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

February 17, 2024 updated by: Zhimin Shao, Fudan University

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

548

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • HuiPing Li, MD
          • Phone Number: +86-010-88121122
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing Cancer Hospital
        • Contact:
          • Xiaohua Zeng, MD
          • Phone Number: +86-023-65311341
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • ChuanGui Song, MD
          • Phone Number: +86-591-83357896
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital
        • Contact:
          • Kun Wang, MD
          • Phone Number: +86-020-83827812
    • Guangzhou
      • Guangdong, Guangzhou, China, 510062
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • ShuSen Wang, MD
          • Phone Number: +86-020-87343292
    • Jiangsu
      • Nantong, Jiangsu, China, 226006
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
          • ZhiXian He, MD
          • Phone Number: +86-513-85052504
        • Contact:
          • SuJie Ni, MD
      • Yangzhou, Jiangsu, China, 225009
        • Recruiting
        • Northern Jiangsu People's Hospital
        • Contact:
          • DeYuan Fu, MD
          • Phone Number: +86-0514-87373114
    • Liaoning
      • Shenyang, Liaoning, China, 110801
        • Recruiting
        • Liaoning Cancer Hospital & Institute
        • Contact:
          • Tao Shen, MD
          • Phone Number: +86-024-81916684
        • Contact:
          • Qiang Zhang, MD
      • Shenyang, Liaoning, China, 110002
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
          • YueE Teng, MD
          • Phone Number: +86-024-83283333
        • Contact:
          • YingYing Xu, MD
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Breast cancer institute of Fudan University Cancer Hospital
        • Sub-Investigator:
          • Ying Zhou
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhi-Ming Shao, MD
        • Sub-Investigator:
          • Min He, MD
        • Sub-Investigator:
          • Linxiaoxi Ma, MD
      • Shanghai, Shanghai, China, 201204
        • Recruiting
        • Shanghai first maternity and infant hospital
        • Contact:
          • ZhiGang Zhuang, MD
          • Phone Number: +86-021-20261000
      • Shanghai, Shanghai, China, 200233
        • Recruiting
        • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
        • Contact:
          • Zan Shen, MD
          • Phone Number: +86-021-64369181
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Jin Yang, MD
          • Phone Number: +86-029-85323217
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Ting Luo, MD
          • Phone Number: +86-028-85422114
    • Zhejiang
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo Medical Center Lihuili Hospital
        • Contact:
          • WeiZhu Wu, MD
          • Phone Number: +86-574-87018701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm-A

BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W + Chemotherapy ddEC-P(described below). This was followed by maintenance therapy with BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W to complete treatment with a total duration of 1 year from the first dose.

Chemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks.
Drug: Antivascular therapy
BP102 (anti VEGFR)
Drug: Chemotherapy
ddEC-P
Active Comparator: Arm-B
Chemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks.
Drug: Chemotherapy
ddEC-P

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iDFS
Time Frame: 5 years
invasive disease-free survival
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 5 years
overall survival
5 years
DRFS
Time Frame: 5 years
distant recurrence free survival
5 years
AE
Time Frame: 5 years
adverse effects
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Estimated)

May 30, 2029

Study Completion (Estimated)

May 30, 2031

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

June 11, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCTOP-T-A03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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