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