MDA 2016-0046 Exceptional Responders
Short Title: Exceptional Responders
This clinical trial studies eliminating surgery and how well radiation therapy after systemic therapy works in treating patients with HER2 positive or triple negative breast cancer when image-guided biopsy shows no residual cancer. Patients then receive standard breast radiotherapy.
Study Number:
2016-0046
Study Status:
Enrolling
Treatment Agent:
Radiation, Surgery
Resources and Links
National Clinical Trial Identified Number: NCT02945579
Disease:
- Breast Cancer,
- Estrogen Receptor Negative,
- HER2 Positive Breast Carcinoma,
- HER2/Neu Negative,
- Invasive Breast Carcinoma,
- Progesterone Receptor Negative,
- Triple-Negative Breast Carcinoma,
- Stage 1A, 1B, II, IIA, IIB
Study Phase:
Not applicable
researchcancer@cooperhealth.edu
Article Title
Multicenter trial for eliminating breast cancer surgery or radiotherapy in exceptional responders to neoadjuvant systemic therapy
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WO43919-INAVO121
Short Title: WO43919 - INAVO121
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy.
Study Number:
WO43919-INAVO121
Study Status:
Enrolling
Treatment Agent:
Inavolisib, Fulvestrant, Alpelisib
Resources and Links
National Clinical Trial Identified Number: NCT05646862
Disease:
- Breast
Study Phase:
III
researchcancer@cooperhealth.edu
Article Title
A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib plus Fulvestrant versus Alpelisib plus Fulvestrant in Patients with Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or after CDK4/6 Inhibitor and Endocrine Combination Therapy
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EVoPAR -Prostate 01
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.
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)
Index Extra:
prostate
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CompassHER2
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
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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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
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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Department:
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
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
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
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
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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