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Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis

Jacksonville, FL
- See Details
Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study
This is a prospective, pilot, single arm study to evaluate the incidence of IIC in patients with solid malignancies receiving VSL#3 and ICIs. Given the fact that the effects of over-the-counter probiotics in reducing the risks of IIC remains largely unknown. Given that this is a small pilot study to generate preliminary data, there will be no randomization in this trial. The results of this trial will provide a foundation for the future development of larger definitive randomized controlled trials. Patients with solid malignancy who will be receiving ICI as per standard of care will be enrolled in this trial. Patients will receive VSL#3® 450B sachets probiotics, which will be provided as part of this trial, at least 3 days but preferably 1-2 weeks prior to starting on ICIs. Patients will be followed per standard of care during ICI treatment and continue VSL#3 for 12 more weeks while on ICI. Patients will complete dietary questionnaire and have research blood draws and stool collections at baseline prior to starting VSL#3 and 3 additional time points. Adherence to the probiotic schedule will be captured in a study diary. Adverse events as well as incidence and severity of IIC will be graded using NCI CTCAE version 5. Patients will have imaging performed per standard of care.

Primary Goal

To evaluate the incidence of immune checkpoint inhibitors (ICI)-induced colitis (IIC) in patients with solid malignancies receiving over-the-counter multi-strain probiotic blend and ICIs in both cohorts: (1) anti-CTLA-4 +/- anti-PD-1/PD-L1, and (2) anti-PD-1/PD-L1 +/- chemo.

Secondary Goals

To evaluate the safety of multi-strain probiotic blend in cancer patients receiving ICIs.

To evaluate the clinical outcomes related to IIC, including the incidence of IIC, hospitalization, treatment delays, and administration of immunosuppressants.

Exploratory Goals

To evaluate changes in gut microbiome with ICIs and multi-strain probiotic blend.

To evaluate changes in immune response with ICIs and multi-strain probiotic blend.
Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Contact us for the latest status
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Site IRB:
Jacksonville, Florida: 21-012363

NCT ID:
NCT06508034

Sponsor Protocol Number:
MC210304
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY)

Rochester, MN
- See Details
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY)
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Open for enrollment
View complete study & contact information

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Site IRB:
Rochester, Minnesota: 20-009787

NCT ID:
NCT01042379

Sponsor Protocol Number:
097517

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

See Details

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1/2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Scottsdale/Phoenix, Ariz.	Open for enrollment
Jacksonville, Fla.	Open for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 23-007173
- Scottsdale/Phoenix, Arizona: 23-007173
- Jacksonville, Florida: 23-007173
NCT ID:
NCT05563220
Sponsor Protocol Number:
STML-ELA-0222

Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

Scottsdale/Phoenix, AZ
- See Details
Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

The purpose of this study is to determine freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor at 3 years.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Open for enrollment
View complete study & contact information

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Site IRB:
Scottsdale/Phoenix, Arizona: 24-010140

NCT ID:
NCT01766297

Sponsor Protocol Number:
BRE007-12

A Study to Evaluate Immune-related Biomarkers for Pathological Response in Stage II-III HER2-positive Breast Cancer

Jacksonville, FL, Rochester, MN, Scottsdale/Phoenix, AZ

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A Study to Evaluate Immune-related Biomarkers for Pathological Response in Stage II-III HER2-positive Breast Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to evaluate invasive disease-free survival (iDFS) of multi-epitope HER2 vaccine vs. placebo in combination with ado-trastuzumab emtansine (TTT-DM1) in patients with stage II-III HER2+ breast cancer with residual disease post-neoadjuvant chemotherapy, and to evaluate the safety of multi-epitope HER2 vaccine given concurrently with T-DM1 maintenance therapy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment
Rochester, Minn.	Open for enrollment

Print study details

Site IRB:
- Scottsdale/Phoenix, Arizona: 18-009483
- Jacksonville, Florida: 18-009483
- Rochester, Minnesota: 18-009483
NCT ID:
NCT04197687
Sponsor Protocol Number:
MC1835-ACCRU-BR-1701

MC230302

Jacksonville, FL
- See Details
MC230302
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study
This is a prospective, phase II trial to assess feasibility of patients undergoing NSM willingness to be randomized to neurotization or not. Feasibility is to be established in preparation for a larger, multi-site randomized prospective trial aimed at determining if neurotization improves objective and subjective patient outcomes. Patients undergoing NSM through an inframammary incision with prosthetic-based reconstruction will be randomized to undergo neurotization of the NAC (intervention) or not (control).

Feasibility will be defined as the accrual of 7 patients within a year (or 14 patients within 2 years).

Hypothesis: Patients undergoing NSM will be willing to enroll in a randomized trial to determine if neurotization improves patient-reported satisfaction outcomes and improves sensation, compared with nipple sparing mastectomy without neurotization.

1. Primary Objective

To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization.

2. Secondary Objectives

To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization.

To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization.

To determine rate of mastectomy skin flap necrosis following NSM via the SKIN score.
Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Open for enrollment
View complete study & contact information

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Site IRB:
Jacksonville, Florida: 23-004411

NCT ID:
NCT06153836

Sponsor Protocol Number:
MC230302
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer

Rochester, MN
- See Details
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  1/2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

The purpose of this study is to investigate the safety, effectiveness, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by effectiveness that will be assessed from fluorescence imaging observations and data.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Contact us for the latest status
View complete study & contact information

Print study details
Site IRB:
Rochester, Minnesota: 23-003574

NCT ID:
NCT05900986

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Contact us for the latest status	View complete study & contact information

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

See Details

Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for Locally Advanced or Metastatic ER+/HER2− Breast Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 23-003926
- Jacksonville, Florida: 23-003926
- Scottsdale/Phoenix, Arizona: 23-003926
NCT ID:
NCT05696626
Sponsor Protocol Number:
SMX 22-002

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

See Details

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

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Contact us for the latest status	View complete study & contact information
Rochester, Minn.	Contact us for the latest status
Scottsdale/Phoenix, Ariz.	Contact us for the latest status

Print study details

Site IRB:
- Jacksonville, Florida: 24-011564
- Rochester, Minnesota: 24-011564
- Scottsdale/Phoenix, Arizona: 24-011564
NCT ID:
NCT06435429
Sponsor Protocol Number:
JZP598-303

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

See Details

Trial of 225Ac-DOTATATE (RYZ101) Alone and with Pembrolizumab in Subjects with ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs (TRACY-1)

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1/2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 24-010409
- Jacksonville, Florida: 24-010409
- Scottsdale/Phoenix, Arizona: 24-010409
NCT ID:
NCT06590857
Sponsor Protocol Number:
RYZ101-201

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Search Results 31-40 of 104 for breast cancer

Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY)

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

A Study to Evaluate Immune-related Biomarkers for Pathological Response in Stage II-III HER2-positive Breast Cancer

MC230302

LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer

Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for Locally Advanced or Metastatic ER+/HER2− Breast Cancer

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

Trial of 225Ac-DOTATATE (RYZ101) Alone and with Pembrolizumab in Subjects with ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs (TRACY-1)

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