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New treatment option for Stereotactic Radiotherapy
Official title Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC
ClinicalTrials.gov ID: NCT06165900
What this study is testing
What is adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)?
adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) is an investigational medicine, being studied as a potential treatment for stereotactic radiotherapy.
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
- This study was an open-label, multicenter, randomized study. It is planned to include 136 patients with stage II-III triple negative breast cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 75, women only
You may be able to join if
- Treatment-naïve breast cancer female patients aged ≥ 18 years and ≤ 75 years;
- Histopathologically confirmed early or locally advanced triple-negative invasive breast cancer according to the latest ASCO/CAP guidelines, meeting...
- Clinical stage II-III invasive breast cancer with measurable lesions according to RECIST 1.1;
- ECOG score 0-1;
- Able to tolerate preoperative and postoperative adjuvant radiotherapy after assessment by a radiologist;
You likely can't join if
- Patients with metastatic breast cancer or bilateral breast cancer;
- Patients with inflammatory breast cancer or occult breast cancer;
- Patients received any anti-tumor therapy within 12 months before signing the informed consent form, including chemotherapy, targeted therapy...
- Patients previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other treatments against PD-1/PD-L1 inhibitors;
- Female patients who are pregnant and lactating, female patients who are fertile and have a positive baseline pregnancy test, or female patients of...
- Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic...
See the full eligibility criteria
- Treatment-naïve breast cancer female patients aged ≥ 18 years and ≤ 75 years;
- Histopathologically confirmed early or locally advanced triple-negative invasive breast cancer according to the latest ASCO/CAP guidelines, meeting the following conditions: (1) pathological type is triple-negative...
- Clinical stage II-III invasive breast cancer with measurable lesions according to RECIST 1.1;
- ECOG score 0-1;
- Able to tolerate preoperative and postoperative adjuvant radiotherapy after assessment by a radiologist;
- Appropriate level of organ function
- Patients voluntarily participate in and sign the informed consent form, are expected to have good compliance and cooperate with the study according to the requirements of the protocol.
- Patients with metastatic breast cancer or bilateral breast cancer;
- Patients with inflammatory breast cancer or occult breast cancer;
- Patients received any anti-tumor therapy within 12 months before signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy or tumor...
- Patients previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other treatments against PD-1/PD-L1 inhibitors;
- Female patients who are pregnant and lactating, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive...
- Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic drug abuse, alcoholism ;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) test, or positive hepatitis B core antibody (HBcAb) test followed by positive...
- Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, 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.