Clinical trial NCT02909751: Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer
Official title: Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pathological complete response
timeFrame: 26 weeks from date of inclusion
Secondary outcomes:
measure: Correlation of changes in NK-cells with pathological complete response
timeFrame: 26 weeks from date of inclusion
measure: Correlation of changes in ctDNA with pathological complete response
timeFrame: 26 weeks from date of inclusion
measure: Number of patients with grade 3-4 side effects
timeFrame: 29 weeks from date of inclusion
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle hospital, Department of Oncology
Study officials:
affiliation: Vejle Hospital
name: Erik H Jakobsen, MD
role: STUDY_CHAIR
References: