Clinical Trials

    Showing 1 - 10 of 36 Gland and Hormone Related Diseases

    Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer (INTEGRAL)

    Status: Open Not Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Kelsey Banaglorioso

    Phone: 346.238.5740

    The purpose of this research study is to test the safety and effectiveness of docetaxel chemotherapy and pembrolizumab plus adenoviral-mediated interleukin-12 (ADV/IL-12) gene therapy in patients with anthracycline-refractory, triple negative breast ... Read more >

    Multicenter, Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair

    Status: Enrolling

    Investigator: Warren Ellsworth

    Study Coordinator: Valentina Villarroel

    Phone: 346.238.4384

    This is a multicenter registry study to collect utilization, safety, and outcomes data from medical record chart review of nerve reconstruction procedures throughout the body with Avance® Nerve Graft. Addendum 1 (MATCH) establishes a comparative a... Read more >

    A Multicenter, Randomized, Double-blind, Sham-controlled study for Assessing the Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals with Type II Diabetes

    Status: Enrolling

    Investigator: Abhishek Kansara

    Study Coordinator:

    Phone:

    This research study is designed to evaluate the safety and effectiveness of the ReCET™ device for improving glycemic (blood sugar) control in individuals with T2D. This study plans to enroll a minimum of 264 and a maximum of 350 participants from ... Read more >

    A Multicenter, Registry Study of Avance® Nerve Graft Utilization, Evaluations and Outcomes in Peripheral Nerve Injury Repair

    Status: Enrolling

    Investigator: Aldona Spiegel

    Study Coordinator: Valentina Villarroel

    Phone: 346.238.4384

    This is a multicenter registry study to collect utilization, safety, and outcomes data from medical record chart review of nerve reconstruction procedures throughout the body with Avance® Nerve Graft. Addendum 1 (MATCH) establishes a comparative a... Read more >

    A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast

    Status: Open Not Enrolling

    Investigator: Hanh Mai

    Study Coordinator: Jawairia Jawed

    Phone: 346.356.3603

    Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This ... Read more >

    A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/?Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/?HER2-negative Breast Cancer

    Status: Enrolling

    Investigator: Kai Sun

    Study Coordinator: Jawairia Jawed

    Phone: 346.356.3603

    This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizum... Read more >

    A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy

    Status: Open Not Enrolling

    Investigator: Sandra Templeton

    Study Coordinator: Juan Morales Viera

    Phone: 786.803.2333

    This is a prospective cohort study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast. The primary objective of the study is to create a de-identified database of patients, test results, treatment decisions and outcomes that ca... Read more >

    A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative

    Status: Open Not Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Alexys Brock

    Phone: 346.238.4814

    This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whe... Read more >

    A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo

    Status: Open Not Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Alexys Brock

    Phone: 346.238.4814

    The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug tha... Read more >

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

    Status: Open Not Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Kelsey Banaglorioso

    Phone: 346.238.5740

    This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, s... Read more >

    A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With ? 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

    Status: Open Not Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Kelsey Banaglorioso

    Phone: 346.238.5740

    This randomized phase III trial studies how well pembrolizumab works in treating triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.... Read more >

    A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

    Status: Open Not Enrolling

    Investigator: Kai Sun

    Study Coordinator: Jawairia Jawed

    Phone: 346.356.3603

    This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologi... Read more >

    A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy (CAMBRIA-1)

    Status: Open Not Enrolling

    Investigator: Kai Sun

    Study Coordinator: Jawairia Jawed

    Phone: 346.356.3603

    This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive loc... Read more >

    A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

    Status: Open Not Enrolling

    Investigator: Hanh Mai

    Study Coordinator: Jawairia Jawed

    Phone: 346.356.3603

    This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in... Read more >

    A Study of DB-1303/?BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

    Status: Open Not Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Anne McCombs

    Phone: 713.441.0528

    The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistoche... Read more >

    Acupuncture Trial

    Status: Open Not Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Alexys Brock

    Phone: 346.238.4814

    A single arm pilot study of 20 patients will be used to determine the feasibility of EA as a treatment for cancer survivors who have been treated with curative intent, but who have persistent CIPN for ?3 months after the cancer treatment is completed... Read more >

    B49: Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer

    Status: Open Not Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Alexys Brock

    Phone: 346.238.4814

    RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different combinations may kill more breast cancer cells. Givin... Read more >

    Capivasertib + CDK4/?6i + Fulvestrant for Advanced/?Metastatic HR+/?HER2- Breast Cancer (CAPItello-292) (CAPItello-292)

    Status: Open Not Enrolling

    Investigator: Kai Sun

    Study Coordinator: Kelsey Banaglorioso

    Phone: 346.238.5740

    A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresecta... Read more >

    Converting HR Breast Cancer Into an Individualized Vaccine

    Status: Open Not Enrolling

    Investigator: Jenny Chang

    Study Coordinator: Rabia Hashmani

    Phone: 346.238.5894

    Hormone receptor positive breast cancer HRBC is the most common cause of BC-related death. HRBC is characterized by a non-immunogenic microenvironment and consequently, modest responses have been observed with immune checkpoint blockade ICB alone or ... Read more >

    DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PLOZASIRAN IN ADULTS WITH HYPERTRIGLYCERIDEMIA (MUIR-3 STUDY)

    Status: Open Not Enrolling

    Investigator: Abhishek Kansara

    Study Coordinator: Zinah Rasheed

    Phone: 713.363.7536

    This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of plozasiran injection in approximately 1328 adult subjects with HTG. After informed consent, subjects will be assessed for eligib... Read more >

    DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PLOZASIRAN IN ADULTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHASTA-3 STUDY)

    Status: Open Not Enrolling

    Investigator: Abhishek Kansara

    Study Coordinator:

    Phone:

    This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of plozasiran injection in approximately 1328 adult subjects with HTG. After informed consent, subjects will be assessed for eligib... Read more >

    Fulvestrant Plus Abemaciclib With or Without Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer

    Status: Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Alexys Brock

    Phone: 346.238.4814

    The study will investigate if a one month drug holiday from the CDK4/6 inhibitor drug, abemaciclib, will restore the body's sensitivity to the drug and make the subsequent treatment of abemaciclib plus fulvestrant more effective.... Read more >

    IMPACT ON SURVIVAL OF FAITH-BASED SPIRITUAL CARE OR PSYCHOTHERAPY COMBINED WITH PALLIATIVE CARE VERSUS PALLIATIVE CARE ALONE IN PATIENTS WITH NON-CURATIVE MALIGNANCIES

    Status: Enrolling

    Investigator: Hanh Mai

    Study Coordinator: Natolie Hamilton

    Phone: 469.267.9275

    This phase III clinical trial will evaluate the impact on survival of adding chaplain-provided spiritual care or psychotherapy/meditation to standard-of-care (SOC) and palliative measures, plus chemotherapy if recommended, and comparing it with SOC a... Read more >

    Multicenter Phase I/Ib Trial of Olaparib in Combination With Vorinostat in Patients With Relapsed/Refractory and/or Metastatic Breast Cancer

    Status: Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Alexys Brock

    Phone: 346.238.4814

    This is a Phase I/Ib study testing the safety and preliminary efficacy of olaparib and vorinostat when used together in participants with relapsed/refractory and or metastatic breast cancer. Cancer cells grow in an uncontrolled manner and this causes... Read more >

    Multicenter Phase II Trial of Durvalumab (MEDI4736) With Trastuzumab and Pertuzumab Combination in HER2-Enriched and HER2-Amplified Breast Cancer (DTP Trial)

    Status: Open Not Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Jawairia Jawed

    Phone: 346.356.3603

    The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with human epidermal growth factor receptor 2 (HER2)-enriched breast cancer.... Read more >

    Neoadjuvant Combination Therapy of Lenvima® plus Transcatheter Arterial Chemoembolization (TACE) for Transplant-Eligible Patients with Large Hepatocellular Carcinoma

    Status: Open Not Enrolling

    Investigator: Maen Abdelrahim

    Study Coordinator: Elsie Rizk

    Phone: 713.441.2557

    We propose a regimen of six months neoadjuvant lenvatinib in combination with transcatheter arterial chemoembolization (TACE) prior to liver transplantation in patients with hepatocellular carcinoma (HCC) beyond Milan Criteria. Clinical, outcomes, an... Read more >

    Open-label study of Androgen Receptor Inhibition with dArolutamide plus Androgen Deprivation Therapy (ADT) Versus ADT in men with Metastatic Hormone-Sensitive Prostate Cancer Using an External Control Arm (ARASEC)

    Status: Open Not Enrolling

    Investigator: Eleni Efstathiou

    Study Coordinator: Derek Cole

    Phone: 713.441.5607

    This is a phase 2 open label single arm study using an external control arm, to assess if the addition of darolutamide to ADT provides superior efficacy in terms of progression-free survival (PFS), as compared to ADT alone for men diagnosed with meta... Read more >

    PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2

    Status: Open Not Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Kelsey Banaglorioso

    Phone: 346.238.5740

    This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). Th... Read more >

    Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

    Status: Enrolling

    Investigator: Kai Sun

    Study Coordinator: Kelsey Banaglorioso

    Phone: 346.238.5740

    The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembr... Read more >

    Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

    Status: Open Not Enrolling

    Investigator: Eleni Efstathiou

    Study Coordinator: Gabrielle Hayes

    Phone: 734.415.918

    The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone.... Read more >

    REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy

    Status: Open Not Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Alexys Brock

    Phone: 346.238.4814

    This study is investigating whether breast cancer patients who experience vaginal dryness while on anti-estrogen treatment could benefit from either vaginal estrogen or from a vaginal moisturizer called Replens.... Read more >

    Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

    Status: Open Not Enrolling

    Investigator: Sindhu Nair

    Study Coordinator: Misbah Baloch

    Phone: 713.790.3311

    This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-posi... Read more >

    Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (PETRANHA)

    Status: Enrolling

    Investigator: Eleni Efstathiou

    Study Coordinator: Gabrielle Hayes

    Phone: 734.415.918

    This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of AZD5305 when given in combination with new hormonal agents (NHAs) in patients with Metastatic Prostate Cancer.... Read more >

    SWOG 1007

    Status: Open Not Enrolling

    Investigator: Polly Niravath

    Study Coordinator: Kelsey Banaglorioso

    Phone: 346.238.5740

    RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestan... Read more >

    TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

    Status: Enrolling

    Investigator: Bin Teh

    Study Coordinator: Natolie Hamilton

    Phone: 469.267.9275

    The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation tr... Read more >

    The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib

    Status: Open Not Enrolling

    Investigator: Kai Sun

    Study Coordinator: Jawairia Jawed

    Phone: 346.356.3603

    This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzuma... Read more >