Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03)

Breast Cancer Clinical Trial

Official title:

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 Immunosuppressed Subtype (BCTOP-T-A03)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909332
• Other study ID #: BCTOP-T-A03
• Status: Recruiting
• Phase: Phase 3
• Start date: June 20, 2023
• Est. completion date: May 30, 2031

Study information

• Verified date: February 2024
• Source: Fudan University
• Contact: Zhi-Ming Shao, MD, PhD
• Phone: +86-021-64175590
• Email: zhimingshao[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 548
• Est. completion date: May 30, 2031
• Est. primary completion date: May 30, 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Antivascular therapy
BP102 (anti VEGFR)
• Chemotherapy
ddEC-P

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Sun Yat-sen University Cancer Center	Guangdong	Guangzhou
China	Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang
China	Breast cancer institute of Fudan University Cancer Hospital	Shanghai	Shanghai
China	Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University	Shanghai	Shanghai
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iDFS	invasive disease-free survival	5 years
Secondary	DRFS	distant recurrence free survival	5 years
Secondary	OS	overall survival	5 years
Secondary	AE	adverse effects	5 years