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 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of Praluzatamab Ravtansine (CX-2009) in Advanced HR-Positive/HER2- Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination with Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer (CTMX-2009-002)

Date Added
September 28th, 2021
PRO Number
Pro00113619
Researcher
Frank Brescia

List of Studies


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

The purpose of this study is to understand if CX-2009 when given by itself to participants with advanced breast cancer is safe and has anti-tumor activity. CX-2009 will be combined with CX-072 to understand if the combination of these two drugs is safe and has anti-tumor activity in participants with advanced triple negative breast cancer.

Institution
MUSC
Recruitment Contact
HCC Clinical Trails Office
843-792-9321
hcc-clinical-trials@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

Prospective validation trial of taxane therapy (docetaxel or weekly paclitaxel) and risk of chemotherapy-induced peripheral neuropathy in African American women

Date Added
November 19th, 2019
PRO Number
Pro00094547
Researcher
Frank Brescia

List of Studies


Keywords
Cancer/Breast
Summary

The purpose of this study is to determine which routine course of treatment, docetaxel or paclitaxel, will result in less servere nerve damage known as peripheral neuropathy for African-American women with breast cancer.

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 Phase lb Study of ASPl948, Targeting an Immune Modulatory Receptor, as a Single Agent and in Combination with a PD-I inhibitor (Nivolumab or Pembrolizumab) in Subjects with Advanced Solid Tumors

Date Added
July 23rd, 2019
PRO Number
Pro00087949
Researcher
John Wrangle

List of Studies


Keywords
Cancer, Cancer/Breast, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung
Summary

This is a research study to find out if the study drug (ASP1948 or ASP1948 plus nivolumab or pembrolizumab) is safe and to determine the safest, most effective dose of the drug. When the safe dose is identified, it will be used to evaluate if the study treatment causes tumors to shrink in patients. During this study, the study drug will be continuously assessed to determine if it is safe and tolerated by patients taking it. The following adverse events have been reported in more than 10% of patients: fatigue, abdominal pain, decreased appetite, back pain, dyspnea (difficulty breathing), hyponatraemia (low sodium levels), anemia (low red cell count), and constipation. Since these events may occur in patients not taking ASP1948 and since there have been no clinical trials comparing patients taking ASP1948 with those not taking ASP1948, it is difficult to know at this time whether they were caused by ASP1948.

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



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