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Diversity & IncluSion in Research Underpinning Prevention & Therapy Trials
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Diversity & Inclusion in Scientific Research Underpinning Prevention & Therapy Trials
Breast Cancer Trials
Phase I/II Trial of Leflunomide in Women with Previously Treated Metastatic Triple Negative Cancer
This is a research study that has two parts, or "phases." The study is looks at a medicine called Leflunomide and how it might help women who have a specific type of breast cancer called metastatic triple-negative breast cancer. In the first phase of the study, they test the medicine's safety and how well people can tolerate it. They start with a small dose and then gradually increase it if it seems safe. They want to make sure it doesn't cause too many side effects. In the second phase, they will look more closely at how effective the medicine is in treating this type of cancer. They'll pay attention to things like how much the cancer shrinks, how long people live without their cancer getting worse, and how the participants feel while taking the medicine.
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body.
Triple Negative Breast Cancer
It is a type of breast cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.
Site:
Mount Sinai
NCT Number:
A Multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
This research study is testing a combination of two medicines for a specific type of breast cancer that has a protein called Androgen Receptor, which is usually found in male hormones. The cancer cells in this type of cancer respond to this protein. However, they don't have another protein called HER2. The study is focused on two medicines: Abemaciclib: This is a medicine that can slow down the growth of cancer cells by targeting specific proteins. Bicalutamide: This medicine is used to block the effects of male hormones. The study wants to see if using Abemaciclib together with Bicalutamide can work well in treating this specific type of breast cancer. They're checking if this combination can help shrink the cancer and slow its growth. In Phase IB, they'll start with a smaller dose and see how people react to it. If it's safe and well-tolerated, they'll move on to Phase II, where they'll give this combination to a larger group to get more information about how well it works.
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body
Triple Negative Breast Cancer:
Breast Cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR) and HER-2 receptors.
Site:
Mount Sinai
NCT Number:
Phase I/II Trial of Leflunomide in Women with Previously Treated Metastatic Triple Negative Cancer
The COMPASSHER2 Trials are a series of research studies focused on a certain type of breast cancer called HER2-positive breast cancer. This trial is a double-blinded, Phase III randomized trial. One group of patients gets a medicine called T-DM1 along with a placebo. T-DM1 is a medicine that treats Her2 positive breast cancer - so both groups get the standard treatment for Her2 positive breast cancer. The other group of patients also gets T-DM1, but in addition, they get a medicine called Tucatinib. Neither group knows whether they're getting the real medicine or the placebo. The goal of this study is to find out if adding Tucatinib to T-DM1 works better than just T-DM1 alone in treating HER2-positive breast cancer. They'll look at things like how well the cancer responds to treatment, how long it takes for the cancer to come back, and how the patients are doing during the treatment.
Double-blinded
Neither the patients nor the doctors know who is getting what treatment. This helps make sure the results are completely not biased
HER-2 positive
It is a type of breast cancer where cancer cells have higher-than-normal levels of HER-2 receptors are called HER-2 positive. These receptors are like tiny doorways on the surface of the cells. HER-2 positive breast cancers tend to grow and spread faster than other kinds, but they also respond well to certain drugs that target the HER-2 receptor.
Randomized Trial
Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment
Placebo:
A placebo is a substance or treatment that has no active medical properties but is given to a patient as if it were a real medication or treatment. It is often used in medical research to compare the effects of a new drug or treatment with the effects of no treatment at all. The idea is to see if the new drug or treatment is genuinely effective by comparing how patients who receive the real treatment fare compared to those who receive the placebo
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body
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)
This is a research study that's in its second phase, and it's looking at a new way of treating a specific type of breast cancer. The focus is on a certain stage of breast cancer, specifically stages II and III, where the cancer has a higher risk of coming back even after the main treatment has been done. This type of breast cancer is known as Estrogen Receptor positive HER-2 negative. Circulating tumor DNA (ctDNA) is like tiny pieces of genetic information from the cancer cells that can be found in the blood. It's like a small trace of the cancer that can be detected without doing a biopsy. Guided second-line adjuvant therapy means they're trying to figure out a treatment plan for after the main treatment, like surgery or chemotherapy. Second-line means the second phase of treatment after the initial one. The study's goal is to see if the new way of treatment, guided by the circulating tumor DNA, works better at reducing the risk of the cancer coming back compared to the standard treatment.
Estrogen Receptor positive HER-2 negative
It is a type of breast cancer where cancer cells have estrogen receptors and are stimulated by the hormone estrogen to grow. These cells also have very little of the protein HER-2. This type of cancer tends to respond very well to therapy, since it tends to grow slowly.
HER-2 positive
It is a type of breast cancer where cancer cells have higher-than-normal levels of HER-2 receptors are called HER-2 positive. These receptors are like tiny doorways on the surface of the cells. HER-2 positive breast cancers tend to grow and spread faster than other kinds, but they also respond well to certain drugs that target the HER-2 receptor.
Site:
Mount Sinai
NCT Number:
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating The Efficacy And Saftey Of Giredestrant Plus Everolimus Compared With Eexmestane Plus Everolimus In Patients With Estrogen Receptor Positive, HER2-Negative, Locally Advanced Or Metastatic Breast Cancer
This is a research study that's in its third and final phase. They're comparing two different treatments for Estrogen Receptor positive HER-2 negative breast cancer. The study wants to see which of the 2 combinations (Giredestrant + Everolimus OR Exemestane+ Everolimus) works better for treating this type of breast cancer that responds to estrogen. They'll be checking how well the cancer responds to treatment, how long people live without the cancer getting worse, and how the patients feel during the treatment. This study is open-label and randomized.
Estrogen Receptor positive HER-2 negative
It is a type of breast cancer where cancer cells have estrogen receptors and are stimulated by the hormone estrogen to grow. These cells also have very little of the protein HER-2. This type of cancer tends to respond very well to therapy, since it tends to grow slowly.
Open label
Patients know which treatments are being given to them
Randomized Trial
Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment
Open Label:
Patients know which treatments are being given to them
Randomized Trial:
Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment
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)
This is a part of a bigger research study called CompassHER2 Trials. The goal of these trials is to find the best ways to treat a specific type of breast cancer called HER2-positive breast cancer. In this part of the study, called EA1181 CompassHER2-pCR, they're focusing on two different phases of treatment for this type of cancer. Part 1: Preoperative THP: Preoperative: This means before surgery. THP: This stands for three different medicines: Taxol (T), Herceptin (H), and Perjeta (P). These medicines are used to treat HER2-positive breast cancer. So, in this part, they're giving these three medicines (Taxol, Herceptin, and Perjeta) to patients before they have surgery to remove the cancer. Part 2: Postoperative HP Postoperative: This means after surgery. In this part, they're giving these two medicines (Herceptin and Perjeta) to patients after they've had surgery to remove the cancer. The specific group of patients they're looking at are those who have a pathologic complete response. This means that after the treatment, there's no evidence of cancer in the tissue that's been removed during surgery. This is a good sign that the treatment is working well.
HER-2 positive breast cancer
It is a type of breast cancer where cancer cells have higher-than-normal levels of HER-2 receptors are called HER-2 positive. These receptors are like tiny doorways on the surface of the cells. HER-2 positive breast cancers tend to grow and spread faster than other kinds, but they also respond well to certain drugs that target the HER-2 receptor.
Sites:
Einstein/Mount Sinai/Columbia
NCT Number:
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 research study is trying out a new treatment called ARV-471 for people who have Estrogen Receptor positive HER-2 negative breast cancer. The patients they're looking at are those who have breast cancer that has grown a lot in the area around the breast or has spread to other parts of the body. These patients have already received treatments like hormonal therapy (to block the hormones that fuel the cancer) and chemotherapy (strong medicines to fight the cancer cells) in the more advanced stages of their disease. The study will be done in two parts: Phase 1: They'll start with a small dose of ARV-471 and see how people react to it. If it seems safe, they'll increase the dose slowly to find the best amount that works well without causing too many side effects. Phase 2: Once they find the right dose from Phase 1, they'll test that dose on a larger group of patients to get a better idea of how well it works. Some patients in this phase will also take ARV-471 with another medicine called Palbociclib (also known as IBRANCE).
Estrogen Receptor positive HER-2 negative
It is a type of breast cancer where cancer cells have estrogen receptors and are stimulated by the hormone estrogen to grow. These cells also have very little of the protein HER-2. This type of cancer tends to respond very well to therapy, since it tends to grow slowly.
Site:
Einstein
NCT Number:
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
This research study is looking at two different treatments for HER-2 positive breast cancer. The study is all about comparing two groups of patients: Group 1: These patients will receive a combination of three medicines before their main treatment. The medicines are paclitaxel, margetuximab, and pertuzumab. These medicines are meant to shrink the cancer and slow its growth. Group 2: These patients will receive another combination of three medicines before their main treatment. The medicines are paclitaxel, trastuzumab, and pertuzumab. Trastuzumab is another medicine that targets the HER2 protein. This treatment happens before their main treatment, and it's called neoadjuvant treatment. The main goal is to see if the combination of medicines in Group 1 (with margetuximab) works better at treating the cancer compared to the combination in Group 2 (with trastuzumab). The patients in the study have Stage II-III breast cancer, which means the cancer has grown but hasn't spread all over the body.
HER-2 positive
It is a type of breast cancer where cancer cells have higher-than-normal levels of HER-2 receptors are called HER-2 positive. These receptors are like tiny doorways on the surface of the cells. HER-2 positive breast cancers tend to grow and spread faster than other kinds, but they also respond well to certain drugs that target the HER-2 receptor.
HER-2 positive
It is a type of breast cancer where cancer cells have higher-than-normal levels of HER-2 receptors are called HER-2 positive. These receptors are like tiny doorways on the surface of the cells. HER-2 positive breast cancers tend to grow and spread faster than other kinds, but they also respond well to certain drugs that target the HER-2 receptor.
Site:
Einstein
NCT Number:
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 research study that will test a new treatment for premenopausal women with Hormone Receptor positive HER-2 negative breast cancer. 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.
Estrogen Receptor positive HER-2 negative
It is a type of breast cancer where cancer cells have estrogen receptors and are stimulated by the hormone estrogen to grow. These cells also have very little of the protein HER-2. This type of cancer tends to respond very well to therapy, since it tends to grow slowly.
Endocrine therapy
Endocrine therapy is a type of treatment for certain hormone-related conditions, like some types of breast or prostate cancer. It works by either blocking the body's production of hormones or interfering with how hormones attach to their respective receptors on cells. In the context of cancer, it's often used to prevent cancer cells from getting the hormones they need to grow, helping to slow down or stop the cancer's progression.
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 kinds of breast cancer. One kind is called HER-2 positive breast cancer. HER-2 positive breast cancers tend to grow and spread faster than other kinds, but they also respond well to certain medicines. There's a research study called HER2CLIMB-05 that wants to figure out if a medicine called tucatinib, when used together with other medicines called trastuzumab and pertuzumab, can help people with HER-2 positive breast cancer that has spread to other parts of the body. This study is like a big experiment where some people will get tucatinib along with the other medicines, and some will get a placebo along with the other medicines. The researchers won't know who is getting which medicine, and the people in the study won't know either. The goal of this study is to find out if using tucatinib can make the situation better for people with HER-2 positive breast cancer that has spread.
HER-2 positive
It is a type of breast cancer where cancer cells have higher-than-normal levels of HER-2 receptors are called HER-2 positive. These receptors are like tiny doorways on the surface of the cells. HER-2 positive breast cancers tend to grow and spread faster than other kinds, but they also respond well to certain drugs that target the HER-2 receptor.
Placebo:
A placebo is a substance or treatment that has no active medical properties but is given to a patient as if it were a real medication or treatment. It is often used in medical research to compare the effects of a new drug or treatment with the effects of no treatment at all. The idea is to see if the new drug or treatment is genuinely effective by comparing how patients who receive the real treatment fare compared to those who receive the placebo
Site:
Einstein
NCT Number:
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)
This research study is focused on a specific protein called HER2/neu that is found in some breast cancers. They want to test a new treatment called GLSI-100, which is made from a combination of two things: a peptide called GP2 and a protein called GM-CSF. They are looking at people who have breast cancer with this HER2/neu protein and have finished some initial treatments. These treatments include Trastuzumab, which is a kind of medicine used to target the HER2/neu protein. The people in this study either have a small amount of leftover cancer (called residual disease) or are at high risk for the cancer coming back. This might be because they still have some cancer-related genetic material (PCR) even after their treatments. The study wants to see if GLSI-100 can help people who still have some cancer left or are at high risk of the cancer returning, even after they've had treatments like Trastuzumab. They'll be checking how well the treatment works and whether it's safe.
Site:
Columbia
NCT Number:
A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer
This is a research study that's trying out a new kind of medicine for the first time. The medicine is called RLY-2608, and it's meant to target a specific protein called PI3Kα. This protein is found in some tumors (abnormal growths) in the body. The study is being done with two groups of people: The first group has advanced tumors. These people will be given only the new medicine, RLY-2608, to see how well it works on its own. The second group has a specific type of advanced breast cancer. They will receive a combination of the new medicine, RLY-2608, and another treatment called Fulvestrant. Fulvestrant is a medicine used to treat breast cancer. The goal of this study is to find out if RLY-2608 is safe to use in people and whether it can help treat advanced tumors and breast cancer. They'll be looking at how well the medicine works in shrinking the tumors, how the patients' bodies respond, and how the patients feel during the treatment.
Advanced cancer
Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.
Site:
Columbia
NCT Number:
A Phase I/II Trial Evaluating the Safety and Efficacy of Eribulin in Combination with Copanlisib inPatients with Metastatic Triple Negative Breast Cancer
This research study is evaluating the safety and whether this combination therapy using Eribulin and Copanlisib stops cancer growth in patients with metastatic triple-negative breast cancer. Eribulin is a type of chemotherapy drug that is commonly used to treat metastatic breast cancer, while Copanlisib is a targeted therapy that inhibits the PI3K pathway, which is often activated in triple-negative breast cancer. The trial is investigating whether the combination of these two drugs can improve treatment outcomes in this patient population.
Triple Negative Breast Cancer
It is a type of breast cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.
Metastatic
cancer that has spread from its original location or organ to other parts of the body.
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
In this research study, they want to see if a new medicine called sacituzumab govitecan can help people with metastatic triple-negative breast cancer. They're looking at people whose cancer cells don't have something called PD-L1. PD-L1 is like a guard protein on special cells that help our body's defense system work. When PD-L1 is blocked, it's like taking off the brakes from our defense system, and it helps our immune cells fight cancer better. So, they're testing this new medicine to see if it can help people with this kind of breast cancer that doesn't have PD-L1. The medicine is a mix of something called an antibody and a drug.
Triple Negative:
It is a type of breast cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body
Triple Negative Breast Cancer
It is a type of breast cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.
Metastatic
cancer that has spread from its original location or organ to other parts of the body.
Antibodies
Antibodies are part of our body's defense system. They are proteins found in the blood that can specifically recognize and remove foreign substances like bacteria or cancer in the body.
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
This is a research study where scientists want to see if two different medicines can help people with Hormone Receptor-positive, HER2-negative breast cancer. The first medicine is called OP-1250. It's a new kind of medicine that fights against cancer. The second medicine is called palbociclib. It's a medicine that helps stop the cancer from growing. The scientists want to find out if these two medicines, when used together, are safe and if they work well against this type of breast cancer. They will give these medicines to adults who have advanced or metastatic breast cancer, which means the cancer has spread. The study wants to see if the two medicines can be given safely together and how much of each medicine people can take without getting too sick. They also want to see if the medicines can help shrink the cancer and make people feel better.
Estrogen Receptor positive HER-2 negative
It is a type of breast cancer where cancer cells have estrogen receptors and are stimulated by the hormone estrogen to grow. These cells also have very little of the protein HER-2. This type of cancer tends to respond very well to therapy, since it tends to grow slowly.
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body
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
In this research study, they want to see if a new medicine called sacituzumab govitecan can help people with metastatic triple-negative breast cancer. Their cancer has either spread to other parts of the body, can't be removed with surgery, or has grown quite a bit but still hasn't spread all over. Pembrolizumab is a medicine that helps the immune system fight cancer, and it's meant to be helpful when the tumors have a protein called PD-L1. This protein can sometimes hide the cancer from the immune system. The goal of the study is to see which treatment works better for this type of breast cancer. The study will look at things like how much the cancer shrinks, how long patients live without their cancer getting worse, and how well the patients tolerate the treatments.
Triple Negative Breast Cancer:
It is a type of breast cancecancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body
Metastatic
cancer that has spread from its original location or organ to other parts of the body.
Triple Negative Breast Cancer
It is a type of breast cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.
Sites:
Einstein/Columbia
NCT Number:
Advanced cancer
Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.
Metastatic:
cancer that has spread from its original location or organ to other parts of the body.
A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbocicliband Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast CancerPreviously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy(VIKTORIA-1)
This research study is trying to figure out if a combination of two medicines, Gedatolisib and Palbociclib, when used with Fulvestrant, works better than the usual treatments for Hormone Receptor-positive HER-2 negative breast cancer. Before joining this study, the patients had already been treated with a specific kind of medicine called a CDK4/6 inhibitor along with another type of drug called a non-steroidal aromatase inhibitor. These medicines were meant to slow down the growth of the cancer. The study is open-label and randomized.
Randomized Trial
Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment
Open label
Patients know which treatments are being given to them
Estrogen Receptor positive HER-2 negative
It is a type of breast cancer where cancer cells have estrogen receptors and are stimulated by the hormone estrogen to grow. These cells also have very little of the protein HER-2. This type of cancer tends to respond very well to therapy, since it tends to grow slowly.
EAY191-N2 Phase 2 Trial of Fulvestrant and Binimetinib in Patients with Hormone Receptor-Positive Metastatic Breast Cancer with a Frameshift or Nonsense Mutation or Genomic Deletion in NF1 A ComboMATCH Treatment Trial
This is a research study called the EAY191-N2 Phase 2 Trial. It is trying to figure out if a combination of two drugs, Fulvestrant and Binimetinib, can help people who have Hormone Receptor-positive breast cancer. The study is specifically looking at patients who have certain genetic changes in a gene called NF1. These changes are called Frameshift or Nonsense Mutation or Genomic Deletion. The goal of this trial, which they call "ComboMATCH Treatment Trial," is to find out if this drug combination is a good match for treating this specific type of breast cancer in people with these genetic changes. They want to see if it helps these patients.
Hormone Receptor positive
It is a type of breast cancer where the cancer cells have receptors on their surface that can attach to hormones in the body, particularly estrogen and/or progesterone. When these receptors attach to hormones, they can stimulate the cancer cells to grow.
Site:
Einstein
NCT Number:
A Phase 1b/2 Study of the PARP Inhibitor Niraparib in Combination with Trastuzumab in Patients with Metastatic HER2 Breast Cancer
This research study is designed to evaluate the safety and efficacy of a drug combination of niraparib and trastuzumab in the treatment of metastatic HER2+ breast cancer. Niraparib is a PARP inhibitor, a type of drug that works by preventing the repair of DNA damage in cancer cells. Trastuzumab is a monoclonal antibody that targets the HER2 protein, which is overexpressed in many HER2+ breast cancers. The study is a single-arm, open-label study, meaning that all participants will receive the same treatment combination and the study will not be blinded. The study is being conducted at multiple medical centers in the United States.
Metastásico
Cáncer metastásico que se ha extendido desde su ubicación original u órgano a otras partes del cuerpo.
HER-2 positivo
Es un tipo de cáncer de mama en el que las células cancerosas tienen niveles superiores a los normales de receptores HER-2. Estos receptores son como minúsculas puertas en la superficie de las células. Los cánceres de mama HER-2 positivos tienden a crecer y diseminarse más rápido que otros tipos, pero también responden bien a ciertos medicamentos que se dirigen al receptor HER-2.
Single arm study:
A study where sample of individuals with the targeted medical condition is given the experimental therapy and then followed over time to observe their response.
Open label
Patients know which treatments are being given to them
An open-label, single-arm, Phase 1b/2 study to investigate the safety, efficacy and pharmacokinetics of LS301-IT in female patients undergoing partial mastectomy and sentinel lymph node biopsy (SLNB) for ductal carcinoma in situ (DCIS) or Stage I-II primary invasive breast cancer
This research study is designed to investigate the safety, efficacy, and pharmacokinetics of LS301-IT, a new drug to help surgeons visualize sentinel lymph nodes during breast cancer surgery. LS301-IT is a fluorescent imaging agent that is injected intravenously before surgery. The agent binds to sentinel lymph nodes, which are the first lymph nodes to drain from the tumor. During surgery, the surgeon uses a special camera to identify the sentinel lymph nodes, which helps them to remove them more accurately. The study is being conducted in two phases: Phase 1b will enroll a small number of patients to determine the safe dose of LS301-IT, and Phase 2 will enroll a larger number of patients to evaluate the efficacy of the drug in helping surgeons to visualize sentinel lymph nodes.
Site:
Einstein
NCT Number:
NCI-2023-02710
10551 A Phase I/Ib Study of Anti-CD47 Hu5F9-G4 (Magrolimab) in Combination with Olaparib in Patients with BRCA1/2-Mutant Tumors
This research study is studying a new type of cancer treatment. The treatment combines two drugs - Magrolimab: This is a drug that helps the immune system recognize and attack cancer cells. Olaparib: This is a drug that blocks the PARP enzyme, which helps cancer cells repair their DNA. By blocking PARP, olaparib can make cancer cells more likely to die. This study is testing this combination of drugs in patients with tumors that have mutations in the BRCA1 or BRCA2 genes. These genes are involved in DNA repair, so tumors with mutations in these genes are often more sensitive to drugs that block PARP. The trial is still in the early stages (Phase I/II), so the main goals are to find the safest dose of the drugs and to see if they are effective in treating cancer. If the trial is successful, it could lead to larger studies that test the drugs in more patients.
Early Stages
Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.
NCI-2022-08654
A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination With the CDK4/6 Inhibitor Ribociclib or With the PI3K Inhibitor Alpelisib in Adult Subjects With Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
This is a research study of a new treatment for breast cancer. The treatment is a combination of two drugs: OP-1250: This is a new drug that is being tested for the first time in humans. It is a type of drug called an estrogen receptor antagonist. This means that it blocks the effects of estrogen on cancer cells. Ribociclib or Alpelisib: These are two drugs that are already approved for the treatment of some types of breast cancer. They work by blocking different pathways that cancer cells use to grow and divide. The trial is being conducted in two parts: Part 1 (Dose Escalation): This part of the trial will enroll a small number of patients to find the safest dose of OP-1250. Part 2 (Expansion): Once a safe dose is found, more patients will be enrolled in the trial to see if the combination of OP-1250 and ribociclib or alpelisib is effective in treating breast cancer. The trial is only for patients with advanced or metastatic HR-positive, HER2-negative breast cancer. This means that the cancer has spread from where it started to other parts of the body, and it is positive for the estrogen and progesterone receptors but negative for the HER2 protein.
NCI-2023-09871
An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
This reserach study is looking at two different treatment options for people with a specific type of breast cancer - estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer that has either spread locally or to other parts of the body (metastatic). Additionally, the cancer cells must have a mutation in a gene called ESR1. Treatments being compared: Lasofoxifene and abemaciclib: Lasofoxifene is a medication that works similarly to estrogen in some tissues but blocks its effects in others. Abemaciclib is a drug that slows down the growth of cancer cells. Fulvestrant and abemaciclib: Fulvestrant lowers the levels of estrogen in the body and blocks its effects on cancer cells. Similar to the other treatment, abemaciclib slows down the growth of cancer cells. The study is looking for men and women, both premenopausal and postmenopausal and is open label and randomized.
Randomized Trial
Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment
Open label
Patients know which treatments are being given to them
NCT-0563-3654
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecanand Pembrolizumab Versus Treatment of Physicians Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
This research study is looking at a new treatment for triple-negative breast cancer. The new treatment being studied in this trial is a combination of two drugs: sacituzumab govitecan and pembrolizumab. Sacituzumab govitecan is a type of drug called an antibody-drug conjugate (ADC). ADCs are made up of an antibody that is linked to a chemotherapy drug. The antibody helps the ADC target cancer cells, and the chemotherapy drug kills the cancer cells. Pembrolizumab is a type of drug called a checkpoint inhibitor. Checkpoint inhibitors help the immune system recognize and attack cancer cells. The goal of the trial is to see if the new treatment is more effective and safe than the standard treatment at improving survival rates and reducing the risk of cancer recurrence.
Triple Negative Breast Cancer:
It is a type of breast cancecancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body
Triple Negative Breast Cancer
It is a type of breast cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.
Sites:
Einstein
NCT Number:
NCI-2022-07859
OPTIMICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients who Achieve PCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body
Triple Negative Breast Cancer
It is a type of breast cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.
This research study is looking at whether a treatment with pembrolizumab is necessary after surgery for patients with early-stage triple-negative breast cancer (TNBC). The trial is designed for patients with early-stage TNBC who achieved pathologic complete response (pCR) after neoadjuvant chemotherapy that also included pembrolizumab. Traditionally, after achieving pCR, patients would receive additional pembrolizumab. This trial is looking to see if skipping this additional pembrolizumab after surgery leads to the same outcome for patients as receiving it.
Sites:
Sinai
NCT Number:
MA.39 Tailor RT A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer
This is a research study to see if some women with breast cancer can skip a type of radiation treatment (regional radiotherapy) without affecting their chances of recovery. The goal is to avoid unnecessary side effects from radiation treatment for some women who may not need it. Women with Early-stage breast cancer that has spread to nearby lymph nodes (low-risk) and have Hormone receptor-positive (ER+) breast cancer, HER2-negative (HER2-) are eligible to participate in this study.v
Hormone Receptor-Positive
It is a type of breast cancer where the cancer cells have receptors on their surface that can attach to hormones in the body, particularly estrogen and/or progesterone. When these receptors attach to hormones, they can stimulate the cancer cells to grow.
Regional Radiotherapy:
Radiotherapy to the whole breast/chest area and the surrounding lymph glands is called regional radiotherapy.
HER-2 negative
It is a type of breast cancer where cancer cells have normal levels of the protein called HER-2. Cancer cells that are HER-2 negative grow more slowly and are less likely come back or spread to other parts of the body than cancers that have too much HER-2.
P-RAD A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer.
This research study is designed to study a new treatment for triple-negative breast cancer (TNBC). The trial is looking at the effectiveness of a combination of preoperative chemotherapy, pembrolizumab, and different radiation doses. Pembrolizumab is a drug that helps the immune system fight cancer cells. The goal of the trial is to see if adding pembrolizumab and different radiation doses to chemotherapy is safe and effective for women with TNBC.
Triple Negative
It is a type of breast cancecancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.
Metastatic:
Cancer that has spread from its original location or organ to other parts of the body
A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO) Her2 Radiation Optimization (HERO).
This is a Phase III randomized research study that is comparing radiotherapy optimization for low-risk HER2-positive breast cancer. It is investigating whether radiotherapy can be omitted for certain patients with low-risk HER2-positive breast cancer who are also receiving HER2-targeted therapy. The goal of the trial is to see if omitting radiation therapy is safe and effective for patients that could potentially reduce treatment burden and side effects for some patients.
Radiotherapy
a cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors. This radiotherapy is a newer method that aims the radiation beam directly on the tissue with cancer.
HER2-positive:
It is a type of breast cancer where cancer cells have higher-than-normal levels of HER-2 receptors are called HER-2 positive. These receptors are like tiny doorways on the surface of the cells. HER-2 positive breast cancers tend to grow and spread faster than other kinds, but they also respond well to certain drugs that target the HER-2 receptor.
Phase 3
A phase 3 clinical trial is a large-scale study designed to assess the effectiveness and safety of a new medical treatment or approach compared to a standard treatment
Randomized:
Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment
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.
This research study is investigating a drug called MK-3475 (pembrolizumab) for triple-negative breast cancer (TNBC). Pembrolizumab is a drug that helps the immune system fight cancer cells. The study is designed to see how pembrolizumab affects the tumor microenvironment, which is the area around the tumor that contains cells and substances. Pembrolizumab is given before surgery (pre-operative) with or without intra-operative Radiation Therapy (IORT). Researchers hope to learn if pembrolizumab can alter the tumor microenvironment in a way that makes the cancer more susceptible to treatment.
IORT
Intraoperative radiation therapy (IORT) is a kind of radiation treatment that is performed during surgery. Radiation therapy (also called radiotherapy) is a cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors. This radiotherapy is a newer method that aims the radiation beam directly on the tissue with cancer.
Triple Negative
It is a type of breast cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.
Pilot Study of Medical Reiki for Women Undergoing Surgery for Breast Cancer Impact on Quality of Life, Medical Recovery Metrics, and Cortisol.
This research study aims to explore how Medical Reiki might influence these aspects during and after surgery.
Site:
Einstein
NCT Number:
Intra-Operative Radiation Therapy (IORT) Using the IntraBeam System A Registry Protocol.
Intra-Operative Radiation Therapy (IORT) refers to radiation therapy delivered directly to the tumor site during surgery. IntraBeam System A is a specific type of equipment used to deliver the radiation therapy. This registry study outlines the procedures for collecting, storing, and analyzing data related to patients who received IORT using the IntraBeam System A. It is designed to gather information about the use of this specific radiation therapy technique for research and quality improvement purposes.
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 research study designed to investigate the effectiveness of two medical technologies in breast-conserving surgery. PD G 506 A: a medical dye or contrast agent designed to highlight specific tissues during surgery.
Eagle V1.2 Imaging System: a medical imaging device used to visualize the contrast agent and potentially other tissues. The researchers aim to determine whether combining the PD G 506 A and the Eagle V1.2 Imaging System can help surgeons better identify and remove cancerous tissue while preserving healthy breast tissue. If successful, this study could lead to improved surgical precision, potentially resulting in better outcomes for patients with breast cancer.
An open-label, single-arm, Phase 1b/2 study to investigate the safety, efficacy and pharmacokinetics of LS301-IT in female patients undergoing partial mastectomy and sentinel lymph node biopsy (SLNB) for ductal carcinoma in situ (DCIS) or Stage I-II primary invasive breast cancer.
This research study aims to gather essential information about the safety and effectiveness of LS301-IT as a potential treatment option for women with early-stage breast cancer. The findings from this study will help determine the drug's suitability for further development and potential use in larger-scale clinical trials. It is a Phase 1b/2, open label and single arm study.
Single Arm
A study where sample of individuals with the targeted medical condition is given the experimental therapy and then followed over time to observe their response.
Open Label
Patients know which treatments are being given to them
I-SPY TRIAL: Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2.
This research study aims to predict how well different cancer treatments will work for individual patients. They do this by using advanced imaging techniques and analyzing the patient's cancer cells at a molecular level. By understanding these details, doctors hope to better predict how patients will respond to different treatments, leading to more effective and personalized care.
NRG-BR007: A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (De-Escalation of Breast Radiation - DEBRA Trial).
This research study is investigating whether it's possible to safely reduce the amount of radiation therapy given to women with early-stage, low-risk breast cancer while still effectively treating the disease. This study is for women with Stage I breast cancer which is an early stage where the cancer is small and hasn't spread, Hormone-sensitive breast cancer which means the cancer cells are fueled by hormones like estrogen, HER-2 negative means the cancer doesn't have too much of a protein called HER-2, which is sometimes involved in cancer growth and the oncotype Recurrence Score less than or equal to 18 (low score indicates low risk).
A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy.
This Phase 3 research study is investigating the effectiveness of a new cancer drug called Dato-DXd, either alone or in combination with another drug called durvalumab. The study focuses on patients with early-stage triple-negative breast cancer that has not been completely eliminated by surgery and chemotherapy. They want to see if these treatments can help these patients more effectively.
Early Stage
Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.
Triple Negative
It is a type of breast cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.