Obesity and Breast CancerNCT03429504
Impact of Body Mass Index on Outcomes of Breast Cancer Management
An observational study of Obesity and Breast Cancer, run by Assiut University.
Trial summary
Obesity has been linked to an increased risk of developing a number of malignancies, including postmenopausal breast cancer. One of the established risk factors for breast cancer development in post-menopausal women is obesity which has further been linked to breast cancer recurrence and poorer survival in pre- and… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Obesity and Breast Cancer
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 12 Feb 2018to 12 Aug 2019
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer that was admitted at clinical oncology and nuclear medicine department, Assiut University Hospital, Egypt
Who may be able to join
- Medical records of female Patients with breast cancer at clinical oncology and nuclear medicine department, Assiut University Hospital between (1st Jan 2012 and 31st Dec 2016), their recorded body mass index and their follow up will be included in the study.
Who cannot join
- Patients' medical records that had no documented weight and height.
- Patients' medical records that had no documented follow up.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Body Mass Index on Outcomes of Breast Cancer Management (Retrospective Study)
Obesity has been linked to an increased risk of developing a number of malignancies, including postmenopausal breast cancer. One of the established risk factors for breast cancer development in post-menopausal women is obesity which has further been linked to breast cancer recurrence and poorer survival in pre- and post-menopausal breast cancer.
Read the detailed description
The biological mechanisms underlying the association between obesity and breast cancer could involve interacting mediators of hormones, adipocytokines, and inflammatory cytokines which link to cell survival or apoptosis, migration and proliferation. Higher level of oestradiol produced in postmenopausal women through aromatization of androgens in the adipose tissues and higher level of insulin, a condition common in obese women, are linked to poorer prognosis in breast cancer. A possible interaction between leptin, insulin and obesity-related markers of inflammation have also been linked to breast cancer outcomes. Non-biological mechanisms could include chemotherapy under-dosing in obese women, suboptimal treatment, and obesity-related complications.
The impact of body mass index on treatment outcome in patients receiving endocrine therapy, there have been consistent results indicating that the efficacy of aromatase inhibitors vary with body mass index; however, the efficacy of tamoxifen is not body mass index-dependent. In the Arimidex, Tamoxifen, Alone or in Combination trial, which compared the efficacy of anastrozole against tamoxifen as an adjuvant treatment for hormone receptor-positive post-menopausal breast cancer patients, anastrozole, a non-steroidal aromatase inhibitor, was significantly less effective in post-menopausal breast cancer patients with a high body mass index, whereas an equal efficacy of tamoxifen was shown across all body mass index levels.
Observational study. Retrospective analysis of data that will be collected from breast cancer patients medical records as body mass index and their response to treatment, progression free survival and overall survival.
- Conditions
- Obesity and Breast Cancer
- Keywords
- Obesity, Breast cancer, Body mass index
- Medical subject headings
- Obesity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese breast cancer patients | Response to treatment and progression free survival in obese breast cancer patients | |
| non obese breast cancer patients | Response to treatment and progression free survival in non obese breast cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of obese breast cancer patients with response to treatment compared to non obese breast cancer patients.
Measured: The cases will be obtained from the medical records of breast cancer patients admitted to the Clinical Oncology and Nuclear Medicine Department, Assiut University hospital from 1st of January, 2012 - 31st December, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start12 Feb 2018 (estimated)
- Primary completion12 Feb 2019 (estimated)
- Study completion12 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obesity and Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moheb Ibrahim Melek, Assiut University
- Investigators
- Aiat M Mohamed, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429504
- Sponsor's protocol ID
- BMIBC
- Status last verified
- Feb 2018
- First submitted
- 6 Feb 2018
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deglise C, Bouchardy C, Burri M, Usel M, Neyroud-Caspar I, Vlastos G, Chappuis PO, Ceschi M, Ess S, Castiglione M, Rapiti E, Verkooijen HM. Impact of obesity on diagnosis and treatment of breast cancer. Breast Cancer Res Treat. 2010 Feb;120(1):185-93. doi: 10.1007/s10549-009-0459-1. Epub 2009 Jul 14.
PubMed 19597985Yung RL, Ligibel JA. Obesity and breast cancer: risk, outcomes, and future considerations. Clin Adv Hematol Oncol. 2016 Oct;14(10):790-797.
PubMed 27930630Protani M, Coory M, Martin JH. Effect of obesity on survival of women with breast cancer: systematic review and meta-analysis. Breast Cancer Res Treat. 2010 Oct;123(3):627-35. doi: 10.1007/s10549-010-0990-0. Epub 2010 Jun 23.
PubMed 20571870Ligibel J. Obesity and breast cancer. Oncology (Williston Park). 2011 Oct;25(11):994-1000.
PubMed 22106549Niraula S, Ocana A, Ennis M, Goodwin PJ. Body size and breast cancer prognosis in relation to hormone receptor and menopausal status: a meta-analysis. Breast Cancer Res Treat. 2012 Jul;134(2):769-81. doi: 10.1007/s10549-012-2073-x. Epub 2012 May 5.
PubMed 22562122Sestak I, Distler W, Forbes JF, Dowsett M, Howell A, Cuzick J. Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: an exploratory analysis from the ATAC trial. J Clin Oncol. 2010 Jul 20;28(21):3411-5. doi: 10.1200/JCO.2009.27.2021. Epub 2010 Jun 14.
