Showing 1 - 10 of 33 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: Jenny Chang

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 br ... 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 comparat ... 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: Open Not Enrolling

Investigator: Abhishek Kansara

Study Coordinator: Michelle Nguyen

Phone: 346.238.4586

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 ... 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 comparat ... 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: Rabia Hashmani

Phone: 346.238.5894

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. ... Read more >

A Pilot Study of Hydroxytyrosol, a Component of Olive Oil for Breast Cancer Prevention In Women At High Risk Of Breast Cancer

Status: Open Not Enrolling

Investigator: Jenny Chang

Study Coordinator:

Phone:

This is a pilot study is evaluating the effect of hydroxytyrosol, a component of Olive oil, on mammographic density in women at high risk of breast through assessing whether mammographic density is reduced in women at high risk of breast cancer ... 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 th ... 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 know ... 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 dru ... 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 chemothera ... 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: Rabia Hashmani

Phone: 346.238.5894

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 hist ... Read more >

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3)

Status: Open Not Enrolling

Investigator: Eleni Efstathiou

Study Coordinator: Gabrielle Hayes

Phone: 734.419.948

The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months. ... 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: Enrolling

Investigator: Kai Sun

Study Coordinator: Alexys Brock

Phone: 346.238.4814

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 definitiv ... 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: Enrolling

Investigator: Hanh Mai

Study Coordinator: Rabia Hashmani

Phone: 346.238.5894

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 disea ... 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 comp ... Read more >

Clinical Phase Ib/II Trial of L-NMMA Plus Docetaxel in the Treatment of Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Rabia Hashmani

Phone: 346.238.5894

This is a Phase Ib/II study assessing the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), recommended Phase 2 dose (RP2D), and efficacy of L-NMMA when combined with docetaxel in refractory locally advanced or metastatic triple neg ... 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 alon ... Read more >

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Alexys Brock

Phone: 346.238.4814

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane. ... Read more >

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

Status: Enrolling

Investigator: Jenny Chang

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 ... 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: Jenny Chang

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 c ... 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: Jenny Chang

Study Coordinator: Rabia Hashmani

Phone: 346.238.5894

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: Enrolling

Investigator: Maen Abdelrahim

Study Coordinator: Fadi Abu-Shahin

Phone: 281.737.0435

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, outcome ... 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: Gabrielle Hayes

Phone: 734.419.948

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 ... 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). ... 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 ... 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: 734.419.948

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: 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 >

Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (PRESERVE-001)

Status: Open Not Enrolling

Investigator: Jenny Chang

Study Coordinator: Kelsey Banaglorioso

Phone: 346.238.5740

This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with a ... 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: 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) ... 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: 734.419.948

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 >

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: Derek Cole

Phone: 713.441.5607

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 radiati ... 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: Enrolling

Investigator: Kai Sun

Study Coordinator: Rabia Hashmani

Phone: 346.238.5894

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 trast ... Read more >