EVoPAR-Prostate 01

Submitted by rfreitag on

Short Title: EVoPAR - Prostate 01  

The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

The Non-HRRm cohort is now closed.  

Study Number:

AZD5305 - D9723C00001

Study Status:

Enrolling

Treatment Agent:

Saruparib, Abiraterone Acetate, Darolutamide, Enzalutamide

Resources and Links

National Clinical Trial Identified Number: NCT06120491

Disease:

  • Metastatic Castration-Sensitive Prostate Cancer,
  • Prostate Cancer

Study Phase:

III

researchcancer@cooperhealth.edu

Article Title

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician’s Choice New Hormonal Agents in Patients with HRRm and non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

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prostate

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CompassHER2

Submitted by rfreitag on

Short Title: CompassHER2

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 trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

Study Number:

A011801

Study Status:

Enrolling

Treatment Agent:

Trastuzumab emtansine, Tucatinib

Resources and Links

National Clinical Trial Identified Number: NCT04457596

Disease:

  • HER2 Positive Breast Carcinoma,
  • Invasive Breast Carcinoma,
  • Multifocal Breast Carcinoma,
  • Synchronous Bilateral Breast Carcinoma

Study Phase:

III

ResearchCancer@CooperHealth.edu

Article Title

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 and Placebo Compared with T-Dm1 and Tucatinib

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DIRECT

Submitted by rfreitag on

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

Article Title

Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy

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BR009

Submitted by rfreitag on

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

Article Title

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

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LU008

Submitted by rfreitag on

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

Article Title

Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for LocallyAdvanced Non-Small Cell Lung Canc

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SunRISe-3

Submitted by rfreitag on

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

Article Title

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and
Safety of TAR-200 in Combination with Cetrelimab or TAR-200 Alone Versus Intravesical
Bacillus Calmette-Guérin (BCG) in Participants with BCG-naïve High-Risk Non-Muscle
Invasive Bladder Cancer (HR-NMIBC

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GY026

Submitted by rfreitag on

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

Article Title

A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with Either Trastuzumab and Hyaluronidase-Oysk (Herceptin Hylecta) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (Phesgo) in Her2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

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