Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer (NeoToc)
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| ClinicalTrials.gov Identifier: NCT02909751 |
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Recruitment Status :
Active, not recruiting
First Posted : September 21, 2016
Last Update Posted : October 8, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | 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 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer |
| Actual Study Start Date : | September 14, 2016 |
| Estimated Primary Completion Date : | March 2019 |
| Estimated Study Completion Date : | April 2020 |
| Arm | Intervention/treatment |
|---|---|
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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 |
Drug: Epirubicin 90 mg/m2 iv
Max. 3 months Drug: Cyclophosphamide 600 mg/m2 iv Max. 3 months Drug: Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv Max. 3 months Drug: Trastuzumab 8 mg/kg iv saturation, then 6 mg/kg iv (HER2 positive patients only) Max. 3 months. Drug: Pertuzumab 840 mg iv saturation, then 420 mg iv (selected HER2 positive patients only) Max. 3 months |
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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 |
Drug: Epirubicin 90 mg/m2 iv
Max. 3 months Drug: Cyclophosphamide 600 mg/m2 iv Max. 3 months Drug: Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv Max. 3 months Drug: Trastuzumab 8 mg/kg iv saturation, then 6 mg/kg iv (HER2 positive patients only) Max. 3 months. Drug: Pertuzumab 840 mg iv saturation, then 420 mg iv (selected HER2 positive patients only) Max. 3 months Dietary Supplement: Tocotrienol 300 mg x 3 daily Max. 6 months |
- Pathological complete response [ Time Frame: 26 weeks from date of inclusion ]
- Correlation of changes in NK-cells with pathological complete response [ Time Frame: 26 weeks from date of inclusion ]
- Correlation of changes in ctDNA with pathological complete response [ Time Frame: 26 weeks from date of inclusion ]
- Number of patients with grade 3-4 side effects [ Time Frame: 29 weeks from date of inclusion ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909751
| Denmark | |
| Vejle hospital, Department of Oncology | |
| Vejle, Denmark | |
| Study Chair: | Erik H Jakobsen, MD | Vejle Hospital |
| Responsible Party: | Vejle Hospital |
| ClinicalTrials.gov Identifier: | NCT02909751 History of Changes |
| Other Study ID Numbers: |
NeoToc |
| First Posted: | September 21, 2016 Key Record Dates |
| Last Update Posted: | October 8, 2018 |
| Last Verified: | October 2018 |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Docetaxel Pertuzumab Albumin-Bound Paclitaxel Cyclophosphamide Trastuzumab Epirubicin Tocotrienols Vitamin E Tocopherols |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors |