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All Metastatic Trials

Halaven® and Afinitor® For Metastatic Triple Negative Breast Cancer

Phase I/IB Trial of Eribulin and Everolimus in Patients With Triple Negative Metastatic Breast Cancer (NCT02120469)

Summary

Researchers are looking for new drugs to treat triple negative (ER-, PR- and HER2-) breast cancer. Eribulin mesylate (Halaven®) is a chemotherapy drug used to treat metastatic breast cancer in patients who have already been treated with other chemotherapy drugs. Everolimus (Afinitor®) is used along with an anti-estrogen drug to treat advanced ER+, HER2- breast cancer. Researchers think it may also be effective in patients who are ER- and HER2-negative.This study is evaluating the safety and best dose of Halaven and Afinitor for treating patients with metastatic triple negative breast cancer.
This is a Phase I trial

Perjeta, Herceptin & Abraxane for HER2+ Advanced Breast Cancer

Phase II Prospective Open Label Single Arm Study of Pertuzumab, Trastuzumab, and Nab-Paclitaxel in Patients With HER-2 Positive Metastatic Breast Cancer (NCT01730833)

Summary

Combining HER2-targeted therapies with chemotherapy may be beneficial when treating HER2+ advanced breast cancer. Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are both HER2 targeted therapies. The chemotherapy drug nab-paclitaxel (Abraxane®) is routinely used to treat advanced breast cancer. This study is evaluating the effectiveness of combining Perjeta, Herceptin, and Abraxne to treat HER2+ advanced breast cancer.
This is a Phase II 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

The Immunotherapy Opdivo & Abraxane for Recurrent HER2-Negative Metastatic Breast Cancer

A Phase 1, Open-Label, Multicenter, Safety Study of Nivolumab (BMS-936558) in Combination With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast Cancer (NCT02309177)

Summary

Researchers are trying to find more effective treatments for metastatic breast cancer. nab-Paclitaxel (Abraxane®) is a chemotherapy drug approved in the treatment of breast cancer that has spread after treatment with combination chemotherapy or that has come back within 6 months after chemotherapy treatment post-surgery. Nivolumab (Opdivo®) is an immunotherapy approved in the treatment of certain types of metastatic melanoma and non-small cell lung cancer. Nivolumab (Opdivo®) blocks a protein called PD-1 (programmed cell death 1). Blocking PD-1 prevents a known pathway found in certain tumors and may allow the body’s own immune cells to attack tumors. This study is primarily evaluating the safety of combining Opdivo with two different regimens of Abraxane in patients with HER2-negative, recurrent metastatic breast cancer. Anti-tumor activity of Opdivo in combination with these two Abraxane regimens will be preliminarily assessed. (This study also is enrolling patients with pancreatic and non-small cell lung cancer).
This is a Phase I trial

Halaven & Keytruda for Metastatic Triple-Negative Breast Cancer

An Open-Label, Single-Arm Multicenter Phase 1b/2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Subjects With Metastatic Triple-Negative Breast Cancer (mTNBC) (NCT02513472)

Summary

Eribulin mesylate (Halaven®) is a chemotherapy drug used to treat metastatic breast cancer that is not responding to other chemotherapy drugs. Pembrolizumab (Keytruda®) is an immunotherapy drug that blocks a programmed cell death (PD-1) protein that keeps the immune system from going after cancer cells. This study is investigating the safety and effectiveness of giving Halaven and Keytruda to patients with metastatic triple-negative breast cancer who have received no more than two prior chemotherapies for metastatic disease.
This is a Phase I-II 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

Xtandi and Taxol for Advanced Triple Negative Breast Cancer

A Phase 3, Randomized, International Study Comparing the Efficacy and Safety of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer (NCT02929576)

Summary

To take part in this study, you must have been diagnosed with locally advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. This study is comparing three different treatment regimens for advanced triple negative breast cancer: Enzalutamide (Xtandi®) and Paclitaxel (Taxol®) together; Xtandi followed by Taxol, and Taxol alone. Xtandi is currently used to treat prostate cancer. Studies suggest it may also be effective as a breast cancer treatment. Taxol is a chemotherapy drug used to treat advanced breast cancer.
This is a Phase III trial

Halaven & Cytoxan for Advanced Breast Cancer

A Phase Ib/II Study of Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies (NCT01554371)

Summary

Combining two or more cancer drugs that work in different ways may be more effective than using one cancer drug at a time. Eribulin (Halaven®) is approved for treating metastatic breast cancer. Cyclophosphamide (Cytoxan®) is approved for treating many different types of cancer, including breast cancer. However, the combination of eribulin and cyclophosphamide is considered experimental. The purpose of this study is to test the safety and effectiveness of the two drugs when they are given together at different doses to patients with locally advanced or metastatic breast cancer (and other solid tumors).
This is a Phase I-II trial

Chemotherapy and a PARP-inhibitor for BRCA1/2+, HER2- Advanced Breast Cancer

A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without the Poly ADP-ribose Polymerase (PARP) Inhibitor Veliparib (ABT-888) in Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic or Locally Advanced Unresectable Breast Cancer Gene (BRCA)-Associated Breast Cancer (NCT02163694)

Summary

Researchers are studying new types of breast cancer drugs and drug combinations. Veliparib is a new type of cancer therapy called a PARP inhibitor. By blocking the PARP enzyme, veliparib keeps cancer cells from repairing DNA damage. Studies suggest that combining veliparib with chemotherapy drugs that damage DNA may make the cancer cells more responsive to the chemotherapy treatment. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs used to treat advanced breast cancer. This study is comparing the effectiveness of veliparib, paraplatin, and Taxol with paraplatin and Taxol alone in treating participants with a BRCA1 or BRCA2 mutation who have advanced HER2-negative breast cancer.
This is a Phase III trial

Camptosar and Veliparib for Advanced Breast Cancer

A Phase I Dose-Escalation Study of Oral ABT-888 (NSC #737664) Plus Intravenous Irinotecan (CPT-11, NSC#616348) Administered in Patients With Advanced Solid Tumors (NCT00576654)

Summary

Irinotecan hydrochloride (Camptosar) is a chemotherapy drug that can kill cancer cells by damaging their DNA. Veliparib is a type of targeted therapy called a PARP inhibitor. It blocks the PARP protein from repairing damaged DNA in cancer cells. Researchers thinks combining a PARP inhibitor with Camptosar will make it more effective. This study is investigating the side effects and best dose of veliparib when it is given along with Camptosar to treat patients with advanced breast cancer.
This is a Phase I trial

MM-398 for Triple Negative Breast Cancer

A Pilot Study in Patients Treated With MM-398 to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages (NCT01770353)

Summary

Researchers are studying new drugs for treating metastatic triple negative breast cancer. MM-398, a new type of targeted therapy, uses a fat molecule (like a bubble) to deliver the chemotherapy drug irinotecan (Camptosar®) to cancer cells. Because the irinotecan is delivered directly to the cancer cell, it can be given at a higher dose. Ferumoxytol (Feraheme) is used during an MRI to improve imaging. It is being used in this study to measure a type of white blood cell called tumor associated macrophages. The goal of this study is to learn more about how MM-398 travels in the body and whether using ferumoxytol is effective in tracking MM-398.
This is a Phase I trial

Alisertib with Taxol for Advanced ER+/HER2- or Triple-Negative Breast Cancer

A Phase II, Multicenter, Randomized, Parallel Group Study to Compare Alisertib in Combination With Paclitaxel vs. Paclitaxel Alone in Patients With Metastatic or Locally Recurrent Breast Cancer (NCT02187991)

Summary

Alisertib (MLN8237) is an oral targeted therapy that blocks an enzyme--Aurora A kinase--that helps cancer cells grow and survive. Studies have found Aurora A kinase in triple-negative and ER+/HER2- breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug commonly used to treat advanced breast cancer. This study is investigating whether giving alisetib with Taxol is more effective than Taxol alone for treating women with ER+/HER2- or triple-negative advanced breast cancer.
This is a Phase II trial

EC1456 For Triple Negative Breast Cancer

A PHASE 1 STUDY OF FOLIC ACID-TUBULYSIN CONJUGATE EC1456 IN PATIENTS WITH ADVANCED SOLID TUMORS (NCT01999738)

Summary

EC1456 is a new type of injectable drug that consists of folate (vitamin B9) linked to a chemotherapy drug called tubulysin B hydrazide (TubBH). The folate receptor is highly expressed in triple negative breast cancer. This suggests that EC1456 might be effective in triple negative breast cancer because the folate would deliver the chemotherapy drug to the cancer cell. This study is evaluating the effect of EC1456 in participants with triple negative breast cancer. This study is also enrolling individuals with other types of advanced solid tumors.
This is a Phase I trial

Halaven for Breast Cancer That Has Spread to the Brain

Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate (NCT02581839)

Summary

Eribulin mesylate (Halaven®) is FDA approved to treat metastatic breast cancer. Researchers are investigating what affect Halaven has on breast cancer cells that have spread to the brain. In this study, researchers will study the safety and effectiveness of giving Halaven to women with breast cancer that has spread to the brain. To be eligible, women must have brain metastases confirmed by MRI.
This is a Phase II trial

Tykerb and Xeloda for HER2-Positive Breast Cancer That Has Spread to the Brain or Spine

Lapatinib with Capecitabine for HER2-Positive Brain Mets (NCT02650752)

Summary

Lapatinib (Tykerb®) is a targeted therapy used to treat advanced HER2-positive breast cancer. Capacitabine (Xeloda®) is a chemotherapy drug used to treat metastatic breast cancer. Laboratory studies suggest there may be treatment benefits from combining Tykerb with Xeloda. This study is evaluating the safety and best dose of Tykerb when it is given with Xeloda to treat metastatic HER2-positive breast cancer that has spread to the brain or spine.
This is a Phase I trial

Capecitabine + BKM120 in Triple Negatvie Breast Cancer With Brain Metastases

Phase II Multicenter Single-arm Study of BKM120 Plus Capecitabine for Triple Negative Breast Cancer (TNBC) Patients With Brain Metastases (NCT02000882)

Summary

BKM120 is an investigational targeted therapy that works by blocking PI3K, a group of proteins that help cancer cells to grow. Capecitabine (Xeloda®) is a chemotherapy drug used to treat triple negative (ER-, PR-, HER2-) breast cancer. Early studies suggest that combining Xeloda with BKM120 may be an effective way to treat triple-negative breast cancer. These studies have also suggested that this treatment may be able to cross the blood-brain barrier, to kill cancer cells. This study is evaluating the safety and effectiveness of BKM120 and Xeloda in patients with triple-negative breast cancer that has spread to the brain.
This is a Phase II trial

Alimta and Nexavar for Recurrent or Metastatic Triple Negative Breast Cancer

Phase 2 Study of Pemetrexed and Sorafenib for Treatment of Recurrent or Metastatic Triple Negative Breast Cancer (NCT02624700)

Summary

Pemetrexed (Alimta®) is a chemotherapy drug approved to treat non-small cell lung cancer. Early studies suggest it may also be effective for treating breast cancer. Sorafenib (Nexavar®) is a type of targeted therapy called a tyrosine kinase inhibitor. It is used to treat liver, kidney and thyroid cancer. Researchers think it may be effective for triple-negative breast cancer. This study is investigating the safety and effectiveness of using Alimta and Nexavar to treat recurrent or metastatic triple-negative breast cancer.
This is a Phase II trial

Etirinotecan Pegol For Brain Metastases From Breast (or Lung) Cancer

A Phase II Study of Etirinotecan Pegol (NKTR 102) in Patients With Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC) (NCT02312622)

Summary

Pegylated irinotecan NKTR-102 is a new version of the chemotherapy drug irinotecan (Camptosar). It was designed to be more effective and have fewer side effects than the original version. This study is investigating how well pegylated irinotecan NKTR-102 works in patients with breast (or lung) cancer that has spread to the brain and has not responded to other treatment.
This is a Phase II trial

Ribocilcib and Taxol in Metastatic Breast Cancer with the Rb Protein

A Phase I Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer (NCT02599363)

Summary

Ribociclib (LEE011) is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. It works by inhibiting two enzymes, CDK4 and CDK6, that help cancer cells grow. Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat breast cancer. Retinoblastoma (RB) is a tumor suppressor protein. Laboratory studies suggest targeting the Rb pathway by inhibiting the CDK4 and CDK6 enzymes may be an effective breast cancer treatment. This study will identify the best dose of ribociclib to use along with Taxol to treat patients with metastatic breast cancer. Interested patients will have their tumor tested for the Rb protein. Only those whose tumor tests positive for this protein will be eligible to enroll.
This is a Phase I 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

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

Ricolinostat and Abraxane for Advanced Breast Cancer

Multi-center Phase IB Trial of ACY-1215 (Ricolinostat) Combined With Nab-paclitaxel in Unresectable or Metastatic Breast Cancer (NCT02632071)

Summary

ACY-1215 (ricolinostat) is an experimental targeted therapy that works by blocking a protein called HDAC6 (histone deacetylase 6), which helps cancer cells grow. It is currently being studied as a treatment for a type of blood cancer called multiple myeloma. Researchers think ricolinostat may be an effective breast cancer treatment. Nab-paclitaxel (Abraxane®) is a taxane-based chemotherapy drug routinely used to treat advanced breast cancer. This study is evaluating the safety and tolerability of using Abraxane with varying doses of ricolinostat to treat advanced breast cancer.
This is a Phase I trial

Immunotherapy and Abraxane for Advanced Triple Negative Breast Cancer

A Study of MPDL3280A in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple Negative Breast Cancer (NCT02425891)

Summary

Researchers are investigating the effectiveness of immunotherapies in patients with triple negative (ER-, PR- and HER2-) breast cancer. MPDL3280a (atezolizumab) is an investigational immunotherapy 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 comparing the safety and effectiveness of Abraxane and atezolizumab to Abraxane and a placebo in patients with previously untreated locally advanced or metastatic triple negative breast cancer.
This is a Phase III trial

Comparing Two Different Doses of Xeloda for Metastatic Breast (and GI) Cancer

Randomized Open-label Trial of Dose Dense, Fixed Dose Capecitabine Compared to Standard Dose Capecitabine in Metastatic Breast Cancer and Advanced/Metastatic Gastrointestinal Cancers (NCT02595320)

Summary

Capecitabine (Xeloda®) is a chemotherapy drug used to treat metastatic breast cancer that has stopped responding to other chemotherapy drugs. Because it is an oral drug, it can be taken at home. This study is comparing the effectiveness and side effects associated with two different doses and dosing schedules of Xeloda in women with metastatic breast cancer. This study is also recruiting individuals with advanced/metastatic gastrointestinal cancer.
This is a Phase II trial

FdCyd + THU For Advanced Breast Cancer

A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU) (NCT00978250)

Summary

Over time, advanced breast cancer can stop responding to a standard treatment. Scientists think that a combination of two experimental drugs, FdCyd (5-fluoro-2'-deoxcytidine), and THU (tetrahydrouridine), may be effective in treating this type of tumor. FdCyd is thought to work by changing what certain genes do in cancer cells. THU does not have any anticancer effects, but it can help keep the other drug, FdCyd, from being broken down by the body. The purpose of this trial is to determine the safety, tolerability, and effectiveness of the combination of FdCyd and THU in men and women with advanced breast cancer that has progressed on at least one standard therapy.
This is a Phase II trial

Carboplatin, Gemzar, and Mifepristone For Advanced Breast Cancer

Carboplatin, Gemcitabine, and Mifepristone for Advanced Breast Cancer and Recurrent or Persistent Epithelial Ovarian Cancer (NCT02046421)

Summary

Researchers are looking for new ways to block cancer cell growth. Cortisol, a glucocorticoid stress hormone and its receptors play a part in the process that gets cancer cells to stop responding to chemotherapy. Mifepristone is a steroid that blocks the glucocorticoid receptor (GR). It also blocks progesterone. Carboplatin (Paraplatin®) and gemcitabine hydrochloride (Gemzar®) are chemotherapy drugs that work in different ways to slow or stop cancer cell growth. This study is will identify the best dose and side effects associated with using mifepristone and Gemzar along with Paraplatin to treat patients with advanced breast cancer. Patients may have received neoadjuvant or adjuvant chemotherapy and up to two prior chemotherapy regimens for stage III or stage IV breast cancer. This trial also is enrolling patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
This is a Phase I trial

Keytruda and Abraxane in HER2-Negative Metastatic Breast Cancer

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

Summary

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

Gemzar, Herceptin and Perjeta for HER2+ Metastatic Breast Cancer

Phase II Study of Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab-Based Therapy, TDM-1, and TDM-1 + Pertuzumab (NCT02252887)

Summary

Gemcitabine (Gemzar®) is a chemotherapy drug used to treat metastatic breast cancer that has not responded to chemotherapy. Trastuzumab (Herceptin®) and Pertuzumab (Perjeta®) are targeted therapies used to treat HER2-positive breast cancer. This study is investigating whether the combination of Gemzar, Herceptin and Perjeta is an effective treatment for patients with HER2+ metastatic breast cancer.
This is a Phase II trial

CORT125134 and Abraxane for Advanced Breast Cancer

Phase 1/2 Study of CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors (NCT02762981)

Summary

To take part in this study, you must be have stage III or stage IV breast cancer. This study is investigating the safety and effectiveness of using the approved breast cancer drug nab-paclitaxel (Abraxane®) along with a new drug called CORT125134. The new drug, CORT125134, is a type of drug called a glucocorticoid receptor antagonist. It is available only in clinical trials.
This is a Phase I-II trial

MM-302 Plus Herceptin For Previously Treated HER2-Positive Advanced Breast Cancer

A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer (NCT02213744)

Summary

Researchers are trying to develop less toxic ways to use effective chemotherapy drugs. MM-302 is a targeted therapy that delivers the chemotherapy drug doxorubicin directly to HER2+ cells. By delivering doxorubicin directly to the cancer cells, researchers believe the drug will cause fewer side effects and less damage to the heart. Trastuzumab (Herceptin®) is used to treat HER2+ tumors. This trial is comparing the safety and effectiveness of MM-302 and Herceptin to chemotherapy and Herceptin in patients with HER2+ advanced breast cancer who were previously treated with Herceptin, who have either progressed on or cannot take pertuzumab (Perjeta®) and ado-trastuzumab emtansine (Kadcyla®) and have not been previously treated with doxorubicin or other anthracyclines.
This is a Phase II-III trial

BAY1217389 and Taxol for Advanced Breast Cancer

An Open-label Randomized Two-arm Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of Oral BAY 1217389 in Combination With Weekly Intravenous Paclitaxel Given in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies (NCT02366949)

Summary

BAY1217389 is a new type of cancer drug called an MPS1 inhibitor. Paclitaxel (Taxol®) is a chemotherapy drug commonly used to treat advanced breast cancer. Laboratory studies suggest that giving BAY1217389 with Taxol may improve Taxol's effectiveness and keep cancer cells responding to Taxol longer. This study will determine the best dose, safety, and tolerability of BAY1217389 when it is given with Taxol to individuals with advanced breast cancer. (This trial is also enrolling individuals with other types of advanced cancer for the first part of the trial and patients with triple negative breast cancer for the second part of the trial.) To be eligible, participants must have no standard therapy available.
This is a Phase I trial

Mifepristone and Halaven For Advanced Triple Negative Breast Cancer

Phase I Study of Mifepristone in Combination With Eribulin in Patients With Locally Advanced/Metastatic Breast Cancer With a Dose Expansion Cohort in Patients With Triple Negative Breast Cancer (NCT02014337)

Summary

Researchers are trying to determine the best drug combination for treating advanced triple negative breast cancer. Laboratory studies suggest that cortisol, a glucocorticoid stress hormone, and its receptors play a part in the process that leads tumors to stop responding to chemotherapy. Mifepristone is a steroid that blocks the glucocorticoid receptor (GR). Blocking this receptor may make chemotherapy more effective. Eribulin (Halaven®) is a chemotherapy drug used to treat advanced breast cancer. This is a two-part study. Part one will determine the best dose of mifepristone to use with Halaven in participants with advanced triple negative breast cancer. Part two will look at the effectiveness of the best dose of mifepristone with Halaven in participants with advanced triple negative breast cancer whose tumors test GR+.
This is a Phase I trial

Chemotherapy, Herceptin, Plus Tykerb for HER2-Positive Metastatic Cancer

Phase II Trial of Metronomic Capecitabine and Cyclophosphamide With Lapatinib and Ttrastuzumab in Patients With HER2 Positive Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen (NCT01873833)

Summary

Researchers are looking for new combination of drugs to treat HER2+ metastatic breast cancer. Cyclophosphamide (Cytoxan®) is a chemotherapy drug that stops the growth of tumor cells. Lapatinib (Tykerb®) is a targeted therapy commonly used with Capacitabine (Xeloda®) to treat HER2+ metastatic breast cancer. Trastuzumab (Herceptin®) is routinely used to treat HER2+ breast cancer. Combining these drugs may be a more effective regimen for treating HER2+ metastatic breast cancer.
This is a Phase II trial

Effect of Doxil on Metastatic Breast Tumor with Low BRCA Expression

A Single Arm Phase II Trial to Assess Association of BRCA1 Protein Expression With Overall Response Rate in Patients With Metastatic Breast Cancer on Pegylated Liposomal Doxorubicin (NCT01990352)

Summary

Doxil® (pegylated liposomal doxorubicin hydrochloride) is a DNA damaging chemotherapy agent used to treat breast and other types of cancers. BRCA proteins are expressed in the cells of breast and other tissue. BRCA1 protein is known to help in DNA damage repair which helps cells to survive. Cancer cells with low expression of BRCA1 protein expression are unable to repair damaged DNA and are more responsive to the effects of chemotherapy. The goal of this study is to learn more about BRCA1 protein expression on tumor growth in patients with metastatic breast cancer being treated with Doxil. Participants will be tested for BRCA1 protein expression and do not need to be BRCA1-positive or BRCA-negative to be eligible for this study.
This is a Phase II trial

Cytoxan plus Keytruda for Metastatic Triple Negative Breast Cancer

Phase II Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer (NCT02768701)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) metastatic breast cancer and have already received at last one prior treatment for your metastatic cancer. This study is looking at the effectiveness of combining a chemotherapy drug with an immunotherapy drug. The chemotherapy drug being used in the study is cyclophosphamide (Cytoxan®). It is commonly used to treat breast cancer. The immunotherapy drug is pembrolizumab (Keytruda®). It is approved for treating metastatic melanoma.
This is a Phase II trial

Ibrance with Cisplatin or Carboplatin for Advanced Breast (and Other) Cancer

A Phase 1 Study of Palbociclib in Combination With Cisplatin or Carboplatin in Advanced Solid Malignancies (NCT02897375)

Summary

To take part in this study, you must have been diagnosed with stage III or stage IV (metastatic) breast cancer. This study is looking at the safety and effectiveness of two different drug combinations. All patients in this study will receive palbociclib (Ibrance®) with a chemotherapy drug, either cisplatin (Platinol®) or carboplatin (Paraplatin®). Ibrance is a new type of targeted drug called a CDK inhibitor. It is approved to treat postmenopausal women with ER-positive, HER2-negative metastatic breast cancer who have not already had an anti-estrogen drug. The two chemotherapy drugs, Platinol and Paraplatin, are are used to treat advanced breast cancer that has not responded to previous chemotherapy treatments.
This is a Phase I trial

BTP-114 for Patients with a BRCA 1/2 Mutation and Advanced Triple Negative Breast Cancer

Escalation Study of BTP-114 in Patients With Advanced Solid Tumors and BRCA or DNA Repair Mutation (NCT02950064)

Summary

To take part in this study, you must have advanced (some stage III and stage IV), triple-negative (ER-/PR-/HER2-) breast cancer and have been told you have inherited a BRCA1/2 mutation. You must also have had at most three other types of chemotherapy treatments. This study is investigating whether a new type of targeted chemotherapy drug is safe and effective when used to treat advanced triple negative breast cancer in women and men who have an inherited BRCA1 or BRCA2 mutation. The new chemotherapy drug is called BTP-114. This study is also recruiting women and men with other types of cancer.
This is a Phase I trial

Abraxane + an Anti-Inflammatory for Advanced Breast Cancer

Pilot Safety and Blood Immune Cell Transcriptional Profiling Study of Weekly Nab Paclitaxel Plus Anakinra in Metastatic Breast Cancer Patients (NCT01802970)

Summary

Studies have suggested that inflammation may play a role in cancer growth. This has led researchers to believe that drugs that work by decreasing inflammation may be useful in treating cancer. Anakinra (Kineret®) is used to treat rheumatoid arthritis. It is a "biologic" medicine. This means that it is closely related to a protein that occurs naturally in the body. Nab paclitaxel (Abraxane®) is a chemotherapy drug used to treat advanced breast cancer. The objective of this study is to determine the safety of giving Kineret along with Abraxane to treat advanced breast cancer.
This is a Phase I trial

BYL719 and Abraxane for Advanced HER2-Negative Breast Cancer

Phase I/II Study of BYL719 and Nab-Paclitaxel in Subjects With Locally Recurrent or Metastatic HER-2 Negative Breast Cancer (NCT02379247)

Summary

Researchers are looking for new ways to treat advanced HER2-negative breast cancer. BYL719 is a new type of drug called a PI3K inhibitor. It slows or stops cancer cells growth by blocking the activity of the PI3K protein. Nab-paclitaxel (Abraxane®) is a chemotherapy drug routinely used to treat advanced breast cancer. This study will determine the best dose, safety, and effectiveness of BYL719 when it is given with Abraxane to treat women with advanced HER2-negative breast cancer.
This is a Phase I-II trial

Gemzar, Herceptin & Perjeta for Previously Treated Advanced HER2+ Breast Cancer

Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer (NCT02139358)

Summary

Researchers are trying to determine the best combination of drugs to use to treat advanced HER2-positive breast cancer. Gemcitabine (Gemzar®) is a chemotherapy drug used to treat advanced breast cancer that has not responded to previous chemotherapy drugs. Trastuzumab (Herceptin®) and Pertuzumab (Perjeta®) are two different types of HER2-targeted therapies. This study is looking at effectiveness of and side effects associated with using Gemzar, Herceptin and Perjeta to treat advanced HER2+ breast cancer in patients who have already been treated with one other chemotherapy drug and a HER-targeted therapy.
This is a Phase I-II trial

Halaven plus PEGPH20 for HER2- Metastatic Breast Cancer

A Randomized, Open-label, Multicenter, Phase 1b/2 Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC) (NCT02753595)

Summary

To be eligible, you must have HER2-negative metastatic breast cancer. Eribulin mesylate (Halaven®) is a chemotherapy drug used to treat metastatic breast cancer. Researchers think more cancer cells will be killed if Halaven is given along with a drug called PEGPH2 than if Halaven is given alone. They also think the combination will be more effective in HER2-negative tumors that have high levels of a fluid called hyaluronan. Studies have shown this fluid can protect cancer cells from cancer drugs.
This is a Phase I-II trial

Halaven vs. Taxol for Advanced Breast Cancer

A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer (NCT02037529)

Summary

Researchers are conducting studies to determine which chemotherapy drugs should be used, and in what order, to treat advanced breast cancer. Eribulin (Halaven®) is currently used to treat metastatic breast cancer that has not responded or has stopped responding to other chemotherapy drugs. Paclitaxel (Taxol®) is one of the most commonly used breast cancer therapies. This study is comparing the effectiveness of Halaven and Taxol when they are used as the first or second treatment in individuals with HER2-negative advanced breast cancer.
This is a Phase III trial

Early Surgery for Newly Diagnosed Stage IV Breast Cancer

Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer (NCT01242800)

Summary

Approximately 3 to 4 percent of patients with newly diagnosed breast cancer have stage IV (metastatic) disease. When this occurs, the tumor is not usually removed unless it is causing symptoms such as ulceration or pain. (This is called palliative surgery.) It is not known whether removing the breast tumor before it causes problems (called early surgery) may help to extend survival. The goal of this trial is to compare early surgery with standard palliative surgery in individuals with metastatic disease who have a tumor in the breast. To be eligible, participants must have an intact primary (not recurrent) tumor in their breast.
This is a Phase III trial

"Rational Dose" Gamma Knife Radiosurgery for Brain Metastases

A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection (NCT02005614)

Summary

The purpose of this study is to collect prospective data for use as a comparator for future subsequent studies attempting to increase the efficacy or reduce the toxicity of Gamma Knife® Radiosurgery is a non-surgical procedure that is recognized as the preferred treatment for brain tumors. "Rational dose" is a method that assesses the best dose of radiation by taking into account tumor volume, prior radiation, and the relative resistance of the tumor to radiation. (Some tumors, like melanomas, are considered radioresistant wheres others, like breast cancer, are considered radiosensitive.) This study is evaluating the effectiveness of and side effects associated with using the rational dose method for gamma knife radiosurgery to treat brain metastases. The information will be used to design future studies on gamma knife radiosurgery. This study is enrolling patients with brain metastases from breast cancer as well as other types of cancers.
This is a Phase II trial

Radiation and Tremelimumab for Breast Cancer That Has Spread to the Brain

A Pilot Study of Brain Irradiation and Tremelimumab in Metastatic Breast Cancer (NCT02563925)

Summary

Breast cancer that has spread to the brain can be treated with whole brain radiation or stereotactic radiosurgery, a procedure that delivers targeted radiation directly to the tumor, thereby protecting healthy brain tissue. Tremelimumab is a new anti-cancer therapy that blocks production of a protein that keeps the immune system from attacking cancer cells. It is approved for the treatment of malignant mesothelioma. This study is investigating the safety and effectiveness of treating women with breast cancer that has spread (metastasized) to the brain with tremelimumab and whole brain radiotherapy or stereotactic radiosurgery.

Treating Spinal Metastases with Conformal High Dose Intensity Modulated Radiation

Conformal High Dose Intensity Modulated Radiation Therapy for Asymptomatic Metastatic Disease to the Thoracic and Lumbar Spine (NCT01654068)

Summary

Intensity-modulated radiation therapy uses computer-generated images to show the size and shape of the tumor. Then, thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the risk of damaging healthy tissue near the tumor. This trial is investigating the effectiveness and side effects associated with using conformal high-dose intensity-modulated radiation therapy for treating patients with metastases to the spine.
This is a Phase II trial

Stereotactic Body Radiation Therapy for Breast Cancer with Limited Metastasis

A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer (NCT02364557)

Summary

When breast cancer spreads to only one or two locations in the body, it is referred to as limited metastatic (oligometastatic) breast cancer. Stereotactic body radiation therapy (SBRT) delivers a high dose of radiation directly to the tumor, reducing the risk of damaging surrounding healthy tissue. Researchers think SRBT may be a promising treatment for women with limited metastases. This study is comparing the effectiveness of using SRBT along with systemic therapy to systemic therapy alone for treating women with newly diagnosed and limited metastases.
This is a Phase II-III trial

A Study to Identify the Best Dose of Stereotactic Radiosurgery to Treat Metastases

A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases (NCT02206334)

Summary

Stereotactic radiosurgery is a type of radiation therapy that is used to deliver a tightly-focused high doses of radiation to an area of the body that contains cancer cells. The aim of this study is to determine the recommended radiation dose for treating different areas of metastases in patients with metastatic breast cancer, non-small cell lung cancer, or prostate cancer.
This is a Phase I trial

Comparing Two Methods for Evaluating Brain Mets After Radiation

Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain (NCT01621906)

Summary

Researchers are trying to develop better methods for evaluating how brain metastases respond to whole brain radiation therapy (WBRT). This study is comparing a positron emission tomography (PET) scanner with a magnetic resonance imaging (MRI) scanner. A PET scanner resembles a CT or MRI scanner. PET scans use radioactive substances, called radioactive markers, to "see" cancer cells. This study will use [18F]FLT as the radioactive marker. FLT is used to image tumor growth. FLT PET scan is a new clinical procedure. (It differs from FDG-PET, which is more commonly used.) This study will help researchers determine whether the FLT PET scan is safe and more effective for evaluating brain metastases than MRI. To be eligible participants must be planning on receiving WBRT.

Enobosarm for Advanced ER-Positive and Androgen Receptor-Positive Breast Cancer

A Phase 2 Open Label, Multi-Center, Multinational, Randomized, Parallel Design Study Investigating The Efficacy and Safety Of GTx-024 On Metastatic or Locally Advanced ER+/AR+ Breast Cancer (BC) in Postmenopausal Women (NCT02463032)

Summary

More than 80% of patients with metastatic ER-positive breast cancer have tumors that are also androgen receptor (AR) positive. Enobosarm (Ostarine®/GTx-024) is a new type of drug called a selective androgen receptor modulator. Early studies suggest that enobosarm may be an effective treatment for metastatic AR+, ER+ breast cancer. This study is investigating the safety, effectiveness, and best dose of enobosarm in treating advanced ER+, AR+ breast cancer in postmenopausal women.
This is a Phase II trial

VT-464 for Androgen Receptor-Positive Advanced Breast Cancer

A Phase 1/2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of VT-464 in Patients With Advanced Breast Cancer (NCT02580448)

Summary

VT-464 is an experimental drug that slows cancer cell growth by blocking the androgen receptor (AR). It is currently being studied in prostate cancer. Researchers think VT-464 may be an effective treatment for certain types of breast cancer. This study is evaluating the safety and efficacy of VT-464 to treat advanced breast cancer. The phase I part of the study will enroll women with triple-negative or ER+/HER2- breast cancer. The phase II part of the study will enroll women with AR+/triple-negative or ER+/HER2- tumor.
This is a Phase I-II trial

Endoxifen or Tamoxifen for Advanced ER+, HER2- Breast Cancer

A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women With Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer (NCT02311933)

Summary

Hormone sensitive tumors are treated with anti-estrogen therapies. Tamoxifen (Nolvadex®) is an anti-estrogen therapy routinely used to treat early-stage and metastatic breast cancer. Endoxifen (z-endoxifen hydrochloride) is an active metabolite of tamoxifen. Scientists think that endoxifen may be a more effective anti-estrogen therapy than tamoxifen. This study is comparing the safety and effectiveness of tamoxifen to endoxifen for treating ER+, HER2- locally advanced or metastatic breast cancer. To be eligible, patents must have been previously treated with an aromatase inhibitor—letrozole (Femara®), anastrozole (Arimidex®) or exemestane (Aromasin®)– in the adjuvant or metastatic setting and have an endocrine-resistant tumor.
This is a Phase II trial

GDC-0810 or Faslodex for ER+, HER2- Advanced Breast Cancer Already Treated With an AI

A Study of GDC-0810 Versus Fulvestrant in Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy (HydranGea) (NCT02569801)

Summary

GDC-0810 is an investigational drug called a selective estrogen receptor degrader (SERD) being studied in tumors that are ER-positive. Fulvestrant (Faslodex®) is a hormone therapy used to treat ER+ metastatic breast cancer in postmenopausal women who have tried other hormone therapies. In this study, researchers are comparing the safety and efficacy of GDC-0810 and Faslodex in women with advanced ER+, HER2- breast cancer whose cancer has progressed following treatment with an aromatase inhibitor.
This is a Phase II trial

Estrogen and an Aromatase Inhibitor in Advanced ER+ Breast Cancer

Phase II Pre-emptive OsciLLation of ER activitY Levels Through Alternation of Estradiol/Anti-estrogen Therapies Prior to Disease Progression in ER+/HER2- Advanced Breast Cancer (NCT02188745)

Summary

Anti-estrogen therapies are used to treat ER+ tumors. However, over time, these tumors can stop responding to these treatments. Laboratory studies suggest that giving a high dose of estrogen to patients whose tumors have stopped responding to an anti-estrogen therapy may get the tumor to respond again to the treatment. This study will investigate how tumors respond when estrogen (17B-estradiol) is given along with an aromatase inhibitor––letrozole (Femara®), anastrozole (Arimidex®) or exemestane (Aromasin®) to treat women with advanced ER+, HER2- metastatic breast cancer. To be eligible for this study, a patient must have been previously treated with tamoxifen, raloxifene, toremifene, or an AI.
This is a Phase II trial

ARN-810 in Postmenopausal Women With Advanced Breast Cancer

An Open-Label, Phase I Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer (NCT01823835)

Summary

Over time, hormone-sensitive tumors can stop responding to hormone therapies. ARN-810 is a new type of anti-estrogen drug called a selective estrogen receptor degrader. It is designed to block and destroy the hormone receptors that drive tumor growth. Laboratory studies suggest it may be effective in women who have stopped responding to other hormonal therapies. This study is looking at the safety and the most effective dose of ARN-810 for treating postmenopausal women with locally advanced or metastatic hormone-sensitive, HER2-negative breast cancer who have already tried previous hormone therapies.
This is a Phase I-II trial

FDG-PET/CT Imaging to Monitor Bone Metastases in Individuals Taking Hormone Therapy

18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) For The Evaluation Of Response To Therapy In Bone-Dominant Metastatic Breast Cancer (NCT02110160)

Summary

FDG-PET/CT uses two imaging techniques at the same time, providing a more detailed assessment of how organs and tissues are functioning. This study is investigating whether FDG PET/CT imaging is an effective way to evaluate how bone metastases respond to hormone therapy. To be eligible, patients must have ER+ metastatic breast cancer that has spread predominantly to the bone and must be planning to start a new hormone therapy.

Faslodex or Tamoxifen for ER-Positive Metastatic Breast Cancer

Treatment of Metastatic Breast Cancer With Fulvestrant or Tamoxifen: A Randomized Phase II Trial With ESR1 Mutation Tested in Circulating Tumor DNA (NCT02913430)

Summary

To take part in this study, you must have ER-positive metastatic breast cancer. You must also have not been treated with Faslodex or tamoxifen since being diagnosed with metastatic breast cancer. This study is comparing how well two different anti-estrogen drugs keep metastatic breast cancer from spreading. The two drugs are fulvestrant (Faslodex®) and tamoxifen (Nolvadex®). Both are used to treat metastatic breast cancer. The researchers will use blood tests to study each patient's circulating tumor DNA—DNA from the cancer that floats in the blood stream—in order to learn more about a mutation called ESR1 and why hormone-sensitive tumors stop responding to anti-estrogen treatments.
This is a Phase II trial

RAD1901 for Advanced ER+ and HER2- Breast Cancer

A Phase I, Multicenter, Open-Label, Two-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer (NCT02338349)

Summary

Over time, hormone-sensitive tumors can stop responding to hormone therapy. Researchers are looking for ways to overcome this problem. RAD1901 is an investigational therapy that is designed to prevent tumor growth by destroying the estrogen receptor, called selective estrogen receptor degrader. This study is looking at the safety, efficacy and best dose of RAD1901 in post-menopausal women with advanced ER+, HER2- breast cancer. To be eligible, a patient must have received no more than two prior chemotherapy regimens and at least six months of hormone therapy.
This is a Phase I trial

Endoxifen For Hormone Receptor-Positive Metastatic Disease

Phase I Trial of Z-Endoxifen in Adults With Refractory Hormone Receptor-Positive Breast Cancer, Desmoid Tumors, Gynecologic Tumors, or Other Hormone Receptor-Positive Solid Tumors (NCT01273168)

Summary

Some hormone-sensitive tumors do not respond to the anti-estrogen drug tamoxifen. Tamoxifen begins working after a protein in the liver called CYP2D6 turns it into endoxifen. Studies have shown that some women do not produce enough CYP2D6 to turn tamoxifen into endoxifen. Researchers think that giving endoxifen directly may overcome this problem. The purpose of this trial is to test the safety and effectiveness of endoxifen in women with hormone receptor-positive metastatic disease that has not responded to standard treatment.
This is a Phase I trial

Plaquenil® & Hormone Therapy for ER-Positive Metastatic Breast Cancer

Phase Ib/II Study of Hydroxychloroquine in Metastatic ER-Positive Breast Cancer Progressing on Hormonal Therapy (NCT02414776)

Summary

Over time, hormone-sensitive tumors can stop responding to anti-estrogen therapies. Hydroxychloroquine (Plaquenil®) is a drug used to treat malaria, rheumatoid arthritis, and lupus. Laboratory studies suggest Plaquenil can get hormone-resistant tumors to start responding to an anti-estrogen therapy. This study is exploring the safety and efficacy of giving Plaquenil with an anti-estrogen therapy to patients with ER+ metastatic breast cancer that has progressed on other anti-estrogen therapies. To be eligible, patients must have at least one metastatic lesion that can be evaluated for tumor response. Patients cannot be on combination hormonal therapy with everolimus (Afinitor®) or any other investigational therapies.
This is a Phase I trial

BYL719 Plus Femara® or Aromasin® for Hormone-Sensitive Advanced Breast Cancer

A Phase I Trial of BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer (NCT01870505)

Summary

Letrozole (Femara®) and exemestane (Aromasin®) are hormone therapies used to treat postmenopausal women with advanced breast cancer. As with other drugs, over time, the breast cancer can stop responding to these treatments. BYL719 is a new drug that blocks PI3 kinase, an enzyme that helps breast cancer cells grow. This study will determine the highest dose of BYL719 that can be given safely along with Femara or Aromasin. To be eligible for this study, a woman must currently be taking Femara or Aromasin to treat locally advanced or metastatic breast cancer.
This is a Phase I trial

Pyrotinib for Metastatic HER2+ Breast Cancer That Has Progressed on HER2+ Therapies

A Two-part Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pyrotinib in Patients With HER2 Positive Solid Tumors Who Failed Prior HER2 Targeted Therapy (NCT02500199)

Summary

Researchers are studying new ways to treat metastatic HER2+ breast cancer that has stopped responding to HER2-targeted therapies. Pyrotinib, a tyrosine kinase inhibitor, is an experimental targeted therapy. It targets both HER1 and HER2. In this study, researchers are investigating the safety, effectiveness and the best dose of pyrotinib to treat HER2+ metastatic breast cancer that has stopped responding to other HER2-targeted therapies. To be eligible, participants must have had their cancer progress after having been on at least two prior HER2-targeted therapies, including trastuzumab (Herceptin®) and/or pertuzumab (Perjeta®), or T-DM1 (Kadcyla®), or lapatinib (Tykerb®).
This is a Phase I trial

CD-839 for Advanced Breast (and other solid) Tumors

A Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminase Inhibitor CB-839, as a Single Agent and in Combination With Chemotherapy in Patients With Advanced Solid Tumors (NCT02071862)

Summary

Researchers are developing new types of targeted cancer therapies. CB-839 is a new type of targeted therapy called a glutaminase inhibitor. Cells use the amino acid glutamine to grow, and CB-839 is designed to block that process. Laboratory studies have shown that CB-839 can slow or stop tumor growth in several different types of tumors. Paclitaxel (Taxol®) is a chemotherapy drug used to treat breast and other types of cancers. This study has two phases. The first phase is designed to determine the best dose of CB-839. This part is open to all breast cancer patients. The second phase will compare the safety and efficacy of CB-839 to CB-839 and Taxol in individuals with advanced triple negative breast cancer.
This is a Phase I 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

Triciribine+Paclitaxel in Locally Advanced or Metastatic HER2 Negative Tumors

A Phase I-II Study of Triciribine Phosphate Monohydrate (TCN-PM) Plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients With Metastatic and Locally Advanced Breast Cancer (NCT01697293)

Summary

Researchers are studying new drugs and new drug combinations for treating locally advanced breast cancer. Triciribine Phosphate Monohydrate (TCN-PM) is a type of new cancer drug called an AKT inhibitor. AKT is a protein that plays a role in cell growth and cell death. In cancer cells, this protein is not working properly, which helps the tumor grow and spread. The researchers think that giving TCN-PM along with the chemotherapy drug paclitaxel (followed later in time by additional chemotherapy) may be more effective than paclitaxel alone. This study is looking at the affect that giving TCN-PM along with paclitaxel has on HER2-negative locally advanced breast tumors. The first phase of this trial will also enroll patients with stage IV (metastatic) breast cancer.
This is a Phase I-II trial

Alpelisib and Fulvestrant for HR+, HER2- Advanced Breast Cancer

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. (SOLAR-1) (NCT02437318)

Summary

Scientists are studying new treatments and new treatment combinations for patients with advanced breast cancer that has stopped responding to hormone therapy. Alpelisib (BYL719) is a type of targeted therapy called a PI3K inhibitor. It works by blocking the PI3K pathway. Earlier studies suggest it may be an effective breast cancer treatment. Fulvestrant (Faslodex®) is used to treat postmenopausal women with hormone-sensitive metastatic breast cancer that has stopped responding to other hormone therapy. This study is comparing the safety and effectiveness of Faslodex and Alpelisib with Faslodex and a placebo in men and postmenopausal women with HR+, HER2- advanced breast cancer. To be eligible, participants must have progressed on or after being treated with an aromatase inhibitor.
This is a Phase III trial

Taxol and Reparixin in Metastatic Triple-Negative Breast Cancer

A Randomized, Double-blind, Placebo-controlled Phase 2 Study of Paclitaxel in Combination With Reparixin Compared to Paclitaxel Alone as Front-line Therapy for Metastatic Triple- Negative Breast Cancer (FRIDA) (NCT02370238)

Summary

Normal stem cells are capable of renewing and sustaining the body's organs and tissues by creating more new cells. Cancer stem cells are thought to fuel tumor growth by making new cancer cells. Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat breast cancer. Reparixin, an investigational drug, is a stem cell-directed therapy that targets a protein called CXCR1 found on cancer stem cells. This study is comparing the safety and effectiveness of reparixin and Taxol with Taxol alone in patients with metastatic triple-negative breast cancer.
This is a Phase II trial

Xofigo to Treat Bone Metastases in Hormone-Sensitive, HER2-Negative Breast Cancer

A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases (NCT02258451)

Summary

Radium-223 dichloride (Xofigo®) is an FDA approved drug to treat bone metastasis in prostate cancer. It works by using radioactive particles that mimic calcium to enter the bone and target cancer cells. Everolimus (Afinitor®) and exemestane (Aromasin®) are used together to treat advanced hormone-sensitive, HER2-negative breast cancer. This study is comparing the safety and effectiveness of Xofigo, Afinitor, and Aromasin to a placebo, Afinitor, and Aromasin for reducing bone metastasis in women with hormone-sensitive, HER2-negative breast cancer.
This is a Phase II trial

Taselisib & Enzalutamide in Triple-Negative Metastatic Tumors with Androgen Receptors

A Phase Ib/II Trial of Taselisib (GDC-0032), a PI3K Inhibitor, in Combination With Enzalutamide in Patients With Androgen Receptor Positive Triple Negative Metastatic Breast Cancer (NCT02457910)

Summary

Some breast cancer tumors have androgen receptors. Enzalutamide (Xtandi®) slows cancer cell growth by blocking the androgen receptor. It is currently used to treat prostate cancer. Taselisib is a new type of cancer drug called a PI3K inhibitor. Combining taselisib with enzalutamide (Xtandi) may be more effective in androgen-sensitive breast cancer than Xtandi alone.This trial is studying the side effects and best dose of taselisib when it is given along with Xtandi to treat patients with androgen receptor positive triple-negative metastatic breast cancer. All patients who are interested in this trial will have their tumor tested for its androgen receptor (AR) status.
This is a Phase I-II trial

Enobosarm for Advanced Androgen Receptor-Positive Triple Negative Breast Cancer

A Phase 2 Open Label, Multi-Center, Multinational Study Investigating The Efficacy and Safety Of GTx-024 On Advanced, Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC) (NCT02368691)

Summary

Androgen receptors are found on many triple negative breast tumors. Researchers think that drugs that target the androgen receptor may be effective breast cancer treatments. Enobosarm (Ostarine®/GTx-024) is a new type of drug called a selective androgen receptor modulator. Laboratory and early studies suggest that it blocks the effects of androgen in the breast. This study is investigating the safety and effectiveness of using enobosarm to treat patients with advanced triple negative breast cancer. To be eligible, patients must have received at least one but no more than two prior chemotherapy regimens.
This is a Phase II trial

BIBF-112 for HER2-Negative Metastatic Inflammatory Breast Cancer

A Phase II Study of BIBF1120 (Nintedanib) for Patients With Metastatic HER2-negative Inflammatory Breast Cancer (IBC) (NCT02389764)

Summary

Inflammatory breast cancer is an aggressive type of breast cancer that is typically treated with chemotherapy prior to surgery. BIBF-1120 (Nintedanib/Ofev®) is a tyrosine kinase inhibitor currently approved to treat scarring of the lungs. Laboratory studies suggest it may also be an effective treatment for inflammatory breast cancer. This study will investigate the safety and efficacy of giving BIBF-1120 after surgery to help control HER2-negative, metastatic, inflammatory breast cancer.
This is a Phase II trial

ARQ092 with Carboplatin and Paclitaxel in Advanced Breast Cancer

An Open-label Phase 1b Study of ARQ 092 in Combination With Carboplatin Plus Paclitaxel in Subjects With Selected Solid Tumors (NCT02476955)

Summary

ARQ092 is a new type of targeted therapy called an AKT inhibitor. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs used to treat advanced breast cancer. Researchers will evaluate the safety and efficacy of using ARQ092 in combination with Paraplatin and Taxol for treating advanced triple-negative breast cancer (and other solid tumors).
This is a Phase I trial

Cabozantinib and Falsodex for Hormone-Sensitive, HER2- Bone Metastases

A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone (NCT01441947)

Summary

Researchers are looking for drugs that will be effective in patients that have breast cancer that has spread (metastasized) to the bone. Cabozantinib (Cometriq®) is an experimental targeted therapy that works by inhibiting several different proteins that are believed to help tumors grow, spread, and form new blood vessels. One of these targets is the MET pathway, which aids tumor growth and is also active in bone cells, which is why researchers believe it may be effective in slowing or stopping bone metastases. Fulvestrant (Falsodex®) is commonly used to treat HR-positive, metastatic breast cancer in postmenopausal women who has stopped responding to other hormonal therapy. The goal of this trial is to determine the effectiveness of cabozantinib when given with fulvestrant for individuals with HR-positive, HER2-negative breast cancer that has spread to the bone in postmenopausal women.
This is a Phase II trial

Perjeta and Herceptin for HER2-Positive Brain Metastases

An Open-Label, Single-Arm, Phase II Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Central Nervous System Progression Post-Radiotherapy in Patients With HER2-Positive Metastatic Breast Cancer (PATRICIA) (NCT02536339)

Summary

Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are targeted therapies used to treat HER2-positive breast cancer. This study is investigating the safety and effectiveness of giving Perjeta along with a high dose of Herceptin to treat HER2-positive metastatic breast cancer that has spread to the brain. To be eligible, participants must have had their brain metastases recur or progress after radiation therapy.
This is a Phase II trial

LY2157299 and Radiation to Treat Metastatic Lesions in Women with Breast Cancer

LY2157299 Monohydrate (LY2157299) and Radiotherapy in Metastatic Breast Cancer (NCT02538471)

Summary

Transforming growth factor-beta (TGFβ) is a protein found at high levels in advanced cancers. Studies suggest it is associated with tumor growth and metastasis. LY2157299 monohydrate is an oral drug that blocks TGF-β. This trial is investigating whether treating some metastatic lesions with radiation in women taking LY2157299 causes other metastatic sites to become smaller. (Scientists refer to this as the "abscopal effect"). To be eligible, participants must have at least 3 distinct metastatic sites with one measurable lesion at least 1 cm in largest diameter.
This is a Phase II trial

Margetuximab or Herceptin with Chemotherapy for HER2+ Advanced Breast Cancer

A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Two Prior Anti-HER2 Therapies and Require Systemic Treatment (SOPHIA) (NCT02492711)

Summary

Trastuzumab (Herceptin®) is a targeted therapy routinely used to treat HER2-positive breast cancer. MAGH22 (Margetuximab) is a new HER2-targeted therapy. This study is comparing the effectiveness of Margetuximab and chemotherapy to Herceptin and chemotherapy in patients with HER2-positive advanced breast cancer. The patient's physician will choose the chemotherapy regimen.
This is a Phase III trial

CDK-Inhibitor for Previously Treated Metastatic Disease

Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer (NCT01037790)

Summary

A new target for treating metastatic breast cancer may be cyclin-dependent kinase (CDK), a family of enzymes involved in cell growth. As the name implies, CDK enzymes are only active in the presence of proteins referred to as cyclins. PD 0332991 (Palbociclib) is a new biological therapy that blocks two different cyclin-dependent kinase enzymes. This, in turn, may slow or stop a cancer's growth. The goal of this trial is to determine the side effects of Palbociclib and how well it works in treating patients with tumors that are no longer responding to standard treatment.
This is a Phase II trial

Xofigo for HR+, HER2- Breast Cancer that Has Spread to the Bone

A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride Versus Placebo When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases Treated With Hormonal Treatment Background Therapy (NCT02258464)

Summary

Radium-223 dichloride (Xofigo®) is a drug used to treat men with prostate cancer that has spread to the bone. Researchers think Xofigo may also work well in women with breast cancer that has spread to the bone. This study is comparing the effectiveness of hormone therapy and Xofigo to hormone therapy and a placebo in women with ER-positive, HER2-negative metastatic breast cancer that has spread to the bone. Xofigo works by releasing radioactive particles that act like calcium to enter the bone and target cancer cells. To take part in this study, there must be at least two places where your breast cancer has spread to your bones.
This is a Phase II trial

Affect of Xgeva on Circulating Tumor Cells in Breast Cancer Patients with Bone Mets

Phase II Study of Denosumab to Define the Role of Bone Related Biomarkers in Breast Cancer Bone Metastasis (NCT01952054)

Summary

Circulating tumor cells are cancer cells that are moving in the bloodstream through the body. Denosumab (Xgeva®) is an FDA approved drug used in patients with bone metastasis to prevent fractures, spinal cord compression, or the need for bone radiation or surgery. This study is investigating whether giving Xgeva in combination with hormone therapy will lower the number of circulating tumor cells found in women with breast cancer with bone metastasis. To be eligible, participants must have at least 3 or more circulating tumor cells found on a blood test.
This is a Phase II trial

Ninlaro and Faslodex for Advanced ER+, HER2- Breast Cancer

Phase I Study of the Combination of MLN9708 and Fulvestrant in Patients With Advanced Estrogen Receptor Positive Breast Cancer (NCT02384746)

Summary

Ixazomib (Ninlaro®) is a type of targeted therapy called a proteasome inhibitor. It is approved for treatment of multiple myeloma. Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat postmenopausal women whose tumors have progressed on other types of hormone therapy. Laboratory studies suggest Ninlaro can kill breast cancer cells that have been treated with Faslodex. This study is investigating the best dose, safety and efficacy of Ninlaro when it is given in combination with Faslodex for treating metastatic ER+/HER2- breast cancer.
This is a Phase I trial

Neratinib & Xeloda or Tykerb & Xeloda for HER2+ Metastases

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting (NCT01808573)

Summary

Researchers are studying new drugs and new drug combinations that may be effective in patients with HER2+ metastatic breast cancer. Neratinib is a new drug being studied in patients with HER2+ tumors. By attaching itself to the cancer cells, it keep the HER2 protein from stimulating tumor growth. Lapatinib (Tykerb®) is a targeted therapy used to treat HER2+ advanced breast cancer. Capecitabine (Xeloda®) is a chemotherapy drug used to treat metastatic breast cancer that has not improved after treatment with certain other anticancer drugs. This trial is comparing the combination of neratinib and Xeloda to the combination of Tykerb and Xeloda in patients in HER2+ metastatic breast cancer who already have received two or more HER2 regimens in the metastatic setting.
This is a Phase III trial

Procaspase Activating Compound-1 for Metastatic Breast (and other) Cancer

(STM-03) Phase I Study of Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies (NCT02355535)

Summary

Procaspase Activating Compound-1 (PAC-1) is a small molecule designed to kill cancer cells by converting the enzyme procaspase-3 to caspase-3. Laboratory studies suggest PAC-1 may be effective in breast and other types of cancer. This study is investigating the safety and effect of PAC-1 in patients with metastatic breast (and other) cancer that has stopped responding to standard therapies.
This is a Phase I trial

Herceptin for HER2-Positive Breast Cancer That Has Spread to the Brain

Phase 1 Trial of Super-selective Intra-arterial Cerebral Infusion of Trastuzumab After Blood-Brain Barrier Disruption for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer (NCT02571530)

Summary

Trastuzumab (Herceptin®) is used to treat HER2-positive breast cancer. It is delivered intravenously. However, the blood-brain barrier prevents much of the drug from getting to cancer cells that have spread to the brain. This study is evaluating the safety of administering a single dose of trastuzumab into an artery in the brain to treat HER2+ brain metastases.
This is a Phase I trial

Study of PF-06647020 for Advanced Triple Negative Breast Cancer and Other Solid Tumors

A First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647020 In Adult Patients With Advanced Solid Tumors (NCT02222922)

Summary

PF-06647020 is a type of targeted therapy called an antibody-drug conjugate. These drugs combine a targeted therapy with chemotherapy in order to deliver the chemotherapy directly to the cancer cells. This study is investigating the safety and best dose of PF-06647020 for treating advanced triple-negative breast cancer (and other solid tumors).
This is a Phase I trial

Basket Study of Entrectinib in Tumors With a NTRK1/2/3, ROS1, or ALK Mutation

An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements (NCT02568267)

Summary

Basket studies enroll patients based on the kind of mutations found in their tumors, rather than the type of cancer they have. This is a basket study of entrectinib (RXDX-101) in individuals with solid tumors that have an NTRK1/2/3, ROS1, or ALK gene rearrangement. To be eligible, a breast cancer patient must have a tumor that tests positive for a NTRK1/2/3, ROS1 or ALK rearrangement.
This is a Phase II trial

AZD5363 for Metastatic Breast (and Other) Cancer

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Patients With Advanced Solid Malignancies. (NCT01226316)

Summary

AZD5363 is a new type of targeted therapy called an AKT protein kinase inhibitor. It works by blocking the AKT1 protein, which plays a role in cancer cell growth. This study is investigating the best dose, safety, and tolerability of AZD5363 in patients with ER+, HER2+ metastatic breast cancer. To be eligible, individuals must have a tumor that has an AKT1 mutation or a PIK3CA mutation and have no available standard therapies.This study is also recruiting individuals with other types of advanced solid tumors.
This is a Phase I trial

Xtandi and Herceptin for HER2+, ER- Advanced Breast Cancer

A Phase 2, Multicenter, Open-label Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Subjects With HER2+ AR+ Metastatic or Locