Home   /  Find a Trial  /  See All TrialsClick to print page Print
 

See All Trials

QuickViews

by Tumor Type:

Inflammatory Breast Cancer
Biomarker status:
 Hormone-positive (ER+ and/or PR+)
 HER2-positive (HER2+)
 Triple negative (ER-/PR-/HER2-)
Inflammatory Breast Cancer
Biomarker status:
 Hormone-positive (ER+ and/or PR+)
 HER2-positive (HER2+)
 Triple negative (ER-/PR-/HER2-)

Sites with evidence of disease:

Triple Negative Breast Cancer
Sites with evidence of disease:


by Trial Type:

 

see All Trials

Sort by zipcode:  

Share

Twitter
Facebook
 
Vaccines and Immunotherapy

Vaccine Plus Herceptin for HER2-Positive Breast Cancer

Combination Immunotherapy With Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-expressing Breast Cancer Patients to Prevent Recurrence (NCT01570036)

Summary

Researchers are investigating whether vaccines can play a role in cancer treatment. Trastuzumab (Herceptin®) is used to treat HER2-positive breast cancer. NeuVax® is a vaccine that uses the E75 peptide, which is a piece of the HER2 protein, to get the immune system to identify and kill HER2-positive cancer cells. GM-CSF is a substance added to the vaccine to improve the immune response. This trial will look at whether Herceptin along with the NeuVax vaccine is better than Herceptin alone at preventing recurrence in patients with stage I-III breast cancer who are at high risk for recurrence. To be eligible, participants must have breast cancer with tumors that express low (1+) or intermediate (2+) levels of HER2.
This is a Phase II trial

A Vaccine to Treat HER2+ Advanced Breast Cancer

A Phase I Study of an Adenoviral Transduced Autologous Dendritic Cell Vaccine Expressing Human HER2/Neu ECTM in Adults With Tumors With 1-3+ HER2/Neu Expression (NCT01730118)

Summary

Researchers are trying to develop new ways treat HER2+ metastatic breast cancer. One approach being studied is a vaccine that would teach the immune system to recognize and kill HER2+ cancer cells. The vaccine that is being used in this study is called AdHER2/neu dendritic cell vaccine. It is custom-made for each patient. This means that each patient's immune cells are collected and then used to produce a vaccine that is just for them. This vaccine is being studied in HER2+ breast cancer as well as other types of HER2+ solid tumors. (Ovarian, colon, non-small cell lung, renal cell, bladder and prostate cancer can also be HER2+.)
This is a Phase I trial

Taxotere & A New Immune Therapy in Metastatic Breast Cancer

A Phase II Double-Blinded, Randomized, Placebo-Controlled Study of Docetaxel in Combination With 1-methyl-D-tryptophan (Indoximod) in Metastatic Breast Cancer (NCT01792050)

Summary

Researchers are studying news types of drugs and new drug combinations that could be used to treat metastatic breast cancer. Docetaxel (Taxotere®) is routinely used to treat breast cancer. Indoximod is a new type of drug called an IDO pathway inhibitor. It works by blocking an enzyme called IDO that plays a role in the immune system. Laboratory studies suggest that giving IDO along with Taxotere can make the Taxotere more effective. The purpose of this study is to see whether combining Taxotere and Indoximod is more effective than using Taxotere alone in patients with metastatic breast cancer.
This is a Phase II trial

A Vaccine to Treat HER2-Positive Metastatic Breast Cancer

Phase II Study to Evaluate the Development of HER2/Neu (HER2)-Specific Memory T Cells After HER2 Peptide-based Vaccination in Patients With Advanced Stage Her2+ Breast Cancer (NCT01729884)

Summary

Vaccines work by teaching the immune system to attack a specific type of invader. Cancer researchers are trying to develop vaccines that will teach the immune system to recognize and kill cancer cells. This study is looking at whether a vaccine designed to teach the immune system to recognize the HER2 protein and kill HER2-positive cancer cells is effective in patients with metastatic HER2-positive breast cancer.
This is a Phase II trial

Vaccine for Metastatic Breast Cancer

A Phase I Vaccine Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer (NCT00715832)

Summary

Vaccines may enable the body to build an immune response to kill tumor cells. This study is investigating a vaccine that uses a molecule called "oncofetal antigen" or OFA that is found only on cancer cells. Because OFA is unique to cancer, the investigators believe it could be used to teach the immune system to kill cancer cells. The purpose of this study is to evaluate the vaccine's safety and to identify what, if any, side effects it causes. The investigators also want to see if the vaccine will get the immune system to build an immune response to cancer cells and stop the cancer from growing.
This is a Phase I trial

HER2 Immunization for Advanced Breast Cancer

Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity (NCT00393783)

Summary

New research in breast cancer attempts to use vaccines to trigger the body’s immune system to fight cancer. An injection of a small amount of cells (DNA that encodes the HER2 protein) into the body may trigger an immune response against other breast cancer cells in your body. The purpose of this trial is to determine the highest dose of the HER2/neu immunization that is safe, and see if it can stimulate an immune response in women with metastatic disease or at high risk for metastatic disease.
This is a Phase I trial

A Vaccine to Prevent Breast Cancer Recurrence

A Phase I Clinical Trial of mTOR Inhibition With Rapamycin for Enhancing Intranodal Dendritic Cell Vaccine Induced Anti-Tumor Immunity In Patients With NY-ESO-1 Expressing Solid Tumors (NCT01522820)

Summary

Researchers are trying to develop vaccines that can teach the immune system to prevent a cancer recurrence. This trial is studying a vaccine, called DEC-205-NY-ESO-1, which may be effective in tumors that produce a peptide named NY-ESO-1. In this study, patients will be given a vaccine that consists of their own white blood cells mixed with DEC-205-NY-ESO-1. Some patients will also receive sirolimus, a drug that suppresses the immune system and is used to prevent rejection during organ transplants. Since laboratory studies suggest sirolimus may also have a role in cancer treatment its inclusion will help the researchers determine if the vaccine is more effective with or without sirolimus. To be eligible for this trial, patients will have their tumors tested for NY-ESO-1. Only patients whose tumors test positive for this peptide can enter the trial. This study is also enrolling patients with other types of cancers.
This is a Phase I trial

Natural Killer Cells and Chemotherapy for Metastatic Disease

Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian, Fallopian Tube, Primary Peritoneal Cancer and Advanced Metastatic Breast Cancer (MT2009-30) (NCT01105650)

Summary

Natural killer cells are a type of lymphocyte (a white blood cell). They are part of the body's immune system, and they play a major role in helping the body fight tumors and viruses. Giving an infusion of natural killer cells, along with cyclosporine and interleukin-2 (IL-2), agents that support them, may be an effective anti-cancer treatment. The goal of this study is to determine the effectiveness of an infusion of natural killer cells immediately followed by treatment with the chemotherapy drugs fludarabine (Fludara®) and cyclophosphamide (Cytoxan®) to individuals with metastatic disease.
This is a Phase II trial

Vaccine Therapy for DCIS

Vaccine Therapy in Treating Patients With Ductal Carcinoma In Situ of the Breast (NCT00923143)

Summary

Researchers are investigating whether a vaccine can be used to treat ductal carcinoma in situ (DCIS). One vaccine now being studied is made from a patient's own T-cells, which are a type of white blood cell. To make the vaccine, the researchers remove the patients T-cells. Next, they coat the T-cells with special proteins that make them into a vaccine that can teach other white blood cells to go after and kill cancer cells. Then, they inject the vaccine into the patient's body. This trial is studying the safety and effectiveness of two different injection sites (in the breast or in a lymph node) for the vaccine in individuals with DCIS that is HER2-positive.
This is a Phase I-II trial

Mammaglobin-A DNA Vaccine for Metastatic Breast Cancer

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Mammaglobin-A DNA Vaccine in Breast Cancer Patients With Metastatic Disease (NCT00807781)

Summary

Researchers are trying to find more effective treatments for metastatic breast cancer. Mammaglobin-A is a protein that is found in 80 percent of breast tumors. Scientists think that a vaccine that contains mammaglobin-A DNA may get the body to generate an immune response to and go after and kill breast cancer cells. The overall goal of this trial is to study the safety of a vaccine that contains mammaglobin-A DNA in individuals with metastatic breast cancer. To be eligible, participants must have had stable disease for at least 30 days.
This is a Phase I trial

Evaluating the Safety of Vaccine For Early Stage Breast Cancer

A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage IB-IIIA Breast Cancer (NCT01532960)

Summary

Despite treatment advances, some patients with early stage breast cancer will go on to experience a recurrence. Because a recurrence may not happen for many years, there is a period of time after surgery when a breast cancer vaccine may be able to stop potential metastases from spreading. Researchers are exploring whether peptides consisting of small protein fragments associated with breast cancer can stimulate immune cells such as cytotoxic T lymphocytes to kill tumor cells. This study is investigating whether a vaccine that contains breast specific peptides can trigger an immune response in participants with early stage (stage IB to IIIA) breast cancer. To be eligible, participants must have completed treatment for breast cancer between 45 days and 6 months (180 days) prior to enrollment.

Phase 1 Study of ONT-10 in Breast and Other Cancers

Phase 1 Study of ONT-10, a Liposomal MUC1 Cancer Vaccine, in Patients With Solid Tumors (NCT01556789)

Summary

Scientists are trying to develop vaccines that use the immune system to fight cancer. MUC1 is a protein that is found on more than 70 percent of all cancers, and it one of the three most important tumor proteins for vaccine development. ONT-10 is a therapeutic vaccine that researchers believe will stimulate both antibodies and immune cells that can block MUC1. This trial will evaluate the safety of, and the immune response associated with, repeat dose vaccination of ONT-10 in patients with breast and other cancers associated with MUC1.
This is a Phase I trial

A Breast Cancer Vaccine for Metastatic or Triple-Negative Breast Cancer

Clinical Trial of Autologous cMet Redirected T Cells Administered Intratumorally in Patients With Breast Cancer (NCT01837602)

Summary

Researchers are investigating whether they can use vaccines to teach the immune system to go after cancer cells. This study will test a vaccine developed for each patient by adding special genetic material to T-cells that are removed from and then infused back into the body. The genetic material teaches the T-cells to fight cancer cells. To be eligible, participants must have either metastatic breast cancer that has stopped responding to at least one standard therapy or newly diagnosed operable triple negative breast cancer.
This is a Phase I trial

Cryoablation Before Surgery to Stimulate the Immune System

NCT01856036: Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers (NCT01856036)

Summary

Researchers are studying various ways to get the immune system to respond to cancer cells. Cryoablation involves placing a hollow, thin tube (called a cryoprobe) directly into the tumor to freeze and destroy cancer cells. Studies suggest that cryoablation may also stimulate an immune response that fights tumor cells. This study is investigating the impact that cryoablation has on the immune system when it is used before breast cancer surgery in patients with breast tumors that are ER+, HER2- and less than 1.5 cm in size. Women with metastatic disease at diagnosis who elect to have their primary tumor removed by surgery are eligible for enrollment.
This is a Phase II trial

Vaccine Therapy and Chemotherapy to Treat Metastatic Disease

Vaccine Therapy Before and After Dose-Intensive Induction Chemotherapy Plus Immune-Depleting Chemotherapy in Treating Patients With Metastatic Breast Cancer (NCT00048893)

Summary

Vaccines may enable the body to build an immune response to kill tumor cells. Giving vaccine therapy with chemotherapy may kill more tumor cells than chemotherapy alone. This trial is studying the side effects, best way to give, and best dose of vaccine therapy given before and after two regimens of chemotherapy: the first, a high-dose regimen, primarily for targeting cancer cells, and the second, primarily for depleting the body of immune cells. After chemotherapy, patients will be re-infused with immune cells collected after their first vaccination. This trial is for patients with newly diagnosed metastatic breast cancer.
This is a Phase I-II trial

Stereotactic Radiation for Lung or Liver Metastases

Phase I/II Study of Stereotactic Body Radiation Therapy to Metastatic Lesions in the Liver or Lung in Combination With Monoclonal Antibody to OX40 in Patients With Progressive Metastatic Breast Cancer After Systemic Therapy. (NCT01642290)

Summary

Stereotactic body radiation therapy (SBRT) is a technique that delivers high-dose, focused radiation to treat small, isolated tumors, including cancers in the lung and liver. SBRT systems are often referred to by their brand names, such as CyberKnife®. The anti-OX40 monoclonal antibody has been studied in patients with advanced solid tumors. Studies suggest that activating the immune system with OX40 can help shrink tumors. This is a phase I/II study to determine the maximum tolerated dose of stereotactic body radiation given with anti-OX40 in patients with tumors that have spread to to the lung or liver.
This is a Phase I-II trial

Vaccine for Stage II and III Breast Cancer with The WT1 Protein

Study of GSK2302024A Antigen-Specific Cancer Immunotherapeutic Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer (NCT01220128)

Summary

High levels of a protein called WT1 have been found to be associated with the development of certain types of cancer. Recent studies have found that WT1 also is present in some breast cancer tumors. This trial is studying the safety and clinical activity of an experimental cancer treatment vaccine that works by triggering an immune response to the WT1 protein. The vaccine will be given before surgery in combination with standard therapy to patients with stage II or stage III breast cancer. To be eligible, tumors must test positive for the WT1 antigen.
This is a Phase II trial

FANG Vaccine For Advanced Breast Cancer

Phase I Trial of Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer (NCT01061840)

Summary

Studies suggest that vaccines that enable the body to build an immune response to tumor cells might be effective and have few side effects. The FANG (bi-shRNAfurin and GMCSF autologous tumor cell) vaccine works by stimulating tumor surface proteins, which then increases the number of immune cells that attack breast cancer cells with these proteins. The goal of this trial is to study the safety of and tumor response to the FANG vaccine in individuals with advanced breast cancer who have no acceptable form of standard therapy.
This is a Phase I trial

Vaccine Treatment for HER2+ Early-Stage Breast Cancer

Prevention of Recurrence in Early-Stage,Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax(TM) Treatment (NCT01479244)

Summary

Because cancer cells start out as normal cells, the immune system doesn't always see them as "bad." Researchers are trying to develop vaccines that will teach the immune system to respond to and kill cancer cells. NeuVax™ is an experimental vaccine that teaches the immune system to target HER2-positive breast cancer cells. The goal of this trial is to determine the safety and effectiveness of NeuVax™ for preventing recurrence in women who have been treated for HER2-positive breast cancer that has spread to the lymph nodes.
This is a Phase III trial

Vaccine Plus Cytoxan® to Treat Stable Metastatic Disease

A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer (NCT01516307)

Summary

Researchers are looking for ways to use the body's immune system to fight cancer. The immune system identifies and removes unwanted substances from the body by looking for markers called antigens. Globo H is an antigen that is commonly found on the surface of breast cancer cells. OPT-822/OPT-821 is an experimental vaccine that is designed to help stimulate the body's immune system to fight cells that express Globo H. The goal of this study is to determine the effectiveness of OPT-822/OPT-821 when it is given with the standard chemotherapy drug cyclophosphamide (Cytoxan®). To be eligible, participants must have metastatic disease that has stabilized or have had a partial or complete response after at least 1 previous treatment with chemotherapy. Individuals currently receiving hormone therapy or bisphosphonate therapy will be allowed to continue this treatment while on the study. Individuals who currently only have disease in the bone must have previously had metastases elsewhere.
This is a Phase II trial

Vaccine With Basilixumab for Metastatic Breast Cancer

A Study of hTERT/Survivin Multi-Peptide Vaccination With Basiliximab And Prevnar For Patients With Metastatic Breast Cancer (NCT01660529)

Summary

Researchers believe that vaccines may be effective cancer treatments. Recent observations support the idea that the enzyme telomerase is essential for the formation of human tumors. In a recent study, three-quarters of breast tumors tested positive for human telomerase reverse transcriptase (hTERT). Researchers believe that a vaccine that teaches the immune system to target hTERT may be an effective breast cancer treatment. This study is testing a hTERT/survivin/CMV multipeptide vaccine in women with metastatic breast cancer. The vaccine is given along with the monoclonal antibody basiliximab, GM-CSF and Prevnar, which each work in different ways to help the immune system target the cancer cells.

Vaccine With Ampligen for HER2+ Stage II-IV Breast Cancer

Phase I-II Study of HER2 Vaccination With Poly(I) • Poly(C12U) (Ampligen®) as an Adjuvant in Optimally Treated Breast Cancer Patients (NCT01355393)

Summary

New treatments are needed for women with HER2+ tumors, as these tumors can stop responding to the treatments that are currently available. Researchers are investigating whether a vaccine that can teach your immune system to generate an immune response to the HER2 protein can be effective in treating this type of breast cancer. Adjuvants are natural substances that are given in small amounts along with a vaccine; they are used to help the vaccine produce a stronger immune response. Granulocyte-macrophage Colony Stimulating Factor (GM-CSF), is a commonly used adjuvant. Ampligen is another adjuvant that is now being evaluated. This trial is studying the side effects and best dose of Ampligen when given with vaccine therapy and sargramostim (GM-CSF) to treat patients with stage II-IV HER2-positive breast cancer.
This is a Phase I-II trial

Vaccine Therapy for HER2+ Metastatic Breast Cancer

Phase I Active Immunotherapy Trial With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 and Nor-MDP Adjuvant in Patients With Advanced Solid Tumors (NCT01376505)

Summary

Researchers are studying whether vaccines can teach the body’s immune system to kill cancer cells. About 30% of all breast tumors make too much of a protein called human epidermal growth factor receptor 2 (HER2). Scientists believe a vaccine that incorporates a small amount of the HER2 protein may get the immune system to recognize and go after HER2+ cancer cells. The purpose of this trial is to determine the best dose for and the side effects of a new HER2 vaccine when it is used to treat individuals with HER2+ metastatic breast cancer.
This is a Phase I trial

Aromasin® and Cytoxan® for Hormone Sensitive Metastatic Breast Cancer

Phase II Trial of Exemestane With Immunomodulatory Cyclophosphamide in ER and/or PR-positive and HER2/Neu Negative Metastatic Breast Cancer (NCT01963481)

Summary

This phase II trial studies how well exemestane and cyclophosphamide work in treating patients with estrogen receptor (ER) -positive, progesterone receptor (PR) -positive, and human epidermal growth factor receptor (HER)2-negative stage IV breast cancer.
This is a Phase II trial

Breast Cancer Vaccine Therapy With or Without Trastuzumab

Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer (NCT00971737)

Summary

Cancer vaccines may help the body build an effective immune response to tumor cells. Cyclophosphamide (Cytoxan®) is a chemotherapy drug used to treat breast cancer. Trastuzumab (Herceptin®) is a biological therapy used to treat HER2+ tumors. Both work in a way that may increase the number of immune cells and make the immune response stronger. It is not yet known whether giving cyclophosphamide together with vaccine therapy is more effective with or without trastuzumab (Herceptin®). This trial is studying the safety and effectiveness of giving cyclophosphamide with vaccine therapy with or without trastuzumab in women with HER2-negative metastatic breast cancer who have progressed on standard therapy, or for whom no standard therapy exists.
This is a Phase II trial

Gene Therapy and Chemotherapy for Metastatic Breast Cancer

Cyclophosphamide and Fludarabine Followed By Laboratory-Treated Lymphocytes and High-Dose Aldesleukin in Treating Patients With Metastatic Cancer (NCT00670748)

Summary

Gene therapy is a promising area of cancer research that involves changing the genetic makeup of a cell to improve the body’s natural ability to fight cancer. This trial will genetically modify cells in the immune system (lymphocytes) to target and kill tumor cells that express a specific cancer-related protein (NY-ESO-1). The agent aldesleukin (Proleukin®) will be used to increase lymphocyte activity. The purpose of this trial will be to study the side effects and best dose of genetically modified lymphocytes when given with aldesleukin, together with chemotherapy drugs cyclophosphamide (Cytoxan®) and fludarabine (Fludara®), for treating patients with metastatic cancer who have not responded to previous treatment.
This is a Phase II trial

AVX901: A Vaccine for Advanced HER2-Positive Breast Cancer

A Phase I Study To Evaluate The Antitumor Activity And Safety Of DUKE-002-VRP(HUHER2-ECD+TM), An Alphaviral Vector Encoding The HER2 Extracellular Domain And Transmembrane Region, In Patient With Locally Advanced Or Metastatic ... (NCT01526473)

Summary

New approaches are needed for treating HER2-positive tumors. A vaccine that teaches the immune system to go after cancer cells may be an effective cancer treatment. The experimental vaccine AVX901 (HER2 VRP) teaches the immune system to attack cells that make too much HER2. Normal cells do not do this, so the immune system will only go after the cancer cells. The purpose of this study is to evaluate the vaccine's safety as well as its ability to get the immune system to attack cancer cells in women with advanced HER2+ breast cancer.
This is a Phase I trial

Dendritic Cell Vaccine After Neoadjuvant Therapy for HER2+ Breast Cancer

Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer Post Neoadjuvant Chemotherapy (NCT02061423)

Summary

Dendritic cells are immune cells that break down cancer cells into smaller pieces. This makes it easier for the immune system to recognize and attack cancer cells. The process of making a dendritic cell vaccine includes taking immune cells from the patient with cancer, treating the cells in the lab, and then infusing the cells back into the body, where they should provoke an immune response to the patient's cancer cells. This study is investigating the safety and immune activity of a dendritic cell vaccine in patients with HER2-positive breast cancer who are at high risk for recurrence because they still have cancer cells remaining following neoadjuvant therapy (therapy given before surgery).
This is a Phase I trial