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Search Results 1-10 of 53 for breast cancer

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Locations: Jacksonville, FL
Study status: Open/Status Unknown

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(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer

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

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(Z)-Endoxifen For The Treatment Of Premenopausal Women With 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:
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 open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part.

The PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50/50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries from making estrogen. This part will help determine the best dose of (Z)-endoxifen by measuring the drug levels in the blood and how long the body takes to remove it.

The Treatment Cohort has been simplified to a single study arm (Z)-endoxifen + goserelin. Up to 20 participants will be enrolled that have a baseline Ki-67 ≤ 10% and 45 participants will be enrolled that have a baseline Ki-67\>10%.

A key goal of the study is to see if (Z)-endoxifen can slow down or stop tumor growth as measured by a reduction in Ki-67 levels. Tumor tissue samples will be taken by breast biopsy after about 4 weeks of treatment to check levels of this biomarker. If the tumor shows signs of response, participants can continue treatment for up to 24 weeks or until they have surgery.

Study participation is up to 6 months (24 weeks of treatment) followed by surgery and a one-month follow up visit.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Contact us for the latest status	View complete study & contact information
Jacksonville, FL	Contact us for the latest status
Rochester, MN	Contact us for the latest status

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Site IRB:
22-011685
NCT ID:
NCT05607004
Sponsor Protocol Number:
ATOS-Z-201

Pre-Op / Post-Op Hypofractionation Radiotherapy In Breast Cancer

Scottsdale/Phoenix, AZ, Jacksonville, FL
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Pre-Op / Post-Op Hypofractionation Radiotherapy In 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 ths study is to determine the outcomes and toxicity profile of preoperative treatment including chemotherapy and hypofractionated radiotherapy for different breast cancer risk groups.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, AZ

Open for enrollment
View complete study & contact information

Jacksonville, FL

Contact us for the latest status

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Site IRB:
22-009070

NCT ID:
NCT06635980

Sponsor Protocol Number:
GMROA2234

A Study Of Elacestrant Versus Standard Endocrine Therapy In Women And Men With ER+,HER2-, Early Breast Cancer With High Risk Of Recurrence

Albert Lea, MN, Scottsdale/Phoenix, AZ, Eau Claire, WI, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN

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A Study Of Elacestrant Versus Standard Endocrine Therapy In Women And Men With ER+,HER2-, Early Breast Cancer With High Risk Of Recurrence

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 primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Albert Lea, MN	Open for enrollment	View complete study & contact information
Scottsdale/Phoenix, AZ	Open for enrollment
Eau Claire, WI	Open for enrollment
Jacksonville, FL	Open for enrollment
La Crosse, WI	Open for enrollment
Mankato, MN	Open for enrollment
Rochester, MN	Open for enrollment

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Site IRB:
24-012591
NCT ID:
NCT06492616
Sponsor Protocol Number:
STML-ELA-0422

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

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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

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
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 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).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Contact us for the latest status	View complete study & contact information
Jacksonville, FL	Contact us for the latest status
Rochester, MN	Contact us for the latest status

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Site IRB:
23-003894
NCT ID:
NCT05673200
Sponsor Protocol Number:
10546

Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25

Scottsdale/Phoenix, AZ, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN

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Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25

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 determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Open for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
La Crosse, WI	Closed for enrollment
Mankato, MN	Closed for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
24-000635
NCT ID:
NCT05879926
Sponsor Protocol Number:
NRG-BR009

Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy Of BTX-9341 In Advanced And/or Metastatic Breast Cancer

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

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Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy Of BTX-9341 In Advanced And/or 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
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 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Open for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
24-007855
NCT ID:
NCT06515470
Sponsor Protocol Number:
BTX-9341-101

Cognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors

Scottsdale/Phoenix, AZ, Eau Claire, WI, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN

See Details

Cognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors

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 stduy is to examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Contact us for the latest status	View complete study & contact information
Eau Claire, WI	Contact us for the latest status
Jacksonville, FL	Contact us for the latest status
La Crosse, WI	Contact us for the latest status
Mankato, MN	Contact us for the latest status
Rochester, MN	Contact us for the latest status

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Site IRB:
24-009311
NCT ID:
NCT05896189
Sponsor Protocol Number:
NRG-CC011

Tissue Reinforcement For Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)

Scottsdale/Phoenix, AZ, Jacksonville, FL
- See Details
Tissue Reinforcement For Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
- 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.
About this study

This record is for the Prospective treatment arm, the Retrospective cohort will have a seperate protocol and IRBe record.
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Prospective Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Retrospective Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. The Study Device is investigational, which means it has not yet been used nor approved by the FDA for this treatment. The data collected in this study will be compared to the data collected in the Retrospective Arm.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, AZ

Open for enrollment
View complete study & contact information

Jacksonville, FL

Open for enrollment

Print study details
Site IRB:
24-011255

NCT ID:
NCT06556654

Sponsor Protocol Number:
TBR 22-07

Study Of Sacituzumab Govitecan-hziy And Pembrolizumab Versus Treatment Of Physician's Choice In Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery And Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

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

See Details

Study Of Sacituzumab Govitecan-hziy And Pembrolizumab Versus Treatment Of Physician's Choice In Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery And Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

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 goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
23-010665
NCT ID:
NCT05633654
Sponsor Protocol Number:
GS-US-595-6184

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, FL

Open for enrollment
View complete study & contact information

Print study details
Site IRB:
23-004411

NCT ID:
NCT06153836

Sponsor Protocol Number:
MC230302

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

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Search Results 1-10 of 53 for breast cancer

(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer

Pre-Op / Post-Op Hypofractionation Radiotherapy In Breast Cancer

A Study Of Elacestrant Versus Standard Endocrine Therapy In Women And Men With ER+,HER2-, Early Breast Cancer With High Risk Of Recurrence

Testing The Addition Of An Anti-cancer Drug, ASTX727, To Chemotherapy (Paclitaxel) And Immunotherapy (Pembrolizumab) For Metastatic Triple-Negative Breast Cancer

Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25

Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy Of BTX-9341 In Advanced And/or Metastatic Breast Cancer

Cognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors

Tissue Reinforcement For Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)

Study Of Sacituzumab Govitecan-hziy And Pembrolizumab Versus Treatment Of Physician's Choice In Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery And Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

MC230302

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