Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer

NCT ID: NCT02909751

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-14
• Study Completion Date: 2019-01-21

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant chemotherapy

HER2 negative:

Four cycles of 3-weekly epirubicin 90 mg/m2 iv and cyclophosphamid 600 mg/m2 iv followed by Four cycles of taxane, i.e. 3-weekly docetaxel 100 mg/m2 iv or weekly paclitaxel 80 mg/m2 iv

HER2 positive:

Four cycles of taxane, i.e. 3-weekly docetaxel 100 mg/m2 iv or weekly paclitaxel 80 mg/m2 iv + 3-weekly trastuzumab (8 mg/kg iv saturation, then 6 mg/kg iv) and possibly pertuzumab (840 mg saturation, then 420 mg iv) followed by Four cycles of 3-weekly epirubicin 90 mg/m2 iv and cyclophosphamid 600 mg/m2 iv

Group Type: ACTIVE_COMPARATOR

Epirubicin 90 mg/m2 iv

Intervention Type: DRUG

Max. 3 months

Cyclophosphamide 600 mg/m2 iv

Intervention Type: DRUG

Max. 3 months

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

Intervention Type: DRUG

Max. 3 months

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

Intervention Type: DRUG

Max. 3 months.

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

Intervention Type: DRUG

Max. 3 months

Neoadjuvant chemotherapy + tocotrienol

HER2 negative:

Four cycles of 3-weekly epirubicin 90 mg/m2 iv and cyclophosphamid 600 mg/m2 iv followed by Four cycles of taxane, i.e. 3-weekly docetaxel 100 mg/m2 iv or weekly paclitaxel 80 mg/m2 iv.

Daily: Tocotrienol 300 mg x 3

HER2 positive:

Four cycles of taxane, i.e. 3-weekly docetaxel 100 mg/m2 iv or weekly paclitaxel 80 mg/m2 iv + 3-weekly trastuzumab (8 mg/kg iv saturation, then 6 mg/kg iv) and possibly pertuzumab (840 mg saturation, then 420 mg iv) followed by Four cycles of 3-weekly epirubicin 90 mg/m2 iv and cyclophosphamid 600 mg/m2 iv.

Daily: Tocotrienol 300 mg x 3

Group Type: EXPERIMENTAL

Epirubicin 90 mg/m2 iv

Intervention Type: DRUG

Max. 3 months

Cyclophosphamide 600 mg/m2 iv

Intervention Type: DRUG

Max. 3 months

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

Intervention Type: DRUG

Max. 3 months

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

Intervention Type: DRUG

Max. 3 months.

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

Intervention Type: DRUG

Max. 3 months

Tocotrienol 300 mg x 3 daily

Intervention Type: DIETARY_SUPPLEMENT

Max. 6 months

Interventions

Epirubicin 90 mg/m2 iv

Max. 3 months

Intervention Type: DRUG

Cyclophosphamide 600 mg/m2 iv

Max. 3 months

Intervention Type: DRUG

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

Max. 3 months

Intervention Type: DRUG

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

Max. 3 months.

Intervention Type: DRUG

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

Max. 3 months

Intervention Type: DRUG

Tocotrienol 300 mg x 3 daily

Max. 6 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik H Jakobsen, MD

Role: STUDY_CHAIR

Vejle Hospital

Locations

Vejle hospital, Department of Oncology

Vejle, , Denmark

Countries

Denmark

Other Identifiers

NeoToc

Identifier Type: -

Identifier Source: org_study_id