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NeoMET Study in Neoadjuvant Treatment of Breast Cancer

NCT01929811 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-04-06

No results posted yet for this study

Summary

To evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in neoadjuvant treatment of breast cancer patients. The aim is to evaluate whether metformin can increase the pCR rate combination with TEC regimen in neoadjuvant setting.

Conditions

  • pCR Rate
  • BCT Rate
  • Safety

Interventions

DRUG

Metformin

Metformin: 500mg tid, orally (500mg daily in first cycle) on day 1 to day 21 of each 21 day cycle

DRUG

Docetaxel

75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.

DRUG

Epirubicin

75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.

DRUG

cyclophosphomide

500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Kunwei Shen, Dr. · Ruijin Hospital

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
2013-10-31
Primary Completion
2020-06-30
Completion
2020-06-30

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 NCT01929811 on ClinicalTrials.gov