Breast CancerPhase 2NeoTocNCT02909751
Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer
A Phase 2 study testing Epirubicin 90 mg/m2 iv, Cyclophosphamide 600 mg/m2 iv and Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv in people with Breast Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Epirubicin 90 mg/m2 iv, Cyclophosphamide 600 mg/m2 iv and Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Sep 2016to 21 Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Breast Cancer
- Being tested
- Epirubicin 90 mg/m2 iv, Cyclophosphamide 600 mg/m2 iv, Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv, Trastuzumab 8 mg/kg iv saturation, then 6 mg/kg iv (HER2 positive patients only), Pertuzumab 840 mg iv saturation, then 420 mg iv (selected HER2 positive patients only)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epirubicin 90 mg/m2 ivDrug
Max. 3 months
Cyclophosphamide 600 mg/m2 ivDrug
Max. 3 months
Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 ivDrug
Max. 3 months
Trastuzumab 8 mg/kg iv saturation, then 6 mg/kg iv (HER2 positive patients only)Drug
Max. 3 months.
Pertuzumab 840 mg iv saturation, then 420 mg iv (selected HER2 positive patients only)Drug
Max. 3 months
Tocotrienol 300 mg x 3 dailyDietary supplement
Max. 6 months
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy | Active comparator | 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 Receives: 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) |
| Neoadjuvant chemotherapy + tocotrienol | Experimental | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Measured: 26 weeks from date of inclusion
Secondary outcomes (3)
Correlation of changes in NK-cells with pathological complete response
Measured: 26 weeks from date of inclusion
Correlation of changes in ctDNA with pathological complete response
Measured: 26 weeks from date of inclusion
Number of patients with grade 3-4 side effects
Measured: 29 weeks from date of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start14 Sep 2016
- Primary completion21 Jan 2019
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik H Jakobsen, MD, Study chair, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909751
- Sponsor's protocol ID
- NeoToc
- Acronym
- NeoToc
- Status last verified
- May 2021
- First submitted
- 16 Sep 2016
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT02909751
- Acronym / sponsor ID
- NeoToc / NeoToc
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy | Active comparator | 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)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 |
| Neoadjuvant chemotherapy + tocotrienol | Experimental | 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 dailyHER2 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epirubicin 90 mg/m2 ivMax. 3 months | Drug | Neoadjuvant chemotherapy, Neoadjuvant chemotherapy + tocotrienol |
| Cyclophosphamide 600 mg/m2 ivMax. 3 months | Drug | Neoadjuvant chemotherapy, Neoadjuvant chemotherapy + tocotrienol |
| Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 ivMax. 3 months | Drug | Neoadjuvant chemotherapy, Neoadjuvant chemotherapy + tocotrienol |
| Trastuzumab 8 mg/kg iv saturation, then 6 mg/kg iv (HER2 positive patients only)Max. 3 months. | Drug | Neoadjuvant chemotherapy, Neoadjuvant chemotherapy + tocotrienol |
| Pertuzumab 840 mg iv saturation, then 420 mg iv (selected HER2 positive patients only)Max. 3 months | Drug | Neoadjuvant chemotherapy, Neoadjuvant chemotherapy + tocotrienol |
| Tocotrienol 300 mg x 3 dailyMax. 6 months | Dietary supplement | Neoadjuvant chemotherapy + tocotrienol |
Primary outcome
Pathological complete response
Time frame: 26 weeks from date of inclusion
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik H Jakobsen, MD study chair
Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epirubicin 90 mg/m2 iv, Cyclophosphamide 600 mg/m2 iv and Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv in people with Breast Cancer, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: 26 weeks from date of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.