24.0568:  Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT trial

Principal Investigator: Brian Dong, MD

Phase:  II

Description:  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.

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05710328?term=NCT05710328&rank=1

24.0402:  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

24.0018:  A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab Compared with Investigator Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients with PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

 Principal Investigator: Brian Dong, MD

 Phase:  III

 Description:  This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT06103864

24.0005:  A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence

 Principal Investigator: Brian Dong, MD

Phase:  III

Description:  This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05774951?term=NCT05774951&rank=1

23.0890:  A Phase III, Open-label, Randomised 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  TROPION-Breast04 

Principal Investigator: Brian Dong, MD 

Phase:  III 

Description:  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. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT06112379?term=NCT06112379&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

23.0066:  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.