RecruitingPhase 2NCT06735131

The Optimal Radioimmunotherapy Combinations for Advanced TNBC

A Prospective, Multicenter Clinical Trial Exploring the Optimal Combination Strategies of Radiotherapy and Immunotherapy for Advanced Triple-Negative Breast Cancer

Sponsor

Sun Yat-sen University

Enrollment

60 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

Triple Negative Breast Cancer(TNBC)

Summary

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

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing combinations of radiation therapy and immunotherapy for women with triple-negative breast cancer (TNBC) — an aggressive type that does not respond to hormone or HER2 therapies — that is advanced or has spread to other parts of the body. **You may be eligible if...** - You have inoperable or metastatic triple-negative breast cancer (confirmed by testing) - You have not received chemotherapy for your advanced or metastatic disease - You have 1 to 5 tumor lesions that are suitable for radiation therapy - Your general health score (ECOG) is 0 or 1 **You may NOT be eligible if...** - You have already received chemotherapy for advanced disease - Your cancer does not qualify as triple-negative - You are in poor general health 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.

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Interventions

RADIATIONradiotherapy 5 Gy × 5 fractions, once a day

5 Gy × 5 fractions, once a day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy

RADIATIONradiotherapy 8 Gy × 5 fractions, once a day

8 Gy × 5 fractions, once a day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy

RADIATIONradiotherapy 8 Gy × 3 fractions, once every other day

8 Gy × 3 fractions, once every other day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy

RADIATIONradiotherapy 10 Gy× 3 fractions, once every other day

10 Gy × 3 fractions, once every other day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy

RADIATIONradiotehrapy 0.5Gy twice-a-day × 2 days, repeat for 4 cycles (total 8Gy)

0.5 Gy twice-a-day × 2 days, on the first 2 days of the first 4 cycles of toripalimab and chemotherapy (total 8Gy)

DRUGToripalimab

Toripalimab (240 mg IV, d1, Q3W)

DRUGchemotherapy regimen selected by the investigator

Regimens to be selected from: (1) Nab-paclitaxel (125 mg/m2 IV, days 1, 8, Q3W) (2) Gemcitabine (1000 mg/m² IV, days 1 and 8, Q3W) + carboplatin (AUC=2 IV, days 1 and 8, Q3W)

Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT06735131

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