PubMed 20547990
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Body Mass Index on Outcomes of Breast Cancer Management (Retrospective Study)
- ClinicalTrials.gov ID
- NCT03429504
- Acronym / sponsor ID
- BMIBC
- Conditions
- Obesity and Breast Cancer
- Keywords
- Obesity, Breast cancer, Body mass index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 Feb 2018 (estimated)
- Primary completion
- 12 Feb 2019 (estimated)
- Study completion
- 12 Aug 2019 (estimated)
- First posted
- 12 Feb 2018 (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.
Obesity has been linked to an increased risk of developing a number of malignancies, including postmenopausal breast cancer. One of the established risk factors for breast cancer development in post-menopausal women is obesity which has further been linked to breast cancer recurrence and poorer survival in pre- and post-menopausal breast cancer.
Detailed description
The biological mechanisms underlying the association between obesity and breast cancer could involve interacting mediators of hormones, adipocytokines, and inflammatory cytokines which link to cell survival or apoptosis, migration and proliferation. Higher level of oestradiol produced in postmenopausal women through aromatization of androgens in the adipose tissues and higher level of insulin, a condition common in obese women, are linked to poorer prognosis in breast cancer. A possible interaction between leptin, insulin and obesity-related markers of inflammation have also been linked to breast cancer outcomes. Non-biological mechanisms could include chemotherapy under-dosing in obese women, suboptimal treatment, and obesity-related complications.
The impact of body mass index on treatment outcome in patients receiving endocrine therapy, there have been consistent results indicating that the efficacy of aromatase inhibitors vary with body mass index; however, the efficacy of tamoxifen is not body mass index-dependent. In the Arimidex, Tamoxifen, Alone or in Combination trial, which compared the efficacy of anastrozole against tamoxifen as an adjuvant treatment for hormone receptor-positive post-menopausal breast cancer patients, anastrozole, a non-steroidal aromatase inhibitor, was significantly less effective in post-menopausal breast cancer patients with a high body mass index, whereas an equal efficacy of tamoxifen was shown across all body mass index levels.
Observational study. Retrospective analysis of data that will be collected from breast cancer patients medical records as body mass index and their response to treatment, progression free survival and overall survival.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese breast cancer patients | – | –Response to treatment and progression free survival in obese breast cancer patients |
| non obese breast cancer patients | – | –Response to treatment and progression free survival in non obese breast cancer patients |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer that was admitted at clinical oncology and nuclear medicine department, Assiut University Hospital, Egypt
Key inclusion criteria (1 listed)
- Medical records of female Patients with breast cancer at clinical oncology and nuclear medicine department, Assiut University Hospital between (1st Jan 2012 and 31st Dec 2016), their recorded body mass index and their follow up will be included in the study.
Key exclusion criteria (2 listed)
- Patients' medical records that had no documented weight and height.
- Patients' medical records that had no documented follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentage of obese breast cancer patients with response to treatment compared to non obese breast cancer patients.
Time frame: The cases will be obtained from the medical records of breast cancer patients admitted to the Clinical Oncology and Nuclear Medicine Department, Assiut University hospital from 1st of January, 2012 - 31st December, 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Background: PubMed 19597985Deglise C, Bouchardy C, Burri M, Usel M, Neyroud-Caspar I, Vlastos G, Chappuis PO, Ceschi M, Ess S, Castiglione M, Rapiti E, Verkooijen HM. Impact of obesity on diagnosis and treatment of breast cancer. Breast Cancer Res Treat. 2010 Feb;120(1):185-93. doi: 10.1007/s10549-009-0459-1. Epub 2009 Jul 14.
- Background: PubMed 27930630Yung RL, Ligibel JA. Obesity and breast cancer: risk, outcomes, and future considerations. Clin Adv Hematol Oncol. 2016 Oct;14(10):790-797.
- Background: PubMed 20571870Protani M, Coory M, Martin JH. Effect of obesity on survival of women with breast cancer: systematic review and meta-analysis. Breast Cancer Res Treat. 2010 Oct;123(3):627-35. doi: 10.1007/s10549-010-0990-0. Epub 2010 Jun 23.
- Background: PubMed 22106549Ligibel J. Obesity and breast cancer. Oncology (Williston Park). 2011 Oct;25(11):994-1000.
- Background: PubMed 22562122Niraula S, Ocana A, Ennis M, Goodwin PJ. Body size and breast cancer prognosis in relation to hormone receptor and menopausal status: a meta-analysis. Breast Cancer Res Treat. 2012 Jul;134(2):769-81. doi: 10.1007/s10549-012-2073-x. Epub 2012 May 5.
- Background: PubMed 20547990Sestak I, Distler W, Forbes JF, Dowsett M, Howell A, Cuzick J. Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: an exploratory analysis from the ATAC trial. J Clin Oncol. 2010 Jul 20;28(21):3411-5. doi: 10.1200/JCO.2009.27.2021. Epub 2010 Jun 14.
- Individual participant dataSharing planned: No
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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.
Aiat M Mohamed, MD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Breast Cancer, run by Assiut University.
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 1 inclusion and 2 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 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Samir S Mohamed, MD (00201222302375, samir@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of obese breast cancer patients with response to treatment compared to non obese breast cancer patients. (time frame: The cases will be obtained from the medical records of breast cancer patients admitted to the Clinical Oncology and Nuclear Medicine Department, Assiut University hospital from 1st of January, 2012 - 31st December, 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429504, which also lists 6 linked publications.
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 12 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.