Actively Recruiting

Phase 2
All Genders
NCT06735131

The Optimal Radioimmunotherapy Combinations for Advanced TNBC

Led by Sun Yat-sen University · Updated on 2025-12-03

60

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

W

West China Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study aims to explore the best combination patterns of radiotherapy and immunotherapy for advanced triple-negative breast cancer (TNBC).

CONDITIONS

Official Title

The Optimal Radioimmunotherapy Combinations for Advanced TNBC

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Inoperable locally advanced or metastatic triple-negative breast cancer with ER and PR <1% and HER2 negative or ER/PR ≤10% deemed unsuitable for endocrine therapy
  • No prior chemotherapy for advanced or metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Presence of 1 to 5 tumor lesions suitable for radiotherapy, each between 0.5 and 5 cm
  • At least one measurable lesion outside the radiation field for evaluation
  • Suitable for chemotherapy with nab-paclitaxel or gemcitabine plus carboplatin as selected by investigator
  • Brain metastases allowed if no local therapy needed at enrollment or if treated with assigned radiotherapy
  • Prior PD-1/PD-L1 therapy for early-stage disease permitted
  • Ability to provide tumor tissue sections or agree to tumor biopsy during screening
  • Adequate organ and bone marrow function, including neutrophil count ≥1.5×10^9/L, platelet count ≥90×10^9/L, hemoglobin ≥90 g/L, no recent blood transfusions or growth factor treatments
  • Liver function with bilirubin ≤1.5× upper limit of normal and ALT/AST ≤2.5× ULN (or ≤5× ULN if liver metastases present)
  • Renal function with serum creatinine ≤1.5× ULN or creatinine clearance >60 mL/min
Not Eligible

You will not qualify if you...

  • Prior platinum-containing chemotherapy during adjuvant or neoadjuvant phase with less than 6 months between last treatment and recurrence or metastasis
  • Radiotherapy within 12 weeks before enrollment unless for adjuvant purposes with lesions outside previous radiation field
  • Extensive tumor metastases involving surrounding normal tissues unable to tolerate radiotherapy
  • Significant fluid retention such as ascites, pleural effusion, or pericardial effusion
  • Need for long-term systemic corticosteroid treatment
  • Active autoimmune diseases
  • Severe ongoing infections
  • Other conditions deemed unsuitable for study participation by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

Loading map...

Research Team

S

Shusen Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here