Triple attack: radiation, immunotherapy, and chemo take on tough breast cancer
NCT ID NCT06627712
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding targeted radiation (SBRT) to standard chemotherapy and immunotherapy can improve outcomes for people with early-stage triple-negative breast cancer (TNBC). TNBC is harder to treat than other breast cancers, and this combination aims to boost the immune system's ability to kill cancer cells. About 318 participants will receive the treatment before surgery, and researchers will measure how many have no cancer remaining at that point.
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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 318 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2024
- Expected to finish
-
Nov 2031
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 65 years
- Sex
-
Female participants only
- Healthy volunteers
-
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\. Histologically or cytologically confirmed TNBC (ER-, PR-, HER2-) * 2\. cT1cN1-2M0 or cT2N0-2M0;(AJCC 7th) * 3\. ECOG performance status of 0-1; * 4\. Adequate bone marrow function, defined as: Hb ≥ 9.0 g/dL (90 g/L); ANC ≥ 1,500/mcL (1.5 × 10\^9/L); PLT ≥ 100,000/mcL (100 × 10\^9/L) and no blood transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing; * 5\. Adequate liver function, defined as: TBIL ≤ 1.5× upper limit of normal (ULN); If no liver metastases, AST and ALT ≤ 2.5× ULN; if liver metastases are present, AST or ALT ≤ 3.0× ULN; ALP ≤ 1.5× ULN; if liver metastases ≤ 2× ULN; Serum albumin ≥ 30g/L; * 6\. Adequate coagulation function: INR or PT, APTT ≤ 1.5× ULN. Participants on anticoagulant therapy should have these laboratory indices closely monitored; * 7\. Adequate renal function, defined as creatinine ≤ 1.5× ULN or Ccr ≥ 50 mL/min calculated using the Cockcroft-Gault formula corrected for body surface area; * 8\. Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram (ECHO); * 9\. No severe organic heart disease or arrhythmias; * 10\. Women of childbearing potential (aged 15-49 years) must have a negative pregnancy test within 7 days before starting treatment. Both male and female participants of reproductive potential must agree to use effective contraceptive measures during the study period and for 3 months after discontinuation of treatment; * 11\. Voluntary signed informed consent by the study participant. Exclusion Criteria: * 1\. Patients with a history of mental illness or those diagnosed with mental disorders at the time of enrollment in the clinical trial. * 2\. Patients with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent them from responding normally. * 3\. Poorly controlled tumor-related pain. * 4\. Patients participating in other clinical studies simultaneously. * 5\. Patients with active or past autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis. * 6\. A history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scans at screening. * 7\. Active pulmonary tuberculosis. * 8\. Severe cardiovascular diseases occurring within 3 months prior to the start of study treatment (e.g., NYHA class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmias, or unstable angina. * 9\. Patients who underwent significant surgical procedures, other than diagnostic surgeries, within 4 weeks prior to the start of the study treatment, or are expected to require significant surgical procedures during the study period. * 10\. Patients who had malignant tumors other than breast cancer within the last 5 years, except for malignancies in the study that have negligible risks of metastasis or death (e.g., a 5-year overall survival rate \> 90%), such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ, or stage I uterine cancer. * 11\. Patients who experienced severe infections within 4 weeks prior to the start of the study treatment, including but not limited to those requiring hospitalization due to infections, bacteremia, severe pneumonia, or any active infection that may impact patient safety. * 12\. Patients who have previously received allogeneic stem cell or solid organ transplants. * 13\. Any other diseases, metabolic dysfunctions, physical examination abnormalities, or clinical laboratory abnormalities that contraindicate the use of the study drug, may affect the interpretation of results, or pose a high risk of treatment complications for the patient.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for TNBC - triple-negative breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
West China Hospital, Sichuan University
RECRUITINGSichuan, Chengdu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Real-World data match trial results for pembrolizumab in Triple-Negative breast cancer?
- Can Gene-Edited immune cells tame Hard-to-Treat cancers?
- Can a One-Time Anti-Inflammatory shot during surgery curb Triple-Negative breast Cancer's return?
- Triple-Drug cocktail aims to stall aggressive breast cancer
- Could a vaccine stop Triple-Negative breast cancer from coming back?
- Engineered immune cells take aim at Mesothelin-Positive tumors