Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer

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/ECHO 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. Intrauterine device without hormone is considered safe.
• Written and orally informed consent

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
• Immunosuppressive treatment (other than prednisolone during neoadjuvant chemotherapy)
• Vitamin or nutritional supplements (other than multivitamin tablet and calcium tablet with vitamin D)
• Active or latent viral/bacterial infection
• Rheumatoid arthritis or other autoimmune disease
• Other malignant disease within the 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