Tocotrienol in combination with preoperative chemotherapy for women with breast cancer

Phase 1

• Conditions: Breast cancer; MedDRA version: 19.0 Level: LLT Classification code 10006188 Term: Breast cancer female NOS System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000080-16-DK
• Lead Sponsor: Vejle Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 78

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/EKKO 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. Spiral without hormone is considered safe.
•Written and orally informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

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
•Immunosupressive treatment (other than prednisolone during neoadjuvant chemotherapy)
•Vitamin or nutritional supplements (other than multivitamin table and calcium tablet with vitamin D)
•Active or latent viral/bacterial infection
•Rheumatoid arthritis or other autoimmune disease
•Other malignant disease within 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 6 months after start of treatment;Main Objective: Evaluation of the frequency of pathologic complete response in breast cancer patients treated with neoadjuvant chemotherapy combined with tocotrienol.;Secondary Objective: Investigation of the dynamics of NK-cell activity, TILs, CTC, and ctDNA in breast cancer patients during treatment with neoadjuvant chemotherapy in combination with tocotrienol.;Primary end point(s): The rate of pathologic complete response in breast cancer patients treated with neoadjuvant chemotherapy in combination with tocotrienol.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Correlation of NK-cells, TILs, CTC, and ctDNA with response.<br> 2. Toxicity of the treatment<br> ;<br> Timepoint(s) of evaluation of this end point: 1. 6 months after start of treatment<br> 2. 6 months after start of treatment<br>