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Sequential Neo-adjuvant Chemotherapy Followed by Capecitabine Vs. Conventional Adjuvant Chemotherapy in Breast Cancer

NCT03011060 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1588

Last updated 2017-01-10

No results posted yet for this study

Summary

This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by Capecitabine could achieve additional benefits over traditional postoperative chemotherapy. In the study group, patients that do not achieve pathological complete response(pCR) will receive sequential neo-adjuvant chemotherapy followed by Capecitabine. In the control group, patients will be treated with postoperative adjuvant chemotherapy.

Conditions

  • Breast Neoplasm Female

Interventions

PROCEDURE

Neo-adjuvant Chemotherapy

A preoperative chemotherapy based on anthracyclines and taxanes.

DRUG

Capecitabine

Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.

Sponsors & Collaborators

  • First Hospital of China Medical University

    collaborator OTHER

  • The Second Affiliated Hospital of Harbin Medical University

    collaborator OTHER

  • Qingdao University

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • Baotou Cancer Hospital

    collaborator OTHER

  • The First Hospital of Jilin University

    lead OTHER

Principal Investigators

  • Fan Zhimin, Professor · The First Hospital of Jilin 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
2016-12-31
Primary Completion
2024-12-31
Completion
2025-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03011060 on ClinicalTrials.gov