Clinical Trials

Trastuzumab Deruxtecan and Durvalumab Before Surgery for the Treatment of Patients with Stage III, HER2-Expressing Inflammatory Breast Cancer

TRUDI: A Phase II Study of Neoadjuvant Trastuzumab Deruxtecan and Durvalumab (MEDI 4736) for Stage III, HER2-Expressing Inflammatory Breast Cancer

Phase II

This phase II trial tests how well trastuzumab deruxtecan with durvalumab, given prior to surgery (neoadjuvant) works in treating stage III, HER-2 expressing inflammatory breast cancer. Trastuzumab deruxtecan is a monoclonal antibody called traztuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors and delivers deruxtecan to kill them. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant trastuzumab deruxtecan with durvalumab may kill more cancer cells in patients with stage III, HER2 expressing inflammatory breast cancer.

Start date: 2023-05-04.

This trial is being offered at including in the following states:

MA

For more information including sites offering the trial visit this NCI page: NCI-2023-03834

Stopping Anti-HER2 Therapy to Improve Outcomes for Exceptional Responder Patients with Metastatic HER2-Positive Breast Cancer, The STOP-HER2 Trial

The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab – Outcomes in Patients with HER2+ Metastatic Breast Cancer

Phase II

This trial includes Her-2 positive tumors, which are very rare among men with breast cancer. Please check your eligibility.

This phase II trial studies how well stopping anti-HER2 therapy works in improving outcomes of patients with HER2-positive breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and have experienced long-term benefit from first-line treatment (exceptional responders). Patients with metastatic HER2-positive breast cancer are currently treated with systemic drugs indefinitely. These drugs include chemotherapy and/or biological agents targeting the HER2 protein. The first drug combination administered after diagnosis of metastatic spread (i.e., first-line treatment) usually combines chemotherapy with anti-HER2 agents (trastuzumab with or without pertuzumab). Chemotherapy is administered for a limited number of months, and anti-HER2 agents are continued indefinitely as maintenance therapy. Some of these patients experience a long-term benefit from first-line treatment without cancer growth and can be defined as “exceptional responders.” Nevertheless, all patients with this type of tumor typically continue maintenance treatment with anti-HER2 therapy indefinitely. Exceptional responders usually receive treatment for many years. Information learned from this trial may help researchers understand whether maintenance anti-HER2 treatment can be safely stopped in patients with exceptional response to first-line therapy.

Start date: 2023-04-19.

This trial is being offered at including in the following states:

MA

For more information including sites offering the trial visit this NCI page: NCI-2023-03485

Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients with Breast Cancer

Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases from Breast Carcinoma Involving the Spine

Phase NA

This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.

Start date: 2023-04-07.

This trial is being offered at including in the following states:

FL

For more information including sites offering the trial visit this NCI page: NCI-2023-00240

Dendritic Cell Vaccines against Her2/Her3 for the Treatment of Leptomeningeal Disease from Triple Negative Breast Cancer or HER2+ Breast Cancer

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed against HER2/HER3 in Patients with Leptomeningeal Disease (LMD) from Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC)

Phase I

This trial includes triple negative tumors, which are very rare among men with breast cancer. Please check your eligibility.

This phase I trial tests the safety, side effects, and best dose of dendritic cell vaccines against Her2/Her3 in treating patients with triple negative breast cancer or HER2+ breast cancer that has spread to the brain and spinal cord tissue (leptomeningeal metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. The dendritic cell vaccine is made utilizing blood cells collected from a procedure called leukapheresis. Infusing dendritic cell vaccines directly into the thin fluid-filled space between the lining of the spinal cord and brain via a surgically implanted reservoir under the scalp (Ommaya reservoir) may cause a stronger immune response, and may kill more tumor cells.

Start date: 2023-03-28.

This trial is being offered at including in the following states:

FL

For more information including sites offering the trial visit this NCI page: NCI-2023-03180

Tamoxifen and Alpelisib Compared to Fulvestrant and Zotatifin for the Treatment of Newly Diagnosed or Recurrent Estrogen Receptor Positive, HER2 Negative Breast Cancer

An Umbrella, Randomized, Controlled, Pre-Operative Trial Testing Integrative Subtype-Targeted Therapeutics in Estrogen Receptor-Positive, HER2-Negative Breast Cancer

Phase II

This phase II trial compares the effect of combination therapy with alpelisib and tamoxifen vs. tamoxifen alone and combination therapy with zotatifin and fulvestrant vs. fulvestrant alone in patients with estrogen receptor (ER) positive, HER2-negative breast cancer that is newly diagnosed or has come back (recurrent). Breast cancer survival rates in early stage, ER positive, HER2 negative breast cancer have improved with modern oncology management, but a significant number of patients eventually develop distant recurrence and die from cancer that has spread from where it first started (primary site) to other places in the body (metastatic) disease. Tamoxifen and fulvestrant are in a class of hormone therapy medications known as antiestrogens. They block the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Alpelisib is in a class of medications called kinase inhibitors. It works to treat cancer by blocking an enzyme called PI3K that signals tumor cells to multiply. By inhibiting this enzyme, it helps to stop the spread of tumor cells. Zotatifin is a selective inhibitor of a family of proteins called eIF4A. It may prevent the growth of tumor cells and may kill them. This trial will help researchers determine whether combination therapy with tamoxifen and alpelisib or fulvestrant and zotatifin may be more effective than hormone therapy alone in treating patients with estrogen receptor positive, HER2-negative breast cancer.

Start date: 2023-03-20.

This trial is being offered at including in the following states:

CA

For more information including sites offering the trial visit this NCI page: NCI-2023-02578

Testing the Usual Treatment of Radiation Therapy and HER2-Targeted Therapy to HER2-Targeted Therapy Alone for Low-Risk HER2-Positive Breast Cancer, The HERO Trial

A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO*) *Her2 Radiation Optimization (HERO)

Phase III

This trial includes Her-2 positive tumors, which are very rare among men with breast cancer. Please check your eligibility.

This phase III trial compares the usual treatment of breast radiation and HER2-targeted drugs following surgery and chemotherapy to using the usual treatment approach without radiation in treating patients with low-risk HER2-positive breast cancer. The usual approach is defined as care most people get for this type of cancer. The usual approach for patients who have undergone surgery, chemotherapy, and HER2-targeted therapy and are not in a study is treatment with radiation therapy to the breast and continuing HER2-targeted therapy. HER2-targeted drugs attach to the HER2 receptor proteins on the surface of breast tumor cells and block the HER2 receptors from receiving growth signals in HER2-positive breast cancer. By blocking the growth signals, HER2-targeted drugs can slow or stop the growth of HER2-positive breast cancer. Radiation therapy uses high energy sources of radiation to kill tumor cells and shrink tumors. The usual approach for patients who have undergone surgery, chemotherapy, and HER2-targeted therapy and are not in a study is treatment with radiation therapy to the breast and continuing HER2-targeted therapy. Omitting radiation from the usual treatment approach may avoid the potential short-term and long-term risks of radiation in patients with low-risk HER2-positive breast cancer and may have the same effect as the usual approach in preventing cancer from coming back (recurrence ).

Start date: 2023-03-13.

This trial is being offered at including in the following states:

CA | IA | IL | MD | MI | MO | NE | NJ | NY | OH | OK | OR | PR | RI | UT | WA

For more information including sites offering the trial visit this NCI page: NCI-2022-09157

Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer, A ComboMATCH Treatment Trial

A ComboMATCH Treatment Trial 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

Phase II

This ComboMATCH phase II trial compares the usual treatment alone (fulvestrant) to using binimetinib plus the usual treatment in patients with hormone receptor positive breast cancer that has spread to other places in the body (metastatic) and has an NF1 genetic change. Fulvestrant is a hormonal therapy that binds to estrogen receptors in tumor cells, resulting in estrogen receptor destruction and decreased estrogen binding, which may inhibit the growth of estrogen-sensitive tumor cells. Binimetinib is a targeted therapy that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of binimetinib to fulvestrant in breast cancers with an NF1 genetic change could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to fulvestrant alone.

Start date: 2023-03-06.

This trial is being offered at including in the following states:

AZ | CA | IA | ID | MI | MT | NV | OH | OR | PA | PR | TX | WA

For more information including sites offering the trial visit this NCI page: NCI-2022-07265

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Phase I Study Targeting DNA Methyltransferases in Metastatic Triple-Negative Breast Cancer

Phase I

This trial includes triple negative tumors, which are very rare among men with breast cancer. Please check your eligibility.

This phase I trial tests the safety, side effects, and best dose of ASTX727 when given in combination with a usual approach of treatment with paclitaxel and pembrolizumab in patients with triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). The usual approach is defined as care most people get for this type of cancer. The usual approach for patients with metastatic triple negative breast cancer who are not in a study is chemotherapy with drugs like paclitaxel, carboplatin, cisplatin, eribulin, vinorelbine, capecitabine, gemcitabine, doxorubicin or cyclophosphamide. There is a protein called PD-L1 that helps regulate the body’s immune system. For patients who have PD-L1+ tumors, immunotherapy (pembrolizumab) is usually added to paclitaxel or carboplatin/gemcitabine as initial treatment. For patients who have PD-L1-negative tumors, chemotherapy alone is used, without immunotherapy. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ASTX727 with usual treatment approach with paclitaxel and pembrolizumab may be able to shrink or stabilize the tumor for longer than the usual approach alone in patients with metastatic triple negative breast cancer.

Start date: 2023-03-02.

This trial is being offered at including in the following states:

For more information including sites offering the trial visit this NCI page: NCI-2022-10810

Talazoparib for the Treatment of PALB2 Mutation Associated Advanced Breast Cancer

A Phase 2 Clinical Trial of Talazoparib Monotherapy for PALB2 Mutation Associated Advanced Breast Cancer

Phase II

This phase II trial studies how well talazoparib works for the treatment of breast cancer with a PALB2 gene mutation that has spread to other places in the body (advanced). Talazoparib is an inhibitor of poly adenosine diphosphate-ribose polymerase (PARP), an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Giving talazoparib may work better in treating patients with advanced breast cancer.

Start date: 2023-02-23.

This trial is being offered at including in the following states:

CA

For more information including sites offering the trial visit this NCI page: NCI-2023-01961

TACTIVE-U: A Study to Learn About the Study Medicine (Called ARV-471) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)

TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF ARV-471 (PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY A (ARV-471 IN COMBINATION WITH ABEMACICLIB)

Phase I_II

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: – is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy – is sensitive to hormonal therapy (it is called estrogen receptor positive); and – is no longer responding to previous treatments This study is divided into separate sub-studies. For Sub-Study A: All participants will receive ARV-471 and a medicine called abemaciclib. ARV-471 will be given by mouth, at home, 1 time a day. Abemaciclib will be given by mouth, at home, 2 times a day. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective. Participants will continue to take ARV-471 and abemaciclib until their cancer is no longer responding, or side effects become too severe. They will have visits at the study clinic about every 4 weeks.

Start date: 2023-02-23.

This trial is being offered at including in the following states:

CA | MO | TX

For more information including sites offering the trial visit this NCI page: NCI-2023-01696