Clinical trial · Interventional
Neoadjuvant Dose-dense EC Followed by ABX With PD-1 for Triple Negative Breast Cancer Patients
Neoadjuvant Anthracycline Followed by Toripalimab Combined With Nab-paclitaxel in Patients With Early Triple-negative Breast Cancer
NCT04418154CI-TRIAL-00077358NeoTENNISunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the efficacy and safety for dose-dense epirubicin hydrochloride with cyclophosphamide followed by nanoparticlealbumin-bound paclitaxel with PD-1 in neoadjuvant therapy for patients with triple-negative breast cancer, and to explore the predictive value of biological markers for the treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EC-ABX/PD-1
- description
- Patients who are treated with epirubicin hydrochloride andcyclophosphamide followed by nanoparticlealbumin-bound paclitaxel and Toripalimab
- interventionNames
- Drug: epirubicin hydrochloride
- Drug: Cyclophosphamide
- Drug: Albumin bound paclitaxel
- Drug: Toripalimab
Primary outcomes (1)
- measure
- Total Pathologic complete response (tpCR)
- timeFrame
- Immediately after the surgery
- description
- Defined as no residual invasive cancer cells are found in the pathological examination of breast and axillary lymph node; if only residual in situ cancer cells are present in the surgical specimens, it can also be considered as achieving a pathological complete response.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 to 70 years old, female. * Patients with histologically confirmed unilateral primary invasive breast cancer who meet the criteria of cT2-4NanyM0. * Patients with ER negative and PR negative by immunohistochemistry (IHC), and HER-2 negative disease. HER2-negative disease was defined as follows: disease whose HER-2 is 1+ or negative by IHC, or fluorescence in situ hybridization (FISH) is negative if IHC is 2+. * According to the RECIST 1.1 criteria, there is at least one measurable objective lesion. * Eastern Cooperative Oncology Group (ECOG) performance score 0-1. * Baseline left ventricular ejection fraction (LVEF) is greater than or equal to (\>/=) 55%. * Bone marrow function is required as follows: neutrophils are more than or equal to (\>/=) 1.5×109/L, platelets more than or equal to (\>/=) 100×109/L, and hemoglobin more than or equal to (\>/=) 90g/L. * Hepatic and renal function are required as follows: serum creatinine is less than or equal to (\</=) 1.5 times of upper limits of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) less than or equal to (\</=) 2.5 times of ULN, and total bilirubin less than or equal to (\</=) 1.5 times of ULN or \</= 2.5 times of ULN if patient is with Gilbert's syndrome. * With good compliance with the planned treatment, are able to understand the follow-up procedures of this study and sigh the informed consent form. Signed informed consent. Exclusion Criteria: * Received radiotherapy, chemotherapy, surgery or other targeted and immunotherapy for triple-negative breast cancer before enrollment. * With heart disease classified as New York Heart Association class (NYHA) grade II or above (including grade II) are identified by the investigator. * With severe systemic infection or those with other serious illnesses. * Known to be allergic or intolerant to chemotherapy drugs or their excipients. * With a history of autoimmune diseases or those using glucocorticoids or immunosuppressive drugs. * With known active stage of HBV or HCV infection or hepatitis B DNA ≥500, or patients with chronic abnormal liver function. * With a history of abnormal thyroid function. * With grade ≥ 2 peripheral neuropathy. * With a clear history of neurological or mental disorders, including epilepsy or dement. * Previous non-breast malignancy within 5 years prior to study entry excluding healed cervical carcinoma in situ and non-melanoma skin cancer. * History of other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ and non-melanoma skin cancer. * Pregnancy or lactation, and patients of childbearing potential who refuse to use adequate contraception during the course of this study. * Prior participation in other studies within 30 days prior to the administration of the first dose of the investigational drug. * Patients who are deemed to be unsuitable for this study by investigators.
References
Publications (1)
- DERIVEDHe M, Hao S, Ma L, Xiu B, Yang B, Wang Z, Xue J, Chi Y, Xiong M, Chen J, Huang X, Liu X, Wu S, Xiao Q, Huang Y, Shui R, Cao A, Li J, Di G, Yang W, Hu X, Liu G, Yu K, Jiang Y, Wang Z, Shao Z, Wu J. Neoadjuvant anthracycline followed by toripalimab combined with nab-paclitaxel in patients with early triple-negative breast cancer (NeoTENNIS): a single-arm, phase II study. EClinicalMedicine. 2024 Jun 28;74:102700. doi: 10.1016/j.eclinm.2024.102700. eCollection 2024 Aug. PMID 39045544