Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-13 @ 7:55 AM
Study NCT ID:
NCT02909751
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2016-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'C485206', 'term': 'pertuzumab'}, {'id': 'D024508', 'term': 'Tocotrienols'}], 'ancestors': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014810', 'term': 'Vitamin E'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-19', 'studyFirstSubmitDate': '2016-09-16', 'studyFirstSubmitQcDate': '2016-09-16', 'lastUpdatePostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological complete response', 'timeFrame': '26 weeks from date of inclusion'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with histologically verified breast cancer (adenocarcinoma)\n* Age ≥ 18 years.\n* Neoadjuvant treatment indicated according to departmental guidelines\n* PS 0-2 and suited for surgery.\n* Normal heart function, LVEF ≥ 50% by MUGA/ECHO in patients receiving neoadjuvant trastuzumab\n* Normal bone marrow function: Hemoglobin ≥ 6 mmol/l; ANC ≥ 1.5x10\\^9/l; Thrombocytes ≥ 100x10\\^9/l.\n* 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.\n* Normal kidney function: Creatinine ≤ upper level of normal. In case of increased creatinine, measured/calculated GFR must be ≥ 50 ml/min.\n* 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.\n* Written and orally informed consent\n\nExclusion Criteria:\n\n* Bilateral breast cancer or suspected dissemination. Verified by bilateral mammography, bone scintigraphy, chest and abdomen CT, and PET-CT.\n* Pregnant and breastfeeding women\n* Mental or social conditions that will prevent treatment or follow-up\n* Other simultaneous experimental treatment\n* Immunosuppressive treatment (other than prednisolone during neoadjuvant chemotherapy)\n* Vitamin or nutritional supplements (other than multivitamin tablet and calcium tablet with vitamin D)\n* Active or latent viral/bacterial infection\n* Rheumatoid arthritis or other autoimmune disease\n* Other malignant disease within the past 5 years excl. non-melanoma cancer of the skin and carcinoma in situ cervicis uteri.\n* Previous treatment with docetaxel, paclitaxel, epirubicin, cyclophosphamide, trastuzumab, pertuzumab or tocotrienol\n* Hypersensitivity to any of the active or auxiliary substances'}, 'identificationModule': {'nctId': 'NCT02909751', 'acronym': 'NeoToc', 'briefTitle': 'Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vejle Hospital'}, 'officialTitle': 'Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer', 'orgStudyIdInfo': {'id': 'NeoToc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Neoadjuvant chemotherapy', 'description': 'HER2 negative:\n\nFour 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\n\nHER2 positive:\n\nFour 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:\n\nFour 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.\n\nDaily: Tocotrienol 300 mg x 3\n\nHER2 positive:\n\nFour 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.\n\nDaily: Tocotrienol 300 mg x 3', '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)', 'Dietary Supplement: Tocotrienol 300 mg x 3 daily']}], 'interventions': [{'name': 'Epirubicin 90 mg/m2 iv', 'type': 'DRUG', 'description': 'Max. 3 months', 'armGroupLabels': ['Neoadjuvant chemotherapy', 'Neoadjuvant chemotherapy + tocotrienol']}, {'name': 'Cyclophosphamide 600 mg/m2 iv', 'type': 'DRUG', 'description': 'Max. 3 months', 'armGroupLabels': ['Neoadjuvant chemotherapy', 'Neoadjuvant chemotherapy + tocotrienol']}, {'name': 'Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv', 'type': 'DRUG', 'description': 'Max. 3 months', 'armGroupLabels': ['Neoadjuvant chemotherapy', 'Neoadjuvant chemotherapy + tocotrienol']}, {'name': 'Trastuzumab 8 mg/kg iv saturation, then 6 mg/kg iv (HER2 positive patients only)', 'type': 'DRUG', 'description': 'Max. 3 months.', 'armGroupLabels': ['Neoadjuvant chemotherapy', 'Neoadjuvant chemotherapy + tocotrienol']}, {'name': 'Pertuzumab 840 mg iv saturation, then 420 mg iv (selected HER2 positive patients only)', 'type': 'DRUG', 'description': 'Max. 3 months', 'armGroupLabels': ['Neoadjuvant chemotherapy', 'Neoadjuvant chemotherapy + tocotrienol']}, {'name': 'Tocotrienol 300 mg x 3 daily', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Max. 6 months', 'armGroupLabels': ['Neoadjuvant chemotherapy + tocotrienol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vejle', 'country': 'Denmark', 'facility': 'Vejle hospital, Department of Oncology', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'overallOfficials': [{'name': 'Erik H Jakobsen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vejle Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vejle Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}