- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02909751
Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer (NeoToc)
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: Epirubicin 90 mg/m2 iv
- Drug: Cyclophosphamide 600 mg/m2 iv
- Drug: Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv
- Drug: Trastuzumab 8 mg/kg iv saturation, then 6 mg/kg iv (HER2 positive patients only)
- Drug: Pertuzumab 840 mg iv saturation, then 420 mg iv (selected HER2 positive patients only)
- Dietary supplement: Tocotrienol 300 mg x 3 daily
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Vejle, Denmark
- Vejle Hospital, Department of Oncology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 |
Max. 3 months
Max. 3 months
Max. 3 months
Max. 3 months.
Max. 3 months
|
Experimental: 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 |
Max. 3 months
Max. 3 months
Max. 3 months
Max. 3 months.
Max. 3 months
Max. 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pathological complete response
Time Frame: 26 weeks from date of inclusion
|
26 weeks from date of inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation of changes in NK-cells with pathological complete response
Time Frame: 26 weeks from date of inclusion
|
26 weeks from date of inclusion
|
Correlation of changes in ctDNA with pathological complete response
Time Frame: 26 weeks from date of inclusion
|
26 weeks from date of inclusion
|
Number of patients with grade 3-4 side effects
Time Frame: 29 weeks from date of inclusion
|
29 weeks from date of inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Erik H Jakobsen, MD, Vejle Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protective Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Micronutrients
- Antibiotics, Antineoplastic
- Vitamins
- Antioxidants
- Docetaxel
- Cyclophosphamide
- Trastuzumab
- Epirubicin
- Vitamin E
- Tocopherols
- Tocotrienols
- Pertuzumab
Other Study ID Numbers
- NeoToc
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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