Actively Recruiting
Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-11-08
24
Participants Needed
1
Research Sites
408 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
RATIONALE: Patients with HER2-negative breast cancer not responding to initial neoadjuvant chemotherapy might have lower chances for a pathologic complete response (pCR) at definitive surgery, indicating worse prognosis. Adoptive cell therapy has demonstrated efficacy in advanced breast cancer, but whether the addition of adoptive cell therapy to neoadjuvant chemotherapy could increase the pCR rate remains unclear. Tumor-draining lymph node-derived lymphocytes (LNLs) that have abundant tumor-reactive T cells, but not exhausted T cells, are easy to produce. It is not yet known whether LNL treatment is safe and effective in patients with HER2-negative breast cancer not responding to neoadjuvant chemotherapy. PURPOSE: This phase I trial is mainly to investigate the safety of autologous LNL in patients with HER2-negative breast cancer not responding to neoadjuvant chemotherapy.
CONDITIONS
Official Title
Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged between 18 and 70 years
- Signed informed consent for study participation
- Histologically confirmed invasive breast cancer by core needle biopsy
- Received two cycles of doxorubicin or epirubicin plus cyclophosphamide with stable disease confirmed by breast MRI
- Breast cancer staging: primary tumor at least 1 cm by MRI, N0-3, M0
- HER2-negative breast cancer as defined by immunohistochemistry and FISH
- Known hormone receptor status, Ki67 value, and tumor grade if available
- No prior breast cancer therapies except specified chemotherapy
- Accessible tumor-draining lymph nodes without prior sentinel lymph node biopsy or axillary lymph node dissection
- ECOG performance status of 0 or 1
- Adequate normal organ function including blood counts, liver, kidney, coagulation, heart, and lung function
- Negative pregnancy test and use of contraception if of childbearing potential
- Recovery from prior therapy-related adverse events to Grade 1 or normal organ function except specified conditions
You will not qualify if you...
- Metastatic breast cancer
- Active or progressing additional malignancy within last 5 years except certain skin and thyroid cancers
- History of significant cardiovascular disease or recent myocardial infarction
- Interstitial pneumonia, active pneumonia, or serious respiratory diseases
- Active infection requiring systemic therapy or unexplained fever above 38.5°C
- Recent arterial or venous thrombotic events within 5 months
- Psychiatric, alcohol, or substance abuse disorders
- Pregnancy or breastfeeding
- Active or history of autoimmune disease requiring systemic treatment
- History of congenital or acquired immunodeficiency
- Recent or untreated tuberculosis
- Known active hepatitis B or C without controlled viral levels
- Receipt of live vaccine within 4 weeks before enrollment or planned during study
- History of bone marrow or organ transplant
- Prior treatment with study-related drugs except specified chemotherapy
- Known allergy or hypersensitivity to study drugs or components
- Contraindications to IL-2 such as epilepsy or active gastrointestinal bleeding
- History of Grade 2 or higher neuropathy
- Recent use of long half-life angiogenesis inhibitors
- Use of prohibited medications not stopped 7 days before enrollment
- Any condition or abnormality that may interfere with study participation or safety as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
S
Shicheng Su, M.D., Ph.D.
CONTACT
E
Erwei Song, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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