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Vaccines and Immunotherapy

Chemotherapy, Her2 Targeted Therapy & Immunotherapy Before Surgery in HER2+ Breast Cancer

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab (neoHIP) (NCT03747120)

Summary

To take part in this study you must have HER2 positive stage I, II or III breast cancer and have not yet received any treatment for your breast cancer.

This study will compare the safety and effects (good or bad) of three different breast cancer treatment regimens that will be given before breast cancer surgery. The drugs used in different combinations in the treatment regimens are the HER2-targeted therapy trastuzumab (Herceptin®); the HER2-targeted therapy pertuzumab (Perjeta®); the immunotherapy pembrolizumab (Keytruda®); and the chemotherapy drug paclitaxel (Taxol®).


This is a Phase II trial

Keytruda plus Taxol for Metastatic HER2-Negative Breast Cancer

LCI-BRE-H2N-PEPP-001: A Pilot Study of Paclitaxel Plus Pembrolizumab in Patients With Metastatic HER2-Negative Breast Cancer (The PePPy Trial) (NCT03018080)

Summary

To take part in this study, you must have HER2-negative metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of using the chemotherapy drug paclitaxel (Taxol®) along with the immunotherapy pembrolizumab (Keytruda®) to treat metastatic HER2-negative breast cancer. The researchers are studying two different treatment regimens. In one regimen, patients will receive Taxol followed by Taxol and Keytruda at the same time. In the other, patients will receive Taxol and Keytruda at the same time. Taxol is routinely used to treat breast cancer. Keytruda is approved to treat certain types of cancers.


This is a Phase II trial

MEDI4736 and Chemotherapy Before Surgery for Stage I-III Triple Negative Breast Cancer

Single Arm Neoadjuvant Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) Concomitant With Weekly Nab-paclitaxel and Dose-dense Doxorubicin/Cyclophosphamide (ddAC) Chemotherapy for Clinical Stage I-III Triple Negative Breast Cancer (NCT02489448)

Summary

MEDI4736 is a new immunotherapy drug. By blocking a protein called PD-1 (programmed cell death 1), it allows the immune system to go after cancer cells. Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®)--known as AC chemotherapy--and nab-paclitaxel (Abraxane®) are routinely used to treat breast cancer. Giving MEDI4736 with this chemotherapy regimen before surgery (called neoadjuvant therapy) may make the chemotherapy more effective. This study will investigate the best dose and effectiveness of MEDI4736 for use with this chemotherapy regimen when it is given before surgery to individuals with stage I-III triple negative breast cancer.


This is a Phase I-II trial

Chemotherapy plus Atezolizumab Before Surgery for Newly Diagnosed Stage II-III TNBC

Randomized Phase 2 Study of Neoadjuvant Chemotherapy, Carboplatin and Paclitaxel, With or Without Atezolizumab in Triple Negative Breast Cancer (TNBC) (NCT02883062)

Summary

To take part in this study, you must have recently been diagnosed with triple negative (ER-/PR-/HER2-) stage II-III breast cancer and not yet started treatment. You must also be able to have chemotherapy before surgery (mastectomy or lumpectomy). This study is comparing the the safety and effect (good or bad) of giving chemotherapy and immunotherapy before surgery to giving chemotherapy alone before surgery to treat early stage triple negative breast cancer. Atezolizumab (Tecentriq®) is the immunotherapy used in this study. It is a PD-L1 inhibitor approved to treat certain types of bladder and lung cancer. It works by blocking the PD-L1 (programmed cell death-ligand 1) protein. The chemotherapy drugs used in this study are carboplatin (Paraplatin®) and paclitaxel (Taxol®). They are both used to treat breast cancer.


This is a Phase II trial

Keytruda + Chemo or an Aromatase Inhibitor for HER2-Negative Metastatic Breast Cancer

MK-3475 (Pembrolizumab) in Combination With an Anthracycline or Anti-estrogen Therapy in Patients With Triple Negative and Hormone Receptor Positive (HR+ HER2-) Metastatic Breast Cancer (NCT02648477)

Summary

Pembrolizumab (Keytruda®) is an immunotherapy drug that targets the programmed cell death (PD-1) protein. Blocking this protein allows the body's immune system to attack cancer cells. Doxorubicin (Adriamycin®) is a chemotherapy drug commonly used to treat breast cancer. Aromatase inhibitors (anastrozole/Arimidex®, letrozole/Femara®, exemestane/Aromasin®) are used to treat hormone-sensitive tumors in postmenopausal women. This study is investigating the safety and effectiveness of using Keytruda to treat HER2-negative metastatic breast cancer. In this study, patients with triple-negative tumors will receive Adriamycin along with Keytruda, while patients with hormone-sensitive tumors will receive an AI along with Keytruda.To be eligible, participants must not have been treated previously with Keytruda.


This is a Phase II trial

Vaccine Therapy and Chemotherapy for Treating Triple Negative Breast Cancer

Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer (NCT03012100)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) breast cancer. This study is comparing the safety and effectiveness of cyclophosphamide (Cytoxan®) given with a cancer treatment vaccine to Cytoxan given alone. FR alpha peptide vaccine is a personalized vaccine that is made by removing some of your white blood cells and mixing them in a lab with tumor proteins. The vaccine is a type of immunotherapy. This is a treatment that gets your immune cells to fight your cancer. All patients will receive sargramostim (GM-CSF) to prevent neutropenia--a low white blood cell count that increases your risk for infection.


This is a Phase II trial

Atezolizumab & Abraxane for Triple Negative Stage I-III Breast Tumors

Triple-Negative First-Line Study: Neoadjuvant Trial of Nab-Paclitaxel and MPDL3280A, a Pdl-1 Inhibitor in Patients With Triple Negative Breast Cancer (NCT02530489)

Summary

MPDL3280A (atezolizumab) is an new immunotherapy drug that stimulates the body's immune system to go after cancer cells. It works by blocking a protein called programmed cell death ligand-1 (PD-L1) that normally keeps the body's immune system from attacking and destroying tumor cells. Nab-paclitaxel (Abraxane®) is a chemotherapy drug routinely used to treat advanced breast cancer. This study is looking at the safety and effectiveness of using atezolizumab and Abraxane before surgery and then using atezolizumab after surgery to treat stage I-III triple-negative breast cancer. Participants must have not had significant tumor shrinkage from enrollment in another study at M.D. Anderson (NCT02276443) to be eligible for this study.


This is a Phase II trial

Keytruda with Chemotherapy for Metastatic Triple Negative Breast Cancer

A Randomized Phase II Clinical Trial Assessing the Efficacy and Safety of MK-3475 (Pembrolizumab) in Combination With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer (NCT02755272)

Summary

To take part in this study, you must have metastatic triple negative (ER-/PR-/HER2-negative) breast cancer. Pembrolizumab (Keytruda®) is an immunotherapy drug that gets the immune system to seek out cancer cells. It is used to treat advanced melanoma and metastatic non-small cell lung cancer. Researchers want to learn how well Keytruda works with chemotherapy to treat metastatic triple negative breast cancer. In this study, Keytruda will be combined with two chemotherapy drugs currently used to treat advanced breast cancer that has not responded to other chemotherapy drugs: carboplatin (Paraplatin®) and gemcitabine (Gemzar®).


This is a Phase II trial

Keytruda with Taxol or Xeloda for Advanced Triple Negative Breast Cancer

A Pilot and Phase II Study to Assess the Safety, Tolerability and Efficacy of Pembrolizumab Plus Chemotherapy in Metastatic Triple Negative Breast Cancer Patients (NCT02734290)

Summary

This study is looking at the safety and effectiveness of using an immunotherapy drug along with a chemotherapy drug to treat breast cancer that cannot be removed by surgery. The immunotherapy drug is pembrolizumab (Keytruda®). It gets the body's immune system to go after cancer cells. The chemotherapy drug will be paclitaxel (Taxol®) or capacitabine (Xeloda®), depending on which group you are put in. Both drugs are commonly used to treat advanced breast cancer. To take part in this study, you must have advanced triple negative breast cancer.


This is a Phase I-II trial

INT230-6 Injections & Immunotherapy for Treating Advanced Breast Cancer

A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects With Advanced Refractory Cancers (NCT03058289)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and have at least one tumor that can be felt by your doctor or seen on a scan by your radiologist. You also must have tried all other available treatments. INT230-6 is a combination chemotherapy treatment that is injected directly into the tumor. The first part of this study will determine the best dose of INT230-6. The second part will investigate how tumors respond to the best dose of INT230-6 when it is given with an anti-PD-1 immunotherapy. INT230-6 contains the chemotherapy drugs cisplatin (Platinol®) and vinblastine (Velban®) along with a substance that makes them more effective. This study is also recruiting patients with other types of advanced cancers.


This is a Phase I-II trial

Keytruda and Abraxane in HER2 Negative Metastatic Breast Cancer

Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer (NCT02752685)

Summary

Researchers are trying to see which treatment combinations are best for HER2 negative breast cancer. This study is looking at the safety and effectiveness of using a chemotherapy drug along with an immunotherapy drug. The chemotherapy drug is nab-paclitaxel (Abraxane®), which is used to treat advanced breast cancer. The immunotherapy drug is pembrolizumab (Keytruda®), which gets the immune system to go after cancer cells. To take part in this study, you must have metastatic breast cancer that is HER2-negative.

Tecentriq plus Taxol, Herceptin and Perjeta for HER2+ Advanced Breast Cancer

Single Arm, Phase IIA Clinical Trial Assessing The Safety And Efficacy of Atezolizumab in Combination With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer (NCT03125928)

Summary

To take part in this study, you must have HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer. This study will evaluate the safety and effectiveness of adding an immunotherapy to the standard treatment for HER2-positive advanced breast cancer. Atezolizumab (Tecentriq®) is the immunotherapy drug used in this study. It is approved to treat bladder cancer and a type of lung cancer. The standard of care for HER2+ advanced breast cancer treatment is the chemotherapy drug paclitaxel (Taxol®) and the HER2-targeted drugs trastuzumab (Herceptin®) and pertuzumab (Perjeta®).
This is a Phase II trial

Combination of Immunotherapy and Targeted Therapies for HR+ and HER2- Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Hormone Receptor-Positive HER2-Negative Breast Cancer (MORPHEUS-HR+ Breast Cancer) (NCT03280563)

Summary

To take part in this study, you must have HR-positive, HER2-negative advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already been treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor such as palbociclib/Ibrance®, ribociclib/LEE011, or abemaciclib/LY2835219, that your cancer progressed on or did not respond to. This trial is studying 5 different treatment options. Women will receive one, two, or three of the following drugs: the immunotherapy atezolizumab (Tecentriq®), a PD-L1 (programmed cell death-ligand 1) inhibitor approved to treat certain types of bladder and lung cancer; the targeted therapy cobimetinib (Cotellic), which blocks the MEK protein and is approved to treat certain types of melanoma; fulvestrant (Faslodex®), a standard chemotherapy used to treat breast cancer; ipatasertib (GDC-0068), a new type of cancer drug that works by blocking the Akt protein; bevacizumab (Avastin), a monoclonal antibody that keeps tumors from growing the blood vessels they need to survive and is used to treat HER2-negative metastatic breast cancer.


This is a Phase I-II trial

Immunotherapy and Chemotherapy Before Surgery to Treat Triple Negative Breast Cancer

Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer (NeoPACT) (NCT03639948)

Summary

To take part in this study you must be a woman or man with stage I, II or III triple-negative (ER-/PR-/HER2-) breast cancer who has not yet started treatment.

This study is investigating the effect of using the immunotherapy pembrolizumab (Keytruda®) along with chemotherapy before surgery (neoadjuvant therapy). Keytruda is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental. Carboplatin (Paraplatin®) and docetaxel (Taxotere®) are chemotherapy drugs used to treat triple negative breast cancer. Pegfilgrastim is a human granulocyte colony-stimulating factor (GCSF). It is given along with chemotherapy to reduce the risk of neutropenia (low white blood cell count) and infection.


This is a Phase II trial

Tecentriq and Paclitaxel for Triple Negative Advanced Breast Cancer

A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer (NCT03125902)

Summary

To take part in this study, you must have recently been diagnosed with triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer and not yet started treatment. This study is investigating whether a chemotherapy drug works better when it is given along with an immunotherapy. The chemotherapy drug being used in this study is paclitaxel (Taxol®). It is used to treat breast cancer. The immunotherapy drug being used in this study is atezolizumab (Tecentriq®). It is a PD-L1 inhibitor that is currently approved to treat certain types of bladder and lung cancer.


This is a Phase III trial

Carboplatin plus Nivolumab in Advanced Triple Negative Breast Cancer

A Randomized Phase II Trial of Carboplatin With or Without Nivolumab in First- or Second-line Metastatic Triple-negative Breast Cancer (NCT03414684)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. This study is comparing the safety and effects (good and bad) of giving the chemotherapy drug carboplatin (Paraplatin®) alone or with an immunotherapy drug to treat advanced breast cancer. Paraplatin is a chemotherapy drug routinely used to treat advanced breast cancer. The immunotherapy drug used in this study is the PD-1 inhibitor nivolumab (Opdivo®). The drug, which has been approved to treat certain types of cancer, but not breast cancer, stimulates the body's immune system to attack cancer cells by blocking a protein called PD-1 (programmed cell death 1).


This is a Phase II trial

Keytruda with Chemotherapy for Treating HER2- Metastatic Breast Cancer

I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells (CTCs) Positive Her-2 Negative Metastatic Breast Cancer (MBC) (NCT03213041)

Summary

To take part in this study, you must have HER2-negative stage IV (metastatic) breast cancer and a blood test that shows you have a circulating tumor cell (CTC) level ≥ 5. This study is investigating the safety and effects (good or bad) of treating HER2-negative metastatic breast cancer with an immunotherapy drug along with a chemotherapy drug. The immunotherapy drug used in this study is pembrolizumab (Keytruda®). It is a type of immunotherapy called a PD-1 inhibitor. The chemotherapy drug is carboplatin (Paraplatin®). It is used to treat metastatic breast cancer.


This is a Phase II trial

Imlygic™ plus Chemo Before Surgery for Stage II-III Triple Negative Breast Cancer

A Phase 1/2 Study of Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer (NCT02779855)

Summary

To take part in this study, you must be newly diagnosed with stage II or III triple negative (ER-/PR-/HER2-) breast cancer. This study is investigating the best dose of the drug talimogene laherparepvec (Imlygic™) to use along with chemotherapy before surgery. (Treatment before surgery is called neoadjuvant therapy.) Imlygic is a herpes virus that has been genetically modified to destroy cancer cells. It also works as an immunotherapy. The drug, which is injected directly into the tumor, is approved for treating melanoma. It will not cause you to develop herpes. The chemotherapy regimen that will be used in this study is ACT (doxorubicin/Adriamycin®, cyclophosphamide/Cytoxan®, paclitaxel/Taxol®). It is routinely used to treat triple negative breast cancer.


This is a Phase I-II trial

Tecentriq with Chemotherapy After Surgery for Stage II-III Triple-Negative Breast Cancer

A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer (NCT03498716)

Summary

To take part in this study, you must have stage II-III triple negative (ER-/PR-/HER2-) breast cancer. This study is comparing the safety and effectiveness of using an immunotherapy drug along with chemotherapy to chemotherapy alone to treat stage II-III triple negative breast cancer. Atezolizumab (Tecentriq®) is the immunotherapy drug used in this study. It gets the immune system to attack cancer cells by blocking a protein called PD-L1 (programmed cell death-ligand 1). It is used to treat some lung and bladder cancers. Your first chemotherapy drug will be paclitaxel (Taxol®). It will be followed by dose-dense chemotherapy. Your doctor will decide if you receive doxorubicin (Adriamycin®) or epirubicin (Ellence®) and cyclophosphamide (Cytoxan®). You will also receive GM-CSF (sargramostim) or G-CSF (filgrastim) to prevent neutropenia--a low white blood cell count that increases your risk for infection.


This is a Phase III trial

Tesetaxel and Immunotherapy in Advanced HER2- Breast Cancer

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC (CONTESSA TRIO) (NCT03952325)

Summary

To take part in the first cohort, you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have not received prior chemotherapy for advanced disease. To be part of the second cohort, you must be age 65 or older, have advanced or metastatic HER2 negative breast cancer, and have not received prior chemotherapy for advanced disease.

In the first cohort, this study is comparing the safety and effects (good and bad) of an experimental oral chemotherapy drug called tesetaxel when it is given with one of three immunotherapy drugs. In the second cohort, the study is investigating the safety and effects (good and bad) of tesetaxel when it is given alone. The three immunotherapy drugs being used in this study are nivolumab (Opdivo®), pembrolizumab (Keytruda®), and atezolizumab (Tecentriq®). Opdivo and Keytruda are PD-1 inhibitors. They get the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). Both are approved for certain types of cancers. Their use in breast cancer is considered experimental. Tecentriq is a PD-L1 inhibitor. It gets the immune system to go after cancer cells by blocking PD-L1. Tecentriq in combination with Abraxane is an FDA-approved treatment for metastatic triple negative breast cancer.


This is a Phase II trial

Keytruda plus Carboplatin to Treat Chest Wall Breast Cancer

A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease (NCT03095352)

Summary

To take part in this study, you must have locally recurrent (some stage III) or metastatic (stage IV) breast cancer that has spread to the chest wall and cannot be removed by surgery. This study is comparing the safety and effects (good and bad) of giving immunotherapy along with chemotherapy to giving chemotherapy and a placebo to treat breast cancer that has spread to the chest wall. Pembrolizumab (Keytruda®) is the immunotherapy drug used in this study. It is a PDL-1 inhibitor approved to treat certain types of cancers. Carboplatin (Paraplatin®) is the chemotherapy drug used in this study. In this trial, researchers will test tumor biopsies and blood samples before and after treatment in order to learn more about how genes and the immune system affect how tumors respond to immunotherapy.


This is a Phase II trial

Tecentriq & Targeted Therapy or Chemotherapy for Metastatic Triple Negative Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC) (NCT03424005)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer that progressed during or following first-line metastatic treatment with chemotherapy. This study is investigating the safety and effectiveness of 7 different immunotherapy-based treatment combinations in women and men with triple negative (ER-/PR-/HER2-) breast cancer. The immunotherapy being used in this study is atezolizumab (Tecentriq®). It is a PD-L1 inhibitor that works by stimulating the body's immune system to go after cancer cells. It is approved to treat certain types of urinary, bladder and lung cancer. The targeted therapies being used in the study are Ipatasertib (GDC-0068), SGN-LIV1A, bevacizumab (Avastin®) and cobimetinib (Cotellic®). The chemotherapies being used in this study are capecitabine (Xeloda®), gemcitabine (Gemzar®), carboplatin (Paraplatin®) and eribulin (Halaven®).


This is a Phase I-II trial

Opdivo plus Xeloda After Surgery for Triple Negative Breast Cancer

OXEL: A Pilot Study of Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease Following Neoadjuvant Chemotherapy (NCT03487666)

Summary

To take part in this study, you must have triple negative (ER-, PR-, and HER2-), ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or early stage (stage I, stage II or stage III) breast cancer that was treated with chemotherapy before surgery (neoadjuvant treatment). You must not have been treated with capecitabine (Xeloda®) and you must have had tumor cells found in your breast or in your lymph nodes during surgery.

In this study, researchers will compare the effects (good and bad) of using two drugs alone or together after surgery. The two drugs being used in this study are nivolumab (Opdivo®) and capecitabine (Xeloda®). Opdivo is a type of immunotherapy drug called a PD-1 inhibitor. It is approved to treat certain types of metastatic melanoma and non-small cell lung cancer. Its use in breast cancer is considered experimental. Xeloda is a chemotherapy drug used to treat breast cancer.


This is a Phase II trial

Using Personalized T-Cells Along with Chemotherapy to Treat Metastatic Breast Cancer

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer (NCT03412877)

Summary

To take a part in this study, you must have metastatic (stage IV) breast cancer for which standard treatments have not worked.

This study is investigating the safety and effects (good or bad) of an immunotherapy that uses personalized T cells. To create the personalized T cells, cancer cells will be taken from your tumor and white blood cells will be removed from your blood. The cancer cells will be analyzed to learn about the genetic mutations they contain. In a lab, your white blood cells will be modified in ways that will help them go after your tumor cells. They will then be infused into your body. This will take place in the hospital where the research study is taking place. When you receive the infused T cells, you will also be given Aldesleukin, an immune function enhancing drug. Your treatment will also include two chemotherapy drugs: cyclophosphamide (Cytoxan), which is used to treat breast cancer, and fludarabine (Fludara), which is approved to treat chronic lymphocytic leukemia (CLL). This trial also is enrolling patients with other types of metastatic cancer.


This is a Phase II trial

Paclitaxel, Trastuzumab, Pertuzumab With or Without Atezolizumab For HER2+ Metastatic Breast Cancer

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab With Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer (NCT03199885)

Summary

To take part in this study you must be starting treatment for metastatic (stage IV) breast cancer or have had your breast cancer recur after 6 months of neoadjuvant or adjuvant HER2-targeted therapy.

This study is comparing the safety and effects of the combination of pembrolizumab, trastuzumab, paclitaxel, and atezolizumab with the combination of pembrolizumab, trastuzumab, paclitaxel, and a placebo. Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental. Trastuzumab (Herceptin®) is a HER2-targeted therapy used to treat HER2-positive breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat breast cancer. Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor.


This is a Phase III trial

Atezolizumab & Chemotherapy Before Surgery for Stage II-III Triple Negative Breast Cancer

A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer (NCT03197935)

Summary

To take part in this study, you must have been diagnosed with triple negative (ER-/PR-/HER2-) early stage (stage I-III) breast cancer and not yet started treatment. This study is comparing the safety and effects (good and bad) of using immunotherapy and chemotherapy to chemotherapy alone in triple negative breast cancer. The immunotherapy being used in this study is atezolizumab (Tecentriq®). It stimulates the body's immune system to go after cancer cells. The chemotherapy drugs being used in this study are nab-paclitaxel (Abraxane®) and AC chemotherapy (doxorubicin/Adriamycin® and cyclophosphamide/Cytoxan®). All three drugs are commonly used to treat breast cancer. Patients enrolled in this study will also receive filgrastim or pegfilgrastim to prevent neutropenia--a very low white blood cell count--from developing.


This is a Phase III trial

Chemotherapy before Surgery with Atezolizumab for Triple Negative Breast Cancer

A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo (NCT03281954)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-), early stage (stage I-III) breast cancer. This study is comparing the safety and effects (good or bad) of using an immunotherapy and the standard of care chemotherapy with using a placebo and the standard of care chemotherapy before and after surgery to treat early-stage triple negative breast cancer. The immunotherapy used in this study is atezolizumab (Tecentriq®). It is a PD-L1 inhibitor approved to treat certain types of bladder and lung cancer. It works by blocking the PD-L1 (programmed cell death-ligand 1) protein.The standard of care chemotherapy drugs used in this study are paclitaxel (Taxol®) and carboplatin (Paraplatin®) followed by doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®) or epirubicin (Ellence®) and cyclophosphamide.


This is a Phase III trial

Carboplatin plus Atezolizumab for Metastatic Triple Negative Breast Cancer

A Phase II Trial of Atezolizumab (Anti-PDL1) With Carboplatin in Patients With Metastatic Triple Negative Breast Cancer (NCT03206203)

Summary

To take part in this study, you must have metastatic (stage IV), triple negative (ER-/PR-/HER2-) breast cancer. This study is investigating whether using a combination of immunotherapy and chemotherapy is better than using chemotherapy alone to treat triple negative metastatic breast cancer. Carboplatin (Paraplatin®) is the chemotherapy drug used in this study. Atezolizumab (Tecentriq®) is the immunotherapy drug used in this study.


This is a Phase II trial

Atezolizumab plus Chemotherapy for Early Relapsing Recurrent Triple Negative Breast Cancer

A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer (NCT03371017)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer. This study is evaluating the safety and effects (good or bad) of giving chemotherapy with an immunotherapy to giving chemotherapy with a placebo. The immunotherapy drug being used in this study is atezolizumab (Tecentriq®). The chemotherapy drugs used in this study are gemcitabine (Gemzar®), carboplatin (Paraplatin®) and capecitabine (Xeloda®). Gemzar is a chemotherapy drug used to treat breast cancer. Paraplatin is a platinum-based chemotherapy drug that is commonly used to treat triple negative breast cancer. Xeloda is commonly used to treat metastatic breast cancer.


This is a Phase III trial

MCLA-128, Herceptin & Chemo or Hormone Therapy for HER2+ or ER+/Low HER2 Breast Cancer

Phase 2 Study of MCLA-128-based Combinations in Metastatic Breast Cancer (MBC): MCLA-128/Trastuzumab/Chemotherapy in HER2-positive MBC and MCLA-128/Endocrine Therapy in Estrogen Receptor Positive and Low HER2 Expression MBC (NCT03321981)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and a tumor that is HER2-positive or ER-positive with low HER2-expression. This study is evaluating the effects (good or bad) of an experimental immunotherapy drug called MCLA-128. If your tumor is HER2+, you will receive MCLA-128 along with the HER2-targeted drug trastuzumab (Herceptin®). If you are ER+, you will receive MCLA-128 along with the same endocrine therapy you received before entering the study: fulvestrant (Faslodex®), exemestane (Aromasin®), letrozole (Femara®) or anastrozole (Arimidex®). The chemotherapy drug used in this study is vinorelbine (Navelbine®).
This is a Phase II trial

Keytruda plus Abraxane Before Surgery for ER+ or PR+ Stage II or III Breast Cancer

A Pilot Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer (NCT02999477)

Summary

To take part in this study, you must have HR-positive (ER+ and/or PR+), HER2-negative stage II or III breast cancer that can be removed by surgery. This study is investigating the safety and effect of different combinations of Keytruda® and Abraxane® when they are given before surgery to patients with stage II or III breast cancer. Pembrolizumab (Keytruda®) is an immunotherapy drug. It gets the body's immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1). It is currently approved to treat certain types of melanoma, head and neck cancer, lung cancer and Hodgkin lymphoma. Nab-paclitaxel (Abraxane®) is a chemotherapy drug approved to treat metastatic breast cancer in patents who have already tried other cancer treatments.
This is a Phase I trial

Keytruda plus Two Chemotherapy Drugs for Metastatic Triple-Negative Breast Cancer

Pilot Study of Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer (NCT03121352)

Summary

To take part in this study, you must have metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. You cannot have had more than two prior therapies for your metastatic diagnosis. This study will determine the effectiveness of giving two chemotherapy drugs along with an immunotherapy drug. The immunotherapy drug used in this study is pembrolizumab (Keytruda®). It is approved to treat some types of metastatic cancer. Carboplatin (Paraplatin®) and nab-paclitaxel (Abraxane®) are chemotherapy drugs routinely used to treat advanced breast cancer.


This is a Phase II trial

Tecentriq and Stereotactic Radiosurgery for Triple Negative Breast Cancer Brain Mets

A Phase II Study of Atezolizumab in Combination With Stereotactic Radiosurgery for Patients With Triple-negative Breast Cancer and Brain Metastasis (NCT03483012)

Summary

To take part in this study, you must have metastatic (stage IV), triple negative (ER-/PR-/HER2-) breast cancer that has spread to the brain. This study is investigating the effectiveness of treating breast cancer brain metastases with stereotactic radiosurgery and an immunotherapy drug. Stereotactic radiosurgery delivers focused radiation to each individual brain metastasis. It is routinely used to treat brain metastases. The immunotherapy drug being used in this study is atezolizumab (Tecentriq®) It gets the immune system to go after cancer cells by blocking a protein called PD-L1 (programmed cell death-ligand 1). It is approved to treat certain types of bladder cancer and lung cancer.


This is a Phase II trial

Hypofractionated Radiation Therapy with MEDI4736 & Tremelimumab for Metastatic Cancer

Phase I Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers (NCT02639026)

Summary

Hypofractionated radiation therapy involves giving larger doses of radiation in fewer sessions over a shorter period of time. MEDI4736 and tremelimumab are two different types of immunotherapy drugs. MEDI4736 blocks the PD-1 (programmed cell death-1) protein. Blocking this protein makes it possible for the immune system to go after cancer cells. Tremelimumab blocks the CTLA-4 protein, which also keeps the immune system from attacking cancer cells. This study is comparing the safety and the effectiveness of two different hypofractionated radiation therapy schedules when used along with MEDI4736 and tremelimumab to treat metastatic breast (and other) tumors.


This is a Phase I trial

Immunotherapy and Radiation Therapy for ER+ HER2- Metastatic Breast Cancer

RACHEL1: A Phase I Radiation and CHEckpoint bLockade Trial in Patients With Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer (NCT03524170)

Summary

To take part in this study, you must be a woman or man with estrogen receptor positive and HER2 negative metastatic (stage IV) breast cancer.

This study will help determine the best dose, safety and effects (good and bad) of an investigational immunotherapy drug called M7824 when used along with radiation therapy to treat patients with ER positive, HER2 negative metastatic breast cancer.


This is a Phase I trial

Keytruda and Radiation Therapy for Early Stage Triple Negative Breast Cancer

Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer With and Without Intra-operative RT: a Window of Opportunity Study (NCT02977468)

Summary

To take part in this study, you must have recently been diagnosed with early stage (stage I-III) triple negative (ER-/PR-/HER2-) breast cancer and not have received any treatment--chemotherapy, radiation or surgery--for your cancer. Giving a drug before surgery allows doctors to study the effect the drug has on cancer cells. This study is looking at the effect that the immunotherapy drug pembrolizumab (Keytruda®) has on triple negative cancer cells. The researchers will also study the effect radiation giving during surgery has on breast cancer cells treated with immunotherapy. Keytruda is approved to treat certain types of lung, head and neck and blood cancers. The radiation treatment, called intraoperative radiation therapy (IORT), delivers a high dose of radiation to the area where the tumor was removed.


This is a Phase I trial

Focused Ultrasound and Pembrolizumab in Advanced Breast Cancer

Focused Ultrasound Therapy to Augment Antigen Presentation and Immune-Specificity of Checkpoint Inhibitor Therapy With Pembrolizumab in Metastatic Breast Cancer (NCT03237572)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have had at least one prior line of therapy in the metastatic setting. This study will evaluate the safety and effects (good and bad) of using high-intensity focused ultrasound (HIFU) along with Keytruda to treat metastatic breast cancer. HIFU is a treatment that works to kill cancer cells with high frequency sound waves. Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells.


This is a Phase I trial

Radiation & A New Immunotherapy Before Pembrolizumab for Advanced Triple Negative Disease

Phase II Window of Opportunity Trial of Stereotactic Body Radiation Therapy and In Situ Oncolytic Virus Therapy in Metastatic Triple Negative Breast Cancer and Metastatic Non-Small Cell Lung Cancer Followed by Pembrolizumab (STOMP) (NCT03004183)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-), advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effect (good and bad) of using stereotactic body radiation therapy, a vaccine and an immunotherapy to treat advanced triple negative breast cancer. Stereotactic body radiation therapy (SBRT) delivers a high dose of radiation directly to the tumor. The vaccine is called ADV/HSV-tk. It is given along with the anti-viral drug valacyclovir. The immunotherapy used in this study is pembrolizumab (Keytruda®). It is approved to treat certain types of cancers. This study is also recruiting patients with advanced non-small cell lung cancer.


This is a Phase II trial

Keytruda and Faslodex for HR+, HER2- Advanced Breast Cancer

A Phase II Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients: Big Ten Cancer Research Consortium BTCRC-BRE16-042 (NCT03393845)

Summary

To take part in this study, you must have HR-positive, HER2-negative advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of using pembrolizumab (Keytruda®) along with fulvestrant (Faslodex®) to treat HR+, HER2- advanced breast cancer. Keytruda is type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers, but not breast cancer. Faslodex is a hormone therapy that is used to treat hormone sensitive breast cancer in postmenopausal women.
This is a Phase II trial

Nivolumab Combined with Ipilimumab and Bicalutamide for HER2 Negative Advanced Breast Cancer

A Phase II Study of Nivolumab Combined With Bicalutamide and Ipilimumab in Metastatic HER2-negative Breast Cancer (NCT03650894)

Summary

To take part in this study you must be a woman with HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer.

This study is testing the safety and effects (good or bad) of using a combination of nivolumab (Opdivo®), ipilimumab (Yervoy®), and bicalutamide (Casodex®). Opdivo® is a type of immunotherapy that gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). Yervoy is an immunotherapy that works by blocking a protein called CTLA-4. Yervoy and Opdivo are approved to be used together to treat patients with melanoma and certain other cancers. Their use in breast cancer is considered experimental. Casodex is an anti-androgen drug used to treat prostate cancer. Some breast cancers contain androgen receptors. Laboratory studies suggest these tumors may respond to anti-androgen therapies.


This is a Phase II trial

Mammaglobin-A DNA Vaccine + Hormone Therapy Before Surgery for ER+, HER2- Breast Cancer

A Phase 1B Randomized Clinical Trial to Evaluate the Safety and Immune Response to a Mammaglobin-A DNA Vaccine in Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy (NCT02204098)

Summary

Mammaglobin-A is a protein that is highly expressed by breast cancer cells. Laboratory studies suggest a mammaglobin-A DNA vaccine may trigger the body's immune system to destroy cancer cells. Hormone therapies are used to treat hormone-sensitive tumors. These medications include anastrozole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®), goserelin (Zoladex®) and tamoxifen. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to study how the cancer responds to the treatment. This study is comparing the immune response seen in women with stage II or III ER-positive, HER2-negative breast cancer who receive a mammaglobin-A DNA vaccine along with hormone therapy or hormone therapy alone before surgery. The type of hormone therapy used will be chosen by the woman's oncologist. To be eligible for the study, a woman must have a breast tumor that expresses mammaglobin-A. In addition, participants must have a tumor Ki67 value of ≤ 10% after 14 days of neoadjuvant hormone therapy in order to be randomized to receive the Mammaglobin-A DNA vaccine.


This is a Phase I trial

Keytruda plus an Anti-Estrogen Drug for HR+ Inflammatory Breast Cancer

A Phase II Study of Anti-PD-1 (Pembrolizumab) in Combination With Hormonal Therapy in Patients With Hormone Receptor (HR)-Positive Localized Inflammatory Breast Cancer (IBC) Who Did Not Achieve a Pathological Complete Response (pCR) to Neoadjuvant Chemotherapy (NCT02971748)

Summary

To take part in this study, you must have hormone-sensitive (ER+/PR+) inflammatory breast cancer. In addition, your tumor must have not completely responded to the chemotherapy you received before surgery. This study is looking at whether it is safe and effective to treat patients with inflammatory breast cancer with an immunotherapy drug along with a standard anti-estrogen drug. The immunotherapy drug being used in this study is pembrolizumab (Keytruda®). Your doctor will choose which anti-estrogen drug you receive: tamoxifen/Nolvadex®, exemestane/Aromasin®, anastorzole/Arimidex®, or letrozole/Femara®. If you are premenopausal, you may also receive an LHRH (lutenizing hormone-releasing hormone) agonist.
This is a Phase II trial

Tecentriq, Cotellic & Halaven for Metastatic Inflammatory Breast Cancer

A Phase II Study of Triple Combination of Atezolizumab + Cobimetinib + Eribulin (ACE) in Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer (NCT03202316)

Summary

To take part in this study, you must have inflammatory advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already been treated with a chemotherapy that your cancer progressed on or did not respond to. In this study, researchers will determine the safety and effect (good or bad) of using a combination of immunotherapy, targeted therapy and chemotherapy to control metastatic inflammatory breast cancer. Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. It is FDA approved to treat certain types of bladder and lung cancer. Cobimetinib (Cotellic®) is a new targeted therapy called an MEK inhibitor. It is approved to treat certain types of melanoma. Eribulin (Halaven®) is a chemotherapy drug approved for treating metastatic breast cancer.


This is a Phase II trial

Olaparib and Durvalumab in Metastatic Triple Negative Breast Cancer

A Phase II, Open Label, Study of Olaparib and Durvalumab (MEDI4736) in Patients With Metastatic Triple Negative Breast Cancer (NCT03801369)

Summary

To take part in this study you must have metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer.

This study is evaluating the safety and effects (good or bad) of using the combination of olaparib (Lynparza®) and durvalumab (Imfinzi®). Lynparza is a PARP inhibitor. It stops the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP). It is approved to treat certain types of ovarian cancer. Imfinzi is a type of immunotherapy drug called a PD-L1 inhibitor. It gets the body's immune system to go after cancer cells. It is approved to treat certain types of lung cancer. Preclinical studies suggest this drug combination may be effective in patients with metastatic triple negative breast cancer.


This is a Phase II trial

SGN-LIV1A and Keytruda for Advanced Triple Negative Breast Cancer

Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer (NCT03310957)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer. This study is looking at the safety and effects (good or bad) of using SGN-LIV1A along with pembrolizumab (Keytruda®) to treat triple negative advanced or metastatic breast cancer. SGN-LIV1A is an investigational drug that targets a protein called LIV-1 that is found on some tumor cells. Keytruda® is a type of immunotherapy drug called a PD-1 inhibitor. It blocks the PD-1 (programmed cell death-1) protein, making it possible for the body's immune system to go after cancer cells. Keytruda is not approved to treat breast cancer. It is approved to treat certain other types of cancer.


This is a Phase I-II trial

Immunotherapy EDP1503 With Pembrolizumab For Advanced Triple Negative Breast Cancer

A Phase I/II Open-label Study of EDP1503 Alone and in Combination With Pembrolizumab in Patients With Advanced Metastatic Colorectal Carcinoma, Triple-negative Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors (NCT03775850)

Summary

To take part in this study you must be a woman or man with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have no other approved treatment options available.

This study is assessing the safety and the effects (good or bad) of the immunotherapy EDP1503 when it is given along with pembrolizumab (Keytruda®). EDP1503 is an experimental immunotherapy that may work by changing the microenvironment that surrounds the cancer cells. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is only approved to treat certain types of cancers. Its use in breast cancer is considered experimental.


This is a Phase I-II trial

Avelumab Plus Talazoparib to Treat Advanced Breast Cancer

A Phase 1b/2 Study To Evaluate Safety And Anti Tumor Activity Of Avelumab In Combination With The Poly(Adenosine Diphosphate [Adp]-Ribose) Polymerase (Parp) Inhibitor Talazoparib In Patients With Locally Advanced Or Metastatic Solid Tumors (NCT03330405)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) or HR+, locally advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of using an immunotherapy along with a targeted therapy to treat advanced breast cancer. The immunotherapy being used in this study is abelumab (Bavencio®). It works by blocking a protein called PD-L1 (programmed cell death-ligand 1). Talazoparib (BMN-637) is a type of targeted therapy called a PARP inhibitor. It prevents the PARP protein from repairing damaged DNA in tumor cells. This study is also enrolling patients with other types of solid tumors.
This is a Phase II trial

Pembrolizumab with Lenvatinib in Previously Treated Advanced Triple Negative Breast Cancer

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005) (NCT03797326)

Summary

To take part in this study you must have triple negative (ER-, PR-, HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer and have already had one or two treatment regimens.

This study is evaluating the safety and effects (good and bad) of using pembrolizumab (Keytruda®) along with lenvatinib (Lenvima®). Keytruda is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells. It is approved to treat certain types of cancers, but its use in breast cancer is considered experimental. Lenvima is a targeted therapy that blocks vascular endothelial growth factor receptor 2 (VEGFR2). It is approved for treating patients with certain types of thyroid, kidney and liver cancers. Its use in breast cancer is considered experimental. This study will also include people with other types of cancers.


This is a Phase II trial

Entinostat, Opdivo and Yervoy in Advanced HER2-Negative Breast Cancer

A Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab With or Without Ipilimumab in Advanced Solid Tumors (NCT02453620)

Summary

Entinostat is a histone deacetylase (HDAC) inhibitor. It is designed to block HDAC enzymes, which are needed for cell growth. Nivolumab (Opdivo®) is an immunotherapy that blocks a protein called PD-1 (programmed cell death 1). Blocking PD-1 may allow the body’s own immune cells to attack cancer cells. It is approved for advanced lung cancer. Ipilimumab (Yervoy®) is an immunotherapy that stimulates T-cells in the body’s immune system. It is approved for treating patients with advanced melanoma. This trial is designed to identify the side effects and best dose of entinostat and Opdivo when the two drugs are given with Yervoy to treat advanced HER2-negative breast cancer.


This is a Phase I trial

Immunotherapy Plus a Targeted Drug for Advanced Triple Negative Breast Cancer

Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With LCL161, Everolimus (RAD001) or Panobinostat (LBH589) (NCT02890069)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. You must also have already received a treatment that your cancer progressed on or did not respond to. This study is looking at whether a new immunotherapy drug is safe and effective when given along with a targeted drug to patients with advanced or metastatic triple negative breast cancer. The immunotherapy drug used in this study is called PDR001. You will receive one of three targeted drugs: LCL161, everolimus (Afinitor®), or panobinostat (LBH589). This study is also enrolling patients with other types of cancer.


This is a Phase I trial

CAR-T Cell Immunotherapy for Metastatic Breast Cancer That Tests CD70 Positive

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70 Expressing Cancers (NCT02830724)

Summary

To take part in this study you must have metastatic (stage IV) breast cancer that tests positive for CD70 and you must have already been treated with a standard therapy. This study is investigating the safety and effects (good or bad) of using a new type of CAR-T immunotherapy. CAR-T is a personalized immunotherapy made from a patient's white blood cells. The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into the patient in the hospital. The CAR-T therapy used in this study is designed to get the immune system to see and kill cancer cells that are CD70+. Along with the CAR-T immunotherapy, you will receive the chemotherapy drugs fludarabine and cyclophosphamide. These drugs are given to deplete the lymph cells. You will also receive aldesleukin, a drug that stimulates the growth and development of T cells.
This is a Phase I-II trial

Durvalumab & Olaparib in Advanced Triple Negative Breast Cancer Treated with Chemotherapy

Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA) (NCT03167619)

Summary

To take part in this study, you must have advanced (some stage III that is inoperable) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-), have already been treated with at least three cycles of a platinum-based chemotherapy and shown response, and have had no more than two prior chemotherapy regimens for metastatic breast cancer.

This study will compare the effects (good or bad) of using the targeted therapy olaparib (Lynparza®) alone or with an immunotherapy drug. Lynparza is approved to treat HER2-negative metastatic breast cancer in patients who test positive for an inherited BRCA mutation. It is a PARP inhibitor, a drug that blocks the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It has been approved to treat certain other types of cancers, and its use in breast cancer is considered experimental.


This is a Phase II trial

BLZ945 Alone or With PDR001 For Metastatic Breast (and Other) Cancer

A Basket Study: A Phase I/II, Open-label, Multi-center Study of the Safety and Efficacy of BLZ945 as Single Agent and in Combination With PDR001 in Adults Patients With Advanced Solid Tumors (NCT02829723)

Summary

This study has two parts. To enroll in the first part, you must have metastatic breast cancer. To enroll in the second part, you must have metastatic triple negative breast cancer. This study is investigating whether a new type of targeted cancer drug is safe and effective when it is given alone or with an immunotherapy drug. This is the first study to test this new targeted drug in cancer patients. The targeted drug being used in this study is called BLZ945. It targets a receptor called CSF1R that plays a role in tumor growth. Some patients who enroll in this study will also receive an immunotherapy drug called PDR001. This study is also enrolling patients with other types of metastatic cancers.


This is a Phase I-II trial

Ribociclib and Immunotherapy to Treat Metastatic Breast Cancer

A Phase 1 Study of the CDK4/6 Inhibitor Ribociclib (LEE011) in Combination With the PD-1 Inhibitor PDR001 in Patients With Metastatic Hormone Receptor-positive Breast Cancer and Metastatic Ovarian Cancer (NCT03294694)

Summary

To take part in this study you must have metastatic (stage IV) breast cancer that is hormone receptor positive and HER2-negative.

This study is evaluating the safety and effects (good or bad) of using ribociclib (Kisqali®) along with an immunotherapy or an immunotherapy and a hormone therapy. Kisqali is a type of targeted therapy called a CDK 4/6 inhibitor. It is approved for use along with an anti-estrogen therapy to treat HR-positive HER2-negative metastatic breast cancer. The aromatase inhibitor being used in this study is fulvestrant (Faslodex®). The immunotherapy being used in this study is spartalizumab (PDR001). It is a type of immunotherapy that targets PD-1. This study also is enrolling patients with metastatic ovarian cancer.


This is a Phase I trial

Study of MGD009 in Metastatic Breast (and other) Tumors With B7-H3

Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients With Unresectable or Metastatic B7-H3-Expressing Neoplasms (NCT02628535)

Summary

Scientists have found that many cancer cells have high levels of a protein called B7-H3. Blocking this protein may be an effective way to treat cancer. MGD009 is a new drug that recognizes B7-H3 on cancer cells. It works by getting immune cells to go after B7-H3-expressing cancer cells. This study is evaluating the safety, tolerability, and best dose of MGD009 for treating metastatic breast (and other) cancers that test positive for B7-H3. Patients will have their tumor tested for the B7-H3 protein. Those whose tumors test positive will be eligible for the study.


This is a Phase I trial

PF-05082566 With Kadcyla® or Trastuzumab For Advanced HER2 Positive Breast Cancer

A Phase 1B Dose Escalation Trial of Human Anti-4-1BB Agonistic Antibody PF-05082566 in Combination With Adotrastuzumab-Emtansine or Trastuzumab in Patients With HER2-Positive Advanced Breast Cancer (NCT03364348)

Summary

To take part in this study you must have HER2 positive advanced (some stage III) or metastatic (stage IV) breast cancer.

This study is investigating the safety and effects (good or bad) of using utomilumab (PF-05082566) with trastuzumab emtansine (Kadcyla®) or trastuzumab (Herceptin®). Utomilumab is an investigational immunotherapy that targets 4-1BB (CD-137), a molecule that stimulates the immune system. Herceptin is a HER2-targeted therapy approved to treat HER2 positive breast cancer. Kadcyla is an antibody-drug conjugate (ADC). It uses Herceptin to deliver the chemotherapy drug DM1 directly to the cancer cells. It is approved to treat HER2 positive metastatic breast cancer.


This is a Phase I trial

MEDI4736 with Lynparza or Cediranib for Advanced Breast (and Other Solid) Tumors

Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination With Olaparib or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancer (NCT02484404)

Summary

MEDI4736 (durvalumab) is an immunotherapy drug that works by blocking a protein called PD-L1 (programmed cell death ligand-1). Blocking this protein allows the body's immune system to go after cancer cells. Olaparib (Lynparza®) is a type of cancer drug called a PARP inhibitor. PARP inhibitors interfere with the cancer cells' DNA, making them more sensitive to chemotherapy. Lynparza is used to treat advanced ovarian cancer in women who have an inherited BRCA1/2 mutation. In phase 1 of this study, researchers studied the safety and effectiveness of using MEDI4736, Lynparza or cediranib to treat advanced breast (and other solid) tumors. Phase 1 is now completed. Phase 2 of this study is open to triple-negative breast cancer patients combining MEDI4736 and olaparib. To be eligible, patients must not have previously been treated with PARP inhibitors, PD-1 or PD-L1 inhibitor or an anti-CTLA4 therapy and not have had more than 3 lines of previous treatments for metastatic disease.


This is a Phase I-II trial

Tecentriq, Perjeta and Hercptin for HER2+ Breast Cancer That Has Spread to the Brain

A Phase II Study of Atezolizumab in Combination With Pertuzumab Plus High-dose Trastuzumab for the Treatment of Central Nervous System Metastases in Patients With Her2-positive Breast Cancer(NCT03417544)

Summary

To take part in this study, you must have HER2-positive, metastatic (stage IV) breast cancer that has spread to the brain. This study is evaluating the safety and effects (good or bad) of using an immunotherapy drug along with a HER2 targeted drug to treat HER2+ metastatic breast cancer. The immunotherapy drug is atezolizumab (Tecentriq®). It is approved to treat certain types of lung and bladder cancers. It gets the immune system to go after cancer cells by blocking a protein called PD-L1 (programmed cell death-ligand 1). The two HER2-targeted drugs used in this study are pertuzumab (Perjeta®) and trastuzumab (Herceptin®).
This is a Phase II trial

Treating Advanced Cancer By Choosing Targeted Therapy Based on Tumor's Genetic Makeup

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study (NCT02693535)

Summary

This study is evaluating the safety and effectiveness of using the tumor's genetic alterations to select an FDA-approved targeted therapy for treatment. In this study, the targeted therapy each patient receives will be selected based on their tumor's specific genetic profile. To be eligible, individuals must have no available standard therapy options. This study is enrolling patients with advanced breast and other cancers.


This is a Phase II trial

Keytruda, Femara & Ibrance for ER+ Metastatic Breast Cancer After Femara & Ibrance

Phase II Study of the Addition of MK-3475 (Pembrolizumab) to Letrozole and Palbociclib in Patients With Metastatic Estrogen Receptor Positive Breast Cancer Who Have Stable Disease But Are Not Responding to Letrozole and Palbociclib (NCT02778685)

Summary

To take part in this study, you must have estrogen receptor-positive (ER+), HER2-negative, metastatic breast cancer. You must have also already been treated with letrozole (Femara®) and palbociclib (Ibrance®). Femara and Ibrance are an approved breast cancer combination. Femara is an anti-estrogen drug. Ibrance is a targeted treatment. Researchers think adding an immunotherapy drug to this combination will make the combination work better in women who already tried it. The immunotherapy drug that will be used in this study is pembrolizumab (Keytruda®). Keytruda is used to treat certain types of melanoma, lung cancer and head and neck cancers. It is available as a breast cancer treatment only in clinical trials.
This is a Phase II trial

MEDI4736 & Lynparza in Metastatic HER2- Breast Cancer in Women with a BRCA Mutation

A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors (NCT02734004)

Summary

Olaparib (Lynparza) is a new type of targeted therapy called a PARP inhibitor. It works by blocking the PARP protein from repairing damaged DNA in cancer cells. Lynparza is approved for treating advanced ovarian cancer in women with a BRCA mutation. MEDI4736 is an immunotherapy that blocks PD-L1 (programmed cell death-ligand 1) protein. Blocking this protein stimulates the immune system to go after cancer cells. This study is investigating the safety and effectiveness of using Lynparaza and MEDI4736 together to treat women with HER2-negative metastatic breast cancer who have a BRCA1 or BRCA2 mutation.


This is a Phase I-II trial

PRS-343 in HER2-Positive Advanced Breast Cancer

A Phase 1, Open-Label, Dose Escalation Study of PRS-343 in Patients With HER2-Positive Advanced or Metastatic Solid Tumors (NCT03330561)

Summary

To take part in this study you must have HER2-positive locally advanced (stage III) or metastatic (stage IV) breast cancer.

This study is testing the safety and effect (good or bad) of PRS-343, an experimental cancer drug. PRS-343 is a new type of cancer treatment. The drug is a HER2-targeted therapy that also stimulates the immune system. This study is also enrolling patients with other types of solid tumors.


This is a Phase I trial

Ibrance, Bavencio and Faslodex for Previously Treated ER+, HER2- Advanced Breast Cancer

Palbociclib After CDK and Endocrine Therapy (PACE): A Randomized Phase II Study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer (NCT03147287)

Summary

To take part in this study, you must have HR+, HER2-negative locally recurrent (some stage III) or metastatic (stage IV) breast cancer. You must have already been treated with a CDK4/6 inhibitor in combination with an anti-estrogen therapy. This study is investigating the safety and effects (good and bad) of using fulvestrant (Faslodex®) alone, in combination with Ibrance®, and in combination with Ibrance and Bavencio®. Faslodex is the anti-estrogen drug used in this study. Palbociclib (Ibrance®) is approved to treat HR+, HER2-negative breast cancer in combination with an anti-estrogen therapy. Avelumab (Bavencio®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat a type of blood cancer.
This is a Phase II trial

Abemaciclib and Keytruda for HR+, HER2- Metastatic Breast (and Non-Small Cell Lung) Cancer

A Phase 2 Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer (NCT02779751)

Summary

To take part in this study, you must have hormone sensitive (ER+/PR+), HER2-negative metastatic (stage IV) breast cancer. This study is investigating whether it is safe and effective to give a new type of targeted treatment along with an immunotherapy drug. The new targeted treatment is called abemaciclib (LY2835219). It is a type of targeted drug called a CDK 4/6 inhibitor. It only is available in clinical trials. Pembrolizumab (Keytruda®) is the immunotherapy drug being used in this study. Keytruda is approved to treat melanoma and non-small cell lung cancer. Its use in breast cancer is considered experimental. This study is also recruiting individuals with metastatic non-small cell lung cancer.
This is a Phase I trial

FATE-NK100 with Herceptin for HER2+ Advanced Breast Cancer

FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors (DIMENSION) (NCT03319459)

Summary

To take part in this study, you must have HER2-positive, advanced (some stage III) or metastatic (stage IV) breast cancer. This study is looking at the safety and effects (good or bad) of using an immunotherapy drug along with Herceptin to treat HER2-positive advanced breast cancer. The immunotherapy drug is called FATE-NK100. It is only available in clinical trials. Herceptin is a targeted therapy approved to treat HER2-positive breast cancer.


This is a Phase I trial

Immunotherapy (PDR001) With a Targeted Therapy for Advanced Triple Negative Breast Cancer

Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)(NCT02900664)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer and have already had at least one prior treatment that your cancer progressed on or did not respond to. Researchers are studying the safety and effects (good or bad) of a new immunotherapy drug when it is given along with a targeted drug for treating advanced or metastatic triple negative breast cancer. If you enroll in this study will receive the immunotherapy drug PDR001. You will also receive one of four targeted drugs: Canakinumab (Ilaris®), CJM112, trametinib, or EGF816. This study is also enrolling patients with other types of cancer.


This is a Phase I trial

CAR-T Immunotherapy for Stage IV Breast Cancer That Has Spread to the Pleura

A Phase I Clinical Trial of Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin (NCT02414269)

Summary

To take part in this study you must have metastatic (stage IV) breast cancer that has spread to the pleura.

This study is investigating the safety and effect (good or bad) of using a new type of CAR-T immunotherapy. CAR-T is a personalized immunotherapy made from a patient's white blood cells. The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into the patient in the hospital. The pleura is the thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity. This CAR-T therapy is designed to target proteins found on cancer cells in the pleura. The CAR-T therapy is given along with acetaminophen and diphenhydramine. These drugs are used to prevent infusion-related reactions.


This is a Phase I trial

Veliparib and/or Tecentriq for BRCA+, Stage III-IV Triple Negative Breast Cancer

A Phase II Multiple-Arm, Open-Label, Randomized Study of PARP Inhibition (Veliparib; ABT-888) and Anti-PD-L1 Therapy (Atezolizumab; MPDL3280A) Either Alone or in Combination in Homologous DNA Repair (HDR) Deficient Triple Negative Breast Cancer (TNBC) (NCT02849496)

Summary

To take part in this study, you must have stage III or IV triple negative (ER-/PR-/HER2-) breast cancer. You must also test positive for the inherited BRCA1/2 mutation. This study is investigating how well two different types of cancer drugs work when they are used alone or together to treat stage III or IV triple negative breast cancer. The two drugs being used in this study are Veliparib (ABT-888) and atezolizumab (Tecentriq). Veliparib (ABT-888) is a new type of targeted drug called a PARP inhibitor. It is available only in clinical trials. Tecentriq is a new immunotherapy drug. It is approved to treat bladder cancer and a type of lung cancer.


This is a Phase II trial

A Cancer Vaccine and Pembrolizumab for Advanced HER2 Positive Breast Cancer

A Phase II Randomized Study to Evaluate the Immunologic and Antitumor Activity of Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Advanced HER2-overexpressing Breast Cancer (NCT03632941)

Summary

To take part in this study you must have recurrent or advanced (some stage III) or metastatic (stage IV) HER2 positive breast cancer.

This study is to comparing the safety and effects (good or bad) of using the investigational tumor vaccine VRP-HER2 alone, to pembrolizumab (Keytruda®) alone, and to both treatments together. The VRP-HER2 cancer vaccine is designed to activate the immune system to go after HER2 positive cancer cells. Keytruda is a type of immunotherapy called a PDL-1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.


This is a Phase II trial

Immunotherapy LY3300054 Alone and in Combination in Advanced Breast Cancer

A Phase 1a/1b Study of a Novel Anti-PD-L1 Checkpoint Antibody (LY3300054) Administered Alone or in Combination With Other Agents in Advanced Refractory Solid Tumors (Phase 1a/1b Anti-PD-L1 Combinations in Tumors-PACT) (NCT02791334)

Summary

To take part in this study you must have locally advanced (stage III) or metastatic (stage IV) breast cancer that is hormone receptor positive and HER2-negative or tests positive for high microsatellite instability (MSI-H). You must also have had at least 1 but no more than 3 chemotherapy regimens in the metastatic setting.

This study is testing the safety and effects (good or bad) of LY3300054 when it is used alone or in combination with a targeted therapy or an immunotherapy. LY3300054 is a type of immunotherapy called a checkpoint inhibitor. There are three other drugs being used in this study. LY3321367 is also an investigational checkpoint inhibitor. Ramucirumab (Cyramza) is a targeted therapy that blocks VEGFR-2, which keeps tumors from forming new blood vessels. It is approved to treat certain types of solid tumors, but not breast cancer. Abemaciclib (Verzenio) is a CDK 4/6 inhibitor approved to treat HR positive and HER2-negative metastatic breast cancer.


This is a Phase I trial

Tecentriq & Cotellic or Idasanutlin for ER+, HER2- Advanced Breast Cancer

BRE 17107: A Phase Ib/II Trial of Atezolizumab (an Anti-PD-L1 Monoclonal Antibody) With Cobimetinib (a MEK1/2 Inhibitor) or Idasanutlin (an MDM2 Antagonist) in Metastatic ER+ Breast Cancer (NCT03566485)

Summary

To take part in this study, you must have ER positive advanced (some stage III) or metastatic (stage IV) breast cancer.

This study is investigating the safety and effects (good or bad) of giving an immunotherapy along with a targeted therapy. The immunotherapy used in this study is the PD-L1 inhibitor atezolizumab (Tecentriq®). It works by stimulating the body's immune system to go after cancer cells. It is approved to treat certain types of cancers but its use in breast cancer is considered experimental. The two targeted therapies being used in this study are cobimetinib (Cotellic®), an MEK-targeted therapy approved to treat melanoma, and idasanutlin, a targeted therapy being studied in clinical trials.


This is a Phase I-II trial

Tamoxifen, Palbociclib, Avelumab Before Surgery in ER Positive Breast Cancer

A Pilot Study of IMMUNe mOdulation in Early Stage Estrogen Receptor Positive Breast Cancer Treated With neoADjuvant Avelumab, Palbociclib, and Tamoxifen: The ImmunoADAPT Study (NCT03573648)

Summary

To take part in this study you must have stage II or stage III ER-positive breast cancer that will be treated with surgery.

This study is investigating whether giving tamoxifen and avelumab before surgery shrinks tumors more than the combination of tamoxifen, avelumab and palbociclib. Tamoxifen (Nolvadex®) is a hormonal therapy used to treat ER-positive breast cancer. Avelumab (Bavencio®) is a type of immunotherapy drug called a PD-L1 inhibitor. It is approved to treat non-small-cell lung cancer. Its use in breast cancer is considered experimental. Palbociclib (Ibrance®) is a CDK inhibitor. It is approved to treat ER-positive, HER2-negative metastatic breast cancer. Giving therapies before surgery, called neoadjuvant treatment, allows researchers to measure how tumors respond to different therapies.


This is a Phase II trial

DS-8201a Plus Immunotherapy for HER2 Positive or HER2 Low Expression Advanced Breast Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of DS-8201a, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer (NCT03523572)

Summary

To take part in this study, you must have HER2 positive or low HER2 expression advanced (some stage III) or metastatic (stage IV) breast cancer that did not respond to standard therapies.

This study will test the safety and effects (good or bad) of an experimental drug called DS-8201 when it is given along with an immunotherapy to treat advanced breast cancer. DS-8201a (Trastuzumab deruxtecan) is a new type of HER2-targeted therapy. It is an antibody-drug conjugate (ADC), which means it uses an antibody to deliver a chemotherapy drug directly to the cancer cells. The immunotherapy being used in this study is the PD-1 inhibitor nivolumab (Opdivo®). By blocking PD-1, it allows your immune system to see and go after cancer cells. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.


This is a Phase I-II trial

MCS110 and PDR001 For Advanced Triple Negative Breast (and Other) Cancer

A Phase Ib/II, Open Label, Multicenter Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies (NCT02807844)

Summary

To take part in this study, you must have advanced triple negative breast cancer and have already been treated with standard treatments or have no standard treatment available. This study is investigating whether it is safe and effective to combine two cancer drugs that work in different ways. The researchers also want to learn more about how these two drugs work together. The two drugs being used in this study are MCS110 and PDR001. MCS110 is a targeted treatment. PDR001 is an immunotherapy drug. Both of these drugs are currently only available in clinical trials. This study is also enrolling patients with advanced pancreatic and endometrial cancers and advanced melanoma (skin cancer).


This is a Phase I-II trial

Keytruda plus Kadcyla for HER2+ Metastatic Breast Cancer

A Phase 1b Study Of Pembrolizumab In Combination With Trastuzumab-DM1 In Metastatic HER2-Positive Breast Cancer (NCT03032107)

Summary

To take part in this study, you must have HER2-positive metastatic (stage IV) breast cancer. This study is investigating the safety, best dose and what effects (good or bad) occur when HER2+ metastatic breast cancer is treated with an immunotherapy and a HER2-targeted drug. The immunotherapy being used in this study is the PD-1 inhibitor pertuzumab (Keytruda®). It is approved to treat certain types of melanoma, lung cancer and head and neck cancer. The HER2-targeted drug is T-DM1 (Kadcyla®), which combines the chemotherapy drug DM1 and the HER2-targeted drug trastuzumab (Herceptin®). It is used to treat HER2+ metastatic breast cancer.
This is a Phase I trial

Keytruda plus Enobosarm for Metastatic Triple Negative Androgen Receptor-Positive Disease

A Phase 2 Clinical Trial of the Combination of Pembrolizumab and Selective Androgen Receptor Modulator (SARM) GTX-024 in Patients With Advanced Androgen Receptor (AR) Positive Triple Negative Breast Cancer (TNBC) (NCT02971761)

Summary

To take part in this study, you must have metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. Your tumor must also be androgen receptor positive (AR+). The researchers will test your tumor for these receptors. This study is looking at the safety and effects (good and bad) of giving an anti-androgen drug along with an immunotherapy drug. The anti-androgen drug is enobosarm (Ostarine®/GTx-024). The immunotherapy drug is pembrolizumab (Keytruda®). It is approved to treat certain types of melanoma, lung, head and neck cancers, and blood cancers.
This is a Phase II trial

NIS793 with Spartalizumab (PDR001) in Patients With Advanced Triple Negative Breast Cancer

A Phase I/Ib, Open-label, Multi-center Dose Escalation Study of NIS793 in Combination With PDR001 in Adult Patients With Advanced Malignancies (NCT02947165)

Summary

To take part in this study you must have locally advanced (stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have no other standard treatment options available.

This study is investigating the safety, effects (good or bad) and best dose of NIS793 when it is used alone or with an immunotherapy. NIS793 is a targeted therapy that binds to the transforming growth factor-beta receptor. Spartalizumab is the investigational immunotherapy being used in this study. It is a type of immunotherapy called a PD-L1 checkpoint inhibitor. This study is also enrolling patients with other types of solid tumors.


This is a Phase I trial

PVSRIPO Vaccine in Stage II, III and IV Triple Negative Breast Cancer

Examining Oncolytic Poliovirus Bioactivity in Tumor Tissue After Intratumoral Administration of PVSRIPO in Women With Triple Negative Breast Cancer (NCT03564782)

Summary

To take part in this study you must be a woman who has stage II-III triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options or who has metastatic (stage IV) TNBC with a local recurrence on the chest wall.

This clinical trial is investigating the safety, effects (good and bad) and best dose of an experimental immunotherapy called PVSRIPO. PVSRIPO is a vaccine made out of a modified poliovirus. The vaccine uses the virus to get the immune system to kill cancer cells. You can not get polio from the vaccine.

Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2 Negative Breast Cancer

NIMBUS: A Phase II Study of Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer (NIMBUS) (NCT03789110)

Summary

To take part in this study you must have HER2 negative metastatic (stage IV) breast cancer that is hypermutated (found to have at least 10 mutations per megabase) on a 300 gene panel test such as Foundation One, Oncopanel, or IMPACT.

This study is testing the safety and effects (good or bad) of using two immunotherapy drugs in combination to treat metastatic breast cancer. Nivolumab (Opdivo®) is a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). Ipilimumab (Yervoy®) gets the immune system to go after cancer cells by blocking a protein called CTLA-4. Yervoy and Opdivo are used in combination to treat patients with melanoma and certain other cancers. Their use in breast cancer is considered experimental.


This is a Phase II trial

ACTR T Cell With Trastuzumab in HER2-Positive Metastatic Breast Cancer

A Phase 1 Study of an Autologous ACTR T Cell Product in Combination With Trastuzumab, a Monoclonal Antibody, in Subjects With HER2-Positive Advanced Malignancies (NCT03680560)

Summary

To take part in this study you must be a woman or man with HER2 positive metastatic (stage IV) breast cancer that has already been treated with other HER2 targeted therapies.

This study is looking at the safety and effects (good or bad) of new type of immunotherapy, called ACTR T cell product (ACTR707 or ACTR087), when it is given in combination with trastuzumab (Herceptin®). ACTR T cell product is made from the patient's own T cells, which are collected at the beginning of the study and then infused back into the patient. ACTR (Antibody-Coupled T-cell Receptor) modified T cells combine immunotherapy with a targeted therapy. Herceptin® is a HER2 targeted therapy used to treat breast cancer.


This is a Phase I trial

A Vaccine for Women with Triple-Negative Tumors Treated with Chemo Before Surgery

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy (NCT02348320)

Summary

This study is investigating the safety and efficacy of a personalized Polyepitope DNA vaccine. A personalized vaccine is produced, in part, from a patient's own cancer cells. This increases the chance the vaccine will successfully stimulate the immune system to go after cancer cells. To be eligible, participants must have received chemotherapy prior to having surgery (called neoadjuvant chemotherapy) and still have some portion of the tumor remaining in the breast.


This is a Phase I trial

PVX-410 Vaccine plus Keytruda for HLA-A2+ Advanced Triple Negative Breast Cancer

A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Pembrolizumab in HLA-A2+ Patients With Metastatic Triple Negative Breast Cancer (TNBC) (NCT03362060)

Summary

To take part in this study you must be a woman with advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. In addition, your tumor must test positive for the HLA A2 protein. This test will be done by the research team. PVX-410 is a new type of vaccine that may help the immune system find and attack cancer cells. Pembrolizumab (Keytruda®) is type of immunotherapy drug called a PD-1 inhibitor that has been approved to treat some cancer types, but not breast cancer. It gets the immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1).


This is a Phase I trial

A Vaccine for Treating HER2-Negative Advanced Breast Cancer

A Phase I Trial of the Safety and Immunogenicity of a Multiple Antigen Vaccine (STEMVAC) in HER2 Negative Advanced Stage Breast Cancer Patients (NCT02157051)

Summary

Vaccines made from DNA from tumor cells may help the body build an effective immune response to the cancer. This study is looking at how cancer cells respond to a new vaccine called STEMVAC that is designed to target a protein on breast cancer stem cells that is resistant to chemotherapy. In this trial, researchers are studying the side effects and best dose of this vaccine for treating HER2-negative, advanced (stage III and IV) breast cancer.


This is a Phase I trial

Keytruda for Metastatic Inflammatory Breast Cancer

A Phase II Study of Anti-PD-1 (MK-3475) Therapy in Patients With Metastatic Inflammatory Breast Cancer Who Have Received Prior Chemotherapy With Clinical Response (NCT02411656)

Summary

Pembrolizumab (Keytruda®) is an immunotherapy that helps the body's immune system slow or stop cancer cell growth by blocking a protein known as programmed cell death receptor (PD-1). It is approved for treating metastatic melanoma. Early studies suggest Keytruda may also be effective for treating metastatic inflammatory breast cancer. This study is looking at the safety and effectiveness of using Keytruda to treat patients with metastatic inflammatory breast cancer.


This is a Phase II trial

An Immunotherapy Drug for Advanced Breast (and Other) Cancers

A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients With Advanced Solid Malignancies and Lymphoma With an Expansion in Select Malignancies (NCT02922764)

Summary

To take part in this study, you must have certain types of stage III breast cancer or stage IV (metastatic) breast cancer. You must also have already tried the standard treatments for your cancer. This study is investigating whether a new immunotherapy drug is safe and effective for treating advanced breast cancer. The immunotherapy drug being studied is called RGX-104. It is only available in clinical trials. Patients with other types of advanced cancer also will be enrolled in this trial.


This is a Phase I trial

Breast Cancer Vaccine for Triple-Negative Breast Cancer Following Chemo Before Surgery

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy (NCT02427581)

Summary

A peptide is a naturally occurring biological molecule made up of amino acids. Researchers have developed a way to create a personalized synthetic long peptide vaccine that can generate an immune response to breast cancer cells by targeting mutations specific to a person's tumor. This study is investigating the side effects and best dose of this vaccine in patients with stage II-III triple-negative breast cancer who received chemotherapy before surgery and still have signs of the tumor in their breast.


This is a Phase I trial

Using Three Immunotherapy Treatments for Advanced Breast Cancer

A Phase 1/2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab (MEDI4736) Plus the Toll-like Receptor Agonist PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers (NCT02643303)

Summary

To take part in this study, you must have locally recurrent advanced (some stage III) breast cancer. This study is evaluating the safety and effects (good and bad) of using three different types of immunotherapy treatments in advanced and metastatic breast cancer. The treatments being used in this study are tremelimumab, durvalumab (MEDI4736) and poly ICLC. This study is also recruiting individuals with other types of advanced cancer.


This is a Phase I-II trial

T Cell Immunotherapy for Advanced Breast (and Other) Cancer

Phase I/II Study of the Treatment of Metastatic Cancer That Expresses MAGE-A3 Using Lymphodepleting Conditioning Followed by Infusion of HLA-DP0401/0402 Restricted Anti-MAGE-A3 TCR-Gene Engineered Lymphocytes and Aldesleukin(NCT02111850)

Summary

To take part in this study, you must have metastatic (stage IV) breast cancer and have received a treatment that your tumor progressed on or did not respond to. In addition, your immune cells must express a molecule called HLA-DP4 and your tumor must express a protein called MAGE-A3. This study will allow researchers to learn about the safety, effects (good and bad), and best dose of a new type of immunotherapy called anti-MAGE-A3. T cells are white blood cells that have the ability to kill cancer cells. For this treatment, T cells are removed from your body, modified to fight cancer cells using anti-MAGE-A3, and then infused back into your body. Aldesleukin is a type of immune function enhancing drug that is given along with the infused T cells.


This is a Phase I-II trial

CAR-T Immunotherapy for CEA+ Metastatic Breast Cancer

Immunotherapy for Peritoneal Carcinomatosis (IPC) - A Phase I Study of the Safety and Efficacy of Anti-CEA CAR-T Cell Intraperitoneal Infusions for Treatment of CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (NCT03682744)

Summary

To take a part in this study, you must have metastatic (stage IV) breast cancer that expresses the protein CEA (carcinoembryonic antigen).

CAR-T is a personalized immunotherapy made from a patient's white blood cells. The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into you by IV in the hospital. The CAR-T therapy being used in this study trains the immune system to attack CEA-positive tumor cells. This study is also enrolling patients with other types of CEA-positive metastatic tumors.


This is a Phase I trial

Keytruda plus Bacterial Therapy for Advanced Breast (and Other) Tumors

A Phase Ib Investigation of Pembrolizumab in Combination With Intratumoral Injection of Clostridium Novyi-NT in Patients With Treatment-Refractory Solid Tumors (NCT03435952)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer.

This study is investigating the safety, effects (good and bad) and best dose of a type of bacteria that researchers believe will prime tumors to respond to an immunotherapy. The bacteria have been modified to remove the chemicals that are poisonous to humans. The bacterial therapy being used in this study is clostridium novyi-NT. The immunotherapy being used in this study is the PD-1 inhibitor pembrolizumab (Keytruda®). Keytruda stimulates the body's immune system to go after cancer cells. It is approved to treat select types of cancers. Its use in breast cancer is considered experimental. You will also receive the antibiotic, doxocyclin. It is given to help keep the growth of the bacteria clostridium novyi-NT under control.


This is a Phase I trial

  • Participation TimeHospital stay for 1 week; 4 visits in the first month; then 1 visit every 3 weeks for up to 1 year
  • Participating research sites
    Research sites: 1 site total

Individualized Immunotherapy for Metastatic Breast (and Other) Cancer

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab (NCT01174121)

Summary

Tumor infiltrating lymphocytes (TILs) are the white blood cells that are found in tumors. The immune system has activated these cells to try to control the cancer's growth. This study is investigating a new type of immunotherapy in which researchers take TILs from tumors, grow the ones that are most effective in fighting the cancer in the laboratory, and then give the cells back to the patient. Previous studies using TIL in melanoma have shown effectiveness in shrinking the tumor. In this study, researchers will study the effectiveness of TIL in shrinking breast (and other) tumors. To be eligible, patients must have tumors that can be surgically removed. The study requires patients to stay in the hospital for about 4 weeks.


This is a Phase II trial

Combination Immunotherapy in HER2-Negative Metastatic Breast Cancer

A Single Arm Phase II Study Evaluating the Efficacy and Safety of MEDI4736 in Combination With Tremelimumab in Patients With Metastatic Her2 Negative Breast Cancer (NCT02536794)

Summary

MEDI4736 and tremelimumab are two new immunotherapy drugs currently being studied in clinical trials. The drugs work in different ways. MEDI4736 targets the programmed cell death 1 (PD-1)/B7H1 protein. Tremelimumab targets the CTLA4 protein. Combining two immunotherapy drugs that work in different ways may be more effective than using one alone. This study is evaluating the safety and efficacy of MEDI4736 and tremelimumab in women with HER2-negative metastatic breast cancer.


This is a Phase II trial

XmAb®23104 for Advanced Triple Negative Breast Cancer (DUET-3)

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (NCT03752398)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options.

This study is investigating the safety, effects (good and bad) and the best dose of an experimental immunotherapy called XmAb®23104. The drug targets both PD-1 (programmed cell death protein 1) and ICOS (inducible T-cell co-stimulator). This study is enrolling patients with other types of metastatic cancers.


This is a Phase I trial

Actimmune and Opdivo for Metastatic Breast (and Other) Solid Tumors

Combination Immunotherapy With Interferon-gamma and Nivolumab for Patients With Advanced Solid Tumors: A Phase 1 Study (NCT02614456)

Summary

Nivolumab (Opdivo®) is an immunotherapy drug used to treat metastatic melanoma. It blocks a protein called PD-1 (programmed cell death-1). By blocking this protein, immune cells are able to go after cancer cells. Interferon-gamma (IFN-γ) is a small protein called a cytokine. Immune cells produce IFN-γ to help prevent infection. Actimmune is the synthetic version of IFN-γ. This study is evaluating the safety and effectiveness of using Actimmune and Opdivo alone and in combination to treat metastatic breast (and other) solid tumors that have progressed on at least one prior systemic therapy. PLEASE NOTE: As of 3/1/2016, there are limited enrollment for breast cancer patients. The first cohorts are already complete, and second cohort has a waitlist, with planned re-opening in April at earliest. Please contact the research site for more information: 215-728-3889.


This is a Phase I trial

Keytruda for Advanced Breast (and Other) Cancers in Women or Men with a BRCA1/2 Mutation

A Basket Trial of Pembrolizumab in Patients With Advanced Solid Tumors and Genomic Instability (NCT03428802)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and have been tested for and found to have a BRCA1 or BRCA2 mutation. This study is investigating the effect of using an immunotherapy drug to treat cancer that has spread outside the breast to nearby tissue or lymph nodes or to other parts of the body. The immunotherapy drug is pembrolizumab (Keytruda®). It is a type of immunotherapy drug called a PD-1 inhibitor. It gets the immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1). It is currently approved to treat certain types of melanoma, head and neck cancer, lung cancer and Hodgkin ly


This is a Phase II trial

Immunotherapy for Advanced Triple Negative Breast Cancer

Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer (NCT03674567)

Summary

To take part in this study, you must be a woman or man with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer.

This study is looking at the best dose, safety and effects (good and bad) of using FLX475 alone or with pembrolizumab (Keytruda®) to treat advanced breast cancer. FLX475 is an investigational targeted therapy that help the immune system go after cancer cells. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.


This is a Phase I-II trial

Immunotherapy for Metastatic Triple Negative Breast (and Other) Cancers

A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of CPI-444 as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable Cancers (NCT02655822)

Summary

Many tumors produce a lot of adenosine, a molecule that interacts with the immune system and keeps immune cells from going after cancer cells. CPI-444 is a new type of immunotherapy drug. It keeps adenosine from being able to tell the immune cells not to go after cancer cells. Atezolizumab (MPDL3280A) is another new immunotherapy drug. It blocks a protein called programmed cell death ligand-1 (PD-L1). Blocking this protein allows the body's immune system to go after cancer cells. This study is looking at the safety and effect of different scheduling cycles for CPI-444 as well as the safety and effect of giving CPI-444 along with MPDL3280A.


This is a Phase I trial

An Immunotherapy for Breast Cancer That Has Come Back in the Chest Wall

A Phase II Study Using Talimogene Laherparepvec as a Single Agent for Inflammatory Breast Cancer (IBC) or Non-IBC Patients With Inoperable Local Recurrence (NCT02658812)

Summary

To take part in this study, your breast cancer must have come back (recurred) in your chest wall. In addition, your doctor must have told you that your cancer cannot be removed by surgery. Imlygic (talimogene laherparepvec) is used to treat melanoma. It is a treatment that is injected (like a shot) directly into a tumor site. Imlygic attacks cancer cells directly. It also gets the immune system to kill cancer cells. This study is looking at whether Imlygic can help control breast cancer that has come back in your chest wall.


This is a Phase II trial

Atezolizumab Before & After Surgery for Stage II or III HER2 Positive Breast Cancer

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer (IMpassion050) (NCT03726879)

Summary

To take part in this study you must have stage II or III HER2 positive breast cancer.

This study (known as IMpassion050) is comparing the safety, side effects, and effectiveness of using an immunotherapy drug or a placebo along with chemotherapy and HER2-targeted therapies. Atezolizumab (Tecentriq®) is the immunotherapy drug being used in this study. It is a PD-L1 (protein programmed cell death-ligand 1) inhibitor that has been approved to treat certain other types of cancers. The other therapies being used in this study are the chemotherapy drugs paclitaxel (Taxol®), doxorubicin (Doxil®), and cyclophosphamide (Cytoxan®), and the HER2-targeted therapies trastuzumab (Herceptin®) and pertuzumab (Perjeta®).


This is a Phase III trial

  • Participation TimeVisits every 2 or 3 weeks for 5 months before surgery, followed by visits every 3 weeks for 1 year
  • Participating research sites
    Research sites: 7 sites total

DCC-3014 in Patients With Advanced Breast Cancer

Multi-center, Phase 1, Open-Label Study of DCC-3014 to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumors (NCT03069469)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer.

This study is investigating the safety, the effect (good or bad) and best dose of DCC-301, an investigational immunotherapy that works by targeting CSF1R, a protein that can suppress the immune system. This study is also recruiting individuals with other types of advanced cancer.


This is a Phase I trial

Mesothelin-Targeted T Cell Immunotherapy for Metastatic Breast Cancer

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Mesothelin-Specific Chimeric Antigen Receptor-Positive T Cells in Patients With Metastatic Mesothelin-Expressing Breast Cancer (CAR-T therapy)(NCT02792114)

Summary

The immune system has two types of white blood cells, B cells and T cells. This study is testing the safety and best dose of an immunotherapy made from your own T cells. Mesothelin is a protein commonly found in breast cancer cells. The mesothelin-targeted T-cell therapy used in this study gets into the cancer cells by attaching itself to these proteins. To take part in this study, you must have HER2-negative metastatic breast cancer and your cancer cells must produce mesothelin proteins. In addition, your doctors must have already used at least one chemotherapy drug to treat your metastatic breast cancer.


This is a Phase I trial

Using Two Immunotherapy Drugs to Treat Metastatic Triple Negative Breast Cancer

A Phase 1b/2 Open-Label Study To Evaluate Safety, Clinical Activity, Pharmacokinetics And Pharmacodynamics Of Avelumab (MSB0010718C) In Combination With Other Cancer Immunotherapies In Patients With Advanced Malignancies (NCT02554812)

Summary

Using two immunotherapy drugs together may kill more cancer cells than using one alone. Avelumab and PF-05082566 are two new immunotherapy drugs now in clinical trials. Both work by blocking a protein called PD-L1. Blocking this protein allows the immune system to find and kill cancer cells. This study is investigating the safety of avelumab and the best dose of it to use along with PF-05082566. To take part in this study, you must have metastatic triple negative (ER-negative, PR-negative, HER2-negative) breast cancer. This study also is enrolling patients with other types of solid tumors. Some of these patients will receive the immunotherapy drug PF-04518600 along with avelumab.


This is a Phase II trial

Keytruda After Neoadjuvant Chemo & Surgery for Stage I-III Triple-Negative Breast Cancer

A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy (NCT02954874)

Summary

To take part in this study, you must have stage I-III triple negative (ER-/PR-/HER2-) breast cancer. You must also have received chemotherapy before surgery—called neoadjuvant treatment—and still have part of the tumor in your breast and/or have been told cancer cells were found in your lymph nodes. This study is investigating whether an immunotherapy drug may be effective for treating triple negative breast cancer. The immunotherapy drug being used in this study is pembrolizumab (Keytruda®). It is approved to treat a certain type of metastatic lung cancer.


This is a Phase III 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

Immunotherapy for Women with Breast Cancer-Related Leptomeningeal Metastases

A Phase I Study of Anti-CD3 x Anti-Her2/Neu (Her2Bi) Armed Activated T Cells (ATC) in Patients With Breast Cancer Leptomeningeal Metastases (NCT03661424)

Summary

To take part in this study you must be a woman with stage IV metastatic breast cancer that has spread to the membranes surrounding the brain and spinal cord. This is called leptomeningeal metastasis. This study is investigating the safety and effect (good or bad) of an experimental immunotherapy made out of T cells that have been activated to go after cancer cells. The treatment is called HER2 BATs. BATs is short for bi-specific antibody. Although trastuzumab (Herceptin®) is used to make the BATs, women do not need to have HER2+ breast cancer to take part in the study.
This is a Phase I trial

Vaccine Plus Chemotherapy Before Surgery in Triple Negative Breast Cancer

A Combined Phase II Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE ISA 51 VG Combined With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer (NCT02938442)

Summary

To take part in this study you must be a woman with stage II or III triple negative breast cancer (ER-, PR- and HER2-) who is going to be treated with standard chemotherapy before surgery.

This study is comparing the safety and effects of an investigational vaccine along with chemotherapy to chemotherapy alone when given before surgery (neoadjuvant therapy). The vaccine, P10s-PADRE, is a peptide-based vaccine that is designed to enhance the immune response and potentially attack tumors. It is given along with Montanide ISA 51 VG, which is designed to enhance an immune response by stimulating cytotoxic T-lymphocytes.


This is a Phase II trial

Vaccine to Prevent Recurrence in Early Stage HER2+ Breast Cancer

A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer (NCT03384914)

Summary

To take part in this study, you must have early stage (stage I-III) HER2+ breast cancer that was treated with chemotherapy and a HER2-targeted therapy before surgery (neoadjuvant). You must also have to have residual disease at the time of surgery following neoadjuvant chemotherapy. This study is investigating the safety and effects (good or bad) of two different vaccines, either dendritic cell vaccines or WOKVAK vaccine. Researchers think will stimulate the immune system in ways that will help reduce your risk of a breast cancer recurrence.
This is a Phase II trial

Opdivo & Yervoy for Patients with Metaplastic Breast Cancer

DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (NCT02834013)

Summary

To take part in this study, you must have metaplastic breast cancer and have already tried at least one other treatment.

This study is investigating the safety and effects (good or bad) of using two types of immunotherapy drugs. Metaplastic breast cancer is a rare form of breast cancer; it makes up fewer than 1% of all breast cancer diagnoses. This study is also enrolling patients with other rare cancers. Nivolumab (Opdivo®) is a type of immunotherapy called a PD-1 inhibitor. Ipilimumab (Yerovy®) is a type of immunotherapy called a CTLA-4 inhibitor. Opdivo and Yervoy are an approved combination for treating melanoma. Neither drug is approved to treat breast cancer.


This is a Phase II trial

M7824 and Halaven for Metastatic Triple Negative Breast Cancer

A Phase Ib Trial of M7824 and Eribulin in Patients With Metastatic Triple Negative Breast Cancer (TNBC) (NCT03579472)

Summary

To take part in this study you must be a woman or man with triple negative (ER- PR- HER2-) metastatic (stage IV) breast cancer

This study is designed to find the best dose of M7824 to use with eribulin (Halaven). M7824 is an investigational immunotherapy drug. It gets immune cells to see cancer cells by blocking PD-L1 and TGF-beta. Halaven is used to treat patients who have already had at least two other anticancer medicines for their metastatic breast cancer and who have already been treated with an anthracycline and a taxane for either early or advanced breast cancer


This is a Phase I trial

Combination Immunotherapies for Advanced Triple Negative Breast Cancer

A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma (NCT03207867)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. This study is investigating the safety and effects (good and bad) of using two different types of immunotherapy drugs at the same time to treat advanced triple negative breast cancer. The two experimental immunotherapies being used in this study are NIR178 and PRD001. NIR178 is an adenosine receptor antagonist. It blocks adenosine, which is found in the microenvironment that surrounds the tumor. PDR001 is a type of immunotherapy called a PD-1 inhibitor. This trial is also enrolling patients with other types of advanced cancers.


This is a Phase II trial

CAR-T Cell Immunotherapy for Triple Negative Breast Cancer

Clinical Trial of Autologous cMET Redirected T Cells Administered Intravenously in Patients With Melanoma & Breast Carcinoma (NCT03060356)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study is evaluating the safety and effectiveness of using a type of immunotherapy called CAR T-cell therapy to treat advanced and metastatic breast cancer. In CAR T-cell therapy, your white blood cells are genetically engineered to produce chimeric antigen receptors (CARs) that can identify cancer cells. This study is also enrolling patients with advanced melanoma.

MK-1454 and Keytruda for Patients With Advanced Breast Cancer

Phase 1 Open Label, Multicenter Study of MK-1454 Administered by Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors or Lymphomas (NCT03010176)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer and have a tumor that has not responded to, or has stopped responding to, other treatments.

This study will determine the best dose and safety of MK-1454, an immunotherapy drug that earlier studies suggest may make tumors more likely to respond to pembrolizumab (Keytruda®). Keytruda is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to go after cancer cells. It is approved to treat certain types of cancer, but not breast cancer. This study also is enrolling patients with other types of cancer.


This is a Phase I trial

Immunotherapy with AB154 or AB154 and AB122 in Advanced Breast Cancer

A Phase 1 Study to Evaluate the Safety and Tolerability of AB154 Monotherapy and Combination Therapy in Participants With Advanced Malignancies(NCT03628677)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer that can not be treated with any standard therapies.

This study is comparing the safety and effects (good or bad) of using the immunotherapy drug AB154 alone with using it in combination with the immunotherapy drug AB122. AB154 is an investigational drug that stimulates the immune system by blocking a checkpoint called TIGIT. AB122 is an investigational immunotherapy that gets the immune system to go after cancer cells by blocking PD-1. This study is also enrolling patients with other types of cancers.


This is a Phase I trial

HER2 BATs and Keytruda for Treating Metastatic Breast Cancer

A Phase I/II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated T Cells (ATC) and Pembrolizumab Combination Therapy in Women With Metastatic Breast Cancer (NCT03272334)

Summary

To take part in this study, you must have metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of using an immunotherapy along with a new type of immunotherapy that uses a HER2 antibody to treat metastatic breast cancer. Pembrolizumab (Keytruda®) is the immunotherapy used in this study. It is a type of immunotherapy called a PD-1 inhibitor. HER2 bispecific antibody armed T cells (BATs) are the new type of immunotherapy used in this study. If you enroll in this study, you will have your white blood cells collected by leukapheresis procedure.


This is a Phase I-II trial

Keytruda & Decitabine Followed by Chemo Before Surgery for Locally Advanced HER2- Disease

T-Cell Immune Checkpoint Inhibition Plus Hypomethylation for Locally Advanced HER2-Negative Breast Cancer - A Phase 2 Neoadjuvant Window Trial of Pembrolizumab and Decitabine Followed by Standard Neoadjuvant Chemotherapy (NCT02957968)

Summary

To take part in this study, you must have HER2-negative locally advanced (some stage III) breast cancer. Giving chemotherapy before surgery (called neoadjuvant treatment) can shrink the tumor. It also allows researchers to study the effect the treatment has on the cancer cells. This study will evaluate the safety and effectiveness of using immunotherapy before standard neoadjuvant chemotherapy. The immunotherapy used in this study is pembrolizumab (Keytruda®). It is approved to treat certain types of metastatic lung cancer. It will be given along with the chemotherapy drug decitabine (Dacogen®), which is used to treat a certain type of blood cancer.


This is a Phase II trial

TSR-033 with an Anti-PD-1 Immunotherapy for Advanced Breast Cancer

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-033, an Anti-LAG-3 Monoclonal Antibody, Alone and in Combination With an Anti-PD-1 in Patients With Advanced Solid Tumors (NCT03250832)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already received a treatment that your cancer progressed on or did not respond to. There are two parts to this study. In part I, researchers will determine the best dose of the immunotherapy TSR-033. In part II, researchers will compare the safety and effects (good and bad) of TSR-033 when it is given with an immunotherapy that blocks PD-1. TSR-033 is an experimental immunotherapy that blocks the protein LAG-3.This study is also recruiting patients with other types of cancer.


This is a Phase I trial

KY1044 and Atezolizumab Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of KY1044 as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies (NCT03829501)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer that has not responded to other treatment options.

This study is evaluating the safety and the effects (good or bad) of using KY1044 alone or with Tecentriq® (atezolizumab) to treat advanced breast cancer. KY1044 stimulates immune cells to go after and kill cancer cells. It also kills the T regulatory cells that keep immune cells from killing the cancer cells. Tecentriq® (atezolizumab) is a type of immunotherapy called a PD-L1 (programmed cell death-ligand 1) inhibitor. It is approved to treat advanced triple negative breast cancer, as well as certain types of bladder and lung cancer.


This is a Phase I-II trial

Immunotherapy Galinpepimut-S and Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1/2 Study of Galinpepimut-S in Combination With Pembrolizumab (MK 3475) in Patients With Selected Advanced Cancers (NCT03761914)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not responded to other treatment options.

This study is assessing the safety, effects (good and bad) and best dose of the immunotherapy galinpepimut-S when it is used along with pembrolizumab (Keytruda®). Galinpepimut-S is a vaccine that targets the protein WT1. Higher than normal amounts of this protein are found on the surface of breast and certain other cancer cells. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.


This is a Phase I-II trial

T Cell Immunotherapy for Patients With NY-ESO-1 Advanced Breast Cancer

Phase II Study of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes (NCT01967823)

Summary

To take part in this study you must have locally advanced (stage III) or metastatic (stage IV) breast cancer that tests positive for NY-ESO-1.

This study is evaluating the safety and effects (good and bad) of treating cancer with white blood cells that have been modified in a lab to target NY-ESO-1 on cancer cells. For the procedure, your white blood cells are removed, modified, and then infused back into your body along with Aldesleukin, a drug that enhances immune function. You will also receive the chemotherapy drugs cyclophosphamide (Cytoxan®) and fludarabine (Fludara®).You will be admitted to the hospital for some of the procedure. This trial also is enrolling patients with other types of metastatic cancer.


This is a Phase II trial

A Vaccine-Based Immunotherapy For Stage IV Triple Negative Breast Cancer

A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of Escalating Doses And Treatment Intensification Of A Vaccine-based Immunotherapy Regimen-2 (Vbir-2) (Pf-06936308) For Advanced Non-small Cell Lung Cancer And Metastatic Triple-negative Breast Cancer (NCT03674827)

Summary

To take part in this study, you must have metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-).

This study will investigate the safety and effects (good or bad) of increasing doses of a vaccine-based immunotherapy called TPF-06936308. The vaccine is designed to make immune cells find and then stop the growth of cancer cells. This study is also enrolling patients with advanced non-small cell lung cancer.


This is a Phase I trial

ABBV-368 plus Opdivo for Advanced Breast (and Other) Cancer

A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors (NCT03071757)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already received a treatment that your cancer progressed on or did not respond to. This study is investigating the safety and best dose of a new immunotherapy, called ABBV-368. In this study patients will receive the drug alone or in combination with the immunotherapy drug nivolumab (Opdivo®). Opdivo is approved to treat certain types of metastatic melanoma and non-small cell lung cancer. It blocks a protein called PD-1.This study is also enrolling patients with other types of cancer.


This is a Phase I trial

Two Immunotherapy Drugs for Advanced Breast Cancer

A Basket Study: A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination With M9241(NHS-IL12) in Subjects With Locally Advanced, Unresectable, or Metastatic Solid Tumors (COMBO) (NCT02994953)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety, side effects and best dose of the immunotherapy drug NHS-IL12 when it is given in combination with the immunotherapy drug avelumab. NHS-IL12 is an investigational drug. Avelumab (Bavencio) is currently approved for treating certain types of cancers.


This is a Phase I trial

Chemotherapy & Endocrine Therapy With or Without Pembrolizumab in ER+ and HER2- Stage I, II or III Breast Cancer

A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756)(NCT03725059)

Summary

To take part in this study you must have estrogen receptor (ER) positive HER negative stage I, II or III breast cancer.

This study is comparing the effectiveness of giving the immunotherapy pembrolizumab (Keytruda®) along with standard of care pre-surgery chemotherapy and post-surgery hormone therapy to using standard of care pre-surgery chemotherapy and post-surgery hormone therapy alone. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.


This is a Phase III trial

Personalized Cancer Vaccine plus Atezolizumab for Advanced Breast (and Other) Tumors

A Phase 1a/1b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Tumors (NCT03289962)

Summary

To take part in this study, you must have triple negative, locally advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of using a personalized cancer vaccine alone or with an immunotherapy to treat advanced breast cancer. The personalized cancer vaccine is called RO7198457. The immunotherapy being used in this study is the PD-L1 inhibitor atezolizumab (Tecentriq®). It works by blocking the PD-L1 (programmed cell death-ligand 1) protein and is approved to treat certain types of bladder and lung cancer. This study is also recruiting patients with other types of solid tumors.


This is a Phase I trial

LAG525 plus Spartalizumab or Carboplatin in Advanced Triple-Negative Breast Cancer

A Phase II Open-label, Randomized, Three-arm, Multicenter Study of LAG525 Given in Combination With Spartalizumab (PDR001), or With Spartalizumab and Carboplatin, or With Carboplatin, as First or Second Line Therapy in Patients With Advanced Triple-negative Breast Cancer (NCT03499899)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that progressed on one prior taxane-based chemotherapy regimen.

This study will evaluate the best dose, safety and effect (good or bad) of the experimental immunotherapy drug LAG525 when it is used along with another type of experimental immunotherapy and/or chemotherapy. LAG525 gets the immune system to go after cancer cells by blocking a protein called LAG-3. Spartalizumab (PDR001), the other immunotherapy drug used in this study, is an experimental checkpoint inhibitor. The chemotherapy drug being used in this study is carboplatin (Paraplatin®). It is approved to treat triple negative breast cancer.


This is a Phase II trial

NZV930, PDR001 and NIR178 Immunotherapies in Advanced Triple Negative Breast Cancer

A Phase I/Ib, Open-label, Multi-center, Study of NZV930 as a Single Agent and in Combination With PDR001 and/or NIR178 in Patients With Advanced Malignancies.(NCT03549000)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options.

This study is comparing the safety and effects (good or bad) of NZV930 alone or in combination with PDR001 and/or NIR178. NZV930 is an investigational targeted therapy that blocks the CD73 protein. Blocking this protein allows T cells and other immune cells to attack the tumor. PDR001 is an investigational immunotherapy. It is a type of immunotherapy called a PD-1 inhibitor. NIR178 is an investigational immunotherapy. It is an immune checkpoint inhibitor that gets the immune system to attack cancer cells by blocking the adenosine A2A receptor (A2AR).


This is a Phase I trial

INCAGN01876 plus Immunotherapies in Advanced Triple Negative Breast (and Other) Cancer

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (NCT03126110)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. This study will allow researchers to learn about the safety and effect (good and bad) of giving a new immunotherapy along with one or two approved immunotherapy drugs. The new immunotherapy drug is called INCAGN01876. The two FDA-approved immunotherapy drugs are nivolumab (Opdivo®) and ipilimumab (Yervoy®). These drugs are approved to treat certain types of cancers, but not breast cancer. This study is also recruiting patients with other types of advanced or metastatic solid tumors. Only phase I of this study is open to triple negative breast cancer patients.


This is a Phase I-II trial

CAR T-Cell Therapy For Metastatic ROR1 Positive Triple Negative Breast Cancer

Phase I Study of Adoptive Immunotherapy for Advanced ROR1+ Malignancies With Defined Subsets of Autologous T Cells Engineered to Express a ROR1-Specific Chimeric Antigen Receptor (NCT02706392)

Summary

To take part in this study you must have metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not responded to other treatment options and that tests positive for ROR1.

This study is assessing the safety, effects (good and bad) and best dose of an experimental CAR-T immunotherapy that targets cancer cells that test positive for ROR1. CAR-T is a personalized immunotherapy made from a patient's white blood cells. The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into the patient in the hospital. The CAR-T therapy being used in this study trains the immune system to attack ROR1-positive tumor cells. It is given along with the chemotherapy drugs fludarabine phosphate and cyclophosphamide. These drugs are given to deplete lymph cells. This study is also enrolling patients with other types of ROR1-positive metastatic tumors.


This is a Phase I trial

ABBV-181: An Immunotherapy Drug for Advanced Breast (and Other Solid) Tumors

A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-181, a Monoclonal Antibody , in Subjects With Advanced Solid Tumors (NCT03000257)

Summary

To take part in this study, you must have metastatic (stage IV) or locally advanced (some types of stage III) breast cancer that cannot be removed by surgery. This study is looking at whether a new type of immunotherapy drug is safe and effective in patients with metastatic or locally advanced breast cancer. The study will also determine the best dose of the drug to use. The drug is called ABBV-181. It is only available in clinical trials. This study is also enrolling patients with other types of advanced cancer. This study has two parts. If you are in the first part, called the dose escalation phase, you can take part if you have already been treated with PD-1/PD-L1 immunotherapy drugs. If you are in the second part, called the dose expansion phase, you cannot have had any PD-1/PD-L1 immunotherapy drugs.


This is a Phase I trial

Keytruda and Mifepristone for HER2- Advanced Breast Cancer

Phase II Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer (NCT03225547)

Summary

To take part in this study, you must have HER2-negative advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of using mifepristone and pembrolizumab (Keytruda®) together to treat HER2-negative advanced breast cancer. Mifepristone is a steroid that has been shown to block the glucocorticoid receptor. Researchers think blocking the glucocorticoid receptor may make Keytruda more effective. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to go after cancer cells. It is approved to treat certain types of cancer, but not breast cancer.


This is a Phase II trial

XmAb20717 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb20717 in Subjects With Selected Advanced Solid Tumors (DUET-2) (NCT03517488)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options.

This study is testing the safety, effects (good and bad) and best dose of an experimental immunotherapy called XmAb20717 that blocks two proteins on immune cells, PD-1 and CTLA4. Blocking these proteins helps your immune system see and go after cancer cells.


This is a Phase I trial

A New Treatment Vaccine for HER2-Low-Expressing Advanced Breast Cancer

Phase I Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Low-Expressing (IHC 1+/2+) Breast Cancer(NCT02751528)

Summary

To take part in this study, you must have been diagnosed with HER2-low-expressing, advanced (some stage III) or stage IV breast cancer. Your tumor is considered HER2-low-expressing if the results of your IHC test were 1+ (negative) or 2+ (borderline). Note: Not all tumors are tested with an IHC test. This study is investigating how HER2-low expressing tumors respond to a new HER2 treatment vaccine. The vaccine being used in this study is called ETBX-021.
This is a Phase I trial

Tavo & Pembrolizumab (Immunotherapy) in Advanced Triple Negative Tumors

A Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid Plus Electroporation in Combination With Intravenous Pembrolizumab Therapy in Patients With Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer (NCT03567720)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer.

This clinical trial will study tumor response to and the effects (good or bad) of using Tavo-EP and pembrolizumab (Keytruda®) together to treat advanced breast cancer. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells. It is approved to treat certain types of cancers, and its use in breast cancer is considered experimental. Tumor infiltrating lymphocytes (TILs) are immune cells that have moved from the blood into a tumor cell. Studies have found that tumors with fewer TILs do not respond as well to immunotherapy. Tavo-EP (Tavo™) activates the immune system in a way that brings more TILs into the tumors. It is administered through electroporation, an electric current that makes it possible to put a drug or DNA into a cell. Researchers think using Tavo with Keytruda will make tumors more likely to respond to Keytruda.


This is a Phase II trial

NKTR-262 and NKTR-214 with or without Opdivo for Advanced TNBC (and Other) Cancers

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-262 in Combination With NKTR-214 and in Combination With NKTR-214 Plus Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies (REVEAL) (NCT03435640)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer. In this study, researchers will evaluate the safety and best dose of two experimental immunotherapy drugs when they are given with or without the immunotherapy drug nivolumab (Opdivo®) to treat advanced breast cancer. NKTR-262 and NKTR-214 are the experimental immunotherapy drugs being used in this study. Opdivo is a type of immunotherapy drug called a PD-1 inhibitor. It is approved to treat certain types of metastatic melanoma and non-small cell lung cancer.


This is a Phase I-II trial

Vaccine & Immunotherapy After Standard Care for Stage II-III Triple Negative Breast Cancer

A Randomized Phase 1 Trial of Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy (NCT03199040)

Summary

To take part in this study, you must be newly diagnosed with stage II or III triple negative (ER-, PR-, HER2-) breast cancer. This study is investigating the effect of a personalized vaccine given alone or with an immunotherapy drug in women newly diagnosed with triple negative breast cancer who have already received standard of care therapy. The personalized vaccine used in this study is a neoantigen DNA vaccine. Durvalumab (Imfinzi®) is an immunotherapy drug that works by stimulating the body's immune system to go after cancer cells. It is approved to treat certain types of lung cancer.


This is a Phase I trial

FT500 Alone or With Immunotherapy for Advanced HER2-positive Breast Cancer

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (Phase 1) (NCT03841110)

Summary

To take part in this study, you must have HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer and have had your cancer progress after being treated with nivolumab (Opdivo®), pembrolizumab (Keytruda®) or atezolizumab (Tecentriq®).

This study is evaluating the safety and effects (good or bad) of giving FT500 alone or with immunotherapy. FT500 is a natural killer (NK) cell immunotherapy. NK cells are specialized immune cells that can fight cancer cells. Cyclophosphamide and fludarabine are chemotherapy drugs used to deplete lymph cells. Opdivo, Tecentriq and Keytruda are each a type of immunotherapy drug called a PD-1 (programmed cell death-1) inhibitor. They are approved to treat certain other types of cancers, but their use in breast cancer is considered experimental. This study is also enrolling patients with other types of cancers.


This is a Phase I 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

OB-822 & OBI-821 for Early-Stage Triple Negative Breast Cancer at High Risk for Recurrence

A Phase III, Randomized, Double-blind, Placebo Controlled Study of Adagloxad Simolenin (OBI 822)/OBI 821 Treatment for High Risk Early Stage Triple Negative Breast Cancer Patients, Defined as Residual Invasive Disease Following Neoadjuvant Chemotherapy OR ≥4 Positive Axillary Nodes (NCT03562637)

Summary

To take part in this study, you must have early stage (stage I, II and IIIA) triple negative (ER-/PR-/HER2-) breast cancer and have completed chemotherapy. You must have cancer cells remaining if you had neoadjuvant (before surgery) chemotherapy or had 4 or more positive lymph nodes at the time of surgery if you had adjuvant (after surgery) chemotherapy.

This study will see if treating patients at risk for recurrence with an immunotherapy reduces the risk of the cancer coming back. Adagloxad simolenin (OBI-822) is the investigational immunotherapy used in this study. It is given along with the investigational drug OBI-821, which is designed to help stimulate the immune system to fight cancer cells.


This is a Phase III trial

NKTR-214 with Opdivo for Advanced Triple Negative Breast Cancer (and Other Solid Tumors)

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-214 and Nivolumab in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies (PIVOT) (NCT02983045)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the best dose, safety and effects (good and bad) of using an investigational immunotherapy along with the immunotherapy drug Nivolumab (Opdivo®) to treat advanced or metastatic triple negative breast cancer. The investigational therapy NKTR-214 targets a protein found on immune cells called CD-122. Targeting the protein gets the immune system to go after cancer cells. Opdivo®) is a type of immunotherapy called a PD-1 (programmed cell death 1) inhibitor. It is approved to treat certain types of cancers, but not breast cancer. Researchers believe using the two immunotherapies together will treat cancer more effectively.


This is a Phase I-II trial

Keytruda for Advanced BRCA+ Breast Cancer

Open Label, Phase II Pilot Study of Immune Checkpoint Inhibition With Pembrolizumab in Advanced BRCA-mutated Breast Cancers (NCT03025035)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and have been tested and told that you have the inherited BRCA (BRCA1 or BRCA2) mutation. This study is looking at the safety and effect of using the immunotherapy drug pembrolizumab (Keytruda®) to treat advanced or metastatic breast cancer in patients with a BRCA mutation.


This is a Phase II trial

Immunotherapy Plus Chemotherapy for Advanced Triple Negative Breast Cancer

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast and Gynecologic Malignancies (NCT03719326)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has progressed on or not responded to available therapies.

This study will evaluate the best dose, safety and effects (good or bad) of AB928 when it is used along with pegylated liposomal doxorubicin (PLD) to treat advanced triple-negative breast cancer. AB928 is a targeted therapy that researchers think can boost the immune system. Pegylated liposomal doxorubicin (Doxil®) is a chemotherapy drug used to treat breast cancer.


This is a Phase I trial

Vaccine Therapy to Prevent Recurrence in Breast Cancer Survivors

A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine (WOKVAC) Encoding Epitopes Derived From Three Breast Cancer Antigens (IGFBP-2, HER2, and IGF-IR) in Patients With Breast Cancer (NCT02780401)

Summary

To take part in this study, you must have had a breast tumor that was HER2-negative and that had spread to your lymph nodes. You must also have completed chemotherapy, radiation and/or treatment with a targeted drug within the last 28 days. This study is investigating the safety of a new DNA vaccine researchers have developed that may reduce the risk of a breast cancer recurrence. The vaccine, called WOKVAC, is designed to get the immune system to see and go after cancer cells. The vaccine is available only in a clinical trial.


This is a Phase I trial

A Vaccine and Durvalumab After Surgery for Stage II or III Triple Negative Breast Cancer

A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Durvalumab in Human Leukocyte Antigen (HLA)-A2+ Subjects Following Standard Treatment of Stage II or III Triple Negative Breast Cancer (NCT02826434)

Summary

To take part in this study, you must have been diagnosed with stage II or III triple negative (ER-/PR-/HER2-) breast cancer and have already received the standard treatment for your tumor's stage. This study is looking at whether it is safe and effective to combine two different types of immunotherapy--a vaccine and a targeted drug. The vaccine being studied is called PVX-410. It is only available in clinical trials. The targeted drug is durvalumab. It is being studied in clinical trials for breast and other types of cancer. It blocks a protein called PD-L1 (programmed cell death ligand-1).


This is a Phase I trial