Breast cancer MedDRA version: 19.0 Level: LLT Classification code 10006188 Term: Breast cancer female NOS System Organ Class: 100000004864
Conditions
Interventions
Product Name: Epirubicin
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: Epirubicin
CAS Number: 56390-09-1
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women with histologically verified breast cancer (adenocarcinoma) • Age = 18 years. • Neoadjuvant treatment indicated according to departmental guidelines • PS 0-2 and suited for surgery. • Normal heart function, LVEF = 50% by MUGA/EKKO in patients receiving neoadjuvant trastuzumab • Normal bone marrow function: Hemoglobin = 6 mmol/l, ANC = 1.5x10^9/l. Thrombocytes = 100x10^9/l. • Normal liver function: Bilirubin = 1.5 x upper level of normal, ALAT = 2.5 x upper level of normal, BASP = 2.5 x upper level of normal. • Normal kidney function: Creatinine = upper level of normal. In case of increased creatinine measured/calculated GFR must be = 50 ml/min. • Fertile women must present a negative pregnancy test and use a safe contraceptive during and 3 months after the treatment. Spiral without hormone is considered safe. • Written and orally informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: • Bilateral breast cancer or suspected dissemination. Verified by bilateral mammography, bone scintigraphy, chest and abdomen CT, and PET-CT. • Pregnant and breastfeeding women • Mental or social conditions that will prevent treatment or follow-up • Other simultaneous experimental treatment • Immunosupressive treatment (other than prednisolone during neoadjuvant chemotherapy) • Vitamin or nutritional supplements (other than multivitamin table and calcium tablet with vitamin D) • Active or latent viral/bacterial infection • Rheumatoid arthritis or other autoimmune disease • Other malignant disease within past 5 years excl. non-melanoma cancer of the skin and carcinoma in situ cervicis uteri. • Previous treatment with docetaxel, paclitaxel, epirubicin, cyclophosphamide, trastuzumab, pertuzumab or tocotrienol • Hypersensitivity to any of the active or auxiliary substances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 6 months after start of treatment;Main Objective: Evaluation of the frequency of pathologic complete response in breast cancer patients treated with neoadjuvant chemotherapy combined with tocotrienol.;Secondary Objective: Investigation of the dynamics of NK-cell activity, TILs, CTC, and ctDNA in breast cancer patients during treatment with neoadjuvant chemotherapy in combination with tocotrienol.;Primary end point(s): The rate of pathologic complete response in breast cancer patients treated with neoadjuvant chemotherapy in combination with tocotrienol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Correlation of NK-cells, TILs, CTC, and ctDNA with response. 2. Toxicity of the treatment ; Timepoint(s) of evaluation of this end point: 1. 6 months after start of treatment 2. 6 months after start of treatment | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Unit, Oncology
Vejle Hospital
Outcome results
None listed