Showing 1 - 10 of 31 Gland and Hormone Related Diseases
Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer (INTEGRAL)

Status: Enrolling

Investigator: Jenny Chang

Study Coordinator: Kelsey Banaglorioso

Phone: 832.406.0291

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:

Phone:

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

Status: Enrolling

Investigator: Aldona Spiegel

Study Coordinator:

Phone:

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: Enrolling

Investigator: Dharamvir Jain

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: Dharamvir Jain

Study Coordinator: Kelsey Banaglorioso

Phone: 832.406.0291

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 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: 832.406.0291

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: Enrolling

Investigator: Dharamvir Jain

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 >

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 >

Assessing the Accuracy of Tumor Biopsies After Chemotherapy to Determine if Patients Can Avoid Breast Surgery

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Kelsey Banaglorioso

Phone: 832.406.0291

This phase II trial studies how well biopsy of breast after chemotherapy works in predicting pathologic response in patients with stage II-IIIA breast cancer undergoing breast conserving surgery. Tumor tissue collected from biopsy before surgery ... 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. ... 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 Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Tanya Khan

Phone: 346.238.5655

The reason for this trial is to compare DS-8201a to other treatments being used for HER2-low breast cancer that has spread to other parts of the body. DS-8201a is a new medicine for breast cancer that has not been approved yet by the Food and ... 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: Rabia Hashmani

Phone: 346.238.5894

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 >

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 [DESTINY-Breast03]

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Rabia Hashmani

Phone: 346.238.5894

Primary Objective: • To compare the efficacy of DS-8201a to investigator’s choice by means of progression-free survival (PFS). Secondary Objectives: • To further investigate the efficacy of DS-8201a compared to investigator’s choice on: ? ... 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 >

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: 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: Open Not Enrolling

Investigator: Maen Abdelrahim

Study Coordinator:

Phone:

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 >

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: Dharamvir Jain

Study Coordinator: Kelsey Banaglorioso

Phone: 832.406.0291

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 >

Phase 3 Study of Sacituzumab Govitecan vs Physician's Choice in Subjects With Hormonal Receptor-Positive Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Who Have Failed at Least 2 Prior Chemotherapy Regimens

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Rabia Hashmani

Phone: 346.238.5894

This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and safety of Sacituzumab Govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- MBC, after failure of at least 2, and no mo ... Read more >

Phase II Trial of Alpelisib with iNOS Inhibitor and Nab-paclitaxel in Patients with HER2 negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)

Status: Enrolling

Investigator: Polly Niravath

Study Coordinator: Kelsey Banaglorioso

Phone: 832.406.0291

This is a research study to test the safety and effectiveness of using the drug alpelisib together with chemotherapy (nab-paclitaxel) and a drug called L-NMMA in patients with HER2 negative metastatic or locally advanced metaplastic breast cance ... Read more >

Phase II Window of Opportunity Trial of Stereotactic Body Radiation Therapy and In Situ Oncolytic Virus Therapy in Metastatic Triple Negative Breast Cancer and Metastatic Non-Small Cell Lung Cancer Followed by Pembrolizumab

Status: Open Not Enrolling

Investigator: Jenny Chang

Study Coordinator: Gabrielle Hayes

Phone: 734.419.948

This is a Phase II trial to determine the efficacy and safety of stereotactic body radiation therapy (SBRT) and in situ oncolytic virus therapy used as a window of opportunity treatment before pembrolizumab in patients with metastatic triple neg ... 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: Tanya Khan

Phone: 346.238.5655

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: Enrolling

Investigator: Jenny Chang

Study Coordinator: Kelsey Banaglorioso

Phone: 832.406.0291

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 >

SWOG 1007

Status: Open Not Enrolling

Investigator: Polly Niravath

Study Coordinator: Kelsey Banaglorioso

Phone: 832.406.0291

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 exem ... Read more >