Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vejle Hospital
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer
