Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer

• Status: Completed
• Trial end date: 2019-01-21
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

• Lead Sponsor: Vejle Hospital
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Docetaxel; Epirubicin; Paclitaxel; Pertuzumab; Tocopherols; Tocotrienols; Trastuzumab; Vitamin E

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/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