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Breast Cancer Trials

Phase I/II Trial of Leflunomide in Women with Previously Treated Metastatic Triple Negative Cancer

This is a medical 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

The 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

Site:

Mount Sinai / Columbia

NCT Number:

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

Site:

Mount Sinai

NCT Number:

Open Label:

Patients know which treatments are being given to them

NCI-2022-02453

A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast

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. 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.

Metastatic:

cancer that has spread from its original location or organ to other parts of the body. 

Site:

Mount Sinai

NCT Number:

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

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)

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.

Site:

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 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

The 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

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.

This is a 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.

Site:

Einstein

NCT Number:

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 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:

NCI-2020-02319

A Phase I/II Trial Evaluating the Safety and Efficacy of Eribulin in Combination with Copanlisib inPatients with Metastatic Triple Negative Breast Cancer

This clinical trial 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 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. 

Site:

Columbia

NCT Number:

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 studyt, 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 protin 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 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. 

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.

Site:

Einstein/Columbia

NCT Number:

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

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.

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. 

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

Site:

Mount Sinai

NCT Number:

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 cancecancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.

Site:

Einstein/Columbia

NCT Number:

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.

Site:

Sinai

NCT Number:

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 medical 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 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.

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

Site:

Einstein

NCT Number:

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 medical 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.

Site:

Einstein

NCT Number:

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.

Site:

Sinai

NCT Number:

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

Site:

Sinai

NCT Number:

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