A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score ≤ 25 (OFSET)

Date Added
April 2nd, 2024
PRO Number
Pro00134426
Researcher
Frank Brescia

List of Studies


Keywords
Cancer, Cancer/Breast, Drug Studies
Summary

This study is for patients with invasive breast cancer among premenopausal, early-stage breast cancer with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 and 0-25. The study is being done to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive disease-free survival (IDFS) among premenopausal patients. The drug being used in this study are aromatase inhibitors. Patients will expect to remain in the study for up to 5years.

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

Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

Date Added
March 5th, 2024
PRO Number
Pro00134455
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Cancer/Breast, Drug Studies
Summary

This study is for patients that have been diagnosed with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III breast cancer. The drug being used Durvalumab, Cyclophospharmide, Doxorubicin, and Paclitaxel. The study is being done to compare breast cancer event-free survival between patients randomized to standard of care neoadjuvant chamotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab. Patients are expected to be in the study for XXmonths.

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

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physicians Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Date Added
March 1st, 2024
PRO Number
Pro00134328
Researcher
Frank Brescia

List of Studies


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

The study is for patients that have been diagnosed with TNBC (Triple Negative Breast Cancer). The treatment drugs being utilized are sacituzumab govitecan (Trodelvy) and pembrolizumab (Keytruda). The main purpose of this study is to determine if the combination of sacituzumab govitecan and pembrolizumab can improve outcomes and delay the return of disease in subjects with high-risk early TNBC. Subjects can expect to be in this study for up to 18 months.

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

OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

Date Added
February 5th, 2024
PRO Number
Pro00133826
Researcher
Frank Brescia

List of Studies


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

This study for subjects that have been diagnosed with triple negative breast cancer (TNBC) and have recently completed preoperative chemotherapy in combination with pembrolizumab, followed by breast surgery. The subjects are expected to be in this study for up to 60 months.

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

Double-blind randomized controlled trial comparing Suvorexant 20 mg to placebo for treatment of insomnia in cancer survivors

Date Added
November 14th, 2023
PRO Number
Pro00130637
Researcher
Sarah Marrison

List of Studies


Keywords
Cancer/Breast
Summary

The proposed research study evaluates the potential of an oral FDA-approved medication, suvorexant, as compared with a placebo control to improve symptoms of sleep disturbance and insomnia in breast cancer survivors currently on hormonal based therapies. Eligible participants will randomly be selected to receive either the suvorexant or a placebo control for a duration of 4 Weeks. Participation in the study will include a screening process for eligibility including information on medical history and surveys regarding symptoms at the start of the study and additionally at 2 and 4 weeks. Potential benefits include improved sleep for individuals randomized to the study medication and potential study risks include loss of confidentiality of health information and a risk of sedation and complex sleep behaviors associated with the medication, suvorexant.

Institution
MUSC
Recruitment Contact
Mattie Banks
856-876-2926
banksmat@musc.edu

A Phase III, Multicenter, Open-label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor-positive/HER2-negative/HER2-Enriched Breast Cancer - HARMONIA Trial

Date Added
August 2nd, 2023
PRO Number
Pro00128890
Researcher
Frank Brescia

List of Studies


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

The study is for patients that have been diagnosed with with a certain type of breast cancer, characterized as HER2 (Human Epidermal Growth Factor Receptor 2)-negative and hormonal receptor (HR)-positive, and with a specific characteristic (molecular subtype) called HeER2-Enriched. The investigational drugs used in this study are Ribociclib and Palbociclib. The main purpose of this study is to learn determine if participants with the specific HER2-Enriched subtype will have delayed progression of the disease when treated with ribociclib compared to palbociclib. Participants can expect to be in this study for up to 5 years.

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

A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer" (HERO)

Date Added
May 17th, 2023
PRO Number
Pro00128928
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Breast
Summary

This study is for people with low-risk HER-2 positive breast cancer. The study is being done to see if treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients who have had surgery, chemotherapy, and HER2-targeted therapy.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-7929321
hcc-clinical-trials@musc.edu

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer.

Date Added
October 20th, 2022
PRO Number
Pro00124481
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Breast
Summary

This study is for women with inflammatory breast cancer. This study is being done to see if by adding the drug olaparib to the usual radiation therapy will lower the chance of their cancer returning.

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

Mental Fatigue and Self-Care in Informal Oncology Caregivers: A Descriptive Mixed Methods Study

Date Added
October 7th, 2022
PRO Number
Pro00122174
Researcher
Megan Wayne

List of Studies

Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Mental Health, Non-interventional
Summary

This study is for anyone 18 years or older who provides unpaid care for a loved one living with cancer outside of the hospital setting. The purpose of this study is to help future caregivers and patients by learning how mental fatigue affects caregivers of persons living with cancer and determine if mental fatigue, participating in self-care activities, and general caregiver quality of life are related. Informal caregivers will be invited to complete a confidential, online survey that takes between 25 and 35 minutes to finish. Caregivers who complete the survey may be contacted and asked to participate in a 45-60 minute follow up interview either online or via phone if they are interested. The results of this study will help guide future research to identify ways healthcare professionals can help caregivers handle the stresses of caregiving and provide the best care possible to their loved ones at home.

Institution
MUSC
Recruitment Contact
Megan Wayne
8433070366
wayneme@musc.edu

MEPITEL FILM FOR THE REDUCTION OF RADIATION DERMATITIS IN BREAST CANCER PATIENTS UNDERGOING POST-MASTECTOMY RADIATION THERAPY: A RANDOMIZED PHASE III CLINICAL TRIAL

Date Added
August 15th, 2022
PRO Number
Pro00122724
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer/Breast
Summary

This study is for patients who have been diagnosed with breast cancer and their doctor has recommended that they receive radiation therapy after their mastectomy to reduce the risk of their breast cancer coming back. This study is being done to see if the severity of skin redness and peeling in the area of radiation can be reduced by applying Mepitel Film during radiation therapy.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org



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