TROPION Breast04

Submitted by rfreitag on

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

Article Title

A Phase III, Open-label, Randomized Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

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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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MajesTEC-9

Submitted by rfreitag on

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

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National Clinical Trial Identified Number: NCT05572515

Disease:

  • Relapsed or Refractory Multiple Myeloma

Study Phase:

III

ResearchCancer@cooperhealth.edu

Article Title

A Phase III Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

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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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