Breast Cancer Clinical Trials
Clinical trials are studies that help us discover and develop new diagnostic tools, therapies and treatments for breast cancer. The ultimate goal is to improve the lives of our patients. Trials involve collaboration across multiple departments, with researchers involved in design, testing and analysis of these studies.
The Breast Care team at Orlando Health Cancer Institute is working on various trials designed to assess a wide range of cancer-fighting options. We strive to improve our standards of care and patient outcomes through medications, therapies, genetics, diet and better screening.
Trials also offer our patients an avenue for gaining early access to promising research that may be used to prevent, diagnose and treat breast cancer.
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OptimICE-pCR: De-Escalation of Therapy in Early-Staging TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy +
OptimICE-pCR: De-Escalation of Therapy in Early-Staging TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
Protocol No: A012103
Age Group: Adult
Disease Sites: Breast
NCT Id: NCT05812807
Phase: III
Principal Investigators: Ana Cuesta Fernandez, MD
Eligibility Document -
Attachment Id: 12832
File Name: A012103 Subject Eligibility _Screening Checklist Version 3_17Jun2025.docx
URL:
Objective
This study looks at whether patients with early-stage triple-negative breast cancer who respond well to chemotherapy and immunotherapy can safely skip additional immunotherapy after surgery, or if continuing it offers better long-term outcomes.
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An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician's Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer. +
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician's Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer.
Protocol No: MK-2870-010
Age Group: Adult
Disease Sites: Breast
NCT Id: NCT06312176
Phase: III
Principal Investigators: Ana Cuesta Fernandez, MD
Eligibility Document -
Attachment Id: 17261
File Name: Subject Eligibility _Screening Checklist MK2870-010 V3_ (1).docx
URL:
Objective
This study is for people with hormone-positive, HER2-negative breast cancer that has spread or can't be removed with surgery. It compares a new drug (MK-2870), alone or with immunotherapy, to standard chemo to see which works better at slowing the cancer down.
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Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination with Immune Checkpoint Blockade in Participants with Advanced Solid Tumors +
Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination with Immune Checkpoint Blockade in Participants with Advanced Solid Tumors
Protocol No: MRNA-4359-P101
Age Group: Adult
Disease Sites: Lung, Melanoma, Skin
NCT Id: NCT05533697
Phase: I/II
Principal Investigators: Yuanbin Chen, MD
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A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer +
A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer
Protocol No: NRG-BR007
Age Group: Adult
Disease Sites: Breast
NCT Id: NCT04852887
Phase: III
Principal Investigators: Patrick Kelly, MD
Eligibility Document -
Attachment Id: 6853
File Name: NRG-BR007_Subject Eligibility _Screening Checklist_V2_08Nov2024 (002).docx
URL:
Objective
This study is for woman with early-stage, hormone-sensitive breast cancer. It's testing if skipping radiation after surgery is just as safe as getting radiation, when patients are also on hormone therapy.
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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/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET) +
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/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)
Protocol No: NRG-BR009
Age Group: Adult
Disease Sites: Breast
NCT Id: NCT05879926
Phase: III
Principal Investigators: Ana Cuesta Fernandez, MD
Eligibility Document -
Attachment Id: 14615
File Name: Subject Eligibility _Screening Checklist NRG-BR009_Version 1.0 23JUL2025.docx
URL:
Objective
This study is for premenopausal women with early-stage breast cancer. It compares two approaches to hormone therapy, with or without chemotherapy, to see which works best at preventing the cancer from coming back. The study uses a lab test (Oncotype DX) to help guide who might benefit from adding chemo.
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