Actively Recruiting
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 2023-08-08
196
Participants Needed
1
Research Sites
617 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 open-label phase I/II trial is to investigate the safety and efficacy of autologous LNL in patients with HER2-negative breast cancer not responding to neoadjuvant chemotherapy.
CONDITIONS
Official Title
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...
- Signed informed consent to participate in the study
- Female aged between 18 and 70 years
- Invasive breast cancer confirmed by core needle biopsy
- Received two cycles of doxorubicin or epirubicin plus cyclophosphamide with stable disease confirmed by breast MRI
- Primary tumor of at least 1 cm by breast MRI, regional lymph nodes N0-3, no distant metastasis (M0)
- HER2-negative breast cancer defined as 0-1+ by immunohistochemistry or 2+ without HER2 amplification by FISH
- Known hormone receptor status, Ki67 value, and if available, tumor grade
- No prior breast cancer therapies except the two cycles of chemotherapy mentioned
- Accessible tumor-draining lymph nodes without prior sentinel lymph node biopsy or ipsilateral axillary lymph node dissection
- ECOG performance status of 0 or 1
- Adequate organ function based on blood tests, liver, kidney, coagulation, heart and lung function
- Willingness to use contraception if of childbearing potential with negative pregnancy test before LNL infusion
- Recovery from prior therapy-related adverse events to Grade 1 or better, except certain irreversible conditions
You will not qualify if you...
- Metastatic breast cancer
- Additional malignancy within last 5 years except certain skin and cervical cancers
- History of significant cardiovascular disease including certain heart failures and arrhythmias
- Interstitial or active pneumonia affecting lung function
- Active infection requiring systemic therapy or unexplained fever above 38.5°C
- Recent arterial or venous thrombotic events within past 5 months
- Psychiatric, alcohol, or substance abuse disorders
- Pregnant or breastfeeding
- Active or history of autoimmune disease requiring systemic treatment
- History of congenital or acquired immunodeficiency including HIV
- Tuberculosis in past year or untreated history
- Active hepatitis B or C without controlled viral levels
- Live vaccine within 4 weeks prior to enrollment or planned during study
- History of allogeneic bone marrow or organ transplant
- Prior treatment with study-related drugs except the two chemotherapy cycles allowed
- Hypersensitivity to study drugs or their components
- Contraindications to IL-2 such as refractory epilepsy or active gastrointestinal bleeding
- History of Grade 2 or higher neuropathy
- Recent use of long half-life angiogenesis inhibitors within 4 weeks
- Use of prohibited medications not stopped at least 7 days before enrollment
- Any condition or therapy that may affect study results or participant safety as judged by investigator
AI-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
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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