Breast CancerNUTRIBREASTNCT04389424
Relationship Between Body Composition, Food Consumption, and Micro and Macronutrients With Gene Expression in Breast Cancer
An observational study of Breast Cancer and Endocrine Therapy, run by Instituto Jalisciense de Cancerologia at 1 site in Mexico.
Trial summary
The protocol involves measurement of 25 hidroxy vitamin D, gene expression of cytochrome and vitamin D receptor , endoxifen, tamoxifen, exemestane, and other metobolites related to nutrition and endocrine metabolism. Read more about this study
- Who is it for?
- Ages 18 to 98 years, women only
- Conditions the study is for
- Breast Cancer, Endocrine Therapy, Endocrine Therapy Adverse Reaction
- What is being tested?
- Tamoxifen, Exemestane and Anastrozole
- How many people
- 300 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2017to 30 Jan 2022
- Phase
- Observational
- 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 to 98 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Mexican breast cancer woman
Who may be able to join
- Breast cancer women under endocrine therapy or recurrence of disease after endocrine therapy
- Signed consent
Who cannot join
- Mental retardation
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Jalisciense de Cancerologia
Guadalajara, Jalisco, 45180
JOSE ALFONSO CRUZ RAMOS, MD, 1523314886313, josealfonsocr@gmail.com
About this study
Official title: Evaluation of the Relationship Between Drug Therapy, Food Consumption, Body Composition and Plasma Micronutients Levels With the Expression of Genes Related to Metabolism, Aging and Immunity in Women With Breast Cancer.
The protocol involves measurement of 25 hidroxy vitamin D, gene expression of cytochrome and vitamin D receptor , endoxifen, tamoxifen, exemestane, and other metobolites related to nutrition and endocrine metabolism.
- Conditions
- Breast Cancer, Endocrine Therapy, Endocrine Therapy Adverse Reaction, Vitamin D Deficiency, Nutrition Disorders, Obesity
- Being tested
- Tamoxifen, Exemestane, Anastrozole, Basal, Recurrence
- Keywords
- Vitamin D, Adverse, Cytochrome p450, VDR, Nutrients, Gene Expression, Tamoxifen, Anastrozole, Exemestane
- Medical subject headings
- Breast Neoplasms, Vitamin D Deficiency, Nutrition Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Use of tamoxifen for breast cancer recurrence prevention
ExemestaneDrug
Use of exemestane for breast cancer recurrence prevention
AnastrozoleDrug
Use of anastrozole for breast cancer recurrence prevention
BasalDiagnostic test
Also called Breast cancer initial diagnosis
Initial diagnosis of breast cacner by biopsy or mastectomy
RecurrenceDiagnostic test
Also called Breast cancer recurrence under endoctine therapy
Breast cancer recurrence under endocrine therapy
| Study group | Role | What they receive |
|---|---|---|
| Anastrozole | Breast cancer women with anastrozole treatment Receives: Drug: Anastrozole | |
| Tamoxifen | Breast cancer women with tamoxifen treatment Receives: Drug: Tamoxifen | |
| Exemestane | Breast cancer women with exemestane treatment Receives: Drug: Exemestane | |
| Basal | Breast cancer women luminal type without any endocrine treatment (at initial diagnosis) Receives: Diagnostic Test: Basal | |
| Recurrence | Breast cancer women luminal type with recurrence of disease during endocrine therapy Receives: Drug: Tamoxifen; Drug: Anastrozole; Diagnostic Test: Recurrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hidroxy Vitamin D Concentration
Plasma levels of Hidroxy Vitamin D
Measured: One time after minimum 3 months of tamoxifen, anastrozole or exemestane treatment (endocrine therapy)
Body Composition
Body composition (bioimpedance)
Measured: One time at enroll with at least 3 months of endocrine therapy
Secondary outcomes (4)
Tamoxifen plasma levels
Tamoxifen plasma levels
Measured: One time. After minimum 3 months of tamoxifen treatment
Anastrozole
Anastrozole plasma levels
Measured: One time. After minimum 3 months of anastrozole treatment
Exemestane
Exemestane plasma levels
Measured: One time. After minimum 3 months of exemestane treatment
Recurrence
Recurrence of breast cancer after endocrine therapy with tamoxifen or aromatase inhibitors
Measured: One time. In recurrence after at least 3 months with endocrine therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Sep 2017
- Primary completion15 May 2020 (estimated)
- Study completion30 Jan 2022 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Jalisciense de Cancerologia
- Sponsor type
- Other government
- Collaborators
- University of Guadalajara
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389424
- Sponsor's protocol ID
- 1/15
- Acronym
- NUTRIBREAST
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Drug Therapy, Food Consumption, Body Composition and Plasma Micronutients Levels With the Expression of Genes Related to Metabolism, Aging and Immunity in Women With Breast Cancer.
- ClinicalTrials.gov ID
- NCT04389424
- Acronym / sponsor ID
- NUTRIBREAST / 1/15
- Conditions
- Breast Cancer, Endocrine Therapy, Endocrine Therapy Adverse Reaction, Vitamin D Deficiency, Nutrition Disorders, Obesity
- Keywords
- Vitamin D, Adverse, Cytochrome p450, VDR, Nutrients, Gene Expression, Tamoxifen, Anastrozole
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Instituto Jalisciense de CancerologiaOther government
- Collaborators
- University of Guadalajara
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 15 May 2020 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 15 May 2020 (actual)
- 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 protocol involves measurement of 25 hidroxy vitamin D, gene expression of cytochrome and vitamin D receptor , endoxifen, tamoxifen, exemestane, and other metobolites related to nutrition and endocrine metabolism.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Anastrozole | – | Drug: AnastrozoleBreast cancer women with anastrozole treatment |
| Tamoxifen | – | Drug: TamoxifenBreast cancer women with tamoxifen treatment |
| Exemestane | – | Drug: ExemestaneBreast cancer women with exemestane treatment |
| Basal | – | Diagnostic Test: BasalBreast cancer women luminal type without any endocrine treatment (at initial diagnosis) |
| Recurrence | – | Drug: Tamoxifen, Drug: Anastrozole, Diagnostic Test: RecurrenceBreast cancer women luminal type with recurrence of disease during endocrine therapy |
Who may qualify
- Ages
- 18 to 98 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mexican breast cancer woman
Key inclusion criteria (2 listed)
- Breast cancer women under endocrine therapy or recurrence of disease after endocrine therapy
- Signed consent
Key exclusion criteria (1 listed)
- Mental retardation
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 |
|---|---|---|
| TamoxifenUse of tamoxifen for breast cancer recurrence prevention | Drug | Recurrence, Tamoxifen |
| ExemestaneUse of exemestane for breast cancer recurrence prevention | Drug | Exemestane |
| AnastrozoleUse of anastrozole for breast cancer recurrence prevention | Drug | Anastrozole, Recurrence |
| BasalAlso: Breast cancer initial diagnosisInitial diagnosis of breast cacner by biopsy or mastectomy | Diagnostic test | Basal |
| RecurrenceAlso: Breast cancer recurrence under endoctine therapyBreast cancer recurrence under endocrine therapy | Diagnostic test | Recurrence |
Primary outcome
Hidroxy Vitamin D Concentration
Time frame: One time after minimum 3 months of tamoxifen, anastrozole or exemestane treatment (endocrine therapy)
Plasma levels of Hidroxy Vitamin D
Body Composition
Time frame: One time at enroll with at least 3 months of endocrine therapy
Body composition (bioimpedance)
4 secondary outcomes
Tamoxifen plasma levels
Time frame: One time. After minimum 3 months of tamoxifen treatment
Anastrozole
Time frame: One time. After minimum 3 months of anastrozole treatment
Exemestane
Time frame: One time. After minimum 3 months of exemestane treatment
Recurrence
Time frame: One time. In recurrence after at least 3 months with endocrine therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Instituto Jalisciense de CancerologíaLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Endocrine Therapy, run by Instituto Jalisciense de Cancerologia at 1 site in Mexico.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 May 2020. 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 Mexico. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JOSE ALFONSO CRUZ RAMOS, MD (1523314886313, josealfonsocr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hidroxy Vitamin D Concentration (time frame: One time after minimum 3 months of tamoxifen, anastrozole or exemestane treatment (endocrine therapy)). The study lists 2 primary outcomes in all. 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 15 May 2020.