Metastatic Breast Cancer Clinical Trials
Many individuals with metastatic breast cancer participate in clinical trials to access new treatments that aren’t yet available in other settings. For instance, some patients elect to try novel immunotherapies and hormone-based therapies by enrolling in clinical studies. At the same time, researchers can determine if the therapies under study have the potential to become the future "gold standard" of breast cancer treatment.
At Moffitt Cancer Center, we approach clinical trials in the same way that we approach other types of treatment. Our oncologists:
- Carefully evaluate each patient’s diagnosis to determine if he or she might be a good candidate for any of our open trials
- Provide each patient with the detailed information he or she needs to decide whether to participate in a trial
- Monitor the patient’s progress throughout the trial, making any modifications that might be beneficial (such as increasing or decreasing the dosage of a particular medication) in order to help ensure the best possible outcome
- Take into account the patient’s quality of life, recommending any supportive care therapies that might be helpful or recommending that a patient withdraw from a trial if his or the tumor is not responding to the treatment
Through our clinical trials, Moffitt has helped thousands of patients find new sources of hope in their fight against cancer. Many of these individuals have complex diagnoses, such as metastatic breast cancer, that were once thought to have limited treatment options. As part of our commitment to improving outcomes for every individual with cancer, we’ve positioned ourselves firmly at the forefront of innovative research.
If you’d like to find out if you are a candidate for one of Moffitt’s metastatic breast cancer clinical trials, call 1-813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form online. You do not need a physician’s referral to make an appointment at Moffitt.
-
Clinical Trials
CLINICAL TRIAL 16933
Older Breast Cancer Patients: Risk For Cognitive Decline
Condition: Breast
Intervention:
CLINICAL TRIAL 19000
Evaluation of Anti-Her2 and Anti-Her3 T-Helper Response in Primary Breast Cancer
Condition: Breast
Intervention: Not Applicable ()
CLINICAL TRIAL 19209
Combined Imaging and Blood Biomarkers for Breast Cancer Diagnosis
Condition: Healthy Subjects
Intervention:
CLINICAL TRIAL 19646
Prospective Observational Cohort Study of Patients with Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
Condition: Breast
Intervention: Carvedilol (); Not Applicable ()
CLINICAL TRIAL 20030
TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Positive Breast Cancer
Condition: Breast
Intervention: Not Applicable ()
CLINICAL TRIAL 20487
Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease
Condition: Breast
Intervention: Herceptin (Trastuzumab); Pertuzumab (); Radiotherapy (); Trastuzumab (); rhuMAb HER2 (Trastuzumab)
CLINICAL TRIAL 20899
Phase I/II Study of Stereotactic Radiation and Abemaciclib with or without Imlunestrant in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases (STRONG Trial)
Condition: Breast
Intervention: Abemaciclib (); Endocrine Therapy (); Imlunestrant (); LY2835219 (Abemaciclib); Radiotherapy ()
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)
Condition: Breast
Intervention: Adriamycin (doxorubicin); DC1 Vaccine (); Neulasta (pegfilgrastim); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Taxol (paclitaxel); carboplatin (); cyclophosphamide (); cytoxan (cyclophosphamide); paclitaxel (); pegfilgrastim ()
CLINICAL TRIAL 20915
Neoadjuvant Therapy of HER2 directed Dendritic Cell (DC1) vaccine Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients with HER-2 Positive Breast Cancer (NATASHA trial)
Condition: Breast
Intervention: DC1 Vaccine (); Herceptin (Trastuzumab); Pertuzumab (); Taxol (paclitaxel); Trastuzumab (); paclitaxel (); rhuMAb HER2 (Trastuzumab)
CLINICAL TRIAL 21093
Phase 1/1b/2 Multicenter, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 as a Single Agent and in Combination in Patients with Metastatic or Locally Advanced (Inoperable) RSK2+ Breast Cancer
Condition: Breast
Intervention: Faslodex (fulvestrant); PMD-026 (); fulvestrant ()
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
Condition: Breast
Intervention: CD4+ T Cells (); DC1 Vaccine (); Herceptin (Trastuzumab); Pepinemab (VX15/2503); Trastuzumab (); cyclophosphamide (); cytoxan (cyclophosphamide); rhuMAb HER2 (Trastuzumab)
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
Condition: Immunotherapy
Intervention:
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)
Condition: Breast
Intervention: GLSI-100 (); Placebo ()
CLINICAL TRIAL 21676
Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan with Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer with Brain Metastases (TARGET-TNBC)
Condition: Breast
Intervention: Sacituzumab Govitecan (); Zimberelimab ()
CLINICAL TRIAL 21757
Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer
Condition: Breast
Intervention: Radiotherapy ()
CLINICAL TRIAL 21899
Phase Ib Expansion Study of CX-5461 in Patients with Solid Tumours and BRCA2 and/or PALB2 Mutation
Condition: Multiple
Intervention: CX-5461 ()
CLINICAL TRIAL 22102
A Phase 1b, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants with Solid Tumors
Condition: Multiple
Intervention: XMT-1660 ()
CLINICAL TRIAL 17268-B
I-SPY 2.2 TRIAL - Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2
Condition: Breast
Intervention: AKTi (); AMP-514 (Durvalumab); ARV-471 (); ARX-788 (); Abemaciclib (); Adriamycin (doxorubicin); Cemiplimab (); DAN-222 (); Datopotamab Deruxtecan (); Dostarlimab (); Durvalumab (); Femara (Letrozole); GSK5733584 (); Herceptin (Trastuzumab); LY2835219 (Abemaciclib); Lasofoxifene (); Letrozole (); MEDI4736 (Durvalumab); Niraparib (); PD-1 (); PD-L1 (); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pertuzumab (); REGN2810 (Cemiplimab); Rilvegostomig (); Sarilumab (); T-Dxd (); TSR-042 (Dostarlimab); Taxol (paclitaxel); Taxotere (docetaxel); Trastuzumab (); VV1 (); Z-endoxifen (); Zanidatamab (); carboplatin (); cyclophosphamide (); cytoxan (cyclophosphamide); docetaxel (); doxorubicin (); paclitaxel (); rhuMAb HER2 (Trastuzumab)
CLINICAL TRIAL 22305
First-in-Human Study of STX-478, a Mutant-Selective PI3Ka Inhibitor as Monotherapy and in Combination with Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Condition: Multiple
Intervention: 772256 (Palbociclib); Abemaciclib (); Anastrozole (); Arimadex (Anastrozole); Aromasin (Exemestane); Exemestane (); Faslodex (fulvestrant); Femara (Letrozole); Imlunestrant (); LEE011 (Ribociclib); LY2835219 (Abemaciclib); Letrozole (); Palbociclib (); Ribociclib (); STX478-101 (); fulvestrant ()
CLINICAL TRIAL 22356
A Modular Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimistation, and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients with Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer
Condition: Breast
Intervention: 772256 (Palbociclib); Abemaciclib (); Aromasin (Exemestane); EP0062 (); Elacestrant (); Exemestane (); Faslodex (fulvestrant); LEE011 (Ribociclib); LY2835219 (Abemaciclib); Palbociclib (); Ribociclib (); everolimus (RAD001); fulvestrant ()
CLINICAL TRIAL 22515
Genomic Alterations of PI3K Pathway in HER2-Positive Breast Cancer
Condition: Breast
Intervention:
CLINICAL TRIAL 22617
A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive Metastatic Breast Cancer
Condition: Breast
Intervention: Abemaciclib (); DS-8201a (Trastuzumab Deruxtecan); Faslodex (fulvestrant); LEE011 (Ribociclib); LY2835219 (Abemaciclib); Ribociclib (); Sacituzumab Govitecan (); Taxotere (docetaxel); Trastuzumab Deruxtecan (); Xeloda (capecitabine); capecitabine (); cyclophosphamide (); cytoxan (cyclophosphamide); docetaxel (); fulvestrant ()
CLINICAL TRIAL 22706
A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination with Other Anticancer Therapies in Solid Tumors
Condition: Breast
Intervention: Disitamab Vedotin (); Tucatinib ()
CLINICAL TRIAL 23142
Precision DC: Personalized Neoantigen Dendritic Cell Vaccine Pilot Trial for High Risk Triple Negative Breast Cancer after Neoadjuvant Therapy
Condition: Breast
Intervention: DC1 Vaccine ()
CLINICAL TRIAL 23161
Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing Metastatic Breast Cancer
Condition: Breast
Intervention: DC1 Vaccine (); Elacestrant ()
CLINICAL TRIAL 23179
Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients Throughout Florida
Condition: Multiple
Intervention:
CLINICAL TRIAL 23249
PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial
Condition: Breast
Intervention: ALX148 (); Cemiplimab (); REGN2810 (Cemiplimab); T-Dxd (); Tucatinib (); Vidutolimod (); Zanidatamab ()
CLINICAL TRIAL 23250
Randomized phase 2 clinical trial of nab-paclitaxel + durvalumab (MEDI4736) + tremelimumab + neoantigen vaccine vs. nab-paclitaxel + durvalumab (MEDI4736) + tremelimumab in patients with metastatic triple negative breast cancer
Condition: Breast
Intervention: AMP-514 (Durvalumab); CP-675,206 (tremelimumab); Durvalumab (); Gemzar (gemcitabine); MEDI4736 (Durvalumab); Nab-paclitaxel (Abraxane); Neoantigen (); Paraplatin (carboplatin); Sacituzumab Govitecan (); carboplatin (); gemcitabine (); tremelimumab ()
CLINICAL TRIAL 23255
An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in Patients with Advanced Solid Tumors
Condition: Multiple
Intervention: Olaparib (Lynparza); XL309 ()
CLINICAL TRIAL 23340
A Phase 2 study of alisertib in combination with endocrine therapy in patients with HR+, HER2-negative recurrent or metastatic breast cancer
Condition: Breast
Intervention: Alisertib (MLN8237); Anastrozole (); Arimadex (Anastrozole); Aromasin (Exemestane); Exemestane (); Faslodex (fulvestrant); Femara (Letrozole); Letrozole (); Tamoxifen (); fulvestrant ()
CLINICAL TRIAL 23366
Patient-Reported Outcomes in Recipients of Intralesional Vaccines for Breast Cancer at Moffitt Cancer Center
Condition: Breast
Intervention:
CLINICAL TRIAL 23367
First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and with Endocrine Therapy in Subjects with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer
Condition: Breast
Intervention: RGT419B ()
CLINICAL TRIAL 23378
A phase 1/2, first-in-human study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of AVZO-021 as a single agent and in combination therapy in patients with advanced solid tumors
Condition: Breast
Intervention: 772256 (Palbociclib); AVZO-021 (); Abemaciclib (); Faslodex (fulvestrant); Femara (Letrozole); LEE011 (Ribociclib); LY2835219 (Abemaciclib); Letrozole (); Palbociclib (); Paraplatin (carboplatin); Ribociclib (); Sacituzumab Govitecan (); carboplatin (); fulvestrant ()
CLINICAL TRIAL 23393
A Phase 2, Open-Label Study of PCS6422 with Capecitabine in Patients with Advanced or Metastatic Breast Cancer
Condition: Breast
Intervention: PCS6422 (); Xeloda (capecitabine); capecitabine ()
CLINICAL TRIAL 23426
MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Study)
Condition: Breast
Intervention: Not Applicable ()
CLINICAL TRIAL 23433
Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer following Neoadjuvant Chemotherapy and Surgery
Condition: Breast
Intervention:
CLINICAL TRIAL 23480
A Phase 1/2 Study of a Selective FGFR2/3 Inhibitor, CGT4859, in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors Harboring FGFR2 and/or FGFR3 Genetic Alterations
Condition: Multiple
Intervention: CGT4859 ()
CLINICAL TRIAL 23521
High Intensity Interval Training: Optimizing Exercise Therapy to Mitigate Cardiovascular Disease Risk Following Breast Cancer Chemotherapy
Condition: Breast
Intervention:
CLINICAL TRIAL 23549
A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination with Atezolizumab in Patients with Advanced Solid Tumors
Condition: Thoracic
Intervention: Atezolizumab (Tecentriq); VET3-TGI ()
CLINICAL TRIAL 23585
A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects with Advanced Solid Tumors (The BREAKER-101 Trial)
Condition: Breast
Intervention: Avastin (Bevacizumab); BBO-10203 (); Bevacizumab (); FOLFOX (); Faslodex (fulvestrant); Herceptin (Trastuzumab); LEE011 (Ribociclib); Ribociclib (); Trastuzumab (); fulvestrant (); rhuMAb HER2 (Trastuzumab)
CLINICAL TRIAL 23513
Assessing the DCIS Test Effect on Treatment Strategies in Patients with Ductal Carcinoma in Situ After Breast-Conserving Surgery
Condition: Breast
Intervention:
CLINICAL TRIAL 23572
Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)
Condition: Breast
Intervention: Anastrozole (); Arimadex (Anastrozole); Aromasin (Exemestane); Elacestrant (); Exemestane (); Femara (Letrozole); Letrozole (); Tamoxifen ()
CLINICAL TRIAL 23553
DENALI-1: A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod CAR T, in Heterozygous HLA A*02 Adults with Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA A*02 Expression.
Condition: Immunotherapy
Intervention: A2B395 (); MESNA (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
CLINICAL TRIAL 23559
Aging, DNA Methylation, and Incident Cardiovascular Disease in Breast Cancer Survivors
Condition: Breast
Intervention:
CLINICAL TRIAL 23571
The MIND-BC Study: MIND Diet for Breast Cancer Cognition
Condition: Breast
Intervention:
CLINICAL TRIAL 23697
A Phase 1/1b, Open-label, Multicenter, First-in-human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of VVD-159642, a RAS-PI3KA Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors
Condition: Multiple
Intervention: AMG 510 (Sotorasib); GSK1120212 (Trametinib); Sotorasib (); Trametinib (); VVD-159642 ()
CLINICAL TRIAL 23719
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients with Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Condition: Breast
Intervention: 772256 (Palbociclib); Femara (Letrozole); Inavolisib/Placebo (); Letrozole (); Palbociclib ()
CLINICAL TRIAL 23766
A First-in-Human Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FID-022 as Monotherapy in Patients with Advanced Solid Tumors
Condition: Multiple
Intervention: FID-022 ()