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146 trials contain the search term(s): "triple negative"

A Registry for Patients with a Breast Cancer Genetic Mutation or Triple Negative Tumor

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations (PROGECT) (NCT02302742)

Summary

Women and men who carry an inherited genetic mutation are at increased risk of developing breast cancer. BRCA1 and BRCA2 are the most common genetic mutations associated with breast cancer risk. But there are other mutations that also increase breast cancer risk, including PTEN, P53, PALB2, and others. Previous studies have found that individuals with triple-negative breast cancer are likely to carry the BRCA mutation. This registry study will collect cancer-related information from individuals with triple negative breast cancer and/or inherited genetic mutations. The information collected in the registry will be used to learn more about the relationship between genetic mutations and cancer outcomes in individuals with triple negative breast cancer.

Creating a Model to Study How Triple Negative Tumors Respond to Treatment

Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer (NCT02247037)

Summary

Researchers are trying to identify the best treatment for triple negative (ER-, PR-, HER2-) breast cancer. Giving chemotherapy before surgery (called neoadjuvant treatment) allows researchers to study how a tumor responds to a specific cancer therapy. Scientists are looking for new ways to develop models of triple negative tumors that they can use in the lab to study new drugs or new drug combinations. Placing tumor tissue taken from patients into mice is one way to study new treatments and treatment combinations. In this study, patients will donate tumor tissue for scientists to use to study triple-negative breast cancer. To be eligible for this study, a patient must be a candidate for neoadjuvant treatment and be undergoing surgery at a hospital that is part of the Mount Sinai Health System.

Estradiol in Advanced Triple Negative Tumors that Test Positive for ER Beta

Therapeutic Targeting of ER Beta in Triple Negative Breast Cancer (NCT03941730)

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- and HER2-) breast cancer who has a tumor that tests positive for estrogen receptor beta (ER beta).

This study is investigating the effects (good and bad) of estradiol in the subset of triple negative tumors that test positive for ER beta. Early studies suggest that estradiol--a type of estrogen--slows the growth of tumors that are ER-beta positive.


This is a Phase II trial

L-NMMA plus Taxotere for Advanced Triple Negative Breast Cancer

Clinical Phase Ib Trial of L-NMMA Plus Docetaxel in the Treatment of Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients (NCT02834403)

Summary

Scientists have created new drugs to treat triple negative(ER-, PR-, HER2-) breast cancer. One of these new drugs is called L-NMMA. In this study, researchers will determine the best dose, safety and effectiveness of L-NMMA when it is given with a chemotherapy drug that is used to treat advanced breast cancer. The chemotherapy drug being used is docetaxel (Taxotere®). L-NMMA targets the NOS (nitric oxide synthase) inhibitor. To take part in this study, you must have metastatic triple negative breast cancer or stage III triple negative breast cancer that has already been treated with at least one other chemotherapy drug.


This is a Phase I-II trial

Chemo After Neoaduvant Chemo and Surgery for Basal-Like Triple-Negative Breast Cancer

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy vs. Observation in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy (EA1131) (NCT02445391)

Summary

Most triple-negative breast cancers have basal-like qualities, meaning the cells resemble the basal cells that line the breast ducts. Neoadjuvant chemotherapy (treatment given before surgery) is used to shrink the tumor before surgery. Sometimes the tumor will disappear completely. In other instances, the tumor can be seen during surgery. Cisplatin (Platinol®) and carboplatin (Paraplatin®) are platinum-based chemotherapy drugs that laboratory studies suggest may be effective against basal-like triple-negative breast cancer. This study will investigate whether giving one of these chemotherapy drugs after surgery reduces the risk of recurrence in patients with basal-like triple negative breast cancer who had neoadjuvant therapy that did not make their tumor disappear. Participants will have their tumor specimens tested for basal-like qualities.


This is a Phase III trial

Predicting Response to Cisplatin & Radiation in Advanced Triple Negative Breast Cancer

A Phase II Trial of Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy (NCT02422498)

Summary

Researchers are studying the best way to treat triple-negative (ER-, PR-, HER2-) breast cancer. Cisplatin (Platinol®) is a platinum-based chemotherapy drug being studied in patients with triple-negative breast cancer. Radiation therapy can be used to treat cancer cells that have spread to different parts of the body. Researchers have developed a test that they think can be used to predict how well a patient's tumor will respond to concurrent cisplatin and radiation therapy. The test is performed on a biopsy (tissue sample) of the tumor, taken from the breast or elsewhere in the body. In this study, researchers will evaluate how well the test predicts response to cisplatin and radiation therapy in patients with recurrent (stage III) or metastatic (stage IV) triple-negative breast cancer. The biopsy and radiation will be given at Memorial Sloan Kettering Cancer Center.


This is a Phase II 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

Targeted therapy followed by Chemotherapy for Metastatic Triple Negative Breast Cancer

Phase II Clinical Trial of Treatment With TAK-228 and TAK-117 to Inhibit Homologous Recombination (HR) Followed by Cisplatin and Nab Paclitaxel in Patients With Chemotherapy-pretreated Metastatic Triple Negative Breast Cancer (NCT03193853)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) metastatic (stage IV) breast cancer. Your tumor must also test negative for androgen receptors. In addition, you must have already had chemotherapy (anthracycline, cyclophosphamide, and taxane). This study is investigating the safety and effects (good or bad) of using two targeted drugs followed by chemotherapy to treat triple negative metastatic breast cancer. The targeted drugs used in this study are TAK-228 and TAK-117. Both are mTOR inhibitors. Cisplatin (Paraplatin®) and nab-paclitaxel (Abraxane®) are the chemotherapy drugs used in this study.


This is a Phase II trial

Vectibix, Paraplatin & Taxol Before Surgery For Early Stage Triple Negative Disease

Women's Triple-Negative First-Line Study: A Phase II Trial of Panitumumab, Carboplatin and Paclitaxel (PaCT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NCT02593175)

Summary

To take part in this study, you must have been diagnosed with triple-negative, early-stage breast cancer but not yet had surgery. In addition, you must have a type of tumor that is not likely to get smaller if you receive the standard type of chemotherapy given before surgery. Vectibix, Paraplatin, and Taxol are three different types of cancer drugs. Researchers think that giving all three drugs at the same time before surgery will shrink triple negative tumors. Panitumumab (Vectibix®) is a targeted treatment used to treat certain types of colorectal cancer. Its use in breast cancer is considered experimental. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs that are used to treat breast cancer.


This is a Phase II trial

Xtandi and Taxol Before Surgery for Stage I-III Triple-Negative Breast Cancer

A Phase IIB Study of Neoadjuvant Enzalutamide (ZT) Regimen Therapy in Combination With Weekly Paclitaxel for Androgen Receptor (AR)-Positive Triple-Negative Breast Cancer(NCT02689427)

Summary

To take part in this study, you must have stage I-III triple negative breast cancer (ER-, PR- and HER2-). Your tumor must also be androgen receptor positive (AR+). This study is looking at the safety and effect of giving an anti-androgen drug along with chemotherapy before surgery to patients with triple negative breast cancer. This will allow the researchers to study the effect the drugs have on your breast tumor. If you are enroll in the study, your tumor will be tested to see if is AR+. You can only stay in the study if your tumor is AR+. Androgen receptors (AR) are found on many triple-negative breast tumors. Researchers think drugs that block these receptors could keep breast cancer cells from growing. The anti-androgen drug that will be used in this study is enzalutamide (Xtandi®). It is currently used to treat prostate cancer. It will be given with paclitaxel (Taxol®), a chemotherapy drug used to treat breast cancer.
This is a Phase II trial

Abemaciclib in Advanced Triple Negative Breast Cancer with the Rb Protein

A Phase 2 Study of Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer (NCT03130439)

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. You must also have a tumor that tests positive for the retinoblastoma (Rb) protein. The researchers will test your tumor for this protein. This study will evaluate the safety and effects (good and bad) of an experimental drug called abemacicilb when it is used to treat triple negative breast cancer that tests positive for the Rb protein. The experimental drug is called abemaciclib (LY2835219). It is a type of targeted drug called a CDK4/6 inhibitor. Studies have found that the Rb protein, which can help stop tumors from growing, doesn't work properly in certain cancers.


This is a Phase II trial

Leflunomide in Previously Treated Metastatic Triple Negative Breast Cancer

A Phase I/II Trial of Leflunomide in Women With Previously Treated Metastatic Triple Negative Cancers (NCT03709446)

Summary

To take part in this study you must be a woman with metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer and have had no more than 2 chemotherapy drugs used to treat your metastases.

This study is investigating the safety and effects (good or bad) of leflunomide (Arava®), an oral drug that blocks dihydroorotate dehydrogenase (DHODH). It is approved to treat certain adults with rheumatoid arthritis.


This is a Phase I-II trial

Galunisertib and Taxol for Metastatic Triple Negative Breast Cancer

A Phase Ib Trial of LY2157299 (TGFβR1 Kinase Inhibitor) With Paclitaxel in Patients With Triple Negative Metastatic Breast Cancer (NCT02672475)

Summary

Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat advanced breast cancer. Galunisertib (LY2157299) is a new type of targeted therapy. It works by blocking a protein called TGF-betaR1 kinase. This study will evaluate the best dose and safety of galunisertib and Taxol for treating patients with metastatic triple-negative breast cancer that also tests androgen-receptor negative.


This is a Phase I trial

Istodax and Platinol for Advanced BRCA+ or Triple Negative Breast Cancer

Phase I/II Trial of Cisplatin Plus Romidepsin in Locally Recurrent or Metastatic Triple Negative Breast Cancer or BRCA1 or BRCA2 Mutation Associated Locally Recurrent or Metastatic Breast Cancer. (NCT02393794)

Summary

Romidepsin (Istodax®) is an FDA-approved drug that is currently used to treat a type of lymphoma. Laboratory studies suggest Istodax may also be effective for treating breast cancer. Cisplatin (Platinol®) is a platinum-based chemotherapy drug that studies suggest is effective for treating triple-negative breast cancer. In the first phase of the study, researchers will determine the highest dose of Istodax that can safely and tolerably be used in combination with Platinol. In phase II, this highest dose will be given along with Platinol. Both phases of the study will enroll women with advanced breast cancer who are known to carry a BRCA mutation or who have triple negative breast cancer.


This is a Phase I-II trial

Gedatolisib plus PTK7-ADC for Metastatic Triple Negative Breast Cancer

An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer (NCT03243331)

Summary

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

This study is investigating the safety and effects (good or bad) of using two investigational drugs to treat metastatic triple negative breast cancer. The two drugs are gedatolisib and PTK7-ADC. Gedatolisib is a targeted therapy that works by blocking PI3K and mTOR kinase proteins, which play a role in the cellular pathways that help tumors grow. PTK7-ADC (PF-06647020) targets a protein called PTK7, which is often found on cancer cells. It is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a drug that can kill these cells.


This is a Phase I 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

Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

Phase 2 Trial With Safety Run-In of Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers Big Ten Cancer Research Consortium BTCRC-BRE18-337 (NCT03911973)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer and have a triple negative (ER-, PR-, HER2-) tumor or be BRCA1/2+ and have a HER2 negative tumor. This study is investigating the safety, best dose, and effects (good or bad) of gedatolisib when it is used in combination with talazoparib (Talzenna®). Gedatolisib is an experimental targeted therapy that works by blocking two proteins, called PI3K and mTOR, that help tumors grow. Talzenna is a type of targeted therapy called a PARP inhibitor. It is approved to treat HER2 negative advanced or metastatic breast cancer in women and men with an inherited BRCA mutation.
This is a Phase I-II trial

AC Chemo Followed by Taxol with or without Paraplatin for Triple-Negative Breast Cancer

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast CancerDoxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer (NCT02488967)

Summary

Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®)--known as AC--and paclitaxel (Taxol®) are chemotherapy drugs routinely used to treat breast cancer. Carboplatin (Paraplatin®) is a platinum-based chemotherapy drug that studies suggest is effective for triple-negative breast cancer. This study is comparing the effectiveness of AC followed by Taxol followed by Paraplatin to AC followed by Taxol in patients with triple-negative breast cancer. To be eligible, participants must have had breast cancer surgery with clean margins (cancer-free area around where tumor was removed). Patients who did not have clean margins will need to have radiation therapy to the chest wall before entering the trial.


This is a Phase III trial

HSP90 Inhibitor and Taxol for Advanced Triple Negative Breast Cancer

Phase 1b Study of HSP90 Inhibitor, AT13387 in Combination With Paclitaxel in Patients With Advanced, Triple Negative Breast Cancer(NCT02474173)

Summary

To take part, you must have some stage III-IV triple negative (ER-/PR-/HER2-negative) breast cancer. Researchers have developed a new type of drug called an HSP90 inhibitor. The HSP90 inhibitor being used in this study is named AT13387. This study is investigating whether AT13387 helps kill cancer cells and what side effects women experience when they are given it along with paclitaxel (Taxol®). AT13387 is a new drug that is only available in clinical trials. Taxol is a chemotherapy drug used to treat breast cancer.


This is a Phase I 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

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

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

Reducing Acid Levels Around Cancer Cells to Make Chemo Work Better

Inhibiting Fatty Acid Synthase to Improve Efficacy of Neoadjuvant Chemotherapy (NCT02595372)

Summary

Scientists have found that cancer cells can be surrounded by high acid levels. Laboratory studies suggest reducing these acid levels may make chemotherapy work better in patients with triple negative breast cancer. Omeprazole (Prolisec®) is a drug given to reduce stomach acid. Researchers think giving you Prolisic before you receive chemotherapy may make it easier for the chemotherapy to kill cancer cells. To take part in this study, you must have triple negative breast cancer.

Omeprazole (Prolisec®) is a type of drug called a proton pump inhibitor. It is used to reduce stomach acid levels and to treat gastroesphageal reflux disease (GERD). If you have triple-negative breast cancer (ER-, PR-, and HER2-negative) you typically receive chemotherapy before surgery. This is called neoadjuvant treatment. In this study, the Prolisec is given before the neoadjuvant treatment used for stage IC-III triple-negative breast cancer.


This is a Phase 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

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

ZEN003694 and Talazoparib for Triple Negative Breast Cancer

A Phase 2 Study of ZEN003694 in Combination With Talazoparib in Patients With Triple-Negative Breast Cancer (NCT03901469)

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-) and have been tested for and found to not have inherited the BRCA1 or BRCA2 mutation that increases breast cancer risk.

This study will look at the safety and effects (good and bad) of using the experimental drug ZEN003694 along with talazoparib (Talzenna®). ZEN003694 is a drug taken by mouth that targets the protein BET. This protein helps cancer cells grow. Talzenna is a PARP inhibitor. It prevents the PARP protein from repairing damaged DNA inside tumor cells. It is approved to treat HER2-negative locally advanced or metastatic breast cancer in women and men with an inherited BRCA mutation.


This is a Phase II trial

BRCA Gene Mutations in Latinas with Breast Cancer

BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects (NCT01251900)

Summary

Some women who have triple negative (ER, PR, and HER2-negative) breast cancer also have a BRCA1 or BRCA2 genetic mutation. The number of Latinas with triple negative breast cancer who also have a BRCA1/2 mutation is not known. Learning more about BRCA1/2 mutation rates among Latinas will help researchers provide better treatment to this group of women. The purpose of this trial is to study DNA samples taken from saliva and the medical histories of Latinas who have been diagnosed with breast cancer. Participants can reside anywhere in the U.S.

MM-310 for Metastatic Triple Negative Breast Cancer

A Phase-1 Study Evaluating the Safety, Pharmacology and Preliminary Activity of MM-310 in Patients With Solid Tumors (NCT03076372)

Summary

To take part in this study, you must have metastatic triple negative (ER-/PR-/HER2-) breast cancer. This study will determine the best dose, safety and effect (good and bad) of a new type of targeted drug researchers think will be effective in patients with metastatic triple negative breast cancer. The new drug is called MM-310. It delivers the chemotherapy drug docetaxel (Taxotere®) directly to cancer cells. Results from this study will help researcher determine the best dose of MM-310 to use when it is combined with other anti-cancer drugs. This study is also enrolling patients with other types of solid cancers.


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

BMS-986158 for Advanced Triple Negative Breast (and Other) Cancer

A Basket Study: A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects With Selected Advanced Solid Tumors (NCT02419417)

Summary

To take part in this study, you must have advanced (some stage III) and stage IV triple negative (ER-/PR-/HER2-) breast cancer. This study is investigating whether a new targeted drug for triple negative breast cancer is safe and effective. The new drug being studied is called BMS-986158. It is currently only available in clinical trials. This study also is enrolling patients with other types of advanced cancers.


This is a Phase I-II 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.

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

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

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

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

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

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

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

Carboplatin and Afinitor for Metastatic Triple-Negative Breast Cancer

A Multi-Centered Randomized Phase II Study Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer (NCT02531932)

Summary

Paraplatin (Carboplatin®) is a platinum-based chemotherapy drug used to treat metastatic breast cancer that has not responded to previous treatments. Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow. This study will compare the safety and effectiveness of Carboplatin and Afinitor to Carboplatin alone for treating metastatic triple-negative breast cancer.


This is a Phase II trial

Leronlimab & Carboplatin for Metastatic Triple Negative Breast Cancer That Tests CCR5+

A Phase Ib/II Study of Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC)(NCT03838367)

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 that the researchers find tests positive for CCR5, have received an anthracycline and a taxane before surgery (neoadjuvant therapy) or after surgery (adjuvant therapy), and not have been treated with chemotherapy or a checkpoint inhibitor for metastatic breast cancer.

This study is investigating the best dose, safety and effects (good and bad) of leronlimab when it is used along with carboplatin. Leronlimab is an investigational targeted therapy that blocks CCR5. Carboplatin is a chemotherapy drug used to treat breast cancer.


This is a Phase I-II trial

Taxotere and Paraplatin Before Surgery in ER-, HER2- Stage II-III Breast Cancer

A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery (NCT02124902)

Summary

Researchers are trying to determine the best treatments for triple negative (ER-, PR-, HER2-) breast cancer. Giving chemotherapy before surgery, called neoadjuvant therapy, allows researchers to study the effect that the treatment has on cancer cells. Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat advanced breast cancer. Carboplatin (Paraplatin®) is a chemotherapy drug used to treat advanced breast cancer that has not responded to previous chemotherapy treatments. This study is looking at the effect that Taxotere and Paraplatin have on cancer cells when they are given before surgery to treat patients with stage II or stage III triple-negative breast cancer.


This is a Phase II trial

Targeted Therapy Rebastinib With Carboplatin for Advanced Triple Negative Breast Cancer

An Open Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Carboplatin to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors (NCT03717415)

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, dose and effects (good and bad) of the targeted therapy rebastinib (DCC-2036) when used along with carboplatin (Paraplatin®). Rebastinib targets a receptor called TIE2. Researchers believe blocking this protein will keep tumors from growing and spreading. Paraplatin is a chemotherapy drug routinely used to treat advanced and metastatic triple negative breast cancer.


This is a Phase I-II trial

LY3023414 Followed by Prexasertib in Metastatic Triple Negative Breast Cancer

Pilot Clinical Trial Of Treatment With Oral LY3023414 To Inhibit Homologous Recombination (HR) Followed By Prexasertib In Patients With Chemotherapy-Pretreated Metastatic Triple Negative Breast Cancer (ExIST) (NCT04032080)

Summary

To take part in this study you must be a woman with metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer who has not had more than 3 chemotherapy regimens.

This study is looking at the safety and effects (good and bad) of treating patients with the investigational targeted therapy LY3023414 followed by the investigational targeted therapy prexasertib. LY3023414 is a type of targeted therapy called a PI3K/mTOR inhibitor. Prexasertib is a targeted therapy that blocks checkpoint kinase1 (chk1), which plays a role in chemotherapy drug resistance.


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

Abraxane & Mifepristone in Advanced Triple Neg Breast Cancer with Glucocorticoid Receptors

A Randomized, Placebo-Controlled, Double-Blind, Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel (Nab-Paclitaxel, Abraxane®) With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer (NCT02788981)

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 addition, your tumor sample must test positive for glucocorticoid receptors (GR). This study will determine the safety and effects (good and bad) of using chemotherapy along with a steroid to treat advanced or metastatic triple negative breast cancer. The chemotherapy drug being used in this study is nab-paclitaxel (Abraxane®). It is approved to treat advanced breast cancer. The steroid being used in this study is mifepristone. Researchers believe blocking the glucocorticoid receptor may make chemotherapy more effective.


This is a Phase II trial

Doxil, Avastin and Torisel Before Surgery for Triple-Negative Breast Cancer

Women's Triple-Negative First-Line Study: A Phase II Trial of Liposomal Doxorubicin, Bevacizumab and Temsirolimus (DAT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NCT02456857)

Summary

In this study, participants will receive the experimental drug regimen DAT, which consists of liposomal doxorubicin (Doxil®), bevacizumab (Avastin®), and temsirolimus (Torisel®). Doxil is a chemotherapy drug used to treat breast cancer. Avastin works by keeping the cancer from making the blood vessels it needs to grow. It currently is not approved as a breast cancer treatment. Torisel is an mTOR inhibitor. It works by blocking a protein called mTOR that helps cancer cells grow. Treatment given before surgery--called neoadjuvant therapy---allows researchers to see the effect that the treatment has on the tumor. This study is investigating the effect that the DAT regimen has when it is given before surgery to women with triple-negative breast cancer. To be eligible, patients must have stopped a neoadjuvant anthracycline-based regimen because the cancer progressed or they experienced too many side effects to continue.


This is a Phase II trial

Lynparza and Onalespib for Metastatic Triple Negative Breast Cancer

A Phase 1 Study of PARP Inhibitor Olaparib and HSP90 Inhibitor AT13387 for Treatment of Advanced Solid Tumors With Expansion in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, Peritoneal Cancer, or Recurrent Triple-Negative Breast Cancer (NCT02898207)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) metastatic (stage IV) breast cancer. This study will determine the safety and best dose of two targeted drugs for treating metastatic breast cancer. The two targeted drugs being used in this study are olaparib (Lynparza®) and onalespib (AT13387). Lynparza is a PARP inhibitor. It is approved by the FDA to treat ovarian cancer. Onalespib is an experimental HSP90 inhibitor. This trial is also enrolling patients with other types of cancers.


This is a Phase I trial

Sacituzumab Govitecan for Previously Treated Advanced Triple Negative Breast Cancer

Phase III Study of Sacituzumab Govitecan (IMMU-132) in Refractory/Relapsed Triple-Negative Breast Cancer (ASCENT) (NCT02574455)

Summary

This study is comparing the effects (good and bad) of a new targeted therapy for advanced triple negative breast cancer to a standard of care treatment selected by the patient's oncologist. The targeted therapy is sacituzumab govitecan (IMMU-132). It is an antibody-drug conjugate (ADC). This mean it uses an antibody that can target the protein TROP-2 to help bring the chemotherapy irinotecan (Camptosar®) directly into the cancer cells.


This is a Phase III 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

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

A Diet Restricting Methionine in Early Stage Triple Negative Breast Cancer

A Window of Opportunity Study of Methionine Deprivation in Triple Negative Breast Cancer (NCT03186937)

Summary

To take part in this study, you must have recently been diagnosed with triple negative (ER-/PR-/HER2-) breast cancer and not yet had surgery or any other cancer treatments. This study is investigating the effect of reducing the amount of an amino acid called methionine in your diet has on cancer cells. High methionine foods include nuts, beef, lamb, cheese, turkey, pork, fish, shellfish, soy, eggs, dairy, and beans. Laboratory studies suggest reducing methionine levels can slow cancer cell growth. The cancer cells will be studied after they are removed during your breast cancer surgery.


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

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

Ibrance & Casodex for Metastatic Triple Negative Breast Cancer with Androgen Receptors

Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC) (NCT02605486)

Summary

Palbociclib (Ibrance®) is a targeted therapy that keeps cancer cells from growing by blocking two enzymes, CDK 4 and CDK 6. It is used to treat metastatic breast cancer. Bicalutamide (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 treatment. This study is testing the safety and effectiveness of using Ibrance and Casodex to treat triple negative breast cancer that is androgen receptor positive. To be eligible for this trial, participants must have triple negative, androgen receptor positive, metastatic breast cancer.


This is a Phase I-II trial

ONC201 and Methionine-Restricted Diet in Patients With Advanced Triple Negative Breast Cancer

ONC201 With and Without Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer (NCT03733119)

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 and currently do not follow a vegan or vegetarian diet.

This study will compare the safety and effects (good or bad) of a targeted therapy called ONC201 in patients who are or are not on a methionine-restricted (low-protein) diet. ONC201 is an experimental targeted therapy that targets Akt/ERK and can lead to the death of a tumor cell. Methionine is an essential amino acid that is found in foods that contain protein. The researchers want to see if restricting the amount of methionine in a patient's diet affects how the cancer responds to the drug ONC201.


This is a Phase II trial

LY2606368 For Metastatic Triple Negative or BRCA1/2-Associated Breast Cancer

A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) in Women With BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Non-High Risk Triple Negative Breast Cancer, and High Grade Serous Ovarian Cancer at Low Genetic Risk. (NCT02203513)

Summary

LY2606368 is a new type of cancer drug called a Chk1/2 (checkpoint kinases 1/2) inhibitor. By blocking the activity of Chk1/2, LY2606368 may slow or stop cancer cell growth. Early studies suggest LY2606368 may be an effective treatment for certain types of breast tumors. This study is looking at whether LY2606368 can shrink tumors in patients with metastatic breast cancer who carry a BRCA1/2 mutation or who have a triple-negative (ER-, PR-, HER2-) tumor. To be eligible for this study, patients must have already tried standard treatments.


This is a Phase II 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

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

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

Ipatasertib, Carboplatin and Paclitaxel in Metastatic Triple Negative Breast Cancer

A Phase I/IB Study of Ipatasertib in Combination With Carboplatin or Carboplatin/Paclitaxel in Patients With Metastatic Triple Negative Breast Cancer (NCT03853707)

Summary

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

This study is investigating the best dose of ipatasertib (GDC-0068) when it is used along with paraplatin (Carboplatin®) alone or with paraplatin (Carboplatin®) and paclitaxel (Taxol®). Ipatasertib is an investigational targeted therapy that blocks a protein called AKT that helps cancer cells grow and divide. Carboplatin and Taxol are chemotherapy drugs used to treat breast cancer.


This is a Phase I-II 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

MLN0128 and Alisertib for Metastatic Triple-Negative Breast (and Other Advanced) Cancers

A Phase Ib Study of the Combination of MLN0128 (Dual TORC1/2 Inhibitor) and MLN8237 (Aurora A Inhibitor, Alisertib) in Patients With Advanced Solid Tumors With an Expansion Cohort in Metastatic Triple-negative Breast Cancer (TNBC) (NCT02719691)

Summary

This study is investigating whether it is safe and effective to combine two new cancer drugs. Both drugs are targeted therapies. One drug is called MLN0128. The other is called Alisertib (MLN8237). To take part in this study, you must have metastatic triple negative breast cancer and you must have already been treated with chemotherapy.

MLN0128 is a new type of targeted therapy called an mTOR inhibitor. Alisertib (MLN8237) is a new targeted therapy that blocks an enzyme--Aurora A kinase--that helps cancer cells grow. This trial is also enrolling patients with other types of cancer.
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

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

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

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

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

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

Mirvetuximab Soravtansine & Chemotherapy in FRa+ Metastatic Triple Negative Breast Cancer

A Phase I Dose-Escalation Safety and Tolerability Study of Mirvetuximab Soravtansine (IMGN853) and Gemcitabine in Patients With FRa-positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial Cancer, or Triple Negative Breast Cancer (TNBC) (NCT02996825)

Summary

To take part in this study you must have stage IV metastatic breast cancer that is triple negative (ER-, PR- and HER2-) and folate receptor (FR) alpha-positive. You must not have had more than four lines of chemotherapy. This study is testing the safety and effects (good or bad) of a new drug called mirvetuximab soravtansine when it is given with the chemotherapy drug gemcitabine (Gemzar®). Mirvetuximab soravtansine is an antibody drug conjugate (ADC). It uses a drug that targets folate receptors on cancer cells to deliver the chemotherapy drug soravtansine directly to the tumor. Gemzar® is a chemotherapy drug approved to treat metastatic breast cancer. This study also is enrolling patients with other types of FR+ tumors.
This is a Phase I 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

Jakafi and Chemo Before Surgery for Stage III Triple Negative Inflammatory Breast Cancer

Phase II Study Of Combination Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer (NCT02876302)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) stage III inflammatory breast cancer. This study is designed to learn the safety and effects (good and bad) of using a new targeted drug along with chemotherapy to treat inflammatory breast cancer. The targeted drug is ruxolitinib (Jakafi®). It is used to treat myelofibrosis, a disease of the bone marrow. Laboratory studies suggest Jakafi may make chemotherapy more effective. The chemotherapy drugs that will be used in this study are paclitaxel (Taxol®), doxorubicin (Adriamycin®) and cyclophosophamide (Cytoxan®).


This is a Phase II 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

Cabozantinib Alone or With Atezolizumab in Advanced Triple Negative Breast Cancer

A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors (NCT03170960)

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 already been treated with at least one line of therapy.

This study will assess the safety, best dose, and effects (good and bad) of cabozantinib (Cabometyx®) when it is used alone or with atezolizumab (Tecentriq®). Cabometyx is a targeted therapy that blocks some of the signals that tell cancer cells to grow and divide and that stimulate the blood vessels the cancer cells need grow. It is approved to treat kidney and liver cancer. Its use in breast cancer is considered experimental. Tecentriq is a type of immunotherapy called an immune checkpoint inhibitor. It is approved for use in combination with the chemotherapy drug Abraxane® (nab-paclitaxel) to treat advanced triple-negative, PD-L1-positive breast cancer. This study also is enrolling patients with other types of cancer.


This is a Phase I-II 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

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

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

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

Talazoparib for HER2-Negative Advanced Breast Cancer

A Phase II Clinical Trial of BMN 673 in BRCA1 and BRCA2 Wild-Type Patients With (i) Advanced Triple-Negative Breast Cancer and Homologous Recombination Deficiency as Assessed by the HRD Assay, and (ii) Advanced HER2-Negative Breast Cancer With Either a Germline or Somatic Mutation in... (NCT02401347)

Summary

Talazoparib (BMN 673) is a PARP inhibitor. Studies suggest PARP inhibitors may be effective in some types of breast cancer. Early studies suggest talazoparib may be effective in cancer patients who have an inherited BRCA1/2 mutation. It may also be effective in patients who do not have a BRCA1/2 mutation. This study is investigating the safety and effectiveness of talazoparib in patients with HER2-negative advanced breast cancer who do not have a BRCA1/2 mutation. To be eligible, participants must have advanced triple negative breast cancer or HER2-negative breast cancer with a mutation in another gene. Participants will have their tumor tested for genetic mutations to determine eligibility.


This is a Phase II trial

OTS167PO: A Targeted Therapy for Advanced Triple Negative Breast Cancer

A Phase I Study of OTS167PO, a MELK Inhibitor, to Evaluate Safety, Tolerability and Pharmacokinetics in Patients With Advanced Breast Cancer and Dose-Expansion Study in Patients With Triple Negative Breast Cancer (NCT02926690)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study will determine the safety and effects (good and bad) of using an experimental drug called OTS167PO to treat advanced and metastatic breast cancer. OTS167PO is a type of new treatment called a MELK inhibitor.


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

Ipatasertib with Atezolizumab & Paclitaxel or Nab-Paclitaxel in Advanced TNBC

A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (NCT03800836)

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-).

This study is evaluating the safety and effects (good and bad) of using ipatasertib in combination with atezolizumab (Tecentriq®) and either paclitaxel (Taxol®) or nab-paclitaxel (Abraxane®). Ipatasertib is an investigational targeted therapy that blocks a protein called AKT that helps cancer cells divide and grow. Tecentriq is an immunotherapy that is approved for use in combination with Taxol to treat PD-L1-positive advanced triple negative breast cancer. Taxol and Abraxane are chemotherapy drugs used to treat breast cancer.


This is a Phase I trial

Four Immunotherapy Combinations in Advanced Triple Negative Breast Cancer

A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Immunotherapy Combinations in Adult Patients With Triple-negative Breast Cancer(NCT03742349)

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-); have not received more than two prior lines of chemotherapy, including neoadjuvant or adjuvant chemotherapy; and have had a taxane-based chemotherapy as neoadjuvant or metastatic treatment.

This study will investigate the safety, best dose and effects (good and bad) of spartalizumab and LAG525 when they are used in combination with NIR178, capmatinib, MCS110, or canakinumab. Spartalizumab is an investigational PD-1 immune checkpoint inhibitor. LAG525 is an investigational immune checkpoint inhibitor that targets LAG-3. NIR178 is an investigational immunotherapy. Capmatinib is a targeted therapy that blocks c-Met, which plays a role in cancer cell growth. MCS110 is an investigational immunotherapy that targets M-CSF. Canakinumab is an investigational monoclonal antibody that targets human interleukin-1 beta (IL-1b), which plays a role in inflammation.


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

ONC201 for Estrogen Receptor Positive or Triple Negative Metastatic Breast Cancer

A Phase 2 Study of ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma (NCT03394027)

Summary

To take part in this study, you must have estrogen receptor positive or triple negative (ER-, PR- and HER2-) metastatic breast cancer.

This study will examine the safety and effectiveness of using an experimental drug called ONC201 to slow cancer growth. ONC201 is a new type of cancer drug called an impridone. This study is also enrolling women with advanced endometrial cancer.


This is a Phase II trial

Anetumab Ravtansine in Advanced Triple Negative Tumors That Are Mesothelin-Positive

Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies (ARCS-Multi) (NCT03102320)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR-, HER-) that tests positive for mesothelin, a protein that some tumors overproduce.

The purpose of this study is to test the safety and effects (good or bad) of anetumab ravtansine, a targeted therapy that blocks mesothelin, a protein that helps cells stick together.


This is a Phase I trial

Telaglenastat and Talazoparib for Advanced Triple Negative Breast Cancer

A Phase 1b/2 Open Label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor CB-839 in Combination With the PARP Inhibitor Talazoparib in Patients With Advanced or Metastatic Solid Tumors (NCT03875313)

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-) and have no other standard treatment options available.

This study is investigating the safety, best dose, and effects (good and bad) of CB-839 (Telaglenastat) when it is used along with talazoparib (Talzenna®). CB-839 is an investigational targeted therapy that blocks an enzyme called glutaminase. Talzenna is a type of targeted therapy called a PARP inhibitor. It is approved to treat advanced HER2 negative breast cancer in women and men with an inherited BRCA mutation.


This is a Phase I-II trial

Cediranib + Lynparza for Metastatic Triple Negative Breast Cancer (and Other Solid Tumors)

A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors (NCT02498613)

Summary

This trial is studying the safety and effectiveness of treating metastatic breast cancer (and other solid tumors) with two drugs: Olaparib (Lynparza®) and Cediranib. To take part, you must have metastatic triple negative breast cancer and not have an inherited BRCA 1/2 mutation. Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. Cediranib is a type of drug called an angiogenesis inhibitor. Giving cediranib with Lynparza may make the Lynparza more effective.


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

Immunotherapy INCAGN02385 in Advanced Triple Negative Breast Cancer

A Phase 1 Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02385 in Participants With Select Advanced Malignancies (NCT03538028)

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 will test the safety and effects (good and bad) of a new type of immunotherapy called INCAGN02385. The therapy gets the immune system to see and go after cancer cells by activating a molecule found on T cells called LAG-3. This study is also enrolling patients with other types of cancer.


This is a Phase I 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

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

PF-05212384 + Other Drugs for Advanced ER+, HER2+ or Triple Negative Breast Cancer

A Phase 1B Open-Label Three-Arm Multi-Center Study To Assess The Safety And Tolerability Of PF-05212384 (PI3K/MTor Inhibitor) In Combination With Other Anti-Tumor Agents (NCT01920061)

Summary

Researchers are studying new drug combinations that could be used to treat advanced breast cancer. PKI-587 (PF-05212384) is a type of targeted therapy called an PI3K/mTOR inhibitor. It prevents cancer cells from growing by blocking PI3K and mTOR proteins. Docetaxel (Taxotere®) and cisplatin (Platinol®) are chemotherapy drugs that are routinely used to treat advanced breast cancer. Dacomitinib is a new type of HER2-targeted therapy that is currently being studied in clinical trials. This study is looking at the safety and effectiveness of using taxotere and PF-05212384 to treat advanced ER+ breast cancer; platinol and PF-05212384 to treat advanced triple negative breast cancer, and dacomitinb and PF-05212384 to treat advanced HER2+ breast cancer.
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

Chemokine Modulation and Keytruda in Advanced Triple Negative Breast Cancer

Pilot Open Label Clinical Trial Evaluating the Safety and Efficacy of Chemokine Modulation to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer (NCT03599453)

Summary

To take part in this study you must be a woman with 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 will investigate the safety and effects (good and bad) of using chemokine modulation therapy before treatment with pembrolizumab (Keytruda®). Keytruda is a type of immunotherapy drug called a PD-1 (programmed cell death-1) inhibitor. It is approved to treat at least 10 different types of cancer. Its use in breast cancer is considered experimental. Small proteins called chemokines help get the immune cells to specific organs. Celecoxib (Celebrex®), recombinant interferon alfa-2b, and rintatolimod (Ampligen) each works in a different way to get chemokines to an organ. Chemokine modulation therapy may make Keytruda more effective.

Paraplatin & Taxol Plus AC Before Surgery for Triple Negative Early Stage Breast Cancer

A Phase II Study of Neoadjuvant Carboplatin/Paclitaxel Followed by Dose-Dense Doxorubicin/Cyclophosphamide in Patients With Hormone Receptor Negative, HER2 Receptor Negative Breast Cancer (NCT03301350)

Summary

-To take part in this study, you must be diagnosed with triple negative (ER-/PR-/HER2-) early stage (stage I-III) breast cancer. -In this study, researchers will look at the effect (good or bad) of giving low-dose weekly chemotherapy followed by dose-dense chemotherapy before surgery. -The low-dose chemotherapy used in this study are carboplatin (Paraplatin®) and paclitaxel (Taxol®). -Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®) are the dose-dense chemotherapy used. -Pegfilgrastim (Neulasta®) or filgrastim is given to prevent neutropenia--a very low white blood cell count--from developing during chemotherapy treatment.


This is a Phase II 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

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

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

Vectibix and Chemotherapy Before Surgery for Triple Negative Inflammatory Breast Cancer

A Randomized Phase II Study of Neoadjuvant Carboplatin/Paclitaxel (CT) Versus Panitumumab/Carboplatin/Paclitaxel (PaCT) Followed by Anthracycline-Containing Regimen for Newly Diagnosed Primary Triple-Negative Inflammatory Breast Cancer (NCT02876107)

Summary

To take part in this study, you must be newly diagnosed with stage III, inflammatory triple negative (ER-/PR-/HER2-) breast cancer. This study is investigating whether chemotherapy combinations used to treat advanced breast cancer are more effective when given along with a targeted drug. The treatments are given before you have surgery. The initial chemotherapy combination is carboplatin (Paraplatin®) and paclitaxel (Taxol®). It is followed by doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®)--known as AC. The targeted drug is panitumumab (Vectibix®). It is currently used to treat a certain type of metastatic colorectal cancer. It is not yet known if Vectibix will be effective as a breast cancer treatment.


This is a Phase II trial

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative Breast Cancer

Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study (InCITe) (NCT03971409)

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 and have not had more than three lines of chemotherapy and not more than one checkpoint inhibitor.

This study is looking at the safety and effects (good and bad) of combining the immunotherapy drug avelumab (Bavencio®) with binimetinib, utomilumab, or PF-04518600. Bavencio is type of immunotherapy called a PD-L1 inhibitor. It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental. Binimetinib (Mektovi®) is targeted therapy that blocks MEK, which helps cancer cells grow. It is used to treat metastatic melanoma. Its use in breast cancer is considered experimental. PF-04518600 is an investigational immunotherapy that targets OX40, a protein found on immune cells that have interacted with cancer cells. Utomilumab is an investigational immunotherapy that targets the 4-1BB (CD-137) protein on certain immune cells.


This is a Phase 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

ADCT-301 in Patients With Advanced Triple Negative Breast Cancer

A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) in Patients With Selected Advanced Solid Tumors (NCT03621982)

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 will compare the safety and effects (good or bad) of ADCT-301. It is a new type of targeted therapy that combines the monoclonal antibody HuMax®-TAC™ with a new type of chemotherapy drug called PBD. The monoclonal antibody brings the chemotherapy directly to the cancer cells. This study is also enrolling patients with other types of advanced cancer.


This is a Phase I 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

XmAb®22841 and Pembrolizumab in Advanced Triple Negative Breast Cancer

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®22841 Monotherapy and in Combination With Pembrolizumab in Subjects With Selected Advanced Solid Tumors (DUET-4)(NCT03849469)

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 best dose, safety and effects of XmAb22841 when it is used alone or in combination with pembrolizumab (Keytruda®). XmAb22841 is a new type of immunotherapy that targets CTLA-4 and LAG-3. Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to certain types of cancers. Its use in breast cancer is considered experimental. This study is also enrolling patients with other types of cancers.


This is a Phase I trial

Rubraca & Sacituzumab Govitecan to Treat Metastatic Triple Negative or BRCA+ Tumors

SEASTAR: A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (NCT03992131)

Summary

To take part in this study you must have metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has been treated with at least one standard therapy.

This study is investigating the safety and effects (good and bad) of the combination of rucaparib (Rubraca®) and sacituzumab govitecan. Rubraca is a PARP inhibitor approved to treat recurrent ovarian, fallopian tube, and primary peritoneal cancer. Sacituzumab govitecan is a type of cancer therapy called an antibody-drug conjugate. It uses an antibody that targets cancer cells to deliver the drug SN-38 directly to these cells.


This is a Phase I-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

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

ABBV-151 and ABBV-181 for Advanced Triple Negative Breast Cancer

A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors (NCT03821935)

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 been treated with at least one systemic therapy.

The study is investigating the safety, best dose and effects (good and bad) of ABBV-151 when it used with or without ABBV-181. ABBV-151 is a targeted therapy that blocks a protein called GARP- TGF-β1. ABBV-181 is an experimental PD-1 inhibitor. This type of immunotherapy, called a checkpoint inhibitor, gets the immune system to see and go after cancer cells.


This is a Phase I 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

Capivasertib & Paclitaxel as First Line Treatment for Advanced Triple Negative Tumors

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC. (CapItello290) (NCT03997123)

Summary

To take part in this study you must be receiving your first treatment for advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer.

This study is comparing the effects (good and bad) and effectiveness of paclitaxel (Taxol®) and capivasertib to paclitaxel (Taxol®) and a placebo. Paclitaxel (Taxol®) is a chemotherapy drug that is used to treat breast cancer. Capivasertib is a targeted therapy drug that blocks Akt.


This is a Phase III trial

IPI-549 and Nivolumab in Advanced Triple Negative Breast Cancer

A Phase 1/1b First-In-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549 Monotherapy and in Combination With Nivolumab in Subjects With Advanced Solid Tumors (NCT02637531)

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 been treated with a cytotoxic chemotherapy but not an anti-PD-1 or anti-PD-L1 immunotherapy.

This study is investigating the safety and effects (good and bad) of IPI-549 when it is used in combination with nivolumab (Opdivo®). Opdivo is a type of immunotherapy called a PD-1 (programmed cell death-1) inhibitor. Blocking PD-1 helps immune cells see and go after cancer cells. Opdivo is approved to treat at least eight types of cancer. Its use in breast cancer is considered experimental. IPI-549 is an investigational targeted therapy that blocks an enzyme called PI3K, which plays a role in cancer cell growth.


This is a Phase I 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

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

Radiation But No Surgery After Chemo in Patients with Triple Negative Stage I-II Tumors

Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy (NCT02945579)

Summary

To take part in this study, you must be age 40 or older and have stage I-II breast cancer that is HER2+ or triple-negative (ER-/PR-/HER2-). You must also have already had chemotherapy to shrink your tumor, but no other treatments. Neoadjuvant chemotherapy (treatment given before surgery) is used to shrink the tumor before surgery. The tumor may even disappear. When this occurs, researchers think it may be possible for patients to avoid surgery. This study is looking at whether radiation alone keeps cancer from recurring in women whose biopsy after completing chemotherapy shows no evidence of disease.

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

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

SGN-LIV1A in HER2-Negative Metastatic Breast Cancer

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With LIV-1-Positive Metastatic Breast Cancer (NCT01969643)

Summary

Antibody-drug conjugate (ADC) is a cancer therapy that combines an antibody that targets cancer cells with a drug that can kill cancer cells. Because the antibody only targets cancer cells, the drug does not kill normal cells, making it less likely to cause side effects. SGN-LIV1A is an ADC that targets LIV-1 (SLC39A6), a protein that is expressed by most breast cancer cells, and delivers a cancer drug called monomethyl auristatin E. This study will assess the safety, highest tolerable dose and anti-tumor activity of SGN-LIV1A in women with HER2-negative metastatic breast cancer. To be eligible, participants must have triple negative metastatic breast cancer or HER2-negative, hormone sensitive metastatic breast cancer that can no longer be treated with a hormone therapy.


This is a Phase I trial

PF-06873600 for Metastatic HER2-Negative Breast Cancer

Phase 1/2a Dose Escalation And Expansion Study Evaluating Safety, Tolerability, Pharmacokinetic, Pharmacodynamics And Anti-tumor Activity Of Pf-06873600 As A Single Agent And In Combination With Endocrine Therapy (NCT03519178)

Summary

To take part in this study you must have metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone receptor positive, HER2 negative breast cancer and have already been treated with a CDK 4/6 inhibitor.

This study is evaluating the safety and effects (good or bad) of PF-06873600, a new targeted therapy. PF-06873600 is a cyclin-dependent kinase (CDK) inhibitor. It works by inhibiting the CDK enzymes that help cancer cells grow. Patients in the study with hormone-receptor positive breast cancer will also be treated with an anti-estrogen therapy.


This is a Phase II 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

Lynparza Alone or With a New Drug That Targets DNA Repair in Metastatic TNBC

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant... (VIOLETTE) (NCT03330847)

Summary

To take part in this study you must have metastatic triple negative breast cancer that has been treated with up to two other drug therapies. Also, your tumor must have a mutation in genes that are part of the homologous recombination repair (HRR) pathway, which includes BRCA 1/2. Your tumor will be tested for mutations in these genes as part of the screening process. This study will compare the safety and effects (good and bad) of using olaparib (Lynparza®) alone to using Lynparza along with a new drug that targets DNA repair. Lynparza is a type of drug called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. The experimental drugs used in this study, AZD6738 and AZD1775, also target DNA damage repair.


This is a Phase II trial

  • Participation Time5 initial visits, then 1 visit every 2 months for 18 months, then 1 visit every 3 months
  • Participating research sites
    Research sites: 24 sites total

Chemotherapy & Herceptin Before Surgery for Stage I-III Tumors

A Phase II Study of Neoadjuvant Chemotherapy With and Without Trastuzumab in Patients With Breast Cancer (NCT01750073)

Summary

Giving chemotherapy before surgery may make the tumor smaller, reducing the amount of tissue that needs to be removed during surgery. It also allows researchers to study how tumors respond to certain drugs. Paclitaxel (Taxol®) and cyclophosphamide (Cytoxan®) are two chemotherapy drugs that are routinely used to treat breast cancer. Trastuzumab (Herceptin®) is a targeted therapy that is used to treat HER2-positive breast cancer. This trial is studying the effectiveness of, and the side effects that occur when, giving Taxol and Cytoxan to patients with stage I-III breast cancer. Patients with HER2+ tumors will also receive Herceptin prior to surgery, so that the researchers can study a three drug combination—Taxol, Cytoxan, and Herceptin.
This is a Phase II trial

Breast Tissue Study in Women 50 and Older Having a Lumpectomy

Differential Comparison of the Breast Tumor Microenvironment Between Luminal A and Triple Negative Breast Cancer With and Without Radiation Treatment (NCT03165487)

Summary

To take part in this study, you must have been diagnosed with HER2-negative, stage I or II breast cancer. You must also be at least 50, have had a mammogram within the past six months and be receiving treatment at the Breast Surgery and Radiation Oncology Clinics of Columbia University.

The breast tissue around a tumor--called the microenvironment--affects how the tumor responds to treatments and how likely it is to come back (recur). This study aims to identify molecular markers in this breast tissue. The tissue is collected before and after you receive intraoperative radiatiotherapy. This is a radiation treatment delivered during surgery immediately after the tumor has been removed.

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

Imfinzi & Taxol with Capivasertib, Danvatirsen or Oleclumab for First Line Metastatic TNBC

A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) in Combination With Paclitaxel and Multiple Novel Oncology Therapies and Durvalumab (MEDI4736) + Paclitaxel for First-line Metastatic Triple Negative Breast Cancer. (BEGONIA) (NCT03742102)

Summary

To take part in this study you must be a woman with metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) who is being treated for the first time for metastatic disease.

This study will look at the safety and effects (good and bad) of the combination of durvalumab (Imfinzi®) and paclitaxel (Taxol®) when used alone or with one of three additional therapies. Imfinzi is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It has been approved to treat certain types of cancers, and its use in breast cancer is considered experimental. Taxol is a chemotherapy drug routinely used to treat breast cancer. The three additional therapies are capivasertib, a targeted therapy that blocks Akt; danvatirsen, a targeted therapy that blocks the STAT3 protein; and oleclumab, which targets CD73.


This is a Phase I-II trial

Alpelisib & Enzalutamide in Advanced Breast Cancer That Tests AR+ and PTEN+

Phase Ib Study of BYL719 (Alpelisib) in Combination With Androgen Receptor Inhibitor (Enzalutamide) in Patients With Androgen Receptor (AR)-Positive and PTEN Positive Metastatic Breast Cancer (NCT03207529)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER positive and/or PR positive) or triple negative (ER-, PR-, HER2-) breast cancer that tests AR-positive and PTEN-positive and has been treated with at least one standard therapy.

This study will investigate the best dose, safety, and effects (good and bad) of alpelisib (Piqray®) when it is used along with enzalutamide (Xtandi®). Piqray is a targeted therapy that inhibits PI3K. It is approved to treat advanced hormone receptor positive, HER2 negative breast cancer in patients with a tumor that has a PIK3CA mutation. Xtandi is an oral drug that targets the androgen receptor (AR). It is approved to treat advanced prostate cancer.


This is a Phase I 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.

Ipatasertib and Taxol for HER2- Advanced Breast Cancer

A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (NCT03337724)

Summary

To take part in this study, you must have advanced HER2- (some stage III) or metastatic (stage IV) breast cancer. This study is evaluating the safety and effects (good or bad) of using a new targeted therapy along with paclitaxol (Taxol®) for treating advanced HER2- breast cancer. The targeted therapy, ipatasertib (GDC-0068), blocks a protein called AKt that helps cancer cells divide and grow. Taxol is a chemotherapy drug routinely used to treat breast cancer.


This is a Phase II-III trial

Orteronel For Androgen Receptor-Positive Metastatic Breast Cancer

A Phase II Study With Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR) (NCT01990209)

Summary

Orteronel (TAK-700) is a new type of cancer drug that works by blocking the androgen receptor (AR). It is currently in phase III trials for prostate cancer. Studies have found that about 70-90 percent of primary breast tumors and 75 percent of breast metastases are AR+. Researchers believe orteronel may be an effective treatment for individuals with metastatic breast cancer whose tumors are AR+. This study is investigating the effectiveness of orteronel in individuals with triple negative or ER+ and/or PR+ metastatic breast cancer that is AR+. The researchers will test tumor tissue from a previous biopsy to determine if a tumor is AR+.
This is a Phase II trial

Ifetroban for Stage II or III Breast Cancer With High Risk of Metastatic Recurrence

A Pilot Trial of Ifetroban, A Thromboxane A2 Receptor Antagonist, in Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence (NCT03694249)

Summary

To take part in this study you must have completed treatment for stage II or stage III triple negative breast cancer (ER-, PR- and HER2-).

This study is investigating the safety and effects (good or bad) of using the targeted therapy ifetroban to reduce the risk of a metastatic recurrence. Ifetroban targets the thromboxane A2 receptor. Studies have found that breast cancer cells have more thromboxane A2 receptors than normal cells. Researchers think these receptors may play a role in breast cancer metastasis.


This is a Phase II trial

Stereotactic Body Radiotherapy (SBRT) Combined with Standard of Care Treatment for Metastatic Breast Cancer

A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer (NCT03808337)

Summary

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

This study is comparing the effects (good or bad) of using stereotactic body radiotherapy (SBRT) along with a standard of care treatment to a standard of care treatment alone. SBRT can be used to deliver precise, intense doses of radiation to specific places where the cancer has spread. This study is also enrolling patients with other types of metastatic cancer.


This is a Phase II trial

AVID100 in Advanced Epithelial Carcinomas

Phase 1a/2a Dose Escalation Trial to Determine Safety, Tolerance, MTD, and Preliminary Antineoplastic Activity of AVID100, in Patients With Advanced or Metastatic Solid Tumors of Epithelial Origin (NCT03094169)

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 and tests positive for EGFR over-expression.

This study is to determine the safety and effects (good or bad) of using an experimental targeted therapy called AVID100. AVID100 is a targeted antibody-drug conjugate (ADC). It targets EGFR proteins to deliver a chemotherapy drug called maytansinoid mertansine (DM1). This study is also enrolling patients with other types of tumors that test EGFR positive.


This is a Phase I-II trial

A New Targeted Therapy and Taxol for Advanced Breast Cancer

A Phase 1b Pilot Clinical Trial of Cirmtuzumab, an Anti-ROR1 Monoclonal Antibody, in Combination With Paclitaxel for the Treatment of Patients With Metastatic, or Locally Advanced, Unresectable Breast Cancer (NCT02776917)

Summary

To take part in this study, you must have triple negative (ER-, PR-, or HER2-) or hormone receptor positive (ER+ or PR+), advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of a new type of targeted therapy when it is given along with the chemotherapy drug paclitaxel (Taxol®) to treat advanced breast cancer. The experimental targeted therapy is cirmtuzumab. It blocks proteins found only on cancer cells. Taxol is commonly used to treat breast cancer.
This is a Phase I trial

PRS-343 With Tecentriq in HER2 Positive Advanced Breast Cancer

A Phase 1b, Open-Label, Dose Escalation Study of PRS-343 in Combination With Atezolizumab in Patients With HER2-Positive Advanced or Metastatic Solid Tumors(NCT03650348)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) HER2 positive breast cancer and have been treated with at least one systemic therapy.

This study will investigate the best dose, safety and effects (good and bad) of PRS-343 when it is given along with atezolizumab (Tecentriq®). PRS-343 is a new type of HER2-targeted therapy. Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat advanced triple-negative breast cancer, when used along with paclitaxel, in patients whose tumor tests positive for PD-L1.


This is a Phase I 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

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

TRX518 With Cyclophosphamide And Avelumab in Advanced Breast Cancer

A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors (NCT03861403)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer that is triple negative (ER- PR- HER2-) or be postmenopausal and have advanced or metastatic estrogen receptor positive (ER+) breast cancer. This study is evaluating the safety and effects (good or bad) of giving TRX518, avelumab (Bavencio®), and cyclophosphamide (Cytoxan®) at the same time. TRX518 is an experimental immunotherapy that targets a protein found on immune cells called glucocorticoid-induced TNF-superfamily receptor (GITR). Bavencio is a type of immunotherapy drug called a PD-L1 inhibitor. It is approved to treat some types of cancer. Its use in breast cancer is considered experimental. Cytoxan is a chemotherapy drug used to treat breast cancer. This trial is also enrolling patients with other types of cancer.
This is a Phase I-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

Dinaciclib With Paclitaxel for Advanced Breast Cancer

A Phase I/Ib Dose-escalation Trial of the Cyclin-dependent Kinase Inhibitor Dinaciclib in Combination With Weekly Paclitaxel in Patients With Advanced Solid Tumor Malignancies and Assessment of MYC Oncogene Overexpression (NCT01676753)

Summary

Scientists are developing new targeted therapies that have the potential to be effective against breast and other solid tumors. Dinaciclib is an investigational drug that inhibits cyclin-dependent kinases (CDKs). Paclitaxel (Taxol ®) is a drug routinely used to treat advanced breast cancer. Combining dinaciclib with Taxol may make cancer cells more likely to respond to Taxol. The purpose of this trial is to collect safety data for the combination of weekly Taxol and dinaciclib in patients with advanced breast cancer (and other types of solid tumors). After the dose is determined, the researchers will expand the trial by enrolling 12 patients with advanced triple-negative breast cancer. The researchers will also try to identify biomarkers that can predict which tumors will respond to dinaciclib.


This is a Phase I trial

LY3381916 Alone or With LY3300054 in Metastatic Breast Cancer

A Phase 1a/1b Study of an Anti-IDO-1 Agent (LY3381916) Administered Alone or in Combination With Anti- PD-L1 Checkpoint Antibody (LY3300054) in Solid Tumors (NCT03343613)

Summary

To take part in group 1 of this study you must have metastatic (stage IV) breast cancer and to take part in group 2 you must have metastatic triple negative (ER-, PR- and HER2-) breast cancer.

This study will evaluate the safety, best dose, and effects (good and bad) of LY3381916 when it is given alone or with LY3300054. The immunotherapy LY3381916 gets immune cells to go after cancer cells by targeting the enzyme IDO-1. The immunotherapy LY3300054 is a PD-L1 checkpoint inhibitor. It blocks a protein called PD-L1 that stops the immune system from attacking the cancer cells. This study is also enrolling patients with other types of cancer. Both of these immunotherapies are investigational drugs.


This is a Phase I trial

SBRT Radiation Therapy for Patients With Oligoprogressive Metastatic Breast Cancer

A Randomized Phase II Study Assessing the Efficacy of Local Ablative Radiation Therapy for Metastatic Breast and Lung Cancer Patients With Oligoprogressive Disease (NCT03808662)

Summary

To take part in this study you must have oligoprogessive metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has progressed on at least one other systemic treatment.

Patients with oligoprogressive metastatic breast cancer have a small number of metastatic tumors in one or two other parts of the body. This study will compare the safety and effects (good or bad) of using stereotactic body radiation therapy (SBRT) to treat each site of metastases followed by a standard of care treatment to a standard of care treatment alone. SBRT uses multiple radiation beams to deliver high doses of precision radiation directly to the tumor.


This is a Phase II trial

  • Participation Time1 visit every other day for 6 or 10 days, then coincides with standard treatment
  • Participating research sites
    Research sites: 8 sites total

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

AZD6738 with Chemotherapy and/or Olaparib in Advanced Breast Cancer

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies.(NCT02264678)

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, and best dose of AZD6738 when it is used alone or with the chemotherapy drug carboplatin or the PARP inhibitor olaparib (Lynparza®). AZD6738 is a new type of targeted therapy called an ATR inhibitor. It disrupts a cancer cell's ability to repair its own DNA, which can cause the cancer cells to die. Carboplatin is a chemotherapy drug used to treat breast cancer. Lynparza is a PARP inhibitor approved to treat BRCA+ metastatic breast cancer.
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

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