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Search Results 1-10 of 20 for metastatic breast cancer

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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

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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

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

Adaptive Therapy With Capecitabine For Treatment Of Metastatic ER Positive, HER2 Negative Breast Cancer

Scottsdale/Phoenix, AZ
- See Details
Adaptive Therapy With Capecitabine For Treatment Of Metastatic ER Positive, HER2 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:
  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 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 negative breast cancer.

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

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Site IRB:
23-009851

NCT ID:
NCT06525766

Sponsor Protocol Number:
MC230303

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

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

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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
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

Print study details

Site IRB:
23-007173
NCT ID:
NCT05563220
Sponsor Protocol Number:
STML-ELA-0222

Phase Ib Study Of Axatilimab In Combination With Olaparib In BRCA1/2 And PALB2- Associated Metastatic HER2-negative Breast Cancer

Rochester, MN
- See Details
Phase Ib Study Of Axatilimab In Combination With Olaparib In BRCA1/2 And PALB2- Associated Metastatic HER2-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

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)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, MN

Open for enrollment
View complete study & contact information

Print study details
Site IRB:
25-006382

NCT ID:
NCT06488378

Sponsor Protocol Number:
24-155

Mayo Clinic Location	Status	Contact
Rochester, MN	Open for enrollment	View complete study & contact information

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
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

Print study details

Site IRB:
24-010409
NCT ID:
NCT06590857
Sponsor Protocol Number:
RYZ101-201

Evaluation Of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib In Locally Advanced Or Metastatic ER+/HER2- Breast Cancer With An ESR1 Mutation

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

See Details

Evaluation Of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib In Locally Advanced Or Metastatic ER+/HER2- Breast Cancer With An ESR1 Mutation

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 clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.

The main question the study aims to answer is:

• To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

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:
23-003926
NCT ID:
NCT05696626
Sponsor Protocol Number:
SMX 22-002

Mayo Clinic Location	Status	Contact
Rochester, MN	Open for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, MN	Open for enrollment	View complete study & contact information

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Search Results 1-10 of 20 for metastatic breast cancer

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

Adaptive Therapy With Capecitabine For Treatment Of Metastatic ER Positive, HER2 Negative Breast Cancer

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

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

Phase Ib Study Of Axatilimab In Combination With Olaparib In BRCA1/2 And PALB2- Associated Metastatic HER2-negative 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)

Evaluation Of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib In Locally Advanced Or Metastatic ER+/HER2- Breast Cancer With An ESR1 Mutation

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

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

VS-6766+Abema+Fulv In Met HR+/HER- BC

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