Clinical trial · Interventional
Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer
NCT02909751CI-TRIAL-00051912NeoToccompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide 600 mg/m2 iv | Drug | Cyclophosphamide | ALIAS |
| Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv | Drug | — | UNRESOLVED |
| Epirubicin 90 mg/m2 iv | Drug | Epirubicin | ALIAS |
| Pertuzumab 840 mg iv saturation, then 420 mg iv (selected HER2 positive patients only) | Drug | — | UNRESOLVED |
| Tocotrienol 300 mg x 3 daily | Dietary Supplement | — | UNRESOLVED |
| Trastuzumab 8 mg/kg iv saturation, then 6 mg/kg iv (HER2 positive patients only) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant chemotherapy
- description
- 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
- interventionNames
- 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)
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemotherapy + tocotrienol
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.