Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611813
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Neoadjuvant Chemotherapy in Combination With Toripalimab for HRHER2- Breast Cancer NEOTORCH-BREAST01
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adjuvant Treatment of HRHER2- Breast Cancer With Toripalimab Combined With Neoadjuvant Chemotherapy and Sequential Toripalimab Monoclonal Antibody A Prospective Single-arm Multi-center Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective single arm multi-center phase II clinical trial The primary study objective is to evaluate the pathologic complete responsePCR of Adjuvant treatment of HRHER2- breast cancer with Toripalimab combined with neoadjuvant chemotherapy and sequential Toripalimab monoclonal antibody including the incidences and types of adverse events The secondary study objective is to observe and evaluate the disease-free survival DFS Progression-Free-Survival PFS and Objective Response RateORR
Detailed Description:
1 Breast cancer is the most common malignant tumor among women worldwide with 23 million women suffering from it every year In China the incidence rate of breast cancer is increasing year by year with about 400000 new cases every year which seriously threatens the life and health of women in China Study population participants with HRHER2- breast cancer confirmed by postoperative pathology according to American Joint Committee on Cancer AJCC Union for International Cancer Control UICC 8th Tumor Node Metastasis TNM staging classification
2 Sample size single arm design was used in this study and 50 participants were estimated to be enrolled
3 Histologically confirmed invasive breast cancer with tumor diameterampgt1cm T1c-3 N0-3 M0 All patients were pathohistologically confirmed as HRHER2- breast cancer According to the breast cancer diagnosis and treatment guidelines and specifications of the Chinese Society of Clinical Oncology Luminal B is divided into Luminal B HER2 negative and Luminal B HER2 positive Luminal B HER2 negative is ERPR positive HER2 negative and Ki-67 proliferation index is high or PR low expression Luminal type B HER2 positive is ERPR positive HER2 positive protein overexpression or gene amplification and Ki-67 in any state Therefore HRHER2- breast cancer is a Luminal type breast cancer patient excluding HER2
4 Chemotherapy Phase 1 Epirubicin or Liposomal DoxorubicinCyclophosphamide intravenous infusion of 100 mgm2 Epirubicin or 35 mgm2 liposomal doxorubicin600 mgm2 cyclophosphamide starting from the first day of the third week for a total of 12 weeks
Chemotherapy Phase 2 Paclitaxel administered intravenously at a dose of 260 mgm2 every 3 weeks for a total of 12 weeks During neoadjuvant chemotherapy and postoperative adjuvant therapy use of trastuzumab intravenous infusion of 240 mg once every 3 weeks combined with preoperative and postoperative adjuvant therapy for a total of 1 year
5 Adverse events AEs management To minimize the risk of AEs the investigators will monitor carefully to determine whether or not they are within the expected range Investigators will also conduct a thorough examination and adopt an appropriate system to take any necessary measures to deal with AEs
2 Sample size single arm design was used in this study and 50 participants were estimated to be enrolled
3 Histologically confirmed invasive breast cancer with tumor diameterampgt1cm T1c-3 N0-3 M0 All patients were pathohistologically confirmed as HRHER2- breast cancer According to the breast cancer diagnosis and treatment guidelines and specifications of the Chinese Society of Clinical Oncology Luminal B is divided into Luminal B HER2 negative and Luminal B HER2 positive Luminal B HER2 negative is ERPR positive HER2 negative and Ki-67 proliferation index is high or PR low expression Luminal type B HER2 positive is ERPR positive HER2 positive protein overexpression or gene amplification and Ki-67 in any state Therefore HRHER2- breast cancer is a Luminal type breast cancer patient excluding HER2
4 Chemotherapy Phase 1 Epirubicin or Liposomal DoxorubicinCyclophosphamide intravenous infusion of 100 mgm2 Epirubicin or 35 mgm2 liposomal doxorubicin600 mgm2 cyclophosphamide starting from the first day of the third week for a total of 12 weeks
Chemotherapy Phase 2 Paclitaxel administered intravenously at a dose of 260 mgm2 every 3 weeks for a total of 12 weeks During neoadjuvant chemotherapy and postoperative adjuvant therapy use of trastuzumab intravenous infusion of 240 mg once every 3 weeks combined with preoperative and postoperative adjuvant therapy for a total of 1 year
5 Adverse events AEs management To minimize the risk of AEs the investigators will monitor carefully to determine whether or not they are within the expected range Investigators will also conduct a thorough examination and adopt an appropriate system to take any necessary measures to deal with AEs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None