ELACESTRANT MONOTHERAPY VS. STANDARD OF CARE FOR THE TREATMENT OF PATIENTS WITH ER+/HER2- ADVANCED BREAST CANCER FOLLOWING CDK4/6 INHIBITOR THERAPY: A PHASE 3 RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER TRIAL(EMERALD) Save

Date Added
January 30th, 2020
PRO Number
Pro00094418
Researcher
Antonio Giordano

List of Studies

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

Patients are being asked to take part in this research study because they have estrogen receptor positive (ER+), human epidermal growth factor negative (HER2-) advanced breast cancer. Researchers want to find out if an investigational drug called elacestrant, also known as RAD1901, can help people with their type of advanced breast cancer.

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 Save

Date Added
November 19th, 2019
PRO Number
Pro00094547
Researcher
Antonio Giordano

List of Studies

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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 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

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

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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 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

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