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Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC

NCT01917279 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2020-07-23

No results posted yet for this study

Summary

It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast cancer(mBC).

Conditions

  • Breast Neoplasms
  • Neoplasms by Site
  • Neoplasm Metastasis
  • Breast Diseases
  • Skin Diseases

Interventions

DRUG

Docetaxel plus Capecitabine

Eligible patients will receive treatment with Capecibatine (1000 mg/ m2 twice daily D1-14 Q3W) plus docetaxel(75 mg/m2, D1,Q3W) for a maximum of 6 cycles, or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration. For the the patients with SD, PR or CR after initiate treatment phrase will enter into maintenance treatment phase.

DRUG

Intermittent Capecitabine

Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle

DRUG

Metronomic Capecitabine

Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle

Sponsors & Collaborators

Principal Investigators

  • Binghe Xu, MD, PhD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2020-07-31
Completion
2021-07-31

Countries

  • China

Study Locations

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Entities

Companies

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 NCT01917279 on ClinicalTrials.gov