This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with CDK4/6i and fulvestrant in participants with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capivasertib + fulvestrant and of CDK4/6i + fulvestrant are established separately, the dose and schedule for the triplet combinations (capivasertib + CDK4/6i + fulvestrant) need to be confirmed. Therefore, the initial dose finding Phase Ib part of the study will determine the recommended Phase III doses (RP3D) of the triplet combinations. The Phase III part of the study will evaluate the efficacy, safety and the degree of added benefit of the triplet combinations of capivasertib and fulvestrant with investigator's choice of CDK4/6i (either palbociclib or ribociclib at safe and tolerable doses, once identified) in comparison with a control arm (fulvestrant + investigator's choice of CDK4/6i [palbociclib or ribociclib]) in a ER+ HER2- maC high risk population that did not receive prior endocrine therapy in the advanced setting.
Study Number:
CAPitello-292
Study Status:
Enrolling
Treatment Agent:
Capivasertib, Fulvestrant, Palbociclib, Ribociclib,Abemaciclib
National Clinical Trial Identified Number: NCT04862663
Disease:
Study Phase:
IB/III
researchcancer@cooperhealth.edu
A Phase Ib/III, Open-label, Randomized Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer
Hide from Search:
Off
Physician Name:
Department:
Short Title: XL092-035/Stellar 305
This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease.
Study Number:
XL092-035_ STELLAR-305
Study Status:
Enrolling
Treatment Agent:
Zanzalintinib, Pembrolizumab
National Clinical Trial Identified Number: NCT06082167
Disease:
Study Phase:
Phase II/III
researchcancer@cooperhealth.edu
A Phase II/III, Randomized, Double-Blind, Controlled Study of Zanzalintinib (Xl092) in Combination with Pembrolizumab Vs Pembrolizumab in The First-Line Treatment of subjects with PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Hide from Search:
Off
Physician Name:
Department:
Dr. Valenti joined Cooper University Health Care in 1998. During her tenure, she has served in a variety of roles including staff nurse in the cardiac catheterization and electrophysiology laboratories before transitioning into nurse leadership roles in the heart institute, patient care services, ambulatory operations, and currently, oncology services.
Ms. St. John joined Cooper University Healthcare in April 2024. She provides operational and clinical oversight for Pre-admission Testing, Operating Room Suites, PACU, Pre-op Holding Area, Surgical Care Unit, Short Procedure Unit, and Central Sterile Processing.
Ms. Farnum joined Cooper University Health Care 2024. She is the lead agent of change to improve operating room (OR) processes and OR utilization while simultaneously enhancing the patients’ overall ambulatory experiences at the Voorhees and Moorestown Surgical Centers.
Dr. Autum Shingler-Nace joined Cooper University Health Care in October 2023. She has executive oversight of inpatient and ambulatory surgical and procedural services, including Perioperative Services; Cardiac Catheterization, Electrophysiology, and Gastrointestinal Labs; and Interventional Radiology.
Short Title: INSPIRE-CRT
The INSPIRE-LUNG-CRT trial is a prospective, pilot study investigating the efficacy of incentive spirometry on the incidence and severity of pneumonitis in lung cancer patients undergoing concurrent chemotherapy and radiation therapy with immunotherapy maintenance. Despite advancements in treatment modalities, pulmonary complications remain a significant challenge, often leading to diminished functional capacity and quality of life. This trial aims to establish incentive spirometry as a non-pharmacological intervention to reduce these complications, thereby improving clinical outcomes and patient well-being. Lung cancer treatments are frequently associated with pulmonary toxicities, such as radiation-induced pneumonitis and fibrosis, immunotherapy induced pneumonitis, significantly impacting patient outcomes. Incentive spirometry, a device that encourages deep breathing and lung expansion, has shown promise in postoperative settings but is underutilized in oncology.
Study Number:
INSPIRE-CRT
Study Status:
Enrolling
Treatment Agent:
Not Applicable
National Clinical Trial Identified Number: NCT06688422
Disease:
Study Phase:
III
ResearchCancer@CooperHealth.edu
Incentive Spirometry for Respiratory Enhancement (INSPIRE-CRT) pilot Clinical Trial in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy
Hide from Search:
Off
Physician Name:
Department:
Short Title: CC011
The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.
Study Number:
CC011
Study Status:
Enrolling
Treatment Agent:
N/A
National Clinical Trial Identified Number: NCT05896189
Disease:
Study Phase:
III
researchcancer@cooperhealth.edu
Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double- Blinded Controlled Trial
Hide from Search:
Off
Physician Name:
Department:
Short Title: BN012
This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases.
Study Number:
BN012
Study Status:
Enrolling
Treatment Agent:
Not Applicable
National Clinical Trial Identified Number: NCT05438212
Disease:
Study Phase:
III
researchcancer@cooperhealth.edu
A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients with Resectable Brain Metastases
Hide from Search:
Off
Physician Name:
Department:
