MEPITEL FILM FOR THE REDUCTION OF RADIATION DERMATITIS IN BREAST CANCER PATIENTS UNDERGOING POST-MASTECTOMY RADIATION THERAPY: A RANDOMIZED PHASE III CLINICAL TRIAL

Date Added
August 15th, 2022
PRO Number
Pro00122724
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer/Breast
Summary

This study is for patients who have been diagnosed with breast cancer and their doctor has recommended that they receive radiation therapy after their mastectomy to reduce the risk of their breast cancer coming back. This study is being done to see if the severity of skin redness and peeling in the area of radiation can be reduced by applying Mepitel Film during radiation therapy.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

Date Added
May 10th, 2022
PRO Number
Pro00119953
Researcher
Theodore Gourdin

List of Studies


Keywords
Bladder, Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Prostate, Women's Health
Summary

This study is for patients that have already received standard treatments for their cancer and their cancer has gotten worse or returned after their last treatment. The purpose of this study is to learn about the effects of the study drug XL092 when given alone, in combination with atezolizumab, and in combination with avelumab by testing its safety, the ability of your body to accept the drug(s), to measure the drug(s) and/or its break-down products levels in your blood, and how your body reacts to the drug(s). This research study will be the first time XL092 alone or in combination with atezolizumab will be given to people. The study drugs in this research have not been approved by the United States Food and Drug Administration (FDA). There are two parts in this study, a Dose Escalation part and a Cohort Expansion part. The first part of the study was the Dose Escalation phase, when different participants were given different doses of the study drug until the safest, most effective dose was found; this part of the study has been completed. The study is now enrolling to the Cohort Expansion part of this study, where the dose that has been determined to be safe will be given to more participants with different types of cancer. The Dose Escalation part of this study has stopped and the safe dose has been found. This study is now enrolling to the Cohort Expansion part of this study, where the safe dose of the study drug found in the Dose Escalation part will be given to more participants with different types of cancer. Participants will either be assigned to the treatment group that will receive XL092 alone or the treatment group that XL092 in combination with atezolizumab. Which treatment group they are assigned depends on the type of cancer they have. TXL092 is in tablet form taken by mouth. Avelumab will be given as an intravenous (IV) infusion once every 2 weeks at the study site. Atezolizumab will be given as an intravenous (IV) infusion once every 3 weeks at the study site. Total study duration is expected to be about 6 months but participants could be in the study for up to 2 years.

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

Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Date Added
February 16th, 2022
PRO Number
Pro00115036
Researcher
Gilbert Bader

List of Studies

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

This study is for subjects that have been diagnosed with HR+, HER2-negative breast cancer while still being in a premenopausal hormone status (i.e. females with active ovaries that produce hormones that cause menstrual cycles (even if they are not regular). The investigational drug that will be used is TOL2506. The drug will be given as an injection. The study is to assess suppression of ovarian function
following administration of TOL2506 in premenopausal subjects with HR+, HER2-negative breast cancer. Participants can expect to be in this study for 24 months.

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

KEEP IT (Keeping Each Other Engaged via IT): An Innovative Digital Literacy Training Program for Community Health Workers about Hereditary Breast and Ovarian Cancer among Black Women

Date Added
January 13th, 2022
PRO Number
Pro00116925
Researcher
Caitlin Allen

List of Studies


Keywords
Cancer/Breast, Genetics
Summary

The purpose of this study is to develop, deliver, and evaluate the KEEP IT (Keep Each Other Engaged via IT) CHW Training to increase resources and support for identifying Black women at risk for hereditary breast and ovarian cancer (HBOC). My goals are to conduct focus groups with community health workers to identify topics of interest for the initial curriculum, use a three-round Delphi process to refine and finalize an educational curriculum for CHWs focused on building trainee's digital health literacy to enhance identification and navigation of Black women at high-risk for HBOC, and to use implementation science methods to deliver and evaluate the educational training program consisting of a 1.5-day virtual workshop followed by five online modules.

Aim 1: Conduct focus groups with up to 10 community health workers to explore the topics that need to be covered as part of the KEEP IT training.

Aim 2: Use a three-round Delphi process to refine and finalize an educational curriculum for CHWs focused on building trainee's digital health literacy to enhance identification and navigation of Black women at high-risk for HBOC

Aim 3: Use implementation science methods to deliver and evaluate the educational training program consisting of a 1.5-day virtual workshop followed by five online modules

Institution
MUSC
Recruitment Contact
Caitlin Allen
873-792-4216
allencat@musc.edu

A PHASE III CLINICAL TRIAL EVALUATING DEESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I, HORMONE SENSITIVE, HER2-NEGATIVE, ONCOTYPE RECURRENCE SCORE ≤ 18 BREAST CANCER

Date Added
August 29th, 2021
PRO Number
Pro00113932
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Breast
Summary

This study is for men and women with breast cancer. The purpose of this study is to compare the usual treatment of breast radiation and hormonal drugs after lumpectomy to using hormonal drugs alone.

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

Pilot study of group video Yogic breathing app in breast cancer survivors

Date Added
August 25th, 2021
PRO Number
Pro00108511
Researcher
Jennifer Harper

List of Studies


Keywords
Breathing, Cancer, Cancer/Breast
Summary

Cancer survivorship is associated with many long-term chronic health issues that arise as a result of cancer
treatment protocols. Non-pharmacological lifestyle and mind-body interventions have been shown to be
effective and critical components of a total-health strategy for cancer survivors. PranaScience Institute seeks to
develop and test a novel group video app for home-based delivery of a Yogic Breathing intervention that
reduces symptoms of cancer treatment survival and supports total-health.

Institution
MUSC
Recruitment Contact
Emily Richardson
(843) 792- 8352
richaemi@musc.edu

Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Date Added
January 19th, 2021
PRO Number
Pro00106552
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer/Breast
Summary

This study is for patients who have low risk breast cancer as indicated by their Oncotype DX Recurrence Score. The purpose of this study is to compare any good and bad effects of not giving regional radiotherapy to using regional radiotherapy.

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

FDG PET to Assess Therapeutic Response in Patients With Bone-Dominant Metastatic Breast Cancer, FEATURE

Date Added
December 22nd, 2020
PRO Number
Pro00106499
Researcher
Frank Brescia

List of Studies


Keywords
Cancer/Breast
Summary

This study is for patients with metastatic breast cancerDoctors are doing this study because they want to find out if FDG-PET/CT imaging is better or worse than the usual approach for monitoring metastatic breast cancer, which is in the bone or mostly in the bone.

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

A "Window Trial" on Curcumin, the Active Compound in Turmeric, for Invasive Breast Cancer Primary Tumors

Date Added
September 17th, 2019
PRO Number
Pro00087179
Researcher
Nancy DeMore

List of Studies


Keywords
Cancer, Cancer/Breast
Summary

This study will assess the safety and toxicity of oral Curcuma longa extract (Curcumin) in patients with breast cancer.
The overall goal of this study is to see if taking BCM-95 (curcumin) will change the make up of the tumors of patients who have breast cancer. BCM-95 is a supplement made from the curcumin plant, which helps to reduce inflammation in the body. BCM-95 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

A Randomized, Double-Blind, Phase III Study of Pembrolizumab versus Placebo in Combination with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2–) Breast Cancer (KEYNOTE-756)

Date Added
May 30th, 2019
PRO Number
Pro00086999
Researcher
Frank Brescia

List of Studies


Keywords
Cancer/Breast, Men's Health, Women's Health
Summary

The purpose of the study is to test the safety and effectiveness of the study drug, pembrolizumab (MK-3475) with certain types of chemotherapy and endocrine therapy, as well as, to see how well the subject's body handles the study drug.
If subject's meet the criteria, they will be assigned to 1 of 2 groups by chance, similar to flipping a coin, in order to decide which study treatment they will receive. Group A will receive the study drug, pembrolizumab, with certain types of chemotherapy and endocrine therapy. Group B will receive placebo, with certain types of chemotherapy and endocrine therapy. Pembrolizumab or placebo will be given by vein about once every 3 weeks.
This is a long-term study, if subject's agree to participate, they will be in the study for approximately 12 years.

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



-- OR --