Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Interview and survey during visit or by phone, 30 - 40 minutes.

Questionnaire

Abenaa M. Brewster, MD, MHS, BS

The goal of this epidemiologic research study is to find out if various risk factors and certain markers (substances that help identify the presence of cancer) that help predict increased occurrence and prognosis (outcome of disease) of breast cancer differ among Mexican, Mexican-American, and African-American women.

An epidemiologic study looks at the patterns, causes, and control of disease in groups of people. Researchers want to see if various risk factors (such as decreased and delayed fertility, obesity, and a sedentary \[low physical activity\] lifestyle) and certain markers that cause breast cancer are different in women in the above groups.

If you have breast cancer and you agree to take part in this study, you will be interviewed by a trained interviewer with a questionnaire at a time convenient for you, either during your visit to MD Anderson or The Rose, or by phone. You will be asked questions about your personal demographics (such as your age and race), environmental exposures, medical history, family history of cancer, and other day-to-day lifestyle factors. It should take about 30-40 minutes to complete the interview. Clinical data about your breast cancer treatment will also be collected from your medical records.

You will also have a one-time blood draw (about 3 tablespoons). If blood cannot be drawn or not enough blood can be drawn, you will have a saliva sample taken where you will be required to spit into a container. If you have already donated blood or a saliva sample in the Mexican-American Cohort Study, a portion of that sample may be used instead of having to collect a new sample. Your blood or saliva sample will be used to look at your DNA (genetic material of cells). The study pathologist will look at possible prognostic markers (substances that predict outcome of disease) from tissue obtained from your surgery.

Neither you nor your regular doctor will receive reports of this research study. The results of this research study will not be placed in your health records. All of your information obtained in this study will be kept confidential either in a password-protected computer or in a locked file cabinet in a secure location.

Your participation will be over in this study when all the data has been collected and analyzed.

This is an investigational study. Up to 1,825 women will take part in this multicenter study. Up to 1125 will be enrolled at MD Anderson.

One-time blood draw (about 3 tablespoons). If blood cannot be drawn or not enough blood can be drawn, a saliva sample will be taken.

Breast Cancers: Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S.

Comparative Study of Breast Cancers and Their Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Rare Diseases

Oculocerebral Syndrome With Hypopigmentation

Antineoplastic Agents

All Drugs and Chemicals

Exemestane

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Aromasin

Pfizer CT.gov Call Center

Observational survey aiming to evaluate the tolerability of Aromasin and the ways in which it is used in clinical practice in France (as adjuvant endocrine therapy).

It was hypothesized that 200 participating doctors would provide the survey with sufficient statistical precision to meet the objectives, with each participating doctor recruiting up to 6 patients. An initial sample of 1000 doctors should be contacted (letter, phone).

These 1000 doctors will initially be chosen at random from a file held by Pfizer of doctors who have agreed to take part in a Pfizer survey.

These doctors will be experienced and qualified in the treatment and management of patients with non-metastatic, surgically-treated breast cancer (medical oncologists, gynaecologists, and medical oncologists/ radiation oncologists). They are practicing in general hospitals, teaching hospitals, CRLCC cancer centres and private clinics treating patients with breast cancer.

Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on December 3, 2010. There were no safety concerns involved in the decision to stop enrollment.

A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients

Any untoward medical occurrence in a patient who received study drug was considered an adverse event without regard to possibility of causal relationship. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Compliant with treatment = followed treatment regimen with exemestane according to initial prescription.

Total duration of adjuvant hormonal therapy with exemestane.

Event-free survival: time between first intake of exemestane and date of last follow-up or date of death for deceased participants (date of relapse or death or last follow-up minus first intake date) + 1 / 365.25 \* 12.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

N = 392, number of participants with baseline age data.

Age Continuous

Sex: Female, Male

Study recruitment was stopped due to difficulty enrolling the target number of participants. There were no safety concerns in the decision to terminate this study.

Pfizer ClinicalTrials.gov Call Center

Safety set: all participants who received at least 1 dose of study medication.

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Therapeutic choice

Adverse events

Safety set. N = number of participants with follow-up visit(s) who discontinued treatment with exemestane.

Reasons for Discontinuation of Aromasin Therapy

Safety set. Information on compliance was not available for subjects who did not have a follow-up visit. N = number of participants with analyzable data.

Percentage of Participants Who Were Compliant With Treatment

Safety set; N = number of participants with analyzable (non-missing) data. For 2 participants lost to follow-up, the duration of exemestane was calculated until the date of lost to follow-up.

Duration of Treatment

ITT population = all participants who received at least 1 dose of study drug and had at least 1 follow-up questionnaire completed. N = number of participants with analyzable (non-missing) data.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Breast Cancers: Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S.	NCT00837499	Breast Cancer	Questionnaire	18 Years -	M.D. Anderson Cancer Center
A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients	NCT01305239	Breast Cancer	Aromasin	45 Years -	Pfizer
A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients	NCT01305239	Breast Cancer	Aromasin	45 Years -	Pfizer

Spots Global Cancer Trial Database for epidemiological