Breast Cancer Clinical Trials

24.0766:  A Phase 1/1b Open-label, Multicenter Clinical Study of MK-0472 as Monotherapy and Combination Therapy in Participants with Advanced/Metastatic Solid Tumors.

Principal Investigator

Rebecca Redman, MD

Phase 

1/1b

Description

The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.

Find more information at ClinicalTrials.gov

24.0721:  A Phase Ib/III, Open-label, Randomised 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 (CAPItello-292)

Principal Investigator

Brian Dong, MD

Phase

1b/III

Description

A Phase Ib/III Open-label, Randomised 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 (CAPItello-292)

Find more information at ClinicalTrials.gov

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.

Find more information at ClinicalTrials.gov

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. 

Find more information at ClinicalTrials.gov

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). 

Find more information at ClinicalTrials.gov

24.0435:  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. 

Find more information at ClinicalTrials.gov

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.

Find more information at ClinicalTrials.gov

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. 

Find more information at ClinicalTrials.gov

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.

Find more information at ClinicalTrials.gov

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.

Find more information at ClinicalTrials.gov

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.

Find more information at ClinicalTrials.gov

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.

Find more information at ClinicalTrials.gov

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.