LOTAM: A RANDOMIZED, PHASE III CLINICAL TRIAL OF LOW-DOSE TAMOXIFEN FOR SELECTED PATIENTS WITH MOLECULAR LOW-RISK EARLY-STAGE BREAST CANCER

Date Added
May 1st, 2025
PRO Number
Pro00144117
Researcher
Abirami Sivapiragasam

List of Studies

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

This study is for subjects that are post-menopausal women that have been diagnosed with early-stage, low molecular risk breast cancer. Subjects are expected to remain in the study for 60months. There will be a total of 25 subjects enrolled locally.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc0clinical-trials@musc.edu

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING EFFICACY AND SAFETY OF GIREDESTRANT COMPARED WITH FULVESTRANT, BOTH COMBINED WITH A CDK4/6 INHIBITOR, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WITH RESISTANCE TO PRIOR ADJUVANT ENDOCRINE THERAPY

Date Added
March 28th, 2025
PRO Number
Pro00141609
Researcher
Abirami Sivapiragasam

List of Studies

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

The study is designed for patients with Estrogen Receptor (ER) positive, HER2-negative advanced breast cancer resistance to prior adjuvant endocrine treatment. The purpose of the study is to determine the effectiveness of Giredestrant compared with Fulvestrant in combinationof CDK4/6i (Palbociclib, Ribociclib and Abemaciclib). The study drug being utilized is giredestrant. The FDA approved drugs will also be utilized: Zoladex and Lupron (LHRH - Luteinizing hormone-releasing hormone agonists) drugs; as well as, Palbociclib, Ribociclib , Fulvestrant, and Abemaciclib.

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

Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence—A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)

Date Added
March 27th, 2025
PRO Number
Pro00142210
Researcher
Abirami Sivapiragasam

List of Studies

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

The study is for patient that have been diagnosed with ER positive HER2 negative early breast cancer. The main purpose is to determine the efficacy and safety of Elacestrant relative to the standard Endocrine therapy. Subject are expected to be enrolled into the study for 36 months.

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

CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients with ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

Date Added
March 25th, 2025
PRO Number
Pro00136956
Researcher
Abirami Sivapiragasam

List of Studies

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

The study is for patient that are receiving camizestrant as a treatment. The main purpose of study is to change the dosage of camizestrant from 150mg to 75mg. This change was prompted by updated, emerging data from ongoing studies showing
no difference in efficacy between the 75 mg and 150 mg doses. Subject can expect to be in this study for up to 24 months.

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

Refining Tamoxifen Dose for Premenopausal Breast Cancer Prevention (RENAISSANCE): A Phase II Single Arm Trial

Date Added
November 21st, 2024
PRO Number
Pro00137081
Researcher
Kevin Hughes

List of Studies

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

This study is for subjects that are premenopausal and have a higher-than-average risk of developing breast cancer. The main purpose of this study is to determine if using change in breast density to guide personalized tamoxifen dosing is better or worse than the usual approach for premenopausal women with dense breast tissue at higher-than-average risk of developing breast cancer. Subjects can expect to be in this study for up to XX months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
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
November 14th, 2024
PRO Number
Pro00138977
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer, 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

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



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