A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial of DS-8201a, An Anti-HER2-Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HRpositive, HER2-Low Expressing, Unresectable and/or Metastatic Breast Cancer Subjects

Date Added
February 25th, 2020
PRO Number
Pro00090546
Researcher
Frank Brescia

List of Studies

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

You are being invited to take part in this research study, because you have a certain type of breast cancer called HER2 (Human Epidermal Growth Factor Receptor 2)-low expressing breast cancer that has spread and/or cannot be completely removed by surgery. The main purpose of this study is to gather information about an experimental drug, DS-8201 a, that may help to treat your disease, as well as, compare it to other standard or "comparator" treatments.

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

Date Added
June 21st, 2019
PRO Number
Pro00090038
Researcher
Frank Brescia

List of Studies

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 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

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

List of Studies

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

Evaluation of Mammographic Breast Density Effect of Aspirin: A Companion to Alliance Study A011502

Date Added
October 18th, 2018
PRO Number
Pro00082693
Researcher
Frank Brescia

List of Studies

Keywords
Cancer/Breast
Summary

This study is for patients with breast cancer who have enrolled or are planning to enroll to the Alliance study A011502, "Aspirin for Breast Cancer Study" (or ABC study).

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

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

Date Added
January 16th, 2013
PRO Number
Pro00022260
Researcher
Frank Brescia

List of Studies

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

A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

Date Added
August 7th, 2012
PRO Number
Pro00017993
Researcher
Frank Brescia

List of Studies

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

This study is being done for the following reasons:
•This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating your type of breast cancer. All of these drugs are used in standard combinations of chemotherapy for breast cancer.
•The researchers also want to learn about the side effects of the combinations of drugs used in this study. Side effect information will also be studied to see if there are any differences between the two-drug and three-drug chemotherapy combinations.
•In order to learn more about cancer tumors, this study includes special research tests that will be done on tumor tissue that was removed during your breast cancer surgery. Information about this study requirement will be explained to you in more detail later in this consent form.

Institution
MUSC
Recruitment Contact
Katherine Halloran
843-792-7035
halloran@musc.edu



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