Impact of Body Mass Index on Outcomes of Breast Cancer Management

Obesity and Breast Cancer Clinical Trial

Official title:

Impact of Body Mass Index on Outcomes of Breast Cancer Management (Retrospective Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03429504
• Other study ID #: BMIBC
• Status: Not yet recruiting
• Phase: N/A
• First received: February 6, 2018
• Last updated: February 6, 2018
• Start date: February 12, 2018
• Est. completion date: August 12, 2019

Study information

• Verified date: February 2018
• Source: Assiut University
• Contact: Samir S Mohamed, MD
• Phone: 00201222302375
• Email: samir[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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 post-menopausal breast cancer.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 12, 2019
• Est. primary completion date: February 12, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients' medical records that had no documented weight and height.

• Patients' medical records that had no documented follow up.

Related Conditions & MeSH terms

• Breast Neoplasms
• Obesity and Breast Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. — View Citation

Ligibel J. Obesity and breast cancer. Oncology (Williston Park). 2011 Oct;25(11):994-1000. Review. — View Citation

Niraula 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. — View Citation

Protani 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. Review. — View Citation

Sestak 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. — View Citation

Yung RL, Ligibel JA. Obesity and breast cancer: risk, outcomes, and future considerations. Clin Adv Hematol Oncol. 2016 Oct;14(10):790-797. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of obese breast cancer patients with response to treatment compared to non obese breast cancer patients.		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