BREAST CANCER

23.0875:  A Phase 3, Randomized, Multi-center, Open-label Study of DB-1303 Versus Investigator Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR plus) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy  (DYNASTY-Breast02). 

Principal Investigator: Brian Dong, MD 

Phase:  III 

Description:  The goal of this clinical trial is to assess the efficacy of DB-1303 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (IHC 2+/ISH- and IHC 1+)population.

More Info:  https://clinicaltrials.gov/study/NCT06018337?term=NCT06018337&rank=1

 

23.0756:  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. 

Principal Investigator: Brian Dong, MD 

Phase:  III 

Description:  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. 

More Info:  https://clinicaltrials.gov/study/NCT05646862?term=NCT05646862&rank=1


23.0066:  A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Versus Investigator Choice of Therapy in Patients With Stage I-IIITriple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03) 

Principal Investigator: Brian Dong, MD 

Phase:  III 

Description:  This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy. 

More Info: https://clinicaltrials.gov/study/NCT05629585?term=NCT05629585&rank=1


22.0978:  A Phase 1, Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MK-4464 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced/Metastatic Solid Tumors

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of MK-4464 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.

More Info:  https://clinicaltrials.gov/ct2/show/NCT05514444?term=NCT05514444&draw=2&rank=1


21.0460: Phase 2 Study of Palliative Radiation in Combination with Pembrolizumab in Subjects with Unresectable/Metastatic Stage IV Breast Cancer

Principal Investigator: Elizabeth Riley, MD, FACP

Phase: II

Description: This is a phase 2, open-label, single-arm trial designed to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) in combination with pembrolizumab following disease progression after two prior lines of standard therapy in unresectable metastatic stage IV breast cancer.

More info: https://clinicaltrials.gov/ct2/show/NCT04990921?term=twisted+pink&draw=2&rank=1

 

21.1039: A Phase 1 dose escalation and expansion study to evaluate safety, tolerability, pharmacokinetic, pharmacodynamic, and anti-tumor activity of PF-07248144 in participants with advanced or metastatic solid tumors

Principal Investigator: Brian Dong, MD

Phase: I

Description: This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination with either fulvestrant or letrozole + palbociclib.

More info: https://clinicaltrials.gov/ct2/show/NCT04606446?term=NCT04606446&draw=2&rank=1

 

19.0495: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Principal Investigator: Harriet Eldredge-Hindy, MD

Phase:  III

Description: The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

More info: https://clinicaltrials.gov/ct2/show/NCT03488693?term=NCT03488693&rank=1

 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).


Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.