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A Study Of Effect Of Megakaryocytes And Platelets In Breast Cancer
La Crosse, WI
The purpose of this study is to determine how megakarocytes (cells in the bone marrow responsible for making platelets, which are necessary for blood clotting) affect the survivial and growth/division patterns of breast cancer stem cells, and the effects of breast cancer cells on megakatocyte survival and function. Through chart review, the study team will look at the relationship different blood components and different breast cancer diagnosis.
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Phase III Study To Assess AZD9833+ CDK4/6 Inhibitor In HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.
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Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving brostallicin together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving brostallicin together with cisplatin works in treating patients with metastatic breast cancer.
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VS-6766+Abema+Fulv In Met HR+/HER- BC
Rochester, MN
This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer.
The names of the study drugs involved in this study are:
VS-6766
Abemaciclib
Fulvestrant
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MC1733, Phase I Trial Of Intratumoral Administration Of A Measles Virus Derivative Expressing The Helicobacter Pylori Neutrophil-activating Protein (NAP) (MV-s-NAP) In Patients With Metastatic Breast Cancer
Rochester, MN
To determine the maximally tolerated dose (MTD) of intratumoral administration of an Edmonston strain measeles virus genetically engineered to express NAP (MV-s-NAP) in patients with metastatic breast cancer; to determine the safety and toxicity of on-time and serial administration of MV-s-NAP in patients with metastic breast cancer.
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Testing Whether Treating Breast Cancer Metastases With Surgery Or High-Dose Radiation Improves Survival
Jacksonville, FL; Rochester, MN
This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic ...
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Study To Evaluate The Safety And Effectiveness Of Localizing Biopsy-Proven Metastatic Axillary Lymph Nodes In Women With Breast Cancer Using Magseed Markers As An Alternative To The Current Practice Of Placing Radioactive Seed Markers
Rochester, MN
The purpose of this study is to evaluate if Magseed is a viable alternative to radioactive seed as a localization method for biopsy proven metastatic breast carcinoma following neoadjuvant chemotherapy.
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Primary Breast Oligoprogressive Metastatic Disease Treated With Stereotactic Body Radiation Therapy To Obviate The Need To Change Systemic Therapy (BOSS)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response, to assess the role of circulating tumor DNA (ctDNA) in stratifying outcomes (and corresponding treatment paradigms) for patients with oligoprogressive breast cancer, and to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response. The future aim of this work is to develop a large, cooperative group trial testing the role of local therapy ...
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Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy Of BTX-9341 In Advanced And/or Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study includes a dose escalation part (Part A) where small groups of participants will receive increasing doses of BTX-9341 or BTX-9341 + fulvestrant followed by a dose expansion part (Part B) where participants will receive the dose of BTX-9341 selected in Part A + fulvestrant.
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Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter, Phase 1b/2 trial. The purpose of phase 1b part of the trial aims to determine the recommended phase II dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, and ribociclib. The Phase 2 part of the trial will evaluate the effectiveness and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.
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A Study Of TAS-120 In Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the antitumor activity of TAS-120 as monotherapy or in combination with Fulvestrant in the treatment of patients with metastatic breast cancer harboring fibroblast growth factor receptor (FGFR) amplifications.
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ACT-MBC: A Study Of Circulating Tumor Cells (CTCs) In Metastatic Breast Cancer (MBC) (ACT-MBC)
Albert Lea, MN; Eau Claire, WI; Mankato, MN; Rochester, MN
Collection of blood to track serial circulating tumor cells (CTCs) in subjects with metastatic breast cancer (MBC). Study will also collect data from investigators are Mayo Clinic and the Mayo Clinic Health Systems to determine effectiveness of the proposed process.
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Alisertib With Or Without Fulvestrant In Treating Patients With Locally Advanced Or Metastatic, Endocrine-Resistant Breast Cancer
Rochester, MN
This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer.
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A Study To Evaluate Estrogen Receptor (ER) Reactivation Therapy For Breast Cancer
Rochester, MN
The purpose of this study is to evaluate whether or not treatment with alternating 17B-estradiol / anti-estrogen therapies on a defined 8-week / 16-week schedule will more effectively prevent cancer growth than continuous treatment with either type of therapy in patients with metastatic anti-estrogen-resistant ER+ breast cancer.
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A Study To Analyze Symptoms And Quality Of Life Issues In Women Living With Metastatic Breast Cancer
Jacksonville, FL
The purpose of this study is to gain an understanding of the lived experiences of symptoms and quality of life issues experienced by women with metastatic breast cancer.
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Collection Of Specimens And Clinical Data For Patients With Recurrent Or Metastatic Breast Cancer Or Male Breast Cancer
Rochester, MN
The purpose of this study is to collect blood samples and fresh tissue from biopsies of metastatic lesions from Mayo Clinic patients with metastatic breast cancer. The biospecimens will be used for analysis of genetic alterations in germline and tumor DNA and for tracking of response to therapy using blood-based liquid biopsy approaches.
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A Study To Evaluate LY3484356 Alone Or Combined With Anticancer Therapies To Treat Patients With Breast Or Endometrial Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to identify the recommended Phase 2 dose (RP2D) of LY3484356 administered as monotherapy and in combination with other anticancer therapies in patients with locally advanced or metastatic ER+ breast cancer or ER+ recurrent, persistent, or metastatic endometrial endometrioid cancer (EEC).
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Efficacy And Safety Of Tislelizumab In Combination With Fruquintinib In Participants With Selected Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this research is to see how well fruquintinib works in combination with tislelizumab in participants with metastatic colorectal cancer (mCRC).
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Study Of Magrolimab Combination Therapy To Treat Unresectable, Locally Advanced Or Metastatic Triple-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of the Safety-Run-in Cohort 1 of this study is to evaluate the safety, tolerability, and recommended Phase 2 dose of magrolimab in combination with nab-paclitaxel or paclitaxel. In Phase 2 Cohort 1, the study will compare the efficacy of magrolimab in combination with nab-paclitaxel or paclitaxel versus nab-paclitaxel or paclitaxel alone as determined by
progression-free survival (PFS) by investigator assessment
The primary purpose of the Safety-Run-in Cohort 2 of this study is to evaluate the safety, tolerability, and recommended Phase 2 dose of magrolimab in combination with sacituzumab govitecan. In Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2) the study will evaluate the efficacy of magrolimab in combination ...
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DiviTum Biomarker Assay For Efficacy In HR+ Metastatic Breast Cancer Patients
Jacksonville, FL
The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor.
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A Study To Evaluate Hormone Concentrations In Patients With Metastatic Cancer
Rochester, MN
The purpose of this study is to correlate the parathyroid hormone-related peptide (PTHrp) levels in the current and new assays in patients with known disease and calcium status.
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Niraparib In Combination With Trastuzumab In Metastatic HER2+ Breast Cancer
Rochester, MN
The purpose of this study is to evaluate a new treatment using a potent Poly polymerase (PARP) inhibitor known as Niraparib. Niraparib will be combined with trastuzumab, a HER2-targeted agent, to evaluate the safety and tolerability in patients with metastatic HER2 positive breast cancer. It is anticipated that the combination of drugs will improve survival and have few side effects.
The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival. Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and fast-growing subtype of breast cancer.
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A Study Of Tucatinib Or Placebo With Trastuzumab And Pertuzumab For Metastatic HER2+ Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body ...
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A Study of Pertuzumab Combined with High-Dose Trastuzumab for Patients who have Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer with Central Nervous System Progression After Radiation Therapy
Jacksonville, FL
This study will examine the safety and effectiveness of pertuzumab combined with high-dose trastuzumab in adult patients who have HER2-positive breast cancer that has spread to the central nervous system and the brain following radiation therapy.
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Lasofoxifene And Abemaciclib To The Combination Of Fulvestrant And Abemaciclib For Locally Advanced Or Metastatic ER+/HER2− Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the PFS of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer with an ESRl mutation.
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Mapping Patient-Centered Decision-Making In
Metastatic Cancer Care Delivery In Florida
Jacksonville, FL
The purpose of this study is to explore and describe metastatic breast cancer (mBC) and metastatic urothelial cancer (mUC) patient perspectives on and experiences with treatment decision-making, including how patients evaluate various treatment options, associated benefits, risks and drawbacks as well as how perceptions and preferences change over time.
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Cisplatin With Or Without Veliparib In Treating Patients With Recurrent Or Metastatic Triple-Negative And/or BRCA Mutation-Associated Breast Cancer With Or Without Brain Metastases
Eau Claire, WI; La Crosse, WI; Rochester, MN
This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer that has come back or has or has not spread to the brain. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin is more ...
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Estradiol In Treating Patients With ER Beta Positive, Triple Negative Locally Advanced Or Metastatic Breast Cancer
Jacksonville, FL; Rochester, MN
The purpose of this trial is to determine how well estradiol works in treating patients with estrogen receptor beta (ER beta) positive, triple negative breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Hormone receptors like ER beta allow the body to respond appropriately to hormones. Triple negative means that the breast cancer does not express other hormone receptors called ER alpha, progesterone, and HER2. In some people with triple negative breast cancer, ER beta is overexpressed. Tumor cells that overexpress ER beta grow slower in the laboratory and ...
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Study Of Trastuzumab Deruxtecan (T-DXd) Vs Investigator's Choice Chemotherapy In HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
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A Study To Evaluate Intravenous TAEK-VAC-HerBy Vaccine Alone And In Combination Treatment In Patients With Advanced Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purposes of this study are to is to assess safety and tolerability of IV administration of TVH vaccine alone and in combination with HER2 antibodies in patients with advanced cancer.
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A Study To Evaluate TVB-2640 And Trastuzumab Plus Paclitaxel Or Endocrine Therapy For Treating Patients With HER2 Positive Advanced Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well FASN inhibitor TVB-2640 and trastuzumab plus either paclitaxel or endocrine therapy with an aromatase inhibitor work in treating patients with HER2 positive breast cancer that has spread to other places in the body. FASN inhibitor TVB-2640 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and trastuzumab, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Endcocrine therapy helps reduce ...
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Safety And Preliminary Efficacy Of OBT076 In Recurrent/Metastatic CD205+ Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safety and tolerability of OBT076, and to define the maximum tolerated dose (MTD) and/or the RP2D of OBT076.
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Breast MR
Rochester, MN
The purpose of this study is to examine the capability of contrast enhanced breast PCD-CT in staging breast cancer within the breasts and regional nodes of human subjects. Developing and using a PCD-CT imaging technique and postprocessing algorithms, dedicated for breast cancer detection.
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A Study Of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) In Postmenopausal Women With Breast Cancer
Rochester, MN
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.
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Immune Archetecture Of Stage 4 Triple-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to identify who may or may not be a good fit for specific cancer treatments. Investigators will be attempting to identify markers that may make someone resistant to specific therapies in order to avoid harsh treatments that would not be effective or target more effective treatments at the offset.
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A Study Of Taxane, Trastuzumab, And Pertuzumab With Or Without Atezolizumab In Treating Metastatic Breast Cancer Patients
Eau Claire, WI; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with trastuzumab, pertuzumab, and atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving ...
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Cell Free DNA Analysis And Circulating Tumor Cell Characterization In Metastatic Breast Cancer
Rochester, MN
The objective of this study is to provide preliminary data to support the development of selected technologies for the efficient and reliable analyses of cell free DNA (cfDNA) and circulating tumor cells (CTCs) in the setting of metastatic breast cancer.
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A Study To Evaluate Lasofoxifene Versus Fulvestrant In Advanced Or Metastatic ER+/HER2− Breast Cancer Patients With An ESR1 Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the activity of lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2− breast cancer with an acquired ESR1 mutation and who have disease progression on an aromatase inhibitor (AI) in combination with a cyclin dependent kinase (CDK) 4/6 inhibitor. The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2−) breast cancer with an ESR1 mutation.
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Highly Selective CDK7 Inhibitor Q901 In Selected Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab
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STOP-HER2: Stopping Trastuzumab In HER2+ MBC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to see if anti-HER2 treatment be safely stopped in patients with HER2-positive metastatic breast cancer (MBC) that have had exceptional response to treatment. Exceptional response" is considered as cancer progression being controlled for three years or more since starting anti-HER2 treatment.
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A Study Of Tucatinib Plus Trastuzumab Deruxtecan In HER2+ Breast Cancer
Rochester, MN
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.
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A Randomized Phase III Trial Of Eribulin Compared To Standard Weekly Paclitaxel As First- Or Second-Line Therapy For Locally Recurrent Or Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a two arm Phase III trial in first and second-line HER2 negative patients with locally recurrent or metastatic breast cancer. The primary endpoint is overall survival (OS), and the objective is to test for the superiority of eribulin mesylate over standard weekly paclitaxel. Patients will be randomized between the experimental and control arm with equal allocation (1:1) within strata defined by prior adjuvant taxanes, hormone receptor status, and line of therapy. Subjects will continue protocol directed therapy until documentation of disease progression, development of unacceptable toxicity, or withdrawal of consent. Those who discontinue study treatment without radiological progression ...
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An Expanded Access Study of Iniparib Combined with Gemcitabine and Carboplatin for the Treatment of Breast Cancer
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to offer pre-approval drug access of iniparib combined with gemcitabine and carboplatin, in order to provide potential clinical benefit to patients who have ER-, PR-, and HER2-negative metastatic breast cancer.
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Phase Ib Study Of Axatilimab In Combination With Olaparib In BRCA1/2 And PALB2- Associated Metastatic HER2-negative Breast Cancer
Rochester, MN
This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer. The names of the study drugs involved in this study are: * Axatilimab (a type of antibody) * Olaparib (a type of PARP inhibitor)
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The BEACON Study (Breast Cancer Outcomes With NKTR-102)
Jacksonville, FL; Rochester, MN
The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.
The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.
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A Study to Evaluate ctDNA Diagnostics in Recurrent Breast Cancer Patients
Rochester, MN
The purpose of this study is to to establish a minimally-invasive blood based test for the detection of clinically actionable genetic changes in breast cancer patients.
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Adaptive Therapy With Capecitabine For Treatment Of Metastatic ER Positive, HER2 Negative Breast Cancer
Scottsdale/Phoenix, AZ
This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 ...
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Study Of Sacituzumab Govitecan-hziy And Pembrolizumab Versus Treatment Of Physician's Choice And Pembrolizumab In Patients With Previously Untreated, Locally Advanced Inoperable Or Metastatic Triple-Negative Breast Cancer (ASCENT-04)
Rochester, MN
The purpose of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
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A Study To Evaluate The Safety Of Lasofoxifene In Combination With Abemaciclib In Advanced Or Metastatic ER+/HER2− Breast Cancer With ESR1 Mutation
Jacksonville, FL; Rochester, MN
The purpse of this study is to evaluate the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2− breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.
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Testing The Addition Of An Anti-cancer Drug, ASTX727, To Chemotherapy (Paclitaxel) And Immunotherapy (Pembrolizumab) For Metastatic Triple-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety, side effects, and best dose of ASTX727 when given together with paclitaxel and pembrolizumab in patients with triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic).
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Randomized, Open Label, Clinical Study Of The Targeted Therapy, Palbociclib, To Treat Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
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A Phase I/II, Open-label, Multi-center Trial Of [177Lu]Lu-NeoB In Combination With Capecitabine In Adult Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression On Previous Endocrine Therapy In Combination With A CDK4/6 Inhibito
Rochester, MN
The purpose of this study is to determine the recommended doses (RD) and dosing regimens of [ 177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary antitumor activity of two different doses/regimens of [177Lu]Lu-NeoB in combination with capecitabine (dose optimization).
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Trial Of 225Ac-DOTATATE (RYZ101) Alone And With Pembrolizumab In Subjects With ER+, HER2-negative Unresectable Or Metastatic Breast Cancer Expressing SSTRs (TRACY-1)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended phase 2 dose (RP2D), the optimal treatment regimen and to evaluate preliminary efficacy of RYZ101 in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally advanced and unresectable or metastatic breast cancer.
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Phase Ib Study Of Axatilimab In Combination With Olaparib In BRCA1/2 And PALB2- Associated Metastatic HER2-negative Breast Cancer
Rochester, MN
This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer. The names of the study drugs involved in this study are: * Axatilimab (a type of antibody) * Olaparib (a type of PARP inhibitor)
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A Phase 3, Randomized, Open-label, Controlled Study Comparing The Efficacy And Safety Of Zanidatamab To Trastuzumab, Each In Combination With Physician’s Choice Chemotherapy, For The Treatment Of Participants With Metastatic HER2-positive Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy.
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A Study To Test Sacituzumab Govitecan Therapy In Patients With HER2-Negative Breast Cancer And Brain Metastases
Rochester, MN
The purpose of this study is to analyze the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as Trop-2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan may shrink the cancer in the brain and/or extend the time until the cancer gets worse.
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Pembrolizumab And Binimetinib In Treating Patients With Locally Advanced Or Metastatic Triple Negative Breast Cancer
Jacksonville, FL
This phase I/II trial studies the best dose of pembrolizumab and binimetinib and how well it works when giving together with pembrolizumab in treating patients with triple negative breast cancer that has spread to other parts of the body. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and binimetinib may work better in treating patients with triple negative breast cancer.
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A Study Of Alisertib In Combination With Endocrine Therapy In Patients With HR-positive, HER2-negative Recurrent Or Metastatic Breast Cancer (ALISCA-Breast1)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.
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Genetic Analysis In Blood And Tumor Samples From Patients With Advanced Or Metastatic Estrogen Receptor Positive And HER2 Negative Breast Cancer Receiving Palbociclib And Endocrine Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and endocrine therapy. Examine the genetic changes associated with the cancer and comparing the genetic material from the cancer tissue with the genetic material found in the blood may help doctors to develop customized treatment for breast cancer.
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Z-Endoxifen Hydrochloride in Treating Patients with Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to other places in the body (metastatic) or has come back at or near the same place as the original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells. Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use of estrogen by tumor cells.
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Avelumab With Binimetinib, Sacituzumab Govitecan, Or Liposomal Doxorubicin In Treating Patients With Stage IV Or Unresectable, Recurrent Triple Negative Breast Cancer
Rochester, MN
The purpose of this study is to evaluate how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent).
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A Study Of Pembrolizumab And Ruxolitinib Phosphate For Treating Patients With Metastatic Stage IV Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the side effects and best dose of ruxolitinib phosphate when given together with pembrolizumab for treating patients with stage IV triple negative breast cancer that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ruxolitinib phosphate together may work better in treating patients with stage IV triple negative breast cancer.
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A Study To Evaluate Tucatinib And Trastuzumab In Solid Tumors With HER2 Alterations
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant. The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.
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A Study To Investigate LYL797 In Adults With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC). The first part of the study will determine the safe dose for the next part of the study, and will enroll TNBC patients only. The second part of the study will test that dose in additional TNBC patients and NSCLC patients.
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Study Of TBio-6517, Given Intratumorally, Alone Or In Combination With Pembrolizumab, In Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) alone and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).
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A Trial To Evaluate The Safety Of GEN1046 In Patients With Malignant Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors.
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A Study To Evaluate Feasibility Of In Vivo Sensitivity Screen Using Direct Tumor Microinjection And FDG-PET In Patients With Relapsed/Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Or Stage IV Breast Cancer
Rochester, MN
The purpose of this study is to assess the safety of in vivo in host drug sensitivity testing in patients with breast cancer and patients with lymphoma (nodal, extranodal masses, or cutaneous lesions).
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A Study To Evaluate The Safety And Efficacy Of A2B395, An Allogeneic Logic-gated CAR T, In Participants With Solid Tumors That Express EGFR And Have Lost HLA-A*02 Expression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the recommended dose of A2B395 that is safe for patients * Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy ...
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A Study To Evaluate Circulating Tumor DNA (CtDNA) And Immunophenotyping As Potential Biomarkers In Patients Undergoing Regional Nodal Irradiation For Breast Cancer
Rochester, MN
The purpose of this study is to estimate the circulating tumor DNA (ctDNA)detection rate and mutational load in breast cancer patients with indications for regional nodal irradiation.
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Study Of The Bria-IMT Regimen And CPI Vs Physicians' Choice In Advanced Metastatic Breast Cancer. (BRIA-ABC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor \[Retifanlimab\], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.
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Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.
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Combination Study Of SV-BR-1-GM In Combination With INCMGA00012 And Retifanlimab
Jacksonville, FL
The purpose of this study is to evaluate SV-BR-1-GM in metastatic or locally recurrent breast cancer patients, in combination with the PD-1 inhibitor INCMGA00012 and the IDO inhibitor epacadostat. Patients who with advanced breast cancer who have failed prior therapies will be eligible to enroll in this study. The study will evaluate SV-BR-1-GM in combination with INCMGA00012 and epacadostat. Treatment cycles will be every 3 weeks with evaluations for tumor progression or response every 6-12 weeks.
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A Phase 1/2 Study Of CYT-0851 In B-Cell Malignancies And Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose for evaluation in these patients.
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Study Of SAR444881 Administered Alone And In Combination With Other Therapeutics In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Part 1 is comprised of three sub-parts: SAR444881 administered alone (Sub-Part 1A), SAR444881 administered in combination with pembrolizumab (Sub-Part 1B), and SAR444881 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of SAR444881 per indication are administered in combination with ...
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A Study Of SGN-B7H4V In Advanced Solid Tumors
Jacksonville, FL
The purpose of this study is to test the safety and side effects of a drug called SGN-B7H4V in participants with solid tumors. A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A ...
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Mayo Clinic Cancer Center Neuro-Oncology Program Registry And Biobank For The Study Of Nervous System Tumors
Rochester, MN
Biospecimen banks are a modern attempt to centralize collections of human blood and tissue samples along with health information and personal history. The Neuro-Oncology Program Registry and Biobank will be used for research purposes to increase our understanding of nervous system tumors.
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A Study To Evaluate Exercise For Cancer Patients At Risk Of Falling
Rochester, MN
The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.