NCT01929811

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

6.7 years

First QC Date

August 11, 2013

Last Update Submit

March 28, 2022

Conditions

pCR RateBCT RateSafety

Outcome Measures

Primary Outcomes (1)

  • pathologic complete response rate

    To compare pathologic complete response (pCR) rate to neoadjuvant chemotherapy between Docetaxel, Epirubicin and Cyclophosphamide (TEC) arm and TEC plus Metformin arm in breast cancer. Definition of pCR is no invasive tumor in primary breast and axillary lymph node.

    5 months

Secondary Outcomes (3)

  • Clinical response rate

    up to 4.5 months

  • safety profile

    up to 4.5 months

  • breast conservation therapy (BCT) rate

    5 months

Study Arms (2)

Metformin arm

EXPERIMENTAL

Docetaxel: 75mg/m2, d1, q3w\*6 Epirubicin: 75mg/m2, d1, q3w\*6 Cyclophosphamide: 500mg/m2, d1, q3w\*6 Metformin: 500mg tid, orally (500mg daily in first cycle)

Drug: MetforminDrug: DocetaxelDrug: EpirubicinDrug: cyclophosphomide

TEC

OTHER

Docetaxel: 75mg/m2, d1, q3w\*6 Epirubicin: 75mg/m2, d1, q3w\*6 Cyclophosphamide: 500mg/m2, d1, q3w\*6

Drug: DocetaxelDrug: EpirubicinDrug: cyclophosphomide

Interventions

MetforminDRUG

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

Also known as: Metformin HCL, Metformin hydroehloride
Metformin arm
DocetaxelDRUG

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

Metformin armTEC
EpirubicinDRUG

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

Metformin armTEC
cyclophosphomideDRUG

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

Metformin armTEC

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women aged ≥18 years and \< 70 years with life expectancy \> 12 months
  • Measurable disease in breast or axillary lymph node, histologically confirmed invasive breast cancer by core needle biopsy, T≥2cm or stage IIb or stage III according AJCC classification, fine-needle aspiration is encouraged to every patient with metastasis suspicious nodes;
  • Biopsy specimens are available for ER, PgR, Her2 and proliferation biomarker detection;
  • Adequate bone marrow function: Neutrophil ≥ 1.5\*109/L; Hb ≥ 100g/L; PLT ≥ 80\*109/L;
  • Adequate liver and renal function:
  • Serum AST ≤ 90U/L
  • Bilirubin ≤ upper limit of normal (UNL) range
  • Serum creatinine ≤110 umol/L，calculated creatinine clearance should be ≥ 60 mL/min;
  • BUN ≤ 7.1mmol/L;
  • Has ECOG Performance Score 0-1;
  • BMI ≥ 25kg/m2 or hyperglycemia or hyperlipemia or hypertension;
  • Willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up;
  • Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study;
  • Written informed consent according to the local ethics committee requirements.

You may not qualify if:

  • Prior systemic or loco-regional treatment of breast cancer, including chemotherapy;
  • Metastatic breast cancer;
  • With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma;
  • Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease;
  • Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive;
  • Contraindication for using dexamethasone, chemotherapy agents or metformin;
  • History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP \>180mmHg or diastolic BP \>100mmHg);
  • Has peripheral neuropathy ≥ grade 1;
  • Patient is pregnant or breast feeding (not willing to stop breast feeding);
  • Not willing to take core needle biopsy or patients with psychiatric disorder or other diseases leading to incompliance to the therapy
  • Known severe hypersensitivity to any drugs in this study;
  • Treatment with any investigational drugs within 30 days before the beginning of study treatment.
  • History of lactic or other metabolic acidosis
  • Consumption of \> 3 alcoholic beverages per day (on average)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Linyi People's Hospital

Linyi, Shandong, 276003, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

  • Huang J, Tong Y, Hong J, Huang O, Wu J, He J, Chen W, Li Y, Chen X, Shen K. Neoadjuvant docetaxel, epirubicin, and cyclophosphamide with or without metformin in breast cancer patients with metabolic abnormality: results from the randomized Phase II NeoMET trial. Breast Cancer Res Treat. 2023 Feb;197(3):525-533. doi: 10.1007/s10549-022-06821-y. Epub 2022 Dec 16.

    PMID: 36525180DERIVED

MeSH Terms

Interventions

MetforminDocetaxelEpirubicin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Kunwei Shen, Dr.

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 11, 2013

First Posted

August 28, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

CN(2)