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Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer (NeoToc)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02909751
Recruitment Status : Active, not recruiting
First Posted : September 21, 2016
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

Study Description
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Brief Summary:
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.

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 Design
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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
Actual Primary Completion Date : January 2019
Estimated Study Completion Date : April 2021

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Arms and Interventions
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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

 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
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


Outcome Measures
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Primary Outcome Measures :
  1. Pathological complete response [ Time Frame: 26 weeks from date of inclusion ]

Secondary Outcome Measures :
  1. Correlation of changes in NK-cells with pathological complete response [ Time Frame: 26 weeks from date of inclusion ]
  2. Correlation of changes in ctDNA with pathological complete response [ Time Frame: 26 weeks from date of inclusion ]
  3. Number of patients with grade 3-4 side effects [ Time Frame: 29 weeks from date of inclusion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Denmark
Vejle hospital, Department of Oncology
Vejle, Denmark
Sponsors and Collaborators
Vejle Hospital
Investigators
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Study Chair: Erik H Jakobsen, MD Vejle Hospital
More Information
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Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT02909751    
Other Study ID Numbers: NeoToc
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tocotrienols
Vitamin E
Tocopherols
Docetaxel
Cyclophosphamide
Trastuzumab
Epirubicin
Pertuzumab
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
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors