NCT03123770

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

The Efficacy and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Followed by Docetaxel in Breast Cancer Patients: A Multicentric, Open-label, Non-randomized Concurrent Control, Non-inferiority Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Pegylated liposomal doxorubicin	a new kind of doxorubicin
DRUG	Cyclophosphamide	traditional chemotherapy drug
DRUG	Epirubicin	traditional chemotherapy drug used in breast cancer
DRUG	Docetaxel	traditional chemotherapy drug used in breast cancer

Timeline

• Start date: 2016-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2017-04-21
• Last updated: 2019-04-10

Locations

1 site across 1 country: China