NCT06691594Not yet recruitingPhase 2
Neoadjuvant Treatment of Triple-Negative Breast Cancer with Stereotactic Radiotherapy, PD-1 Monoclonal Antibody, and Chemotherapy
Prospective, Single-arm, Phase II Study of Stereotactic Radiotherapy Combined with PD-1 Monoclonal Antibody and Chemotherapy As Neoadjuvant Treatment for Triple-negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 20 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary aim is to evaluate the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in patients with triple-negative breast cancer, with the endpoint being the pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment. This is a single-arm study. Eligible participants will receive : neoadjuvant treatment consisting of SBRT followed by Envafolimab (PD-1 inhibitor), chemotherapy and immunotherapy (Envafolimab). Surgery will be performed after the last chemotherapy cycle. Pathological evaluation will assess the treatment response. Patients will receive adjuvant immunotherapy (Envafolimab) up to 1 year post-surgery.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 14 Nov 2024
- Start date
- Feb 2025
- Primary completion date
- Nov 2028
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06691594
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From Feb 2025 to the primary completion date, Nov 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of immunosuppressants or systemic steroids (within 2 weeks prior to enrollment)
- Known allergy to any component of the investigational drugs
- Other factors likely to cause early study termination (e.g., serious concurrent illnesses, significant lab abnormalities, or social/family circumstances affecting safety/data collection)
Other illness
- Occult breast cancer
- Bilateral breast cancer
- History of other malignancies that may affect survival
- Active autoimmune disease or history of autoimmune disease
- Uncontrolled cardiac symptoms or diseases
- Active infection or unexplained fever \> 38.5°C during screening/before first dose
Other
- Breast tumor unsuitable for SBRT
- Unable to undergo MRI scanning
Who the study is looking for
- Signed written informed consent prior to enrollment
- Age ≥ 18 years
- ECOG PS score 0-1
- Newly diagnosed T1c N1-2 or T2-3 N0-2 breast cancer
- Triple-negative breast cancer with PD-L1 CPS \< 10
- Hemoglobin ≥ 10.0 g/dl, neutrophils ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L
- BUN ≤ 1.5 × upper limit of normal (ULN), creatinine ≤ 1.5 × ULN
- Serum bilirubin ≤ 1.5 × ULN, alkaline phosphatase (AKP), AST, and ALT ≤ 2.5 × ULN
- Women of childbearing potential must be willing to use contraception during the study
- Negative serum or urine pregnancy test within 7 days prior to treatment
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.