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: 20652
File Name: A012103 Subject Eligibility _Screening Checklist Version 4 02.03.2026(3).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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A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery +
A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery
Protocol No: MK-2870-012-07
Age Group: Adult
Disease Sites: Breast
NCT Id: NCT06393374
Phase: III
Principal Investigators: Ana Cuesta Fernandez, MD
Eligibility Document -
Attachment Id: 23873
File Name: MK-2870-012 Subject Eligibility Screening Checklist_07APR2026.docx
URL:
Objective
Evaluate efficacy of adjuvant MK-2870 plus Pembrolizumab vs TPC in TNBC patients who did not achieve pCR after neoadjuvant 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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Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study +
Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study
Protocol No: OHCI-BRE-26-001-NCT
Age Group: Adult
Disease Sites: Breast
NCT Id: NCT05929768
Phase: III
Principal Investigators: Jose Najera, MD
Objective
To compare event-free survival between tow neoadjuvant chemotherapy regimens with pembrolizumab in patients with early-stage triple negative breast cancer
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