Breast Cancer Clinical Trial
— NeoTocOfficial title:
Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer
Verified date | May 2021 |
Source | Vejle Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | January 21, 2019 |
Est. primary completion date | January 21, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Vejle hospital, Department of Oncology | Vejle |
Lead Sponsor | Collaborator |
---|---|
Vejle Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathological complete response | 26 weeks from date of inclusion | ||
Secondary | Correlation of changes in NK-cells with pathological complete response | 26 weeks from date of inclusion | ||
Secondary | Correlation of changes in ctDNA with pathological complete response | 26 weeks from date of inclusion | ||
Secondary | Number of patients with grade 3-4 side effects | 29 weeks from date of inclusion |
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