• Read more about Jeff’s Weight Loss Surgery Success Story

When Jeff's weight started to impact his performances and his health, he turned to Cooper and a team who could help him succeed. Not only was Jeff’s weight affecting his performance, he was beginning to develop serious chronic illnesses

• Read more about DIRECT

Short Title: DIRECT

This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy.

Study Number:

EA1211

Study Status:

Enrolling

Treatment Agent:

Chemotherapy

Resources and Links

National Clinical Trial Identified Number: NCT05710328

Disease:

• HER2-Positive Breast Carcinoma,
• Invasive Breast Carcinoma

Study Phase:

II

researchcancer@cooperhealth.edu

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Physician Name:

• Kamel Abou Hussein, MD

Department:

• Breast Cancer

• Read more about Topical Tamoxifen

Short Title: Topical Tamoxifen 

Women with atypical hyperplasia (AH) and lobular carcinoma in situ (LCIS) are at increased risk of breast cancer (BC) (~1-2 % per year). Over two decades ago, placebo-controlled randomized trials established that oral tamoxifen (20 mg/day) reduces breast cancer risk by 50% in generally defined high risk women, with ~70% reduction in women at high risk specifically due to atypical hyperplasia.[1] Years later, the side effects and toxicity of oral tamoxifen at 20 mg/day remain a significant barrier to its uptake and longterm compliance.[2, 3] To address the issue of toxicity, two main strategies have been pursued: 1) using a lower dose of oral tamoxifen, and 2) using a topical formulation of tamoxifen to avoid systemic side effects. The investigators will perform a prospective study of women with AH or LCIS who will take a short course of prevention therapy; breast tissue samples will be evaluated pre- and post-therapy to identify and evaluate very early biomarkers of response. The overall goal of the study is to evaluate short-term changes in background breast tissue induced by either low-dose oral tamoxifen or topical 4-OHT gel in women with AH or LCIS.

Study Number:

19-011444

Study Status:

Enrolling

Treatment Agent:

Tamoxifen, Topical 4-OHT (4-hydroxytamoxifen) gel

Resources and Links

National Clinical Trial Identified Number: NCT04570956

Disease:

• Breast Cancer,
• Breast Atypical Hyperplasia,
• Breast Lobular Carcinoma in Situ,
• Breast Atypical Lobular Hyperplasia

Study Phase:

IIB

researchcancer@cooperhealth.edu

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Physician Name:

• Catherine E. Loveland-Jones, MD, MS, FACS

Department:

• Breast Cancer

• Read more about TROPION Breast04

Short Title: TROPION Breast04

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 pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Study Number:

D926QC00001

Study Status:

Enrolling

Treatment Agent:

Dato-DXd, Durvalumab, Pembrolizumab, Doxorubicin, Epirubicin, Cyclophosphamide, Paclitaxel, Carboplatin, Capecitabine, Olaparib

Resources and Links

National Clinical Trial Identified Number: NCT06112379

Disease:

• Breast Cancer

Study Phase:

III

researchcancer@cooperhealth.edu

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Physician Name:

• Kamel Abou Hussein, MD

Department:

• Breast Cancer,
• Hematology and Medical Oncology

• Read more about BR009

Short Title: OFSET

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 breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

Study Number:

BR009

Study Status:

Enrolling

Treatment Agent:

Ovarian Function Suppression, Aromatase Inhibitor, Adjuvant Chemotherapy, Ovarian Function Suppression

Resources and Links

National Clinical Trial Identified Number: NCT05879926

Disease:

• Breast Cancer

Study Phase:

III

ResearchCancer@CooperHealth.edu

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Physician Name:

• Danny Markabawi, MD

Department:

• Hematology and Medical Oncology

• Read more about LU008

Short Title: LU008

This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to standard treatment (image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab) versus standard treatment alone in treating patients with non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation that uses a computer to create picture of the tumor, to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue.

Study Number:

LU008

Study Status:

Enrolling

Treatment Agent:

Cisplatin, Carboplatin, Paclitaxel, Pemetrexed, and Etoposide

Resources and Links

National Clinical Trial Identified Number: NCT05624996

Disease:

• Locally Advanced Lung Non-Small Cell Carcinoma,
• Stage IIB Lung Cancer AJCC v8,
• Stage III Lung Cancer AJCC v8

Study Phase:

III

ResearchCancer@CooperHealth.edu

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Physician Name:

• Joseph F. Lombardo, DO, PharmD

Department:

• Radiation Therapy,
• Lung Cancer

• Read more about MajesTEC-9

Short Title: MajesTEC-9

Multiple myeloma is an incurable, malignant, plasma cell disorder. Teclistamab (JNJ-64007957) is a full-size, Immunoglobulin G (IgG) 4 proline, alanine, and alanine (PAA) bispecific antibody that targets the cluster of differentiation (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). With its dual binding sites, teclistamab is able to draw CD3 positive T cells in close proximity to BCMA positive cells, resulting in T-cell activation and subsequent lysis of BCMA positive cells. Pomalidomide is a third-generation immunomodulatory imide drug (IMiD) that exerts potent, direct tumoricidal and immune-enhancing effects and Carfilzomib is a second-generation proteasome inhibitor that inhibits proteasome which results in disruption of protein turnover and induces apoptosis.

Study Number:

MajesTEC-9

Study Status:

Enrolling

Treatment Agent:

Teclistamab, Pomalidomide, Bortezomib, Dexamethasone, Carfilzomib

Resources and Links

National Clinical Trial Identified Number: NCT05572515

Disease:

• Relapsed or Refractory Multiple Myeloma

Study Phase:

III

ResearchCancer@cooperhealth.edu

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Physician Name:

• Tulin Budak-Alpdogan, MD

Department:

• Hematology and Medical Oncology

• Read more about SunRISe-3

Short Title: SunRISe-3

Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The mainstay of treatment for HR-NMIBC is transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or in combination with cetrelimab will be evaluated and compared against intravesical BCG.

Study Number:

SunRISe-3

Study Status:

Enrolling

Treatment Agent:

TAR-200, Cetrelimab, BCG Vesiculture

Resources and Links

National Clinical Trial Identified Number: NCT05714202

Disease:

• Bladder Cancer,
• BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

Study Phase:

III

ResearchCancer@CooperHealth.edu

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Physician Name:

• Jeffrey J. Tomaszewski, MD

Department:

• Hematology and Medical Oncology,
• Bladder Cancer

• Read more about GY026

Short Title: GY026

This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. 

Study Number:

GY026

Study Status:

Enrolling

Treatment Agent:

Carboplatin, Hyaluronidase-zzxf/Pertuzumab/Trastuzumab, Paclitaxel, Trastuzumab/Hyaluronidase-oysk

Resources and Links

National Clinical Trial Identified Number: NCT05256225

Disease:

• Endometrial Serous Adenocarcinoma,
• Uterine Corpus Carcinosarcoma

Study Phase:

II/III

Researchcancer@cooperhealth.edu

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Physician Name:

• David P. Warshal, MD, FACOG

Department:

• Gynecologic Cancer Center