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The Latest Developments in Breast Cancer Research

researcher in the lab

Researchers in the Breast Oncology Program are uncovering new and improved ways to treat breast cancer. Here's a look at some of the latest developments in breast cancer research at Moffitt Cancer Center.

More information about other breast cancer treatments is also available here.

Dr. Brian Czerniecki
Dr. Brian Czerniecki

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Creating Preventive Vaccines. One of Dr. Brian Czerniecki’s primary areas of research interest is the development of immunotherapy, including preventive vaccines, against lethal forms of breast cancer and other solid-tumor cancers. Toward that end, he works to identify molecular targets in early breast cancer that can be used to prevent invasion and metastasis.

Harnessing The Gut Microbiome. The team is investigating how bacteria in the gut can help the function of DC1 dendritic cells to best eliminate cancer. The team is seeking to identify the optimal GI gut microbiome from patients who have a complete response from treatment so that nutritional supplements can be made to get the correct GI "bugs" to help the patient’s immune response function optimally. Funding is particularly appreciated in this area as this work is in its early stages but appears to be most promising as a natural cure for many types of cancers.

New Clinical Trials to Open. By mid-year, the Breast Oncology Program expects to open two new clinical trials using a patient’s own white cells to elicit an immune response to cancer. In the case of triple negative breast cancer, the immunotherapy will be mixed with chemotherapy for the desired response. For HER2 positive breast cancer patients, the goal will be for the therapy to reduce the need for chemotherapy.

Treating Triple Negative Breast Cancer. A major project has been initiated that uses the herpes virus as a viral therapy to infect cancer cells and rev up the immune system to kill the cancer. Called viral immune therapy, it has been used to treat melanoma and is now helping to fight triple negative breast cancer at Moffitt.

Studying Immune Response. The team has submitted a manuscript demonstrating how the immune response eliminates HER2 breast cancer by causing the "garbage can" in the cell to get rid of all the extra HER2, which then makes the cells permanently inactive and unable to cause metastasis. More importantly, it tells us how to use the immune system to make therapies work in patients who become resistant to our current therapies.

Predicting Response. An immune blood test developed in the Czerniecki research laboratory appears to predict with high accuracy those patients likely to have a complete response to vaccines and chemotherapy. It may provide a path toward eliminating chemotherapy and guiding a pure immunotherapy treatment.

Preventing Recurrence. The team is conducting a multicenter trial to prevent recurrence in HER2 positive patients with residual disease following neoadjuvant therapy. The trial is open at seven other cancer centers across the country, using a breast cancer vaccine developed at Moffitt.

Treating Metastasis. Using a Department of Defense grant, in conjunction with Roswell Park Comprehensive Cancer Center in Buffalo, NY, the team is treating patients with both brain metastasis and central nervous system metastasis, again, using a vaccine developed at Moffitt.

To learn more about the breast cancer clinical trials currently available at Moffitt, contact us at 1-813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form. We welcome patients with or without a referral.

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CLINICAL TRIAL 19337

A Pilot Study Utilizing a HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+ Breast Cancer

Disease Site: Breast

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CLINICAL TRIAL 19603

Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination with Pembrolizumab for First-Line Treatment of Patients with Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer

Disease Site: Breast

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CLINICAL TRIAL 19646

Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III

Disease Site: Breast

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CLINICAL TRIAL 19776

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 Alone and in Combination with Nivolumab in Patients with Advanced Solid Tumors

Disease Site: Any Site, Bones and Joints, Breast, Esophagus, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Soft Tissue

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CLINICAL TRIAL 20030

A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node or T3N0 Positive Breast Cancer

Disease Site: Breast

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CLINICAL TRIAL 20132

Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Disease Site: Any Site, Breast, Lip, Oral Cavity and Pharynx

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CLINICAL TRIAL 20159

A Phase 1 Study of ZW49 in Patients with Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers

Disease Site: Esophagus, Breast

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CLINICAL TRIAL 20487

Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease

Disease Site: Brain and Nervous System, Breast, Leptomeningeal (LMD)

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CLINICAL TRIAL 20897

Phase 1 Dose-Escalation, Dose-Expansion Trial of Intratumoral HER2- and HER3-Primed Dendritic Cells Injections for the Treatment of Early-Stage TNBC and ER Low Positive Breast Cancer (DecipHER)

Disease Site: Breast

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CLINICAL TRIAL 20898

A Modular Phase 2a Multicentre Open-Label Study to Investigate DNA-damage Response Agents (or Combinations) in Patients With Advanced Cancer Whose Tumours Contain Molecular Alterations (PLANETTE)

Disease Site: Any Site, Breast, Colorectal, Endometrial/Uterine, Extrapulmonary small cell lung cancer, Gallbladder, Gastric / Stomach, Gastrinoma, Gastrointestinal, Liver, Lung, Non small cell lung cancer, Other genitourinary, Other GI, Pancreas, Prostate, Reproductive System, Urinary Bladder, Uterus

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CLINICAL TRIAL 20899

Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases

Disease Site: Brain and Nervous System, Breast

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CLINICAL TRIAL 20964

A Phase 2 Basket Study of Tucatinib in Combination with Trastuzumab in Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations

Disease Site: Brain and Nervous System, Breast, Ill-Defined Sites, Lung, Other Digestive Organ, Urinary Bladder, Brain metastasis, Leptomeningeal (LMD)

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CLINICAL TRIAL 21163

A Phase 1/2 Study of Regn7075 (Egfrxcd28 Costimulatory Bispecific Antibody) in Combination with Cemiplimab in Patients with Advanced Solid Tumors

Disease Site: Anus, Breast, Cervix, Colon, Esophagus, Kidney, Lip, Oral Cavity and Pharynx, Lung, Other Digestive Organ, Other Female Genital, Other Male Genital, Other Skin, Other Urinary, Pancreas, Prostate, Stomach

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CLINICAL TRIAL 21180

A First-in-Human, Two-Part, Open-Label, Clinical Study to Assess the Safety, Tolerability and Activity of Intravenous Doses of ICT01 as Monotherapy and in Combination with an Immune Checkpoint Inhibitor, in Patients with Advanced-Stage, Relapsed/Refractory Cancer (EVICTION Study)

Disease Site: Any Site, Breast, Colon, Larynx, Leukemia, other, Lip, Oral Cavity and Pharynx, Lung, Melanoma, skin, Ovary, Prostate, Stomach, Urinary Bladder

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CLINICAL TRIAL 21257

A Phase 1 First-in-Human Study with ABBV-155 Alone and in Combination with Taxane Therapy in Adults with Relapsed and/or Refractory Solid Tumors

Disease Site: Breast, Lung

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CLINICAL TRIAL 21378

Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab / Trastuzumab in Patients with Metastatic HER2-Positive Breast Cancer

Disease Site: Breast

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CLINICAL TRIAL 21587

A Dose-escalation Study of the Safety and Pharmacology of DAN 222 in Subjects with Metastatic Breast Cancer

Disease Site: Breast

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CLINICAL TRIAL 21609

A Phase I Dose Escalation And Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, And Anti-Tumor Activity Of PF-07260437 In Advanced Or Metastatic Solid Tumors

Disease Site: Breast

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CLINICAL TRIAL 21622

A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients with Advanced Hematologic and Solid Tumor Malignancies

Disease Site: Breast, Hodgkin's Lymphoma, Leukemia, other

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CLINICAL TRIAL 21636

A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors

Disease Site: Breast, Colon, Prostate, Urinary Bladder

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CLINICAL TRIAL 21673

A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety ofHER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy(FLAMINGO-01)

Disease Site: Breast

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CLINICAL TRIAL 21701

A Phase 1/1b Dose Escalation/Expansion Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors

Disease Site: Any Site, Breast, Cervix, Esophagus, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung, Other Digestive Organ, Ovary

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CLINICAL TRIAL 21757

Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer

Disease Site: Breast

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CLINICAL TRIAL 21899

Phase Ib Expansion Study of CX-5461 in Patients with Solid Tumours and BRCA2 and/or PALB2 Mutation

Disease Site: Breast, Other Female Genital, Ovary, Pancreas, Prostate

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CLINICAL TRIAL 21937

A Prospective, Multi-Center, Randomized, Double-Arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery

Disease Site: Breast

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CLINICAL TRIAL 22102

A Phase 1b, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants with Solid Tumors

Disease Site: Breast, Other Female Genital, Ovary

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CLINICAL TRIAL 90015

Phase 1 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination with a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects with Advanced Refractory Solid Tumor Malignancies

Disease Site: Breast, Lung, Melanoma, skin, Ovary, Pancreas, Urinary Bladder

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CLINICAL TRIAL 20479

Efficacy of SOAR (Survivors Overcoming and Achieving Resiliency) Survivorship Workshop for Breast Cancer Survivors

Disease Site: Breast

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CLINICAL TRIAL 16933

Older Breast Cancer Patients: Risk For Cognitive Decline

Disease Site: Breast

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CLINICAL TRIAL 19209

Combined Imaging and Blood Biomarkers for Breast Cancer Diagnosis

Disease Site: Breast

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CLINICAL TRIAL 20335

Physician Initiated Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

Disease Site: Breast

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CLINICAL TRIAL 21448

Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer

Disease Site: Breast, Brain metastasis

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CLINICAL TRIAL 21589

BASECAMP-1: An Observational Study Obtaining Solid Tumor Tissue from Subjects with Primary Surgical Resection and Leukapheresis for CAR T-Cell Therapy Manufacturing

Disease Site: Breast, Colon, Esophagus, Lip, Oral Cavity and Pharynx, Lung, Ovary, Pancreas, Rectum, Stomach

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CLINICAL TRIAL 21610

The Influence of Psychosocial Factors on Opioid Decision-Making among Breast Cancer Survivors

Disease Site: Breast

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CLINICAL TRIAL 21760

Nutrition and Lifestyle Needs and Behaviors After Breast Cancer Diagnosis

Disease Site: Breast

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CLINICAL TRIAL 22157

A Mixed-Methods Study to Inform the Use of Patient Education and Digital Technology to Increase the Racial/Ethnic Diversity of Clinical Trial Participants

Disease Site: Breast

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CLINICAL TRIAL 19000

Evaluation of Anti-Her2 and Anti-Her3 T-Helper Response in Primary Breast Cancer

Disease Site: Breast - Female

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CLINICAL TRIAL 21452

Evaluating Gut Microbiome As A Biomarker Of Pathological Complete Response In Patients With Early Triple Negative Breast Cancer - A Pilot Study (TCC)

Disease Site: Breast

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