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Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer

NCT02909751 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-05-20

No results posted yet for this study

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

Interventions

DRUG

Epirubicin 90 mg/m2 iv

Max. 3 months

DRUG

Cyclophosphamide 600 mg/m2 iv

Max. 3 months

DRUG

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

Max. 3 months

DRUG

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

Max. 3 months.

DRUG

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

Max. 3 months

DIETARY_SUPPLEMENT

Tocotrienol 300 mg x 3 daily

Max. 6 months

Sponsors & Collaborators

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Erik H Jakobsen, MD · Vejle Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-14
Primary Completion
2019-01-21
Completion
2019-01-21

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02909751 on ClinicalTrials.gov