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New treatment option for TNBC - Triple-Negative Breast Cancer
Official title SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC
ClinicalTrials.gov ID: NCT06627712
What this study is testing
What is SBRT+PD-1 Inhibitor + Chemotherapy?
SBRT+PD-1 Inhibitor + Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for tnbc - triple-negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Triple-negative breast cancer (TNBC) presents significant challenges due to its limited treatment options and poor efficacy. While neoadjuvant chemotherapy has improved breast-conserving rates and extended survival for TNBC patients, this subtype still faces issues such as restricted treatment modalities, low pathological response rates, and unfavorable prognosis compared to other subtypes.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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...
- 6\. A history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia, or idiopathic...
See the full eligibility 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...
- 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...
- 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...
- 11\. Voluntary signed informed consent by the study participant.
- 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...
- 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...
- 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...
- 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 \>...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Sichuan, Chengdu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sichuan, Chengdu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.