Breast Cancer
Conditions
Brief summary
The purpose of this study is to investigate whether tocotrienol can improve the effect and reduce the side effects of standard chemotherapy before operation for breast cancer.
Interventions
DRUGEpirubicin 90 mg/m2 iv
Max. 3 months
DRUGCyclophosphamide 600 mg/m2 iv
Max. 3 months
DRUGDocetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv
Max. 3 months
DRUGTrastuzumab 8 mg/kg iv saturation, then 6 mg/kg iv (HER2 positive patients only)
Max. 3 months.
DRUGPertuzumab 840 mg iv saturation, then 420 mg iv (selected HER2 positive patients only)
Max. 3 months
DIETARY_SUPPLEMENTTocotrienol 300 mg x 3 daily
Max. 6 months
Sponsors
Vejle Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response | 26 weeks from date of inclusion |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of changes in NK-cells with pathological complete response | 26 weeks from date of inclusion |
| Correlation of changes in ctDNA with pathological complete response | 26 weeks from date of inclusion |
| Number of patients with grade 3-4 side effects | 29 weeks from date of inclusion |
Countries
Denmark
Outcome results
None listed