RecruitingPhase 3NCT05909332

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

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)

Sponsor

Fudan University

Enrollment

764 participants

Start Date

Jun 20, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Triple-Negative Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an anti-vascular drug (which cuts off the blood supply to tumors) to standard chemotherapy works better than chemotherapy alone as additional treatment after surgery for a specific high-risk subtype of triple-negative breast cancer (TNBC) called the BLIS subtype. **You may be eligible if...** - You are a woman aged 18–70 with confirmed triple-negative breast cancer of the BLIS subtype - Your cancer is at stages IIA through IIIC with lymph node involvement, and you have had curative surgery - You did not receive neoadjuvant (pre-surgery) therapy - Your blood counts and organ function are within acceptable ranges - Your surgical wound has fully healed **You may NOT be eligible if...** - You have metastatic (stage IV) breast cancer - You have bilateral breast cancer - You have had another cancer (with some exceptions) - You have significant heart, liver, or kidney disease - You are pregnant, breastfeeding, or unwilling to use contraception - You have an allergy to taxane chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAntivascular therapy

BP102 (anti VEGFR)

DRUGChemotherapy

ddEC-P

Locations(15)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangdong, Guangzhou, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05909332

Related Trials

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer

NCT034128771 location

Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer

NCT0560144010 locations

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

NCT0661828764 locations

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

NCT06982521158 locations

ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer

NCT045238571 location