AEs in the continuous dosing and intermittent dosing cohort, respectively. In the continuous dosing cohort, a high percentage of baseline tumor-infiltrating lymphocytes (>10%) was associated with higher ORR and favorable PFS (p=0.029, 0.054, respectively).ConclusionsThe ORR by this chemo-free regimen was dramatically higher than previously reported ORR by anti-PD-1/PD-L1 antibody or apatinib monotherapy. Camrelizumab combined with apatinib demonstrated favorable therapeutic effects and a manageable safety profile in patients with advanced TNBC.Trial registration numberNCT03394287.

Sign in / Sign up

Export Citation Format

Share Document