Combining Radiotherapy and Immunotherapy for Advanced TNBC
The Optimal Radioimmunotherapy Combinations for Advanced TNBC
Recruiting
Phase 2Interventional Study
Triple-Negative Breast Cancer (TNBC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Sun Yat-sen University · Other
Who this trial is looking for
This trial is looking for patients with advanced triple-negative breast cancer who have not received prior chemotherapy for this stage of the disease. Participants will explore how well a combination of radiotherapy and immunotherapy works.
Are You a Good Fit for This Trial?
You may be able to join if
I have inoperable locally advanced or metastatic triple-negative breast cancer.
I have not received chemotherapy for advanced or metastatic disease.
I have a performance status score of 0 or 1.
I have 1 to 5 tumor lesions that can be treated with radiotherapy.
I have at least one measurable lesion that can be evaluated.
I can get either nab-paclitaxel or gemcitabine + carboplatin.
I can provide tumor tissue samples or agree to a biopsy.
My blood and organ function meet the study requirements.
You may not be able to join if
I have received platinum-containing chemotherapy less than 6 months ago.
I have had radiotherapy within the last 12 weeks.
I have extensive tumor metastasis that cannot tolerate radiotherapy.
I have significant fluid retention issues.
I need long-term systemic corticosteroid treatment.
I have an active autoimmune disease.
I have a severe infection currently.
I have been deemed unsuitable for this trial by the investigator.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This study aims to explore the best combination patterns of radiotherapy and immunotherapy for advanced triple-negative breast cancer (TNBC).
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Inoperable locally advanced/metastatic triple-negative breast cancer (defined as ER and PR \<1%; and HER2 negative as IHC 0 or IHC 1+, or IHC 2+ but negative upon fluorescence in situ hybridization (FISH) testing). Patients with ER/PR ≤10% and deemed unsuitable for endocrine …
Inclusion Criteria:
1. Inoperable locally advanced/metastatic triple-negative breast cancer (defined as ER and PR \<1%; and HER2 negative as IHC 0 or IHC 1+, or IHC 2+ but negative upon fluorescence in situ hybridization (FISH) testing). Patients with ER/PR ≤10% and deemed unsuitable for endocrine therapy by the investigator are also eligible.
2. No prior chemotherapy for advanced/metastatic disease.
3. ECOG PS score of 0 or 1.
4. Presence of 1 to 5 tumor lesions suitable for radiotherapy (individual lesion size between 0.5 and 5 cm, not limited to 1 to 2 organs).
5. At least one measurable lesion outside the radiation field that can be evaluated.
6. Suitable to receive one of the chemotherapy regimens chosen by the investigator: nab-paclitaxel or gemcitabine + carboplatin.
7. Patients with brain metastases are allowed if they do not require local therapy at enrollment or if the metastatic lesion is treated with the assigned radiotherapy regimen.
8. Patients who have previously received PD-1/PD-L1 therapy for early-stage disease are allowed to enroll.
9. Able to provide tumor tissue sections or agree to tumor biopsy during the screening period.
10. Adequate organ and bone marrow function, with specific requirements:
1. Hematology: Neutrophil count (ANC) ≥1.5×10\^9/L; Platelet count (PLT) ≥90×10\^9/L; Hemoglobin (Hb) ≥90 g/L; No blood product transfusion (including red blood cell and platelet products, etc.) or growth factor (including colony-stimulating factors, interleukins, and erythropoietin, etc.) support treatment within 2 weeks prior to examination.
2. Liver function: Serum total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (for patients with liver metastases: ALT and AST ≤5×ULN).
3. Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance \>60 mL/min.
Exclusion Criteria:
1. Received platinum-containing regimens during the adjuvant/neoadjuvant therapy phase, and the interval from the last treatment to recurrence/metastasis is less than 6 months.
2. Have received radiotherapy within 12 weeks prior to enrollment, unless the radiotherapy was for adjuvant purposes and there are lesions outside the previously irradiated field.
3. Extensive tumor metastasis with surrounding normal tissues that cannot tolerate radiotherapy damage.
4. Significant third-space fluid retention (e.g., ascites, pleural effusion, pericardial effusion).
5. Require long-term systemic corticosteroid treatment.
6. Have active autoimmune diseases.
7. Have concurrent severe infections.
8. Other patients deemed unsuitable for enrollment by the investigator.
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