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BRCA Gene Mutations in Latinas with Breast Cancer

BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects (NCT01251900)

Summary

Some women who have triple negative (ER, PR, and HER2-negative) breast cancer also have a BRCA1 or BRCA2 genetic mutation. The number of Latinas with triple negative breast cancer who also have a BRCA1/2 mutation is not known. Learning more about BRCA1/2 mutation rates among Latinas will help researchers provide better treatment to this group of women. The purpose of this trial is to study DNA samples taken from saliva and the medical histories of Latinas who have been diagnosed with breast cancer. Participants can reside anywhere in the U.S.

Evaluating How Breast Cancer Affects Different Ethnic Groups

Ethnic Differences in the Impact of Breast Cancer on Employment Status, Financial Situation, and Quality of Life (NCT01134172)

Summary

Little is known about how breast cancer treatments affect the employment, financial situation, and quality of life of ethnic minority women over a short- or long-term basis. The purpose of this study is to evaluate how breast cancer affects the lives of women from different ethnic groups. To be eligible, women must be receiving treatment for stage I, II or III breast cancer and have been employed prior to their diagnosis. Participants will be asked to find a peer who speaks the same language, is the same age and ethnicity, and will agree to take part in the study.

National Breast Cancer and Lymphedema Registry

National Breast Cancer and Lymphedema Registry (NCT01580800)

Summary

Lymphedema, a painful swelling of the hand, wrist, and/or arm, is a potential long-term side effect of breast cancer treatments that can have a large impact on patients' quality of life. The National Breast Cancer Lymphedema Registry is designed to collect information about the effect early diagnostic and treatment strategies have on the development of lymphedema, its severity, and its impact on quality of life.

A Pregnancy Registry for Women on HER2-Targeted Therapies

An Observational Study of Pregnancy And Pregnancy Outcomes in Women With Breast Cancer Treated With Herceptin, Perjeta In Combination With Herceptin, or Kadcyla During Pregnancy or Within 7 Months Prior To Conception (NCT00833963)

Summary

Trastuzumab (Herceptin®), pertuzumab (Perjeta®) and ado-trastuzumab emtansine (Kadcyla®) are used to treat HER2-positive tumors. These drugs are not approved for use during pregnancy and carry labels that advise women to avoid becoming pregnant or breastfeeding. The MotHER Pregnancy Registry is a U.S.-based, prospective, observational study in women with breast cancer who received at least one dose of these drugs during pregnancy or within 6 months of conception. The primary objective of this Pregnancy Registry is to monitor women who were pregnant when receiving any of these medications to determine the frequency of adverse pregnancy complications or major birth defects.

WISDOM Study: Women Informed to Screen Depending on Measures of Risk

Enabling a Paradigm Shift: A Preference-Tolerant RCT of Personalized vs. Annual Screening for Breast Cancer (NCT02620852)

Summary

To take part in this study, you must be between the ages of 40 and 70 and not have previously been diagnosed with breast cancer or ductal carcinoma in situ (DCIS). You must also be able to receive breast screening at an Athena site: University of California (San Francisco, San Diego, Davis, Los Angeles, and Irvine), or Sanford Health in South Dakota. This study is comparing risk-based screening to annual screening for measuring breast cancer risk and detecting breast cancer. It will help researchers learn if risk-based screening, which helps women learn more about their personal breast cancer risk, is less stressful and as successful at detecting breast cancer. The personalized risk-based screening will take multiple risk factors into consideration, including genetic markers, to determine how often you should have a mammogram.

The Health of Women Study: Learning About the Causes of and Ways to Prevent Breast Cancer

The Health of Women (HOW) Study (NCT02334085)

Summary

The Health of Women (HOW) study is an international online study for women and men with or without a history of breast cancer. Participants in this study complete questionnaires about their health, job, diet and family history, among other topics. The researchers will use the information collected from these questionnaires to gain insight into what causes breast cancer and how to prevent it. This study is open to all women and men of every age, ethnicity, sexual orientation and occupation.

Collecting Information About Metastatic Breast Cancer To Further Research

The Metastatic Breast Cancer Project (MAN002)

Summary

To take part in this study you must be a woman or man living with metastatic breast cancer. The goal of the Metastatic Breast Cancer Project is to accelerate research in treating, curing and preventing metastatic breast cancer. If you take part in the project, you will fill out questionnaires, provide a saliva sample, and share a piece of your stored tumor tissue and copies of your medical records with the researchers. The researchers believe analyzing this data will help them learn more about metastatic breast cancer and make more research advances. The Project was created by a coalition of researchers and breast cancer advocacy organizations.

A Study of the Inherited KRAS-Variant Mutation and Breast Cancer Risk

Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment (NCT02253251)

Summary

Researchers have identified an inherited genetic mutation—a KRAS-variant—that may increase a person's risk of developing breast or other types of cancer. This study will follow participants for 10 years in order to analyze the association between the KRAS-variant mutation and cancer risk. The researchers will also look at the effect that different lifestyle factors have on cancer risk. All participants will have a saliva sample tested for the KRAS-variant. To be eligible, participants must have a personal or family history of breast cancer.

Cancer Support Community Online Survey: The Cancer Experience Registry

Cancer Experience Registry: An Online Initiative to Change the Future of Cancer Care (NCT01295658)

Summary

Researchers are trying to develop programs that can successfully address the needs of people who have experienced breast cancer. The Cancer Experience Registry is an online survey designed to identify and understand the emotional and social needs of women and men who have had a breast cancer diagnosis. It is open to anybody who has been recently diagnosed or is undergoing treatment, living with metastatic disease or years past treatment. This project is sponsored by The Cancer Support Community, an international non-profit dedicated to providing support, education and hope to people affected by cancer.

A Study of Metastatic Breast Cancer Patients Receiving Integrative Oncology

The Canadian/US Integrative Oncology Study (CUSIOS): Advanced Integrative Oncology Treatment for Patients With Advanced Stage Cancer: A Prospective Outcomes Study (NCT02494037)

Summary

Up to 80% of cancer patients in the U.S. receive some form of complementary or alternative medicine. Some patients are treated by naturopathic doctors who are board certified in naturopathic oncology or by traditional Chinese medicine providers with advanced training in oncology. This level of care is often called "advanced integrative oncology" (AIO). Little is known about the benefits AIO may add to cancer care. This study will follow patients with advanced breast (and other) cancer who are also receiving AIO and compare their outcomes to outcomes that would be expected based on findings from other studies. To be eligible, participants must be starting to receive care at a participating Integrative Oncology center.

Assessment of Cancer Concerns at the End of Treatment

Assessment of Cancer Concerns at the End of Treatment (ACE) (NCT02514486)

Summary

Researchers want to learn more about the overall quality of life of long-term breast cancer survivors. This study is looking at patient-reported symptoms, concerns, quality of life and health behaviors of breast cancer survivors who have completed initial treatments. It also is investigating whether it is feasible to to use a web-based program to collect information about breast cancer survivors' experiences. Early stage breast cancer survivors who have completed initial treatment and are within the first year following treatment are eligible for this study.

Effect of Chemo & Hormone Therapy on Hair, Skin & Nails in Early-Stage Breast Cancer

A Prospective, Longitudinal Study of Chemotherapy-Induced Hair Changes and Alopecia, Skin Aging and Nail Changes in Women With Non-Metastatic Breast Cancer (NCT02530177)

Summary

This study is looking at the effect that chemotherapy and hormone therapy have on the skin, hair and nails of women with early-stage breast cancer. The researchers want to see if there are certain clinical factors or genetic markers that can help predict which women are most likely to develop skin, hair or nail problems. To be eligible, participants must be about to start treatment with chemotherapy or hormone therapy for stage 0-III breast cancer.

Comparing Brain Function in Breast Cancer Survivors & Healthy Women 65 Years and Over

Cognition in Older Breast Cancer Survivors: Treatment Exposure, APOE and Smoking History (NCT02122107)

Summary

Thinking and memory abilities normally decrease with age. Genetics and environmental factors, such as smoking, can affect the brain's chemistry or structure and, in turn, affect brain functioning. Chemotherapy can also affect brain function. To learn more about the impact cancer and its treatments have on brain function, this study is comparing thinking and memory abilities in breast cancer survivors who had chemotherapy, breast cancer survivors who did not have chemotherapy, and healthy women age 65 and over who have not had cancer.

An Online Support Community for Women 60 and Older Receiving Chemotherapy

Improving Support for Older Patients Receiving Neo/Adjuvant Chemotherapy for Breast Cancer Using a Novel Social Media Intervention (NCT02639208)

Summary

Not a lot is known about the side effects and experiences of breast cancer patients age 60 and older receiving chemotherapy. It is known that not having good social support can affect quality of life, mood, and outcomes of people with cancer. This research study will evaluate the level of support provided by PatientsLikeMe (PLM), an on-line community for breast cancer patients receiving chemotherapy. The study will also look at whether PLM helps doctors collect information on chemotherapy-related side effects. To be eligible, participants must be at least 60 years old and have not yet started chemotherapy.

Adherence to Aromatase Inhibitors in HR+ Stage I-III Latina & Other Breast Cancer Patients

Adherence of Hispanic / Latina Breast Cancer - Patients to Adjuvant Aromatase Inhibitors - (AIs) (NCT03144037)

Summary

To take part in this study, you must be a postmenopausal women who is taking an aromatase inhibitor (AI) after surgery to treat HR+ (ER+/PR+) stage I-III breast cancer. This study will help researchers learn more about how well women on AI hormone therapy adhere to their treatment regimen. The researchers are making an effort to recruit Latinas who are being treated at Texas Tech University Health Sciences Center in El Paso for this study, but women of all ethnic groups can take part.

iCaRe2: Integrated Cancer Data Repository for Cancer Research

Integrated Cancer Repository for Cancer Research (NCT02012699)

Summary

This study is open to all women and men who have--or have not--had cancer. To take part in this study, you must be at least 19 years old. Study participants will provide blood, urine and tissue samples for a biobank. These specimens will be used by cancer researchers to learn more about cancer risk factors, cancer prevention, early detection and personalized cancer treatments.

Study of Women 50 and Over Who Get CyberKnife Radiation for DCIS or Stage I Breast Cancer

A Multi-Institutional Registry for CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) (NCT02457117)

Summary

There are different types of radiation therapy women can receive as part of their breast cancer treatment. CK-SAPBI (CyberKnife® Stereotactic Accelerated Partial Breast Irradiation) is a type of radiation therapy that delivers a targeted, high dose of radiation over a short period of time with limited damage to surrounding healthy tissue. Results from early studies suggest CK-SAPBI technique is as safe and effective as traditional whole breast radiation. Researchers are establishing a registry for women who are age 50 and older who have received CK-SAPBI therapy and will follow these women for five years. This registry will allow the researchers to collect information about the effectiveness and cosmetic outcomes seen with CK-SAPBI.

Inflammatory Breast Cancer Registry

Inflammatory Breast Cancer (IBC) Registry (NCT00477100)

Summary

Inflammatory breast cancer is a rare, aggressive type of breast cancer in which the cancer cells block the lymph vessels in the skin, causing the breast to appear red and swollen. Researchers have not yet identified any genes or other risk factors that they could use to design better treatments for inflammatory breast cancer. The goal of this study is to collect blood and tissue samples and clinical data from patients with untreated newly diagnosed inflammatory breast cancer. The samples and data will be stored in a research tissue bank and used to help researchers learn more about inflammatory breast cancer.

The CAROLE Study: Heart Health for Breast Cancer Survivors

The CAROLE (CArdiac Related Oncologic Late Effects) Study (NCT03235427)

Summary

To take part in this study, you must be a breast cancer survivor who was diagnosed at least six years ago and did not have heart disease at the time of your breast cancer diagnosis. You must now be between ages 26 to 78 and you must have had your diagnosis when you were between the ages of 18 and 65. This study will will check the heart health of women who have been treated for breast cancer so that the researchers can learn more about how cancer treatments affect the heart.

Risk Factors Among Mexican-American and African-American Women

Comparative Study of Breast Cancers and Their Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S. (NCT00837499)

Summary

Researchers are interested in learning whether breast cancer risk factors differ among women of different racial or ethnic backgrounds. This observational study is investigating whether breast cancer risk factors such as decreased and delayed fertility, obesity, and low physical activity differ among Mexican-American and African-American women. The researchers are also investigating whether certain biomarkers (substances that can be detected in body fluids or tissue that can detect the presence of a disease or provide information how someone is responding to treatment) can help predict which women are at increased risk of having a breast cancer recurrence or dying from their disease. To be eligible, participants must be Mexican-American or African-American and diagnosed with invasive breast cancer within the past 24 months.

Attitude Changes Toward Physical Activity and Nutrition During Breast Cancer Treatment

Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment (NCT02887196)

Summary

To take part in this study, you must have recently been diagnosed with early stage (stage I-III) breast cancer and be planning to be treated with chemotherapy and/or an anti-estrogen treatment after you have surgery. You must not have already had any breast cancer treatments (other than surgery), and you must be able to visit the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge. In this study, researchers will meet with you after you have had surgery and started chemotherapy and/or anti-estrogen treatment to learn about your physical activity and nutrition habits. The researchers intend to use what they learn to develop physical activity and nutrition programs for breast cancer patients and survivors.

Improving Care of Metastatic Breast Cancer Patients Age 70 and Older

Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient Via a Provider Didactic Intervention (NCT03007641)

Summary

To take part in this study, you must be age 70 or older and currently receiving treatment for metastatic breast cancer. Studies have shown breast cancer patients age 70 and older have unique medical needs. The researchers have developed an education program for oncologists about issues and concerns older metastatic breast cancer patients face. In this study, patients will be treated by oncologists who have completed this education program. This will allow the researchers to see if the education program for oncologists benefits older metastatic breast cancer patients.

Memory Problems During Chemotherapy in Patients with Stage I-III Breast Cancer

Longitudinal Pilot Mechanistic Study of the Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients and Non-Cancer Control Participants (NCT03137095)

Summary

To take part in this study, you must have recently been diagnosed with stage I-III breast cancer and be planning to have chemotherapy as part of your treatment. In this study, researchers will give you cognitive tests during your chemotherapy treatment and one month after you have completed treatment. These tests will help the researchers see if and how your cognitive functioning skills, like memory and concentration, change as you receive chemotherapy. Healthy volunteers will also be enrolled.

A Registry for Patients with a Breast Cancer Genetic Mutation or Triple Negative Tumor

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations (NCT02302742)

Summary

Women and men who carry an inherited genetic mutation are at increased risk of developing breast cancer. BRCA1 and BRCA2 are the most common genetic mutations associated with breast cancer risk. But there are other mutations that also increase breast cancer risk, including PTEN, P53, PALB2, and others. Previous studies have found that individuals with triple-negative breast cancer are likely to carry the BRCA mutation. This registry study will collect cancer-related information from individuals with triple negative breast cancer and/or inherited genetic mutations. The information collected in the registry will be used to learn more about the relationship between genetic mutations and cancer outcomes in individuals with triple negative breast cancer.

Sexual and Reproductive Health Study

Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma (NCT01788839)

Summary

Cancer and its treatment may affect sexual and reproductive health. To help researchers learn more about the problems women face, participants in this study will complete questionnaires on sexuality and pregnancy before, during, and after cancer treatment. The information will be used to help doctors identify which women are most likely to have early menopause or develop sexual problems during cancer therapy, or have difficulty getting pregnant after cancer treatment. To be eligible for this study a woman must be age 50 or younger, newly diagnosed with breast cancer, and planning on having, or within one month of starting, chemotherapy.

A Tool to Help Women Decide Whether to Have a Contralateral Preventative Mastectomy

Decision Making Tool for Contralateral Prophylactic Mastectomy (NCT02918474)

Summary

To take part in this study, you must be seeing a surgeon at MD Anderson Cancer Center and have recently been diagnosed with DCIS or stage I-III breast cancer. This study is evaluating whether an online decision support tool designed for women with DCIS or stage I-III breast cancer helps you and your doctor discuss the option of having a contralateral prophylactic mastectomy (removal of breast that does not have cancer). If you take part in this study, you will be answering a questionnaire about the decision support tool.

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