Breast NeoplasmsPhase 1NCT06121570
Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
A Phase 1 study testing Sentinel Lymph Node Biopsy (SLNB), Doxorubicin and Epirubicin in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Sentinel Lymph Node Biopsy (SLNB), Doxorubicin and Epirubicin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Aug 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 before receiving neoadjuvant chemotherapy:
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- The minimum size of the primary tumor was 1 cm in largest diameter by breast MRI, N0-3, M0.
- 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, biological therapy, immunotherapy and surgery.
- 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 last dose of study treatment. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to LNL infusion.
- 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 for second-degree peripheral nerve injury, alopecia, leukoderma, hypothyroidism controlled by thyroid hormone replacement therapy, type 1 diabetes controlled by insulin therapy, and other irreversible toxic events that would not be exacerbated by LNL infusion as judged by the investigator (e.g., hearing loss).
Who cannot join
- 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 potentially curative therapy or in situ cervical cancer.
- 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) myocardial infarction in the past 3 months, (4) supraventricular arrhythmia or ventricular arrhythmia that requires treatments.
- 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.
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- 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 equivalent dose). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
- 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 that are hepatitis C antibody positive may participate provided that the HCV DNA level is normal. Carriers of HBV or HCV must receive anti-virus therapy, and take regular DNA copy number tests during this trial.
- 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, interleukin-2, dimethyl sulphoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (β-lactam antibiotics, gentamicin).
- 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 participation not compatible with the participant's best interest, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Shicheng Su, M.D., Ph.D., +86 13632394954, lnl_trial@126.com
Erwei Song, M.D., Ph.D., +86 13719237746, lnl_trial@126.com
About this study
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
- Breast Neoplasms
- Being tested
- Sentinel Lymph Node Biopsy (SLNB), Doxorubicin, Epirubicin, Cyclophosphamide, Fludarabine
- Keywords
- HER2-Negative, Neoadjuvant Chemotherapy, Lymph Node, Lymphocytes, Adoptive Cell Therapy, Doxorubicin, Epirubicin, Cyclophosphamide, Nab-paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node Biopsy (SLNB)Procedure or surgery
Also called SLNB
A sample of the participant's tumor-draining lymph nodes will be collected and sent to the biotherapy center for LNL isolation and expansion.
DoxorubicinDrug
Doxorubicin will be administered at 60 mg/m^2 IV on Day 1 of Cycles 1-2 of the neoadjuvant chemotherapy of the study.
EpirubicinDrug
Epirubicin will be administered at 100 mg/m^2 IV on Day 1 of Cycles 1-2 of the neoadjuvant chemotherapy of the study.
CyclophosphamideDrug
Cyclophosphamide will be administered at 600 mg/m^2 IV on Day 1 of Cycles 1-2 of the neoadjuvant chemotherapy of the study.
CyclophosphamideDrug
Cyclophosphamide will be administered at 500 mg/m^2 IV daily for three days. Cyclophosphamide will be initiated five days prior to the anticipated LNL transfer, and the precise timing will depend on the rate of in vitro LNL growth.
FludarabineDrug
Fludarabine will be administered at 30 mg/m^2 IV daily for three days. Fludarabine will be initiated five days prior to the anticipated LNL transfer, and the precise timing will depend on the rate of in vitro LNL growth.
Tumor-draining lymph node-derived lymphocyte (LNL)Biological
Also called LNL
Participants receive single infusion of LNL at the recommended phase 2 dose (RP2D).
Interleukin-2Biological
Also called IL-2
Eight to twelve hours after completing the LNL infusion, all participants will receive intermediate-dose decrescendo IL-2 IV.
Nab-paclitaxelDrug
Nab-paclitaxel will be administered at 260 mg/m^2 IV on Day 1 of Cycles 3-6 of the neoadjuvant chemotherapy of the study.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + LNL treatment | Experimental | Participants receive two cycles of doxorubicin or epirubicin, plus cyclophosphamide (AC or EC), followed by neoadjuvant LNL treatment, which consists of non-myeloablative lymphocyte depleting regimen of chemotherapy with cyclophosphamide and fludarabine, followed by infusion of LNL and interleukin-2. After LNL treatment, participants receive four-cycles of nab-paclitaxel as neoadjuvant therapy prior to definitive surgery. The choice of doxorubicin or epirubicin should be the same as the prior neoadjuvant chemotherapy. Receives: Procedure: Sentinel Lymph Node Biopsy (SLNB); Drug: Doxorubicin; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Fludarabine; Biological: Tumor-draining lymph node-derived lymphocyte (LNL); Biological: Interleukin-2; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicity (DLT)
Adverse events are reported based upon Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria. DLT will be defined as a non-hematologic Grade 3 or higher adverse event, occurring within the 28 days immediately after LNL infusion, that is probably or definitely related to LNL infusion, and lasts more than 28 days or does not resolve to Grade<3 despite treatment with dexamethasone at 10 mg per 12 hours IV for 7 days (or other corticosteroid at equivalent dose), and/or tocilizumab at 8mg/kg IV for three times.
Measured: From the LNL infusion up to 28 days post-infusion
Incidence of Grade≥3 Treatment-Emergent Adverse Event (TEAE)
Adverse events are reported based upon CTCAE version 5.0 criteria. The incidence of Grade≥3 TEAE occurring within the 28 days immediately after LNL infusion will be summarized with descriptive statistics.
Measured: From the LNL infusion up to 28 days post-infusion
Secondary outcomes (7)
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 at the time of definitive surgery
pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy assessed by the local pathologist at the time of definitive surgery.
Measured: Up to approximately 26~29 weeks
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants in the analysis population who have achieved complete response (CR) or partial response (PR) assessed by modified RECIST criteria by breast MRI during the study. The percentage of participants who experienced a CR or PR is presented.
Measured: Up to approximately 26~29 weeks
6-month, 1-year and 2-year Event-Free Survival (EFS)
Event-free survival is defined as the time from enrollment to the first date of disease progression while on primary therapy or disease recurrence (local, regional, distant, invasive contralateral breast) after surgery or death due to any cause. Patients who terminate the study without evidence of any of the above events will be censored at the date of their last follow-up tumor assessment. Patients who start a new anti-tumor therapy (with the exception of adjuvant endocrine therapy in ER or PgR positive tumors after surgery) in the absence of disease progression or recurrence will be censored at their last follow-up tumor assessment before the start of the new therapy.
Measured: Up to approximately two years
Overall Survival (OS)
Overall survival is defined as the time from enrollment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
Measured: Up to approximately five years
Levels of multiple different cytokines in blood samples before and after LNL infusion.
Levels of multiple different cytokines in blood samples including Granzyme B, IFN-γ, GM-CSF, IL-2, IL-4, IL-6, etc. will be measured using cytokine chips, ELISA or flow cytometry at various time points before and after LNL infusion.
Measured: Up to approximately two years
Distribution of T cell subsets in blood samples before and after LNL infusion.
Distribution of T cell subsets in blood samples will be measured using flow cytometry at various time points before and after LNL infusion.
Measured: Up to approximately two years
Distribution of T-cell receptor (TCR) clonotype in blood samples before and after LNL infusion.
Distribution of T-cell receptor (TCR) clonotype in blood samples will be measured using TCR sequencing at various time points before and after LNL infusion.
Measured: Up to approximately two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Erwei Song, M.D., Ph.D., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121570
- Sponsor's protocol ID
- [2021] 04-01
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- [2021] 04-01
- Conditions
- Breast Neoplasms
- Keywords
- HER2-Negative, Neoadjuvant Chemotherapy, Lymph Node, Lymphocytes, Adoptive Cell Therapy, Doxorubicin, Epirubicin, Cyclophosphamide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + LNL treatment | Experimental | Procedure: Sentinel Lymph Node Biopsy (SLNB), Drug: Doxorubicin, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Fludarabine, Biological: Tumor-draining lymph node-derived lymphocyte (LNL), Biological: Interleukin-2, Drug: Nab-paclitaxelParticipants receive two cycles of doxorubicin or epirubicin, plus cyclophosphamide (AC or EC), followed by neoadjuvant LNL treatment, which consists of non-myeloablative lymphocyte depleting regimen of chemotherapy with cyclophosphamide and fludarabine, followed by infusion of LNL and interleukin-2. After LNL treatment, participants receive four-cycles of nab-paclitaxel as neoadjuvant therapy prior to definitive surgery. The choice of doxorubicin or epirubicin should be the same as the prior neoadjuvant chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- 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 before receiving neoadjuvant chemotherapy:
Key exclusion criteria (22 listed)
- 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 potentially curative therapy or in situ cervical cancer.
