Status:
ACTIVE_NOT_RECRUITING
Neoadjuvant Dose-dense EC Followed by ABX With PD-1 for Triple Negative Breast Cancer Patients
Lead Sponsor:
Fudan University
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
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 pa...
Detailed Description
This study is an open single arm study, which would undergo optimal two stage designs. 60 patients who are diagnosed with triple-negative breast cancer would have dose-dense epirubicin hydrochloride w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04418154
Start Date
June 9 2020
End Date
December 31 2025
Last Update
May 21 2024
Active Locations (1)
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1
Shanghai Cancer Center, Fudan University
Shanghai, Shanghai Municipality, China, 200000