Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 7 June 2021
• Main ID: NCT02909751
• Date of registration: 16/09/2016
• Prospective Registration: No
• Primary sponsor: Vejle Hospital
• Public title: Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer NeoToc
• Scientific title: Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer
• Date of first enrolment: September 14, 2016
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02909751
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Denmark

Contacts

• Name: Erik H Jakobsen, MD
• Affiliation: Vejle Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Epirubicin 90 mg/m2 iv

Drug: Trastuzumab 8 mg/kg iv saturation, then 6 mg/kg iv (HER2 positive patients only)

Drug: Cyclophosphamide 600 mg/m2 iv

Drug: Pertuzumab 840 mg iv saturation, then 420 mg iv (selected HER2 positive patients only)

Dietary Supplement: Tocotrienol 300 mg x 3 daily

Drug: Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv

Primary Outcome(s)

Pathological complete response [Time Frame: 26 weeks from date of inclusion]

Secondary Outcome(s)

Number of patients with grade 3-4 side effects [Time Frame: 29 weeks from date of inclusion]

Correlation of changes in NK-cells with pathological complete response [Time Frame: 26 weeks from date of inclusion]

Correlation of changes in ctDNA with pathological complete response [Time Frame: 26 weeks from date of inclusion]

Secondary ID(s)

NeoToc

Source(s) of Monetary Support

Please refer to primary and secondary sponsors