Actively Recruiting

Phase 3
Age: 18Years - 70Years
FEMALE
NCT05909332

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

Led by Fudan University · Updated on 2026-01-21

764

Participants Needed

15

Research Sites

414 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18-70 years old
  • Eastern Oncology Collaborative Group (ECOG) physical status score of 0 or 1
  • Histologically confirmed triple-negative breast cancer (negative HER2, ER, and PgR) with basal-like immunosuppressed subtype
  • Stage IIA to IIIC non-metastatic triple-negative breast cancer surgically treated (pT1-3N1-3M0)
  • Adequate blood counts and organ function per defined laboratory tests within 28 days before treatment
  • Surgical incision fully healed before starting the study
  • Use of medically accepted contraception during treatment and for at least three months after last investigational drug dose for women of reproductive potential
  • Ability to understand and sign informed consent and comply with study protocol
Not Eligible

You will not qualify if you...

  • Prior neoadjuvant therapy including chemotherapy, targeted therapy, or radiotherapy
  • Bilateral breast cancer
  • Previous other malignancies except treated basal cell carcinoma or cervical carcinoma in situ
  • Metastatic (Stage 4) breast cancer
  • Any lesion classified as >T4 including skin involvement or inflammatory breast cancer
  • Severe organ dysfunction or insufficiency including heart, lung, liver, or kidney
  • Left ventricular ejection fraction below 50%
  • Severe cardio or cerebrovascular disease within 6 months before randomization
  • Poorly controlled diabetes or severe hypertension
  • Pregnancy, breastfeeding, or inability to use effective contraception
  • Participation in other clinical trials concurrently
  • Known allergy to taxane or excipients
  • Severe or uncontrolled infections
  • History of substance abuse or mental disorders affecting compliance
  • Judged unsuitable for the study by researchers

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 15 locations

1

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

2

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China, 400030

Actively Recruiting

3

Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

Actively Recruiting

4

Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Actively Recruiting

5

Sun Yat-sen University Cancer Center

Guangdong, Guangzhou, China, 510062

Actively Recruiting

6

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China, 226006

Actively Recruiting

7

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China, 225009

Actively Recruiting

8

The First Hospital of China Medical University

Shenyang, Liaoning, China, 110002

Actively Recruiting

9

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China, 110801

Actively Recruiting

10

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

11

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China, 200233

Actively Recruiting

12

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China, 201204

Actively Recruiting

13

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China, 710061

Actively Recruiting

14

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

15

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

Actively Recruiting

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Research Team

Z

Zhi-Ming Shao, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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