Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women With Breast Cancer

Malaysian Tocotrienol Rich Fraction: Immunomodulatory Effect in Women With Breast Cancer

Phase Ib: Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women with Breast Cancer is aimed to determine the highest, safest and tolerable dose of Tocotrienol-rich Fraction (maximal tolerated dose: MTD) that can be used in women with breast cancer.

3+3 step up design method will be used in this study.

Inclusion Criteria:

• Patients with operable breast cancer
• Life expectancy of at least 3 months
• Adequate organ function
• No allergy to Vitamin E and TRF
• Provides consent to participate in trial and adhere to the study protocol

Exclusion Criteria:

• Receiving concomitant chemotherapy, radiotherapy, hormonal, immune therapy or other investigational drugs
• Uncontrolled concurrent illness
• Pregnant / breast feeding women
• Patients who are unable or unwilling to take Tocotrienols, herbal remedies, or non-prescription medications