Last updated on April 2019

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


Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03123770

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Recruitment Status: Open


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