DUniversidad &erio;IncluSion enRinvestigaciontunderpinningPAGprevención &erio;Tensayos de terapia
Diversidad e inclusion en investigacion cientifica a traves de ensayos clinicos de prevencion y terapia
Ensayos de cáncer de mama
NCI-2017-00676
A Multi-Centered Randomized Phase II Comparison of Single-Agent Carboplatin versus the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer
Doctors are testing two different ways to treat a type of breast cancer called advanced triple-negative breast cancer. They want to find out which treatment works better. The first treatment is a medicine called carboplatin, and the second treatment is a combination of carboplatin and everolimus. They will randomly choose which patients get which treatment. The study will take place at multiple hospitals. The goal of this study is to find out which treatment is more effective for patients with advanced triple-negative breast cancer.
CAROLINA DEL NORTET Número:
NCT02531932
Sitio:
Mount Sinai
NCI-2021-09617
A Multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
Doctors are testing two different ways to treat a type of breast cancer called advanced triple-negative breast cancer. They want to find out which treatment works better. The first treatment is a medicine called carboplatin, and the second treatment is a combination of carboplatin and everolimus. They will randomly choose which patients get which treatment. The study will take place at multiple hospitals. The goal of this study is to find out which treatment is more effective for patients with advanced triple-negative breast cancer.
CAROLINA DEL NORTET Número:
NCT05095207
Sitio:
Mount Sinai
NCI-2021-05689
A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with Other Anti-cancer Agents in Patients with Metastatic HER2-low Breast Cancer (DESTINY-Breast08)
Doctors are doing a study to test a medicine called Trastuzumab Deruxtecan (T-DXd) to see if it can help people with metastatic breast cancer that has a low amount of a protein called HER2. They will test the medicine on a group of patients in two phases. n the first phase (1b), they will test different doses of T-DXd to find the best dose that is both safe and effective. They will also test the medicine in combination with other anti-cancer drugs. The study will be open-label, which means that both the doctors and the patients will know what treatment they are receiving. n the second phase, they will test the effectiveness of the best dose of T-DXd in combination with other anti-cancer drugs on a larger group of patients. The study will take place at multiple hospitals. The goal of the study is to determine if T-DXd can be a helpful treatment for people with metastatic breast cancer that has a low amount of HER2, and to determine the best dose and combination of drugs to use for this type of cancer.
CAROLINA DEL NORTET Número:
NCT04556773
Sitio:
Mount Sinai
NCI-2020-03770
The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib
The COMPASSHER2 Trials are a series of studies aimed at finding the best treatment for a type of breast cancer called HER2-positive breast cancer. The COMPASSHER2 Residual Disease study is a phase III randomized trial that will compare two treatments. The first treatment is a medicine called T-DM1, which is used to treat HER2-positive breast cancer. The second treatment is a combination of T-DM1 and another medicine called tucatinib. Patients in the study will be randomly assigned to one of the two treatments, but neither they nor their doctors will know which treatment they are receiving (this is called double-blinding). The study will focus on patients who still have signs of cancer after receiving initial treatment, which is called residual disease. The goal of this study is to determine which treatment is more effective at treating HER2-positive breast cancer with residual disease. By comparing the two treatments, doctors hope to learn which one works better and can help improve the lives of people with this type of cancer.
CAROLINA DEL NORTET Número:
NCT04457596
Sitio:
Mount Sinai/Columbia
NCI-2021-03770
A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, stage II-III, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)
Doctors are conducting a study to test a new approach to treating a type of breast cancer called high residual risk, stage II-III, estrogen receptor positive, HER-2 negative breast cancer. the study is a randomized, Phase II trial, which means that patients will be randomly assigned to different treatment groups. The treatment will be guided by circulating tumor DNA, which is a type of genetic material that is found in the blood of some cancer patients. Patients in the study will receive second line adjuvant therapy, which is treatment given after initial treatment to reduce the risk of cancer returning. The treatment will be guided by the results of a blood test to detect circulating tumor DNA. The goal of the study is to determine if using circulating tumor DNA to guide second line adjuvant therapy can help improve outcomes for patients with high residual risk, stage II-III, estrogen receptor positive, HER-2 negative breast cancer. The study will help doctors learn more about how circulating tumor DNA can be used to personalize cancer treatment and potentially improve patient outcomes.
CAROLINA DEL NORTET Número:
NCT04567420
Sitio:
Mount Sinai
NCI-2021-01373
Converting HR+ Breast Cancer into an Individualized Vaccine
Researchers are exploring a new approach to treating a type of breast cancer called HR+ breast cancer. Instead of traditional treatments like chemotherapy or hormone therapy, they are working on creating an individualized vaccine for each patient. The vaccine would be made using a patient's own tumor cells, which are removed during surgery or biopsy. The tumor cells are then modified in a lab to produce a protein that can stimulate the immune system to attack the cancer cells. The modified cells are then used to create a personalized vaccine for the patient. The goal of this approach is to train the patient's immune system to recognize and destroy the cancer cells, potentially leading to a more targeted and effective treatment. This approach is still in the early stages of research, but it holds promise as a potential new way to treat HR+ breast cancer.
CAROLINA DEL NORTET Número:
NCT03804944
Sitio:
Mount Sinai
NCI-2022-02453
A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer
Doctors are conducting a study to test the safety and effectiveness of a new medicine called DAN-222 in treating a type of breast cancer called metastatic breast cancer. The study is a dose-escalation study, which means that patients will receive increasing amounts of DAN-222 over time to determine the maximum safe and effective dose. The study will also evaluate the pharmacology of the medicine, which means how it works in the body and how the body processes it. Patients in the study will have metastatic breast cancer, which means the cancer has spread from the breast to other parts of the body. The goal of the study is to determine if DAN-222 is safe and effective in treating this type of breast cancer. By testing different doses of DAN-222 and monitoring its effects on patients, doctors hope to learn more about how the medicine works and whether it could be a new treatment option for patients with metastatic breast cancer.
CAROLINA DEL NORTET Número:
NCT05261269
Sitio:
Mount Sinai
NCI-2020-08420
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Doctors are conducting a large study to test a new treatment option for a type of breast cancer called estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer. The study is a Phase III randomized, double-blind, placebo-controlled, multicenter study, which means that patients will be randomly assigned to different treatment groups and neither the patients nor the doctors will know which treatment they are receiving. The study will evaluate the efficacy and safety of a new medicine called GDC-9545 combined with palbociclib compared with the standard treatment of letrozole combined with palbociclib. Both treatments will be given to patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer. The goal of the study is to determine if GDC-9545 combined with palbociclib is a safe and effective treatment option for this type of breast cancer. By comparing it to the standard treatment, doctors hope to learn more about how it works and whether it could be a new and improved treatment option for patients with this type of breast cancer.
CAROLINA DEL NORTET Número:
NCT04546009
Sitio:
Mount Sinai
NCI-2015-00128
NRG-BR003 A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
Doctors are conducting a large study to test different treatment options for a type of breast cancer called triple-negative invasive breast cancer that has spread to the lymph nodes or has a high risk of spreading. The study is a randomized Phase III trial, which means that patients will be randomly assigned to different treatment groups. The study will compare two different adjuvant therapy options: doxorubicin plus cyclophosphamide followed by weekly paclitaxel, and the same treatment with the addition of a medicine called carboplatin. The goal of the study is to determine if the addition of carboplatin to the standard adjuvant therapy is a safe and effective treatment option for triple-negative invasive breast cancer. By comparing the two treatments, doctors hope to learn more about how they work and whether the addition of carboplatin could improve outcomes for patients with this type of breast cancer.
CAROLINA DEL NORTET Número:
NCT02488967
Sitio:
Einstein
NCI-2018-02927
Phase I/II Trial of Leflunomide in Women with Previously Treated Metastatic Triple Negative Cancer
Doctors are testing a medicine called Leflunomide to see if it can help women who have a type of breast cancer that is hard to treat. They want to find out if the medicine is safe to use and how well it works. They will test it on a small group of patients first to make sure it doesn't cause any bad side effects. Then, if it's safe, they will test it on more patients to see if it can slow down or stop the cancer from growing. The goal of this study is to find out if Leflunomide can be a helpful treatment for women with this type of breast cancer.
CAROLINA DEL NORTET Número:
NCT03709446
Sitio:
Mount Sinai
Sitio:
NCI-2018-00191
A Trial of Endocrine Response in Women with Invasive Lobular Breast Cancer
Doctors are conducting a trial to study how women with invasive lobular breast cancer respond to endocrine therapy. Endocrine therapy is a type of treatment that works by blocking the hormones that help cancer cells grow. In this trial, doctors will monitor the effectiveness of endocrine therapy in women with invasive lobular breast cancer. The goal is to better understand how this type of cancer responds to endocrine therapy and to identify any factors that may affect response to the treatment. The study will involve monitoring patients over a period of time and collecting data on how their cancer responds to endocrine therapy, as well as any side effects they experience. By studying how invasive lobular breast cancer responds to endocrine therapy, doctors hope to identify new and improved treatment options for women with this type of cancer.
Sitio:
Einstein
norteConnecticut Número:
NCT02206984
NCI-2018-01455
AVIATOR A randomized, phase II study comparing trastuzumab and vinorelbine in combination with avelumab or avelumab and utomilumab (41BB/CD137 agonist), in patients with HER2-positive metastatic breast cancer who have progressed on prior trastuzumab and pertuzumab
AVIATOR is a clinical trial that is investigating two different treatment regimens for patients with HER2-positive metastatic breast cancer that has progressed after treatment with trastuzumab and pertuzumab. In the study, patients will be randomly assigned to one of two treatment groups. The first group will receive trastuzumab and vinorelbine in combination with a drug called avelumab. The second group will receive the same combination of trastuzumab, vinorelbine, and avelumab, but also with an additional drug called utomilumab. Avelumab is an immunotherapy drug that helps the body's immune system fight cancer cells, while utomilumab is an experimental drug that stimulates immune cells called T-cells to attack cancer cells. The goal of this study is to determine which treatment regimen is more effective in treating HER2-positive metastatic breast cancer that has progressed after prior treatment with trastuzumab and pertuzumab. Researchers will evaluate the safety and efficacy of both treatment regimens, as well as any side effects that patients may experience.
Sitio:
Einstein
norteConnecticut Número:
NCT03414658
NCT-0369-7577
Pilot study assessing the effect of cyclin-dependent kinase 4/6 inhibitors on body composition in patients with ER +/HER2- metastatic breast cancer
This is a small study that looks at how a type of medication called cyclin-dependent kinase 4/6 inhibitors affects the body composition of patients with a specific type of breast cancer. The study is focused on patients with breast cancer that is hormone receptor positive and HER2 negative. The researchers want to see if this medication affects how the body is made up in these patients. This study is just a pilot study, which means that it is a preliminary study to see if a larger study should be conducted in the future.
Sitio:
Einstein
norteConnecticut Número:
NCT03697577
NCI-2019-01531
Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC) A multicenter, multi-arm Translational Breast Cancer Research Consortium study (TBCRC 047 InCITe)
This is a research study that involves multiple medical centers and uses a new combination of treatments to fight a type of breast cancer called metastatic triple negative breast cancer (TNBC). This type of breast cancer can be difficult to treat because it does not have certain receptors that other types of breast cancer do. The new treatment being studied is called innovative combination immunotherapy, which means using different drugs that work together to boost the body's own immune system to fight cancer. The study is called TBCRC 047 InCITe and it is being conducted by the Translational Breast Cancer Research Consortium. The hope is that this new treatment combination can help improve outcomes for patients with TNBC.
Sitio:
Einstein
norteConnecticut Número:
NCT03971409
NCT-0336-8729
A Phase 1b/2 Study of the PARP Inhibitor Niraparib in Combination with Trastuzumab in Patients with Metastatic HER2 Breast Cancer
This is a clinical trial where researchers are testing a new treatment for a type of breast cancer called HER2-positive breast cancer. The treatment combines two drugs called niraparib and trastuzumab. Niraparib is a type of medication that targets cancer cells and trastuzumab is a type of immunotherapy that helps the immune system fight the cancer. The study will be conducted in two phases, the first phase will test the safety of the treatment, and the second phase will test how well the treatment works to fight the cancer. The hope is that this new treatment will be effective in treating HER2-positive breast cancer and improve the quality of life for patients.
Sitio:
Einstein
norteConnecticut Número:
NCT03368729
NCI-2019-07439
EA1181 (CompassHER2-pCR) Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response Part 1 Component of The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer)
EA1181, also known as CompassHER2-pCR, is a clinical trial for patients with HER2-positive breast cancer. The trial is studying the use of a combination of drugs called THP (docetaxel, trastuzumab, and pertuzumab) before surgery to remove the cancer, and then another drug called HP (trastuzumab and pertuzumab) after surgery. The goal of the trial is to see if this treatment combination can help more patients achieve a pathologic complete response, meaning that there is no visible sign of cancer in the breast tissue removed during surgery. This trial is part of a larger effort to find the best possible treatment options for HER2-positive breast cancer.
Sitio:
Einstein/Mount Sinai/Columbia
norteConnecticut Número:
NCT04266249
NCI-2019-06939
A Phase 1/2, open-label, dose escalation, and cohort expansion clinical trial to evaluate the safety, tolerability, and pharmacokinetics of ARV-471 alone and in combination with Palbociclib (IBRANCE) in patients with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER/HER2-) locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting
This is a clinical trial that will test the safety and effectiveness of a new drug called ARV-471 in combination with another drug called Palbociclib (also known as IBRANCE) for the treatment of estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER/HER2-) locally advanced or metastatic breast cancer. The trial will be conducted in two phases: the first phase will test the safety and dosage of ARV-471 alone or in combination with Palbociclib, while the second phase will test the effectiveness of the drugs in a larger group of patients. The study will enroll patients who have received prior hormonal therapy and chemotherapy for their cancer.
Sitio:
Einstein
norteConnecticut Número:
NCT04072952
NCI-2020-06704
MARGetuximab Or Trastuzumab (MARGOT) A phase II study comparing neoadjuvant paclitaxel/margetuximab/pertuzumab to paclitaxel/trastuzumab/pertuzumab in patients with Stage II-III HER2-positive breast cancer
MARGOT is a study for people with Stage II-III HER2-positive breast cancer. The study compares two different treatments given before surgery to remove the cancer. One treatment includes drugs called paclitaxel, margetuximab, and pertuzumab, and the other treatment includes drugs called paclitaxel, trastuzumab, and pertuzumab. The study will see which treatment is better at shrinking the cancer before surgery.
Sitio:
Einstein
norteConnecticut Número:
NCT04425018
NCI-2019-02285
Therapeutic targeting of ER beta in triple negative breast cancer
Triple negative breast cancer (TNBC) is a type of breast cancer that lacks certain receptors, making it difficult to treat with some types of therapies. Researchers are exploring a new approach to treating TNBC by targeting a specific protein called ER beta. This protein is found in some TNBC tumors and may play a role in tumor growth and survival. By targeting ER beta with drugs, researchers hope to slow or stop the growth of TNBC tumors. This is still a new and experimental approach, and more research is needed to determine its effectiveness and safety.
Sitio:
Einstein
norteConnecticut Número:
NCT03941730
NCI-2020-13877
A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter, Study of OP-1250 in Adult Subjects with Advanced and/or Metastatic Hormone Receptor (HR)-positive, HER2-negative Breast Cancer
This is a Phase I dose escalation and dose expansion and Phase II monotherapy open--label, first--in--human study to determine the dose limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), to characterize the safety and pharmacokinetic (PK) profile, and to estimate the preliminary anti-tumor activity of OP-1250 as a single agent in adult subjects with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic or locally advanced breast cancer. This study comprises 2 Phases: Phase I (Part A [Dose Escalation] and Part B [Dose Expansion]) and Phase II. Additionally, all subjects (Phase I and Phase II) will be eligible to participate in 1 of 2 sub-studies. Patients must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease. Patients will be evaluated for treatment emergent adverse events (AEs) during study participation, and toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0.
Sitio:
Einstein
norteConnecticut Número:
NCT04505826
NCI-2021-04400
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)
This study will examine trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary BC who have residual invasive disease in breast or axillary lymph nodes with higher risk of recurrence, which includes patients who were inoperable at disease presentation or had pathological node-positive status after neoadjuvant therapy.
The primary objective is to compare invasive disease-free survival (IDFS) between T-DXd and T-DM1 treatment arms in this population. The key secondary objective of the study is to evaluate disease-free survival (DFS).
Sitio:
Einstein
norteConnecticut Número:
NCT04622319
NCI-2022-09047
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's Choice of Endocrine Therapy Plus Everolimus in Patients With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Doctors are conducting a study to test two different treatments for a type of breast cancer called estrogen receptor positive, HER2-negative, locally advanced or metastatic breast cancer. The study is a randomized Phase III trial, which means that patients will be randomly assigned to one of two treatment groups. One group will receive giredestrant plus everolimus, and the other group will receive exemestane plus everolimus. The goal of the study is to determine if giredestrant plus everolimus is a safe and effective treatment option for this type of breast cancer compared to the current standard treatment of exemestane plus everolimus. Patients in the study will be closely monitored for any side effects and to evaluate the effectiveness of the treatments. By comparing the two treatments, doctors hope to learn more about how they work and which treatment is more effective in treating this type of breast cancer.
Sitio:
Mount Sinai
norteConnecticut Número:
NCT05306340
NCI-2020-13347
P-RAD A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer
Breast cancer is a type of cancer that starts in the breast. When the cancer has spread to nearby lymph nodes, it is called node-positive breast cancer. HER2-negative means the cancer cells do not have a lot of a certain protein called HER2.
In this clinical trial, doctors are testing different ways of treating node-positive, HER2-negative breast cancer before surgery. The treatment will include chemotherapy, which is a medicine that kills cancer cells, and pembrolizumab, which is a type of immunotherapy that helps the body's immune system fight cancer.
The trial is called P-RAD because it will also test different doses of radiation therapy. Radiation therapy uses high-energy rays to kill cancer cells. The different doses of radiation are called no radiation, low dose radiation, and high dose radiation.
The goal of the trial is to see which treatment plan is the most effective in treating node-positive, HER2-negative breast cancer before surgery. The results of this trial will help doctors to better understand the benefits and potential side effects of different treatment options for this type of breast cancer.
Sitio:
Einstein
Número NCT:
NCT04443348
NCI-2021-14390
A Phase 3, Single Arm, Open-Label Study Evaluating Ovarian Suppression Following Three-Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination with Endocrine Therapy in Premenopausal Subjects with Hormone-Receptor Positive (HR), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
This is a study that will test a new treatment for premenopausal women with a certain type of breast cancer. The cancer cells have hormone receptors and do not have a protein called HER2. The treatment combines a medicine called TOL2506 with another treatment called endocrine therapy. TOL2506 is a type of medicine that can stop the ovaries from making hormones. The study will see if using TOL2506 along with endocrine therapy can help stop the cancer from growing. The study will be done with premenopausal women who have already been diagnosed with this type of breast cancer.
Sitio:
Einstein
Número NCT:
NCT04906395
NCI-2020-06176
A231901CD Improving Patient-Centered Communication in Breast Cancer A RCT of a Shared Decision Engagement System (SHARES)
This clinical trial aims to help patients with breast cancer make better decisions about their treatment by improving the way doctors communicate with them. Researchers will test a tool called a Shared Decision Engagement System (SHARES) that can help patients and doctors talk about treatment options in a way that is easier to understand. By using this tool, patients may feel more involved in their care and better able to make decisions that are right for them. The trial will compare patients who use the tool to those who do not, to see if it improves the communication and decision-making process.
Sitio:
Einstein/Columbia
Número NCT:
NCT04549571
NCT-0513-2582
A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2 breast cancer (HER2CLIMB-05)
Breast cancer is a disease where cells in the breast grow too much and can spread to other parts of the body. There are different types of breast cancer, and one type is called HER-2 positive breast cancer. This means that the cancer cells have a lot of something called HER-2 receptors, which are like little doorways on the surface of the cells. HER-2 positive breast cancers tend to grow and spread faster than other types of breast cancer, but they also respond well to certain drugs. HER2CLIMB-05 is a clinical trial that aims to evaluate the effectiveness of tucatinib in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2-positive breast cancer. The study is a randomized, double-blind, phase 3 trial, meaning that patients will be assigned to receive either tucatinib or a placebo (an inactive substance) in addition to trastuzumab and pertuzumab, and neither the patients nor the researchers will know which treatment the patient is receiving. The goal of the study is to determine whether tucatinib can improve the outcomes of patients with metastatic HER2-positive breast cancer.
Sitio:
Einstein
Número NCT:
NCT05132582
NCI-2021-07857
A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants With Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer With Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST)
The ZEST study is a clinical trial that will compare a drug called niraparib to a placebo in people with HER2-negative breast cancer that either has a BRCA gene mutation or is triple-negative. The trial will focus on people who still have signs of the cancer in their blood after receiving standard treatment. Niraparib is a type of drug called a PARP inhibitor, which can help prevent cancer cells from repairing their DNA and dividing. The study aims to see if niraparib is effective in treating this type of breast cancer and if it is safe to use.
Sitio:
Columbia
Número NCT:
NCT04915755
NCI-2022-00634
EMBER-3: A Randomized, Open-Label, Phase 3 Study of LY3484356 vs Investigator's Choice of Endocrine Therapy, in Patients with Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated with Endocrine Therapy
The EMBER-3 study is a medical research study that will compare the effectiveness and safety of a new drug called LY3484356 to the usual hormone therapy for patients with advanced or metastatic breast cancer that is positive for estrogen but negative for HER2. The study will be conducted in patients who have already received hormone therapy but their cancer has continued to grow. The study will be randomized, which means that patients will be assigned randomly to receive either LY3484356 or their doctor's choice of hormone therapy. The study will be open-label, which means that both the patients and the doctors will know which treatment the patient is receiving. The goal of the study is to determine if LY3484356 can provide better outcomes than the current standard of care in this patient population.
Sitio:
Columbia
Número NCT:
NCT04975308
NCI-2022-03768
A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)
FLAMINGO-01 is a clinical trial aimed at evaluating a new treatment called GLSI-100 in people with HER2/neu positive breast cancer. The study will include participants who have residual disease or high-risk PCR after receiving neoadjuvant and postoperative adjuvant trastuzumab-based therapy. GLSI-100 is a combination of two substances called GP2 and GM-CSF that work to stimulate the body's immune system to fight cancer cells. The study will compare the effectiveness and safety of GLSI-100 to a placebo (an inactive substance).
Sitio:
Columbia
Número NCT:
NCT05233916
NCI-2022-05679
A prospective multi-center clinical study evaluating the use of PD G 506 A and the Eagle V1.2 Imaging System for the visualization of carcinoma during breast conserving surgery
This study is looking at a new tool called PD G 506 A and a special imaging system called the Eagle V1.2 to help doctors see cancer cells during breast conserving surgery. This tool and imaging system may help doctors remove all the cancer cells while saving as much healthy breast tissue as possible. The study will be done at multiple hospitals to see if this new tool and imaging system work well for patients having this type of surgery.
Sitio:
Einstein
Número NCT:
NCT04815083
NCI-2017-00394
Alliance Foundation Trials, LLC / Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET) Trial for Low Risk DCIS A Phase III Prospective Randomized Trial
The COMET trial is a research study that compares two different approaches to treating a type of breast cancer called DCIS (ductal carcinoma in situ). One approach is to have surgery to remove the abnormal cells, followed by monitoring without any further treatment. The other approach is to have monitoring without surgery, but with the option to take medication called endocrine therapy. The trial will randomly assign participants to one of these two approaches and will track their progress over time to determine which approach is more effective and safe for treating low-risk DCIS.
Sitio:
Einstein/Mount Sinai
Número NCT:
NCT02926911
NCI-2019-01957
A Randomized Phase II Window-of-opportunity Trial of Ruxolitinib in Patients with High Risk and Premalignant Breast Conditions
In this study, researchers are testing a drug called ruxolitinib in patients with high risk and premalignant (not yet cancerous) breast conditions. Ruxolitinib is a drug that targets a specific pathway involved in inflammation and cell growth, which could potentially prevent the development of breast cancer. The study is a randomized phase II trial, meaning that patients will be randomly assigned to receive either ruxolitinib or a placebo (an inactive substance) before they undergo surgery to remove breast tissue. This is called a "window-of-opportunity" trial because the drug is given during the time between the diagnosis of the high-risk or premalignant condition and the surgery, allowing researchers to study its effects on breast tissue. The goal of the study is to see if ruxolitinib can reduce the number of precancerous cells in the breast tissue and ultimately prevent the development of breast cancer.
Sitio:
Einstein
Número NCT:
NCT02928978
NCI-2015-00014
Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2
In this study, doctors will use pictures of your body (called imaging) and look at your genes (the parts of your body that determine how you look and work) to see if they can predict how well you will respond to treatment. They will take pictures and samples of your cancer at different times during treatment to see if they can see changes that show if the treatment is working or not. This study is called "Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2."
Sitio:
Columbia
Número NCT:
NCT01042379
NCI-2019-04127
Phase 1a/1b Trial of Exercise Treatment with Concurrent First-Line Therapy for Hormone Receptor Positive Metastatic Breast Cancer
Breast cancer is a disease where cells in the breast grow too much and can spread to other parts of the body. Hormone receptor positive breast cancer is a type of breast cancer that grows in response to the hormone estrogen. Metastatic breast cancer means that the cancer has spread to other parts of the body. In this clinical trial, doctors are testing a new treatment for hormone receptor positive metastatic breast cancer. The treatment is a combination of exercise and first-line therapy. First-line therapy is the first type of treatment that is given to a patient with metastatic breast cancer. The trial is divided into two parts, called Phase 1a and 1b. In Phase 1a, doctors will test the safety of the exercise treatment and make sure that it does not cause any harmful side effects when given with first-line therapy. They will also determine the best dose of exercise for patients to receive. In Phase 1b, doctors will test how well the exercise treatment works when given with first-line therapy. The exercise treatment will include activities like walking, cycling, and resistance training. These activities will be done under the supervision of trained exercise specialists. The goal of the exercise treatment is to improve the patient's overall health and well-being, and potentially improve the effectiveness of the first-line therapy. The results of this trial will help doctors to better understand the benefits and potential side effects of exercise treatment in combination with first-line therapy for hormone receptor positive metastatic breast cancer.
Sitio:
Einstein
Número NCT:
NCT03988595
NCI-2019-05158
A Phase 1b open-label, multicenter dose escalation and expansion study of MT-5111 in subjects with previously treated advanced HER2-positive solid tumors
Breast cancer cells with higher-than-normal levels of HER-2 receptors are called HER-2 positive. These HER-2 positive cancers tend to grow and spread faster than breast cancers that are HER-2 negative but are much more likely to respond to treatment with drugs that target the HER-2 receptor. MT-5111 is a de-immunized engineered toxin bodies that targets HER2 for solid tumors. MT-5111 works through a novel mechanism of direct cell-kill.
Sitio:
Mount Sinai
NCT Número:
NCT04029922
NCI-2017-00262
A Phase I, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0077 as a Single Agent in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Solid Tumors and in Combination With Endocrine and Targeted Therapies in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Breast Cancer
This study is testing a new drug called GDC-0077 to see if it is safe and effective for treating certain types of cancer. The drug will be tested in patients who have advanced or spreading tumors that have a certain genetic mutation called PIK3CA. The study will also test if GDC-0077 works better when combined with other cancer treatments. The study will measure how well patients tolerate the drug, how it affects their cancer, and how the drug moves through their body.
Sitio:
Columbia
NCT Número:
NCT03006172
NCI-2018-01519
S1706: A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer
S1706 is a research study that is testing a new treatment for a type of breast cancer called inflammatory breast cancer. The study is comparing a new drug called Olaparib, which is taken along with radiation therapy, to radiation therapy alone. The goal is to see if adding Olaparib to radiation therapy can help improve the outcomes of patients with inflammatory breast cancer. This is a phase II randomized trial, meaning that patients will be randomly assigned to receive either the new treatment or the standard treatment, and the study is still in the early stages of testing.
Sitio:
Columbia
NCT Número:
NCT03598257
NCI-2022-01323
A First-in-Human Study of Mutant-selective PI3K? Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer
The purpose of this study is to test a new drug called RLY-2608 in patients with advanced solid tumors or advanced breast cancer. RLY-2608 is a type of drug called a PI3K inhibitor that targets a specific gene mutation that is commonly found in cancer cells. The study will test RLY-2608 alone and in combination with another drug called fulvestrant. The goal is to see if the new drug is safe and effective in treating cancer.
Sitio:
Columbia
NCT Número:
NCT05216432
NCI-2021-12554
Medical imaging and thermal treatment for breast tumors using Harmonic Motion Imaging (HMI)
Harmonic Motion Imaging (HMI) is a medical technology used for imaging and treating breast tumors. It works by using sound waves to create a picture of the tumor, which doctors can use to see its size and location. HMI can also be used to deliver heat to the tumor, which can help destroy cancer cells. This type of treatment is called thermal treatment. By combining imaging and treatment in one procedure, doctors can more accurately target the tumor and avoid harming healthy tissue.
Sitio:
Columbia
NCT Número:
NCT05219695
NCI-2020-11358
BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline Mutation
BRCA-P is a clinical trial that aims to study the effectiveness of a drug called Denosumab in preventing breast cancer in women who carry a specific gene mutation called BRCA1. This trial is a randomized, double-blind, placebo-controlled, international phase 3 study. This means that participants will be randomly assigned to either receive the study drug or a placebo, and neither the researchers nor the participants will know which one they are receiving. The trial will take place in multiple centers across the world. The goal is to determine if Denosumab can reduce the risk of breast cancer in women who carry the BRCA1 gene mutation.
Sitio:
Columbia
NCT Número:
NCT04711109
NCI-2020-06546
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
This study aims to evaluate the safety of and how well Sacituzumab Govitecan and Pembrolizumab kills cancer cells in patients with triple-negative breast cancer whose tumors express PD-L1. Triple negative breast cancer (TNBC) breast cancer is a cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors. PD-1 is a protein found on T cells (a type of immune cell) that helps keep the body's immune responses (defense system) in check. When this protein is blocked, the 'brakes' on the immune system are released and the ability of T cells to kill cancer cells is increased.
Sitio:
Columbia
NCT Número:
NCT04468061
NCI-2022-00332
Optimizing the use of ketamine to reduce chronic postsurgical pain (KALPAS)
Ketamine is a drug that has been used to treat chronic pain conditions, including chronic postsurgical pain (CPSP). The use of ketamine for CPSP has been studied extensively, and several clinical trials have shown promising results. The KALPAS (Optimizing the use of ketamine to reduce chronic postsurgical pain) study aims to evaluate if ketamine will reduce CPSP in patients undergoing major surgery. The study will also investigate the best dose, how long to give ketamine, and best way to administer it.
Sitio:
Columbia
NCT Número:
NCT05037123
NCI-2022-05168
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
This clinical trial will evaluate sacituzumab govitecan, a novel antibody-drug conjugate, to treat metastatic triple-negative breast cancer (TNBC) that do not express PD-L1. Triple negative breast cancer (TNBC) breast cancer is a cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors. PD-1 is a protein found on T cells (a type of immune cell) that helps keep the body's immune responses (defense system) in check. When this protein is blocked, the 'brakes' on the immune system are released and the ability of T cells to kill cancer cells is increased.
Sitio:
Columbia
NCT Número:
NCT05382299
NCI-2023-02845
A Phase 1 Dose Escalation and Expansion Open-label, Multicenter, Study of OP-1250 in Combination With the CDK4/6 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
The Phase 1 study is a clinical trial that aims to investigate the safety and efficacy of combining OP-1250, a novel anti-cancer agent, with palbociclib, a CDK4/6 inhibitor, in adult patients with advanced or metastatic hormone receptor-positive, HER2-negative breast cancer. Hormone receptor-positive breast cancer means that the cancer cells have receptors for the hormones estrogen and/or progesterone, which promotes their growth. HER2-negative breast cancer means that the cancer cells do not have excess copies of the HER2 gene, which is a protein that promotes the growth of cancer cells. Overall, the study aims to evaluate the safety and tolerability of the combination treatment and determine the recommended Phase 2 dose, as well as assess the preliminary efficacy of the treatment.
Sitio:
Sinai
NCT Número:
NCT05266105
NCT-0297-7468
Effects of MK-3475 on the breast tumor microenvironment in triple negative breast cancer with and without intra-operative RT: a window of opportunity study.
Trastuzumab and pertuzumab are drugs that target the HER-2 receptor on the cancer cells. They can slow down or even stop the growth of the cancer cells. Tucatinib is also a drug that targets the HER-2 receptor, but it works in a different way. The hope is that tucatinib might work even better than trastuzumab and pertuzumab.
Sitio:
Columbia
NCT Número:
NCT02977468
Un estudio de fase 3, abierto, aleatorizado y de dos partes que compara gedatolisib en combinación con palbocicliband fulvestrant con terapias estándar en pacientes con cáncer de mama avanzado HR positivo y HER2 negativo previamente tratados con un inhibidor de CDK4/6 en combinación con terapia con inhibidores de la aromatasa no esteroides (VIKTORIA-1)
El ensayo, VIKTORIA-1, es un gran estudio que prueba diferentes tratamientos para el cáncer de mama avanzado. Se centra en pacientes con un tipo específico de cáncer de mama llamado HR positivo y HER2 negativo. Estos pacientes ya probaron un inhibidor de CDK4/6 con un inhibidor de la aromatasa no esteroideo, pero su cáncer empeoró. El estudio compara tres tratamientos: una nueva combinación de Gedatolisib, Palbociclib y Fulvestrant, las terapias estándar de atención habituales y otra terapia estándar de atención que podría ser diferente de la primera. El ensayo tiene dos partes para probar diferentes grupos de pacientes. El objetivo principal es ver qué tratamiento ayuda a los pacientes a vivir más tiempo sin que el cáncer empeore y detectar posibles efectos secundarios.
Sitio:
miinstein
CAROLINA DEL NORTENúmero T: