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New treatment option for Breast Neoplasms
Official title Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
ClinicalTrials.gov ID: NCT06121570
What this study is testing
What is Doxorubicin?
Doxorubicin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast neoplasms.
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
- 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.
- Phase 1: an early, usually small safety 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 70, women only
You may be able to join if
- In order to be eligible for participation in this trial, the participant must:
- Have signed the informed consent to study participation.
- Be a female subject and aged between 18 and 70 years.
- Provide a core needle biopsy which is histologically confirmed as invasive breast cancer. Excisional biopsy or surgical biopsy is not allowed.
- Have received two cycles of doxorubicin or epirubicin, plus cyclophosphamide, and had stable disease (SD) confirmed by breast MRI.
You likely can't join if
- The participant must be excluded from participating in this trial if the participant:
- Has metastatic breast cancer.
- Has a known additional malignancy that is progressing or requires active treatment within the last 5 years. Exceptions include basal or squamous cell...
- Has a known history of cardiovascular disease, including but not limited to, (1) congestive heart failure (New York Heart Association [NYHA]...
- Has interstitial pneumonia or active pneumonia that has clinical implications, or other respiratory diseases that seriously affect pulmonary function.
- Has an active infection requiring systemic therapy or has an unexplained fever of \>38.5℃ except fevers caused by cancer.
See the full eligibility criteria
Who can join
- In order to be eligible for participation in this trial, the participant must:
- Have signed the informed consent to study participation.
- Be a female subject and aged between 18 and 70 years.
- Provide a core needle biopsy which is histologically confirmed as invasive breast cancer. Excisional biopsy or surgical biopsy is not allowed.
- Have received two cycles of doxorubicin or epirubicin, plus cyclophosphamide, and had stable disease (SD) confirmed by breast MRI.
- Have breast cancer defined as the following combined primary tumor (T), regional lymph node (N), and distant metastasis (M) staging per AJCC for breast cancer staging criteria version 8 based on breast MRI assessment...
- Have HER2-negative breast cancer, defined as 0-1+ by immunohistochemistry or 2+ by immunohistochemistry without HER2 amplification by FISH.
- Have known hormone receptor status (estrogen receptor [ER], progesterone receptor [PgR]), Ki67 value and, if institutional standard permits, known tumor grade.
- Have not received prior therapies for breast cancer, including but not limited to, chemotherapy (except two cycles of doxorubicin or epirubicin, plus cyclophosphamide), radiotherapy, hormonal therapy, targeted therapy...
- Have accessible tumor-draining lymph nodes by surgery to grow LNL. Participants have not received sentinel lymph node biopsy (SLNB) and ipsilateral axillary lymph node dissection (ALND) for the breast cancer lesion.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Demonstrate adequate normal organ function: NOTE: Blood component or cytokine therapy is not allowed within 14 days before surgery.
- Routine blood test:
- Absolute neutrophil count (ANC) ≥1.5×10\^9/L
- Lymphocyte count (LC) \>0.5×10\^9/L
- Platelets (PLT) ≥100×10\^9/L
- Hemoglobin (Hb) ≥90 g/L
- Liver function test:
- AST and ALT ≤2.5×ULN (≤5×ULN for participants with liver metastases)
- ALP ≤2.5×ULN (≤5×ULN for participants with liver or bone metastases)
- Total bilirubin ≤1.5×ULN (≤3.0 mg/dL for participants with Gilbert's syndrome)
- Renal function test:
- Calculated creatinine clearance (CrCL) ≥45 mL/min OR creatinine ≤1.5×ULN
- Coagulation function test:
- APTT ≤1.5×ULN
- INR or PT ≤1.5×ULN
- Doppler echocardiography:
- Left ventricular ejection fraction (LVEF) ≥50%
- Pulmonary function test:
- FEV1 ≥60%
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through one year (or longer as specified by local institutional guidelines) after the...
- Have recovered from prior therapy-related adverse events to Grade≤1 per CTCAE version 5.0 criteria or met the criteria of normal organ function specified above prior to the surgery for obtaining the lymph nodes, except...
What rules you out
- The participant must be excluded from participating in this trial if the participant:
- Has metastatic breast cancer.
- Has a known additional malignancy that is progressing or requires active treatment within the last 5 years. Exceptions include basal or squamous cell carcinoma of the skin, and thyroid cancer that has undergone...
- Has a known history of cardiovascular disease, including but not limited to, (1) congestive heart failure (New York Heart Association [NYHA] functional classification Class \> 2), (2) unstable angina pectoris, (3)...
- Has interstitial pneumonia or active pneumonia that has clinical implications, or other respiratory diseases that seriously affect pulmonary function.
- Has an active infection requiring systemic therapy or has an unexplained fever of \>38.5℃ except fevers caused by cancer.
- Has arterial and/or venous thrombotic events in the past 5 months, e.g., cerebrovascular accident, deep vein thrombosis or pulmonary embolism.
- Has a known psychiatric, alcohol abuse or substance abuse disorders.
- Is pregnant or breastfeeding.
- Has an active autoimmune disease, a history of autoimmune disease, or autoimmune disease that has required systemic treatment (e.g., with use of prednisone at a dose of \>10 mg per day or other corticosteroids at an...
- Has a history of congenital immunodeficiency or acquired immunodeficiency (e.g., positive serology test for HIV).
- Has tuberculosis in the past one year, or has a history of active tuberculosis more than one year but did not receive regular treatments.
- Has known active hepatitis B or hepatitis C. Participants that are hepatitis B surface antigen (HBsAg) or hepatitis B core antigen (HBcAg) positive may participate provided that the HBV DNA level is normal. Participants...
- Has received a live vaccine within 4 weeks prior to enrollment, or plans to receive a live vaccine during this trial.
- Has a history of allogeneic bone marrow or organ transplant.
- Has received the study-related drugs including anthracycline, cyclophosphamide, taxane, fludarabine, interleukin-2, except two-cycle neoadjuvant chemotherapy of doxorubicin or epirubicin, plus cyclophosphamide.
- Has a history of hypersensitivity or allergy to the drugs in this study and any of their components including but not limited to, LNL, doxorubicin/epirubicin, cyclophosphamide, nab-paclitaxel, fludarabine...
- Has contraindication for use of IL-2, including but not limited to, refractory or intractable epilepsy, and active gastrointestinal bleeding.
- Has a history of Grade≥2 neuropathy.
- Has received long half-life angiogenesis inhibitors within four weeks prior to enrollment, e.g., bevacizumab.
- Is receiving any medication prohibited in combination with study treatments as described in the respective product labels, unless medication was stopped within 7 days prior to enrollment.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with participation for the full duration of the study, or render study...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.