Clinical Trial Results:
Tocotrienol in combination with neoadjuvant chemotherapy for women with breast cancer
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Summary
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EudraCT number |
2016-000080-16 |
Trial protocol |
DK |
Global end of trial date |
14 Jan 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jan 2021
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First version publication date |
06 Jan 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
NeoToc
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02909751 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Vejle Hospital
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Sponsor organisation address |
Beriderbakken 4, Vejle, Denmark,
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Public contact |
Clinical Trial Unit, Oncology, Vejle Hospital, kfe.onko@rsyd.dk
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Scientific contact |
Clinical Trial Unit, Oncology, Vejle Hospital, kfe.onko@rsyd.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Dec 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Jan 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Jan 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Evaluation of the frequency of pathologic complete response in breast cancer patients treated with neoadjuvant chemotherapy combined with tocotrienol.
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Protection of trial subjects |
Infusion and monitoring were performed according to institutional guidelines
Anamnesis and clinical examination were performed at each cycle.
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Background therapy |
Antiemetic prophylaxis was given according to institutional guidelines | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 80
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Worldwide total number of subjects |
80
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EEA total number of subjects |
80
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
56
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From 65 to 84 years |
24
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85 years and over |
0
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Recruitment
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Recruitment details |
Danish women with breast cancer Enrollment from April 2016 until July 2018 | |||||||||
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Pre-assignment
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Screening details |
Women with early breast cancer assigned to neoadjuvant chemotherapy according to institutional guidelines | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Arm A Control | |||||||||
Arm description |
Neoadjuvant chemotherapy according to institutional guidelines | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Arm B Experimental | |||||||||
Arm description |
Neoadjjuvant chemotherapy according to institutional guidelines + Tocotrienol | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Tocotrienol
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Investigational medicinal product code |
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Other name |
E-vitamin
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
200 mg x 3
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial (overall period)
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Arm A Control
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Reporting group description |
Neoadjuvant chemotherapy according to institutional guidelines | ||
Reporting group title |
Arm B Experimental
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Reporting group description |
Neoadjjuvant chemotherapy according to institutional guidelines + Tocotrienol | ||
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End point title |
Rate of patological complete response to tocotrienol combined with neoadjuvant chemotherapy in women with breast cancer [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At the operation after 6 months of treatment
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The study was not designed to compare the two treatment arms. Randomization was conducted to avoid selection bias. The study was completed according to "Simon's two-stage minimax design". The protocol dictates further studies only in case of more than 16 patients with pathological complete response in the experimental arm. |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Toxicities were recorded at baseline, before every cycle and postoperative.
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Adverse event reporting additional description |
Toxicities were graded using the National Cancer Institute's Common Toxicity Criteria (NCI-CTC) version 4.0, year 2010
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.0
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Reporting groups
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Reporting group title |
Toxicity
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Non-serious adverse events were not part of the primary endpoint. |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The study was not designed to compare the two treatment arms (control and tocotrienol). Randomisation was conducted to avoid selection bias. The study was completed according to "Simon's two-stage minimax design". | |||
