Efficacy and Safety of Neoadjuvant DC-T in Breast Cancer Patients

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a multicentric, open-label,non-randomized concurrent control, 1:1 match,non-inferiority trial that assesses the efficacy and safety of neoadjuvant chemotherapy regimen DC-T and EC-T in breast cancer patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Collaborators: First Affiliated Hospital of Wenzhou Medical University; First Affiliated Hospital of Zhejiang University; First People's Hospital of Hangzhou; Hangzhou Hospital of Traditional Chinese Medicine; Jinhua Central Hospital; Ningbo No. 1 Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Sir Run Run Shaw Hospital; Women's Hospital School Of Medicine Zhejiang University; Zhejiang Cancer Hospital; Zhejiang Provincial Hospital of TCM; Zhejiang Provincial People's Hospital; Zhejiang Provincial People’s Hospital
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

1. Women aged : 18~70 years.

2. WHO (ECOG) performance status 0-2.

3. Patients who have read and understand the informed consent form and have given written informed consent.

4. Diagnosed as invasive breast cancer by core biopsy

5. Diagnosed pre-surgically as (cTNM Staging)Stage II-III and suit for neoadjuvant chemotherapy.

6. Patients had previously not received chemotherapy，radiotherapy or biotherapy.

7. Normal organ function，meeting the requirement of laboratory testing below:

• WBC≥4.0×109/L,

• NEU≥1.5×109/L,

• PLT≥100×109/L,

• HB ≥10g/dL,

• Scr≤1.5× ULN,

• AST ≤2.5×ULN,

• ALT ≤2.5×ULN,

• TDIL≤1.5×ULN.

8. Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline，（long diameter of primary lesion ≥1cm or minor diameter of lymph node ≥1.5cm）；

Exclusion Criteria:

1. Pregnant or lactating women were excluded.

2. History of receiving organ transplantation（including Autologous bone marrow transplantation and peripheral hematopoietic stem-cell transplantation).

3. Dysfunction of peripheral nerve system caused by other diseases or history of either severe mental disorder or central nervous system disorders.

4. Uncontrolled infection or severe peptic ulcer need treatment.

5. Severe hepatic disease（such as hepatic cirrhosis),nephrosis,respiratory disease or uncontrolled diabetes.

6. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin.

7. Significant abnormal EKG or cardiac disease with drastic symptoms like congestive heart failure or severe coronary disease or uncontrolled arrhythmia or myocardial infarction within 12 months or NYHA level III-IV or LVEF<55% .

8. Be allergic to test drugs.