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Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer

NCT04576143 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2021-08-12

No results posted yet for this study

Summary

Recent clinical studies showed that breast cancer patients especially for those with lymph node metastasis may benefit from dose-dense chemotherapy, like adriamycin and cyclophosphamide (AC) q2w×4→ paclitaxel (P) q2w×4. However, the studies on dose-dense (dd) regimen chemotherapy is mostly based on postoperative adjuvant chemotherapy and the optimum of dose-dense chemotherapy has not been determined for Chinese population with HER2-negative breast cancer patients. In our study, a prospective, randomized, open-label, multi-center clinical study was conducted to compare the efficacy and safety of dose-dense chemotherapy regimen (dd epirubicin/cyclophosphamide (EC) followed by dd paclitaxel (P)) and conventional chemotherapy (epirubicin/cyclophosphamide (EC) followed by docetaxel (T)) as preoperative neoadjuvant chemotherapy in the treatment of HER2-negative breast cancer in Chinese population.

Conditions

Interventions

DRUG

Epirubicin

i.v. 90 mg/m2

DRUG

Cyclophosphamid

i.v. 600 mg/m2

DRUG

Docetaxel

i.v. 100 mg/m2

DRUG

Paclitaxel

i.v. 175 mg/m2

Sponsors & Collaborators

  • Women's Hospital School Of Medicine Zhejiang University

    collaborator OTHER

  • Changxing People's Hospital

    collaborator OTHER

  • Zhejiang Provincial People's Hospital

    collaborator OTHER

  • Hangzhou First People's Hospital, School of Medicine, Zhejiang Universiry

    collaborator UNKNOWN

  • Huizhou Municipal Central Hospital

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Yiding Chen · 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-20
Primary Completion
2023-06-20
Completion
2027-09-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04576143 on ClinicalTrials.gov