New combo therapy aims to boost immune attack on tough breast cancer
NCT ID NCT06735131
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing different ways to combine radiotherapy with the immunotherapy drug toripalimab and chemotherapy for people with advanced triple-negative breast cancer (TNBC). The goal is to find the best schedule that helps control the cancer longer. About 60 participants will receive one of several radiotherapy patterns alongside standard treatment, and researchers will track how many are still progression-free after 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- toripalimab (immunotherapy) plus radiotherapy and chemotherapy
- What this could lead to
- If successful, this could establish a more effective combination treatment for advanced triple-negative breast cancer, potentially improving how long patients live without their cancer worsening.
- What could go wrong
- This is a small, early-phase trial with only 60 participants, so results may not apply to all patients. The added radiotherapy also carries risks like fatigue, skin reactions, or inflammation of nearby organs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Four-Drug combo erase Triple-Negative breast cancer before surgery?
- Can a Custom-Made vaccine outsmart Triple-Negative breast cancer?
- Can a drug combo outsmart a tough breast cancer subtype?
- Can a new drug combo outsmart triple-negative breast cancer?