24.0402:  Study Title:  OPTIMICE-PCR - DE-ESCALATION OF THERAPY IN EARLY-STAGE TNBC PATIENTS WHO ACHIEVE PCR AFTER NEOADJUVANT CHEMOTHERAPY WITH CHECKPOINT INHIBITOR THERAPY 

Principal Investigator: Brian Dong, MD 

Phase:  III 

Description:  The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05812807?term=NCT05812807&rank=1

24.0365:  Study 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 and HER2-Negative Breast Cancer and an Oncotype Recurrence Score greater than or equal to 25 (OFSET) 

Principal Investigator: Elizabeth Riley, MD, FACP 

Phase:  III 

Description:  This Phase III Trial will 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). 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05879926?term=NCT05879926&rank=1

24.0435:  Study Title:  A PHASE III RANDOMIZED TRIAL OF RADIOTHERAPY OPTIMIZATION FOR LOW-RISK HER2-POSITIVE BREAST CANCER (HERO) 

Principal Investigator: Alden Klarer, MD 

Phase:  III 

Description:  This Phase III trial compares the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy versus those who are randomized to receive adjuvant radiotherapy per the standard of care. 

More Info:  https://clinicaltrials.gov/study/NCT05705401?term=NCT05705401&rank=1

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

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.