Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias Save

Date Added
July 31st, 2017
PRO Number
Pro00056235
Researcher
Steven Corso
Keywords
Cancer/Breast, Drug Studies, Joint, Pain
Summary

It is well known that treatment with an aromatase inhibitor (AI) can cause side effects that result in symptoms such as joint pain and stiffness, which can interfere with activities of daily living. In some patients, the treatment has to be stopped because of these symptoms.

The purpose of this study is to compare the effects, good and/or bad, of the study agent, testosterone, with a placebo (an inactive agent) on joint pain caused by taking aromatase inhibitors. The testosterone/placebo is a gel that will be applied to the body in non-fat pad areas. In this study, patients will receive either the testosterone or placebo. They will not receive both.

The study agent, testosterone, used in this study is considered investigational, which means it has not been approved by the Food and Drug Administration (FDA) for routine clinical use. However, the FDA has allowed the use of this agent for this research study.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

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
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
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

A Pragmatic Trial to Evaluate a Guideline-Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia ?Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) Save

Date Added
November 16th, 2016
PRO Number
Pro00061360
Researcher
James Bearden
Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lung
Summary

Some drugs used to treat cancer raise a patient?s risk of febrile neutropenia. Febrile neutropenia is a condition that involves a fever and a low number of neutrophils (a type of white blood cell) in the blood. Having a low number of neutrophils puts a patient at risk of infection. Colony-stimulating factors (CSFs) are medications sometimes given to patients getting cancer treatment to prevent or treat febrile neutropenia. CSFs are given as an injection under the skin or into a vein.

Current guidelines say that doctors should give CSF during cancer treatment based on how likely it is that the drugs will raise the risk of febrile neutropenia. Research shows that many doctors do not follow these guidelines. This may be harming patients. Underuse of CSFs can raise a patient's risk for febrile neutropenia. Overuse or unneeded use of CSFs can lead to side effects, like bone and muscle pain, but give no benefit and can be costly to the patient.

In some clinics there is an automated system that helps doctors decide when to use CSFs. The system prescribes CSFs when there is a high risk that the drugs will cause febrile neutropenia. It does not prescribe CSFs when there is a low risk that the drugs will cause febrile neutropenia. The research study team wants to find out if this type of system can help doctors use CSF when it is needed and not use it when it is not needed. The study team also wants to learn about the benefits and risks of using CSF with cancer treatment drugs that have a moderate (not high and not low) risk of febrile neutropenia.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

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
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

The Impact of False Positive Mammography Results on Breast Cancer Screening Intention in Black Women Save

Date Added
February 22nd, 2016
PRO Number
Pro00049656
Researcher
Deeonna Farr
Keywords
Cancer/Breast, Ethnicity and Disease, Healthy Volunteer Studies, Minorities, Women's Health
Summary

The purpose of this project is to understand how characteristics of mammography facilities, mammography providers, and individual patients influence Black women?s experiences receiving an initial abnormal mammography is determined to be non-cancerous (false positive result). Observations, recordings, surveys and interviews will be used to collect information regarding the various influences on Black women?s experience with a false positive mammography result and their intentions to complete future screening mammograms.

Institution
Palmetto
Recruitment Contact
Deeonna Farr
803-777-7641
farrde@email.sc.edu

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

A Multistage, Phase II Study Evaluating the Safety and Efficacy of Cobimetinib Plus Paclitaxel, Cobimetinib plus Atezolizumab plus Paclitaxel, or Cobimetinib plus Atezolizumab plus NAB-Paclitaxel as First-Line Treatment for Patients with Metastatic Triple-Negative Breast Cancer Save

Date Added
April 14th, 2015
PRO Number
Pro00041847
Researcher
Sara Giordano
Keywords
Cancer, Cancer/Breast
Summary

This study is for patients who have been diagnosed with metastatic triple-negative breast cancer. The investigational drugs in this study are cobimentinib in combination with paclitaxel. The purpose of this study is to estimate the clinical benefit of cobimetinib and paclitaxel relative to placebo and paclitaxel, as
measured by investigator-assessed progression-free survival (PFS). The study will be conducted in two stages. The first stage is a safety run-in stage, which is designed as an early test of the combination of cobimetinib and paclitaxel. In this stage the combination will be given to approximately 12 subjects to evaluate any side effects of the combination. The second stage is the expansion stage where approximately 100 subjects will be given either cobimetinib paclitaxel or placebo paclitaxel (placebo is an inactive substance that looks like cobimetinib). Participants can expect to be in this study for approximately 12 months.

Institution
MUSC
Recruitment Contact
Jean Dangerfield
843-792-9321
dangerfj@musc.edu

Pro00040590: Peers Promoting Exercise Adoption and Maintenance among Cancer Survivors Save

Date Added
March 2nd, 2015
PRO Number
Pro00040590
Researcher
Bernardine Pinto
Keywords
Cancer/Breast, Exercise, Stage I, Stage II, Stage III
Summary

Exercise adoption enhances well-being and recovery from breast cancer. In two previous studies, we have trained community volunteers with the American Cancer Society to provide exercise counseling for breast cancer survivors and the survivors increased their exercise in the short-term (R01 CA132854). This randomized controlled study examines the effects of three maintenance conditions following the 3-month exercise counseling provided by the community volunteers on exercise participation among breast cancer patients at longer follow-ups.
To begin, all study participants (n=150) will receive a 3-month telephone-based exercise program from Reach to Recovery (RTR) volunteers at the American Cancer Society. This will be followed by three maintenance programs during Months 4-9: Reach Plus (participants will receive exercise logs and feedback reports), Reach Plus Phone (monthly counseling calls from coaches, exercise logs and feedback reports) and 3) Reach Plus Messages (monthly email/text messages, exercise logs and feedback reports).
We will enroll 150 women who have completed treatment for breast cancer and assess their exercise behavior, fatigue, quality of life, and mood at baseline (before the 3 month exercise program), 3, 6, 9 and 12 months. The costs and effectiveness of the three groups will be examined to help guide future dissemination of this peer mentoring approach in community-based organizations to enhance cancer survivorship.

Institution
Palmetto
Recruitment Contact
Bernardine Pinto
803-777-9272
pintob@mailbox.sc.edu

ECOG E1Z11: A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS) Save

Date Added
January 21st, 2014
PRO Number
Pro00031246
Researcher
Joanna Metzner-sadurski
Keywords
Cancer, Cancer/Breast
Summary

Many women being treated for breast cancer are treated with drugs known as aromatase inhibitors, which stop the production of estrogen in post-menopausal women. Women taking these drugs often report muscle and joint aches. This is referred to as Aromatase Inhibitor Musculoskeletal Symptoms, or "AIMSS." The reasons for these muscle and joint pains are not known. This study is being conducted to determine the good and/or bad effects of an aromatase inhibitor known as anastrazole on post-menopausal women being treated for breast cancer, and whether their genes can help explain how anastrazole affects the body. The study also hopes to look at how the side efffects from hormone therapy influence patients' quality of life and willingness to continue hormonal treatment.

Institution
MUSC
Recruitment Contact
Kelly Hawthorne
864-725-7129
khawthorne@selfregional.org

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