Stress Reactivity among African American Breast Cancer Survivors Save

Date Added
October 19th, 2018
PRO Number
Pro00060958
Researcher
Chanita Hughes-halbert

Silhouette
Keywords
Cancer/Breast, Inflammation, Minorities
Summary

Outcomes following a breast cancer diagnosis are different by race and ethnicity with African American women having poorer survival compared to Caucasian women. Research has shown that differences in personal health factors can contribute to breast cancer outcomes and explain racial differences. This study will examine how personal-level factors relating to biological, psychological, and physiological issues play a role in outcomes among African American breast cancer survivors.

Institution
MUSC
Recruitment Contact
Melanie Jefferson
843-876-2430
sweatma@musc.edu

Evaluation of Mammographic Breast Density Effect of Aspirin: A Companion to Alliance Study A011502 Save

Date Added
October 18th, 2018
PRO Number
Pro00082693
Researcher
Frank Brescia

Silhouette
Keywords
Cancer/Breast
Summary

This study is for patients with breast cancer who have enrolled or are planning to enroll to the Alliance study A011502, "Aspirin for Breast Cancer Study" (or ABC study).

Institution
MUSC
Recruitment Contact
Nancy McGaha
(864) 725-5105
nmcgaha@selfregional.org

Breast Cancer Survivors' Unmet Needs After Completion of Radiation Treatment Save

Date Added
June 11th, 2018
PRO Number
Pro00068596
Researcher
Michelle Pembroke
Keywords
Cancer/Breast
Summary

Many breast cancer patients experience emotional, physical, psychological and financial issues after treatment ends. Very few studies have explored the unmet needs of breast cancer patients after the completion of radiation treatment. The patient reported findings from this qualitative study will guide a survivorship education program designed to better meet the needs of breast cancer patients.

Institution
MUSC
Recruitment Contact
Michelle Pembroke
904-588-1459
brennami@musc.edu

PHASE III RANDOMIZED TRIAL OF HYPOFRACTIONATED POST MASTECTOMY RADIATION WITH BREAST RECONSTRUCTION Save

Date Added
March 20th, 2018
PRO Number
Pro00076282
Researcher
Jennifer Harper

Silhouette
Keywords
Cancer/Breast
Summary

This study is for patients who have been diagnosed with stage 2 or stage 3 breast cancer and their doctor has recommended that they receive radiation therapy after mastectomy to prevent your breast cancer from coming back. The purpose of this study is to determine whether a short-course radiation therapy option (3 to 4 weeks) after mastectomy is as safe and effective in the setting of breast reconstruction as the usual 5 to 6 week treatment course.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

COMPARISON OF OPERATIVE TO MONITORING AND ENDOCRINE THERAPY (COMET) TRIAL FOR LOW RISK DCIS: A PHASE III PROSPECTIVE RANDOMIZED TRIAL Save

Date Added
October 17th, 2017
PRO Number
Pro00065794
Researcher
Nancy Demore

Silhouette
Keywords
Cancer/Breast
Summary

This study looks at the risks and benefits of the "usual approach" (a combination of surgery, radiation and/or hormonal therapy) compared to the close monitoring approach (meaning the condition is watched with follow-up exams and tests such as mammograms, breast ultrasounds, and breast MRI). This study is being conducted because researchers wish to know whether, after 2 years, clinical and quality of life outcomes for women with low risk DCIS who receive usual treatment are the same as those for women with low risk DCIS who receive close monitoring.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clincal-trials@musc.edu

A "Window Trial" On Boswellia, An Extract From Frankincense, For Breast Cancer and Colon Cancer Primary Tumors Save

Date Added
June 20th, 2017
PRO Number
Pro00067127
Researcher
Nancy Demore

Silhouette
Keywords
Cancer/Breast, Cancer/Gastrointestinal
Summary

The overall goal of this study is to see if taking BosPure (boswellia serrata) will change the make up of the tumors of patients who have breast and colon cancer. BosPure is a supplement made from the boswellia serrata plant, which helps to reduce inflammation in the body. BosPure is not approved by the United State Food and Drug Administration (FDA) for the treatment of your disease.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-cto-clinops@musc.edu

Pilot Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in ER+, Metastatic Breast Cancer Patients Receiving Endocrine Therapy Save

Date Added
February 21st, 2017
PRO Number
Pro00062663
Researcher
Carolyn Britten

Silhouette
Keywords
Cancer/Breast
Summary

The purpose of this study is to identify safe pharmaceutical agents that can reduce the AGE levels in subjects with advanced cancer. The term "AGE" (advanced glycation endpoints) refers to sugar-derived metabolites that are linked to lifestyle choices and can contribute to cancer.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-cto-clinops@musc.edu

Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB) Save

Date Added
May 24th, 2016
PRO Number
Pro00054909
Researcher
Sara Giordano

Silhouette
Keywords
Cancer, Cancer/Breast, Drug Studies, Women's Health
Summary

The purpose of this study is to test study treatments that combine an investigational drug (ONT-380) with two approved drugs (capecitabine and trastuzumab) in subjects with advanced breast cancer to find out what effects, good or bad, it may have on you and your disease.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

URCC 14040: A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral therapy for Treating Insomnia in Cancer Survivors Save

Date Added
March 15th, 2016
PRO Number
Pro00053106
Researcher
Jeffrey Giguere
Keywords
Cancer, Cancer/Brain, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Leukemia, Cancer/Lung, Cancer/Lymphoma, Cancer/Myeloma, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Education, Exercise, Sleep Disorders
Summary

This research study is for patients who have completed all scheduled surgery, chemotherapy and/or radiation therapy for their cancer within the last 6-12 months and are currently having some type of sleep disturbance. While there is no standard treatment for sleep disturbance for cancer survivors, people who do not take part in this study may take over-the-counter or prescription medications, receive cognitive behavioral therapy, or exercise as a means of attempting to manage their sleep problems.

Sleep disturbance, particularly insomnia, is a common problem for cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than you would like. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as your biological clock) to be disrupted and decrease quality of life.

Because there is no ideal standard of care for effectively treating sleep problems in cancer survivors, the purpose of this study is to compare the effectiveness of three different treatments for improving sleep problems and determine which is best. The three treatments are yoga, survivorship health education, and cognitive behavioral therapy (CBT-I).

Study participation will be approximately 8 months.

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
gnorris@ghs.org

A211102, Testing for Atypia in Random Periareolar Fine Needle Aspiration (RPFNA) Cytology after 12 months Metformin (1, 1-Dimethylbiguanide Hydrochloride) Chemoprevention versus Placebo Control in Premenopausal Women Save

Date Added
April 21st, 2015
PRO Number
Pro00043305
Researcher
Jeffrey Giguere
Keywords
Cancer, Cancer/Breast, Women's Health
Summary

This study is for females, ages 25-55, who have tested positive for atypia (early cell changes that are thought to be a marker of breast cancer risk) in the breast, and are considered high risk for the development of breast cancer in the future.

The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (marker of breast cancer risk) in women at increased risk for breast cancer. This study will test for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study sponsor would like to compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better. In this study, patients will get either metformin or a placebo (an inactive product) for the first twelve months. After the first twelve months, women who received placebo during the first twelve months can choose to receive metformin for the second year.

Note: The standard drug used for the "breast cancer prevention" is tamoxifen. If you are eligible to take tamoxifen, you must be offered tamoxifen prevention as part of your clinical care and you must have refused tamoxifen treatment to be on this study. Metformin and tamoxifen are not similar and function differently. This study is not investigating the use of tamoxifen.

While on this research study patients will have the Random Periareolar Fine Needle Aspiration (RPFNA) of their breasts to test for atypia (marker of breast cancer risk), before the study starts, and also at 12 and 24 months (24 month optional for placebo-only group for patients who remain on placebo arm and will not receive metformin) after the study starts. If the pathologist does not identify atypia in the samples you will not be able to participate. You will also provide blood during this study to determine if changes in your blood are related to changes in your breasts. You will need to provide a little less than 4 tablespoons of blood for this research study.

Study participation will last for 48 months (2 years).

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
gnorris@ghs.org

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