Trial Title:
Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03)
NCT ID:
NCT05909332
Condition:
Breast Cancer
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Conditions: Keywords:
triple negative breast cancer
adjuvant therapy
antivascular therapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Antivascular therapy
Description:
BP102 (anti VEGFR)
Arm group label:
Arm-A
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
ddEC-P
Arm group label:
Arm-A
Arm group label:
Arm-B
Summary:
This is a randomized, open-label phase III clinical trial comparing antivascular therapy
combined with standard chemotherapy and standard chemotherapy in adjuvant therapy for
patients with triple-negative breast cancer, basal-like/Immune suppressed subtype.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Women aged 18-70 years old;
- Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1;
- Histological results recorded as TNBC (negative HER2, ER, and PgR status) and BLIS
subtype according to the classification of FUSCC;
- Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically
treated: pT1-3N1-3M0;
- Adequate hematological and end-organ function as defined by the following laboratory
test results, which need to be completed within 28 days prior to the first study
treatment: absolute neutrophil count (ANC) ≥ 1500 cells/μL (no G-CSF support therapy
within 2 weeks prior to day 1 of course 1); Platelet count ≥ 75×109/L (no platelet
transfusion within 2 weeks before day 1 of course 1); hemoglobin ≥ 9.0 g/dL (no RBC
transfusion within 2 weeks before day 1 of course 1); AST, ALT, and alkaline
phosphatase ≤ 3 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN;
serum creatinine ≤ 1ULN and with an endogenous creatinine clearance rate of >50
ml/min (Cockcroft-Gault formula);
- The surgical incision had fully healed prior to the commencement of the study;
- Female participants of reproductive potential are required to use a medically
accepted form of contraception during the course of the study treatment and for at
least three months following the last administration of the investigational drug;
- Sign the Informed Consent Form (ICF). The patient is judged by the investigator to
have the ability to comply with the provisions of the protocol.
Exclusion Criteria:
- Has received neoadjuvant therapy (including chemotherapy, targeted therapy, and
radiotherapy)
- Has bilateral breast cancer;
- Has a previous history of additional malignancy, with the exception of adequately
treated basal cell carcinoma and cervical carcinoma in situ.
- Has metastatic (Stage 4) breast cancer;
- Has any >T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation,
and inflammatory breast cancer);
- Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left
ventricular ejection fraction (LVEF) < 50% (a cardiac ultrasound); severe cardio
cerebral vascular disease within the 6 months previous to randomization (such as
unstable angina, chronic heart failure, uncontrolled hypertension with blood
pressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic
patients with poor blood glucose control; patients with severe hypertension;
- Is pregnant, breastfeeding women, or women of childbearing age who cannot practice
effective contraceptives;
- Patients participating in other clinical trials at the same time;
- Has known allergy to taxane and excipients.
- Has severe or uncontrolled infection;
- Has a history of psychotropic substance abuse and was unable to abandon drug habits
or those with a history of mental disorders;
- the researchers judged patients to be unsuitable for the study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
HuiPing Li, MD
Phone:
+86-010-88121122
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohua Zeng, MD
Phone:
+86-023-65311341
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
ChuanGui Song, MD
Phone:
+86-591-83357896
Facility:
Name:
Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Kun Wang, MD
Phone:
+86-020-83827812
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangdong
Zip:
510062
Country:
China
Status:
Recruiting
Contact:
Last name:
ShuSen Wang, MD
Phone:
+86-020-87343292
Facility:
Name:
Affiliated Hospital of Nantong University
Address:
City:
Nantong
Zip:
226006
Country:
China
Status:
Recruiting
Contact:
Last name:
ZhiXian He, MD
Phone:
+86-513-85052504
Contact backup:
Last name:
SuJie Ni, MD
Facility:
Name:
Northern Jiangsu People's Hospital
Address:
City:
Yangzhou
Zip:
225009
Country:
China
Status:
Recruiting
Contact:
Last name:
DeYuan Fu, MD
Phone:
+86-0514-87373114
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110002
Country:
China
Status:
Recruiting
Contact:
Last name:
YueE Teng, MD
Phone:
+86-024-83283333
Contact backup:
Last name:
YingYing Xu, MD
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Zip:
110801
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Shen, MD
Phone:
+86-024-81916684
Contact backup:
Last name:
Qiang Zhang, MD
Facility:
Name:
Breast cancer institute of Fudan University Cancer Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi-Ming Shao, MD
Phone:
86-21-641755901105
Email:
zhimingshao@yahoo.com
Contact backup:
Last name:
Lei Fan, MD
Phone:
86-21-641755901105
Email:
cmchen@medmail.com.cn
Investigator:
Last name:
Zhi-Ming Shao, MD
Email:
Principal Investigator
Investigator:
Last name:
Min He, MD
Email:
Sub-Investigator
Investigator:
Last name:
Linxiaoxi Ma, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ying Zhou
Email:
Sub-Investigator
Facility:
Name:
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Address:
City:
Shanghai
Zip:
200233
Country:
China
Status:
Recruiting
Contact:
Last name:
Zan Shen, MD
Phone:
+86-021-64369181
Facility:
Name:
Shanghai First Maternity and Infant Hospital
Address:
City:
Shanghai
Zip:
201204
Country:
China
Status:
Recruiting
Contact:
Last name:
ZhiGang Zhuang, MD
Phone:
+86-021-20261000
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Yang, MD
Phone:
+86-029-85323217
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Luo, MD
Phone:
+86-028-85422114
Facility:
Name:
Ningbo Medical Center Lihuili Hospital
Address:
City:
Ningbo
Country:
China
Status:
Recruiting
Contact:
Last name:
WeiZhu Wu, MD
Phone:
+86-574-87018701
Start date:
June 20, 2023
Completion date:
May 30, 2031
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05909332