- 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) myocardial infarction in the past 3 months, (4) supraventricular arrhythmia or ventricular arrhythmia that requires treatments.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel Lymph Node Biopsy (SLNB)Also: SLNBA sample of the participant's tumor-draining lymph nodes will be collected and sent to the biotherapy center for LNL isolation and expansion. | Procedure or surgery | Chemotherapy + LNL treatment |
| DoxorubicinDoxorubicin will be administered at 60 mg/m^2 IV on Day 1 of Cycles 1-2 of the neoadjuvant chemotherapy of the study. | Drug | Chemotherapy + LNL treatment |
| EpirubicinEpirubicin will be administered at 100 mg/m^2 IV on Day 1 of Cycles 1-2 of the neoadjuvant chemotherapy of the study. | Drug | Chemotherapy + LNL treatment |
| CyclophosphamideCyclophosphamide will be administered at 600 mg/m^2 IV on Day 1 of Cycles 1-2 of the neoadjuvant chemotherapy of the study. | Drug | Chemotherapy + LNL treatment |
| CyclophosphamideCyclophosphamide will be administered at 500 mg/m^2 IV daily for three days. Cyclophosphamide will be initiated five days prior to the anticipated LNL transfer, and the precise timing will depend on the rate of in vitro LNL growth. | Drug | Chemotherapy + LNL treatment |
| FludarabineFludarabine will be administered at 30 mg/m^2 IV daily for three days. Fludarabine will be initiated five days prior to the anticipated LNL transfer, and the precise timing will depend on the rate of in vitro LNL growth. | Drug | Chemotherapy + LNL treatment |
| Tumor-draining lymph node-derived lymphocyte (LNL)Also: LNLParticipants receive single infusion of LNL at the recommended phase 2 dose (RP2D). | Biological | Chemotherapy + LNL treatment |
| Interleukin-2Also: IL-2Eight to twelve hours after completing the LNL infusion, all participants will receive intermediate-dose decrescendo IL-2 IV. | Biological | Chemotherapy + LNL treatment |
| Nab-paclitaxelNab-paclitaxel will be administered at 260 mg/m^2 IV on Day 1 of Cycles 3-6 of the neoadjuvant chemotherapy of the study. | Drug | Chemotherapy + LNL treatment |
Primary outcome
Incidence of Dose-Limiting Toxicity (DLT)
Time frame: From the LNL infusion up to 28 days post-infusion
Adverse events are reported based upon Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria. DLT will be defined as a non-hematologic Grade 3 or higher adverse event, occurring within the 28 days immediately after LNL infusion, that is probably or definitely related to LNL infusion, and lasts more than 28 days or does not resolve to Grade<3 despite treatment with dexamethasone at 10 mg per 12 hours IV for 7 days (or other corticosteroid at equivalent dose), and/or tocilizumab at 8mg/kg IV for three times.
Incidence of Grade≥3 Treatment-Emergent Adverse Event (TEAE)
Time frame: From the LNL infusion up to 28 days post-infusion
Adverse events are reported based upon CTCAE version 5.0 criteria. The incidence of Grade≥3 TEAE occurring within the 28 days immediately after LNL infusion will be summarized with descriptive statistics.
7 secondary outcomes
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 at the time of definitive surgery
Time frame: Up to approximately 26~29 weeks
Objective Response Rate (ORR)
Time frame: Up to approximately 26~29 weeks
6-month, 1-year and 2-year Event-Free Survival (EFS)
Time frame: Up to approximately two years
Overall Survival (OS)
Time frame: Up to approximately five years
Levels of multiple different cytokines in blood samples before and after LNL infusion.
Time frame: Up to approximately two years
Distribution of T cell subsets in blood samples before and after LNL infusion.
Time frame: Up to approximately two years
Distribution of T-cell receptor (TCR) clonotype in blood samples before and after LNL infusion.
Time frame: Up to approximately two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erwei Song, M.D., Ph.D. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sentinel Lymph Node Biopsy (SLNB), Doxorubicin and Epirubicin in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shicheng Su, M.D., Ph.D. (+86 13632394954, lnl_trial@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicity (DLT) (time frame: From the LNL infusion up to 28 days post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.