Neoadjuvant Dose-dense EC Followed by ABX With PD-1 for Triple Negative Breast Cancer Patients

• Status: Recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: Female

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 patients with triple-negative breast cancer, and to explore the predictive value of biological markers for the treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Epirubicin; Paclitaxel

Criteria

Inclusion Criteria:

• Female between 18 to 70 years old.

• Patients be diagnosed with primary unilateral invasive breast cancer of cT2-4NanyM0 by histology.

• 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+.

• At least one mensurable objective focus according to RECIST guideline (vision 1.1).

• Eastern Cooperative Oncology Group (ECOG) performance status is less than or equal to (
• 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 (and alanine aminotransferase (ALT) less than or equal to (total bilirubin less than or equal to (if patient is with Gilbert's syndrome.

• Signed informed consent.

• Able to comply with the protocol.

Exclusion Criteria:

• Received any previous therapy including cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason.

• Patients with heart disease whose New York Heart Association class (NYHA) is higher or equal to (>/=) Class II.

• Severe systemic infection or with other severe disease.

• Known hypersensitivity to any of the study drugs or excipients.

• Previous non-breast malignancy within 5 years prior to study entry excluding healed cervical carcinoma in situ and non-melanoma skin cancer.

• Pregnancy, breast-feeding or child-bearing women who refuse contraception during the trial.

• Participants who received any other investigational treatment within 30 days before the first dose of drug investigated.

• Patients who are inconformity to participate in this study according to investigators.