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

Nur Aishah Mohd Taib

Status: Unknown

Conditions: Breast Cancer Female

Treatments: Dietary Supplement: Tocotrienol-rich Fraction (TRF)

Study type: Interventional

Funder types: Other

Identifiers

NCT03855423

853.4

Details and patient eligibility

About

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.

Full description

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

Enrollment: 12 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Tocotrienol-rich Fraction (TRF)

Experimental group

Description:

Pre-operative patients will be receiving TRF at different doses assigned to them in a cohort of 3 patients at each level.

Treatment:

Dietary Supplement: Tocotrienol-rich Fraction (TRF)