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

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

List of Studies

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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 1b Study of ASP1948, Targeting an Immune Modulatory Receptor, as a Single Agent and in Combination with Nivolumab in Subjects with Advanced Solid Tumors Save

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

List of Studies

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

The purpose of this study is to determine at what dose the study drug (ASP1948) is safe and tolerated and how it is processed in the blood of patients with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. When the safe dose is identified, it will be used to evaluate if the study treatment causes tumors to shrink in patients.The screening period for this study can take up to 28 days. The treatment period consists of up to 48 weeks of initial treatment, followed by up to 45 weeks of follow up. If you quality and are willing to continue in the re-treatment period (receiving the study drug again), you will be in the study for an additional 48 weeks.

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

A Phase 1 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Save

Date Added
July 23rd, 2019
PRO Number
Pro00088438
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lung, Cancer/Skin
Summary

The study will have 2 parts (Part A and Part B). Part A of this research study (the dose escalation phase) will test the safety and effectiveness of the different doses of ALKS 4230 (study drug) to find the one that is the safest and most effective. Part B of this study (the dose expansion phase) will use the safe dosing determined in Part A to see how effectively the combination of ALKS 4230 and pembrolizumab treats your solid tumors.LKS 4230 is an investigational (experimental) drug; this means that is has not been approved by the US Food and Drug Administration (FDA) to treat your disease. This is an open-label study which means that all subjects will be taking the active study drugs.You can be in the study for as long as it is clinically beneficial to you.

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

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer Save

Date Added
June 21st, 2019
PRO Number
Pro00090038
Researcher
Antonio Giordano

List of Studies

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Keywords
Cancer/Breast
Summary

This study is for patients with HER2-positive breast cancer that has metastasized. The study is being done to see if the patient's breast cancer can be stabilized and the time that the patient lives with this breast cancer can be lengthened by adding a new drug to the usual combination of drugs.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@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) Save

Date Added
May 30th, 2019
PRO Number
Pro00086999
Researcher
Antonio Giordano

List of Studies

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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

INCREASING SOCIOECONOMICALLY DISADVANTAGED PATIENTS' ENGAGEMENT IN BREAST CANCER SURGERY DECISIONMAKING THROUGH A SHARED DECISION MAKING INTERVENTION Save

Date Added
April 10th, 2019
PRO Number
Pro00087587
Researcher
Andrea Abbott

List of Studies

Silhouette
Keywords
Cancer/Breast
Summary

This study is for breast cancer patients who are making decisions about breast cancer surgery. This study is being done to learn about how patients and their surgeons make decisions about breast cancer surgery.

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

PHASE III PLACEBO-CONTROLLED TRIAL TO EVALUATE DEXAMETHASONE USE FOR EVEROLIMUS INDUCED ORAL STOMATITIS: PREVENTION VERSUS EARLY TREATMENT APPROACHES Save

Date Added
March 19th, 2019
PRO Number
Pro00087480
Researcher
Antonio Giordano

List of Studies

Silhouette
Keywords
Cancer/Breast
Summary

This study is for subjects who have been diagnosed with cancer and will be receiving a drug called everolimus as part of your usual care. The purpose of this study is to see if treating patients with dexamethasone mouthwash at the start of cancer treatment will lower the chance of getting painful mouth sores.

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

A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer Save

Date Added
March 4th, 2019
PRO Number
Pro00086652
Researcher
Frank Brescia

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Breast
Summary

This study is for patients who are 70 years old or over and have been recently diagnosed with estrogen receptor positive, HER2 negative metastatic breast cancer. The purpose of this study is to find out the side effects that the standard, FDA-approved combination treatment of letrozole or fulvestrant and palbociclib has on patients 70 years old and over.

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

A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy, Then in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer Save

Date Added
January 22nd, 2019
PRO Number
Pro00084301
Researcher
Antonio Giordano

List of Studies

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

This is an open-label, nonrandomized, dose escalation and dose expansion, safety, efficacy, PK and PD evaluation study of SAR439859 administered orally as monotherapy, then in combination with palbociclib. The study will last approximately 26 months, and participation in the study may last 4 to 8 weeks or longer. The length of participation in this study will depend on how well subjects tolerate the study drug and the condition of their disease.

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

Stress Reactivity among African American Breast Cancer Survivors Save

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

List of Studies


Profiles_link
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

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