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

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
Antonio Giordano

List of Studies

Silhouette
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

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

List of Studies

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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

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of EVEROLIMUS in Patients with High-Risk, Hormone Receptor-Positive AND HER2/neu Negative Breast Cancer Save

Date Added
January 16th, 2013
PRO Number
Pro00022260
Researcher
Sara Giordano

List of Studies

Silhouette
Keywords
Cancer, Cancer/Breast
Summary

This study is for women or men with hormone responsive breast cancer that has already been removed by surgery and have completed any required chemotherapy or radiation. The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for breast cancer patients. In this study subjects will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.
It is expected that subjects will be enrolled in this study for approximately 54 weeks or until side effects become too great, or until cancer returns. After subjects are finished with study treatment, they will return to the clinic every six months for the first 2 years and then yearly for the next 10 years.

Institution
MUSC
Recruitment Contact
Marietta Gustilo
843-792-2584
gustilom@musc.edu

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