NeoMET Study in Neoadjuvant Treatment of Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Docetaxel; Epirubicin; Metformin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)