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.
OBJECTIVES: Determine the efficacy and safety of neoadjuvant chemotherapy regimen DC-T and EC-T in suitable breast cancer patients. Participants are randomized to 1 of 2 treatment arms. 1. Arm I: Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery. 2. Arm II: Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery. Patients in arms I and II will undergo physical examination, MRI, estimating of side effects every 4 cycles referring to RECIST (Response Evaluation Criteria In Solid Tumor) guideline. To adjust for potential bias, patients in DC-T arm were matched 1:1 to patients in the EC-T arm based on Her-2 and ER status. After finishing 8 cycles of neoadjuvant chemotherapy, every patient will receive mastectomy or breast-conserving surgery and then assess the pCR rate of primary lesion and axillary lymph nodes. Adjuvant radiotherapy and endocrine therapy will be taken if necessary. Every patient will be followed-up for five years to monitor survival condition.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
384
a new kind of doxorubicin
traditional chemotherapy drug
traditional chemotherapy drug used in breast cancer
Cancer institute
Hangzhou, Zhejiang, China
RECRUITINGPathological complete response rate
The pathological complete response rate of primary lesion and axillary lymph nodes
Time frame: 5 years
Side effects
Determine side effects of these drugs like cardiotoxicity ,hematological toxicity,gastrointestinal symptoms and so on.
Time frame: 5 years
Overall survival
Determine the overall survival at 5 years.
Time frame: 5 years
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traditional chemotherapy drug used in breast cancer