Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis
Abstract Chemotherapy serves as the primary therapeutic approach for triple-negative breast cancer (TNBC), yet its efficacy remains unsatisfactory. This study was a single-arm, open-label, single-center clinical trial (NCT05447702) involving patients with newly diagnosed stage II-III TNBC at West Ch...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Publishing Group
2025-07-01
|
| Series: | Signal Transduction and Targeted Therapy |
| Online Access: | https://doi.org/10.1038/s41392-025-02337-1 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849235504460988416 |
|---|---|
| author | Xiaoxiao Liu Chunying Zhuang Lei Liu Ling Xiong Xin Xie Ping He Juanjuan Li Bing Wei Xi Yan Tinglun Tian Xiaorong Zhong Jie Chen Yan Cheng Dan Zheng Peng Cheng Tianlin Sun Weiwei Li Changbin Zhu Shuaitong Chen Chao Fang Jun Fu Shibao Li Jing Jing Ting Luo |
| author_facet | Xiaoxiao Liu Chunying Zhuang Lei Liu Ling Xiong Xin Xie Ping He Juanjuan Li Bing Wei Xi Yan Tinglun Tian Xiaorong Zhong Jie Chen Yan Cheng Dan Zheng Peng Cheng Tianlin Sun Weiwei Li Changbin Zhu Shuaitong Chen Chao Fang Jun Fu Shibao Li Jing Jing Ting Luo |
| author_sort | Xiaoxiao Liu |
| collection | DOAJ |
| description | Abstract Chemotherapy serves as the primary therapeutic approach for triple-negative breast cancer (TNBC), yet its efficacy remains unsatisfactory. This study was a single-arm, open-label, single-center clinical trial (NCT05447702) involving patients with newly diagnosed stage II-III TNBC at West China Hospital. The treatment regimen consisted of camrelizumab (200 mg intravenously every 2 weeks, 12 cycles), apatinib (250 mg orally daily), and alternating chemotherapy [nab-paclitaxel (d1, 8, 15 every 4 weeks) for 4 cycles and epirubicin plus cyclophosphamide (every 2 weeks) for 4 cycles]. From June 2023 to April 2024, 35 patients were enrolled, of whom 1 patient withdrew due to adverse reaction intolerance. At treatment completion, the total pathological complete response (tpCR, ypT0/is, ypN0) rate was 67.6% (23/34), and the breast pCR (ypT0/is) rate was 70.6% (24/34). The overall response rate following neoadjuvant treatment reached 94.1% (32/34). Elevated levels of alanine aminotransferase (38.2%) and aspartate aminotransferase (29.4%) were the most common grade 3-4 adverse events, with no significant toxicities or treatment-related deaths reported. Comprehensive analysis of serum and tissue samples collected before and after neoadjuvant therapy via Olink and RNA sequencing revealed that the treatment induced a complex systemic immune response. These findings enabled the development of two novel scoring systems: a pretreatment response predictive score system for stratification and an efficacy assessment score system for treatment response evaluation. In conclusion, camrelizumab and apatinib combined with chemotherapy have good clinical efficacy and good safety as neoadjuvant treatments for stage II-III TNBC, warranting further investigation and potential clinical application. |
| format | Article |
| id | doaj-art-f885c03ec1fb4a32b8a3eaa9ab3b8fb7 |
| institution | Kabale University |
| issn | 2059-3635 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Nature Publishing Group |
| record_format | Article |
| series | Signal Transduction and Targeted Therapy |
| spelling | doaj-art-f885c03ec1fb4a32b8a3eaa9ab3b8fb72025-08-20T04:02:45ZengNature Publishing GroupSignal Transduction and Targeted Therapy2059-36352025-07-0110111310.1038/s41392-025-02337-1Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysisXiaoxiao Liu0Chunying Zhuang1Lei Liu2Ling Xiong3Xin Xie4Ping He5Juanjuan Li6Bing Wei7Xi Yan8Tinglun Tian9Xiaorong Zhong10Jie Chen11Yan Cheng12Dan Zheng13Peng Cheng14Tianlin Sun15Weiwei Li16Changbin Zhu17Shuaitong Chen18Chao Fang19Jun Fu20Shibao Li21Jing Jing22Ting Luo23Institute of Breast Health Medicine, Breast Center, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan UniversityInstitute of Breast Health Medicine, Breast Center, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan UniversityDepartment of physiology, School of Basic Medical Sciences, Xuzhou Medical UniversityInstitute of Breast Health Medicine, West China Hospital, Sichuan UniversityDepartment of Radiation Oncology, Cancer Center, Affiliated Hospital of Xuzhou Medical University; Cancer Institute, Xuzhou Medical UniversityInstitute of Breast Health Medicine, Breast Center, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan UniversityDepartment of Radiation Oncology, Cancer Center, Affiliated Hospital of Xuzhou Medical University; Cancer Institute, Xuzhou Medical UniversityDepartment of Pathology, West China Hospital, Sichuan UniversityInstitute of Breast Health Medicine, Breast Center, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan UniversityInstitute of Breast Health Medicine, Breast Center, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan UniversityInstitute of Breast Health Medicine, Breast Center, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan UniversityInstitute of Breast Health Medicine, West China Hospital, Sichuan UniversityInstitute of Breast Health Medicine, Breast Center, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan UniversityInstitute of Breast Health Medicine, Breast Center, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan UniversityTranslational Medicine Department, Amoy Diagnostics Co., Ltd.Translational Medicine Department, Amoy Diagnostics Co., Ltd.Translational Medicine Department, Amoy Diagnostics Co., Ltd.Translational Medicine Department, Amoy Diagnostics Co., Ltd.LC-Bio Technology Co., Ltd.LC-Bio Technology Co., Ltd.LC-Bio Technology Co., Ltd.Department of Laboratory Medicine, Affiliated Hospital of Xuzhou Medical UniversityInstitute of Breast Health Medicine, West China Hospital, Sichuan UniversityInstitute of Breast Health Medicine, Breast Center, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan UniversityAbstract Chemotherapy serves as the primary therapeutic approach for triple-negative breast cancer (TNBC), yet its efficacy remains unsatisfactory. This study was a single-arm, open-label, single-center clinical trial (NCT05447702) involving patients with newly diagnosed stage II-III TNBC at West China Hospital. The treatment regimen consisted of camrelizumab (200 mg intravenously every 2 weeks, 12 cycles), apatinib (250 mg orally daily), and alternating chemotherapy [nab-paclitaxel (d1, 8, 15 every 4 weeks) for 4 cycles and epirubicin plus cyclophosphamide (every 2 weeks) for 4 cycles]. From June 2023 to April 2024, 35 patients were enrolled, of whom 1 patient withdrew due to adverse reaction intolerance. At treatment completion, the total pathological complete response (tpCR, ypT0/is, ypN0) rate was 67.6% (23/34), and the breast pCR (ypT0/is) rate was 70.6% (24/34). The overall response rate following neoadjuvant treatment reached 94.1% (32/34). Elevated levels of alanine aminotransferase (38.2%) and aspartate aminotransferase (29.4%) were the most common grade 3-4 adverse events, with no significant toxicities or treatment-related deaths reported. Comprehensive analysis of serum and tissue samples collected before and after neoadjuvant therapy via Olink and RNA sequencing revealed that the treatment induced a complex systemic immune response. These findings enabled the development of two novel scoring systems: a pretreatment response predictive score system for stratification and an efficacy assessment score system for treatment response evaluation. In conclusion, camrelizumab and apatinib combined with chemotherapy have good clinical efficacy and good safety as neoadjuvant treatments for stage II-III TNBC, warranting further investigation and potential clinical application.https://doi.org/10.1038/s41392-025-02337-1 |
| spellingShingle | Xiaoxiao Liu Chunying Zhuang Lei Liu Ling Xiong Xin Xie Ping He Juanjuan Li Bing Wei Xi Yan Tinglun Tian Xiaorong Zhong Jie Chen Yan Cheng Dan Zheng Peng Cheng Tianlin Sun Weiwei Li Changbin Zhu Shuaitong Chen Chao Fang Jun Fu Shibao Li Jing Jing Ting Luo Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis Signal Transduction and Targeted Therapy |
| title | Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis |
| title_full | Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis |
| title_fullStr | Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis |
| title_full_unstemmed | Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis |
| title_short | Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis |
| title_sort | exploratory phase ii trial of an anti pd 1 antibody camrelizumab combined with a vegfr 2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple negative breast cancer neopanda03 efficacy safety and biomarker analysis |
| url | https://doi.org/10.1038/s41392-025-02337-1 |
| work_keys_str_mv | AT xiaoxiaoliu exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT chunyingzhuang exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT leiliu exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT lingxiong exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT xinxie exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT pinghe exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT juanjuanli exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT bingwei exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT xiyan exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT tingluntian exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT xiaorongzhong exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT jiechen exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT yancheng exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT danzheng exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT pengcheng exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT tianlinsun exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT weiweili exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT changbinzhu exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT shuaitongchen exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT chaofang exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT junfu exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT shibaoli exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT jingjing exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis AT tingluo exploratoryphaseiitrialofanantipd1antibodycamrelizumabcombinedwithavegfr2inhibitorapatinibandchemotherapyasaneoadjuvanttherapyfortriplenegativebreastcancerneopanda03efficacysafetyandbiomarkeranalysis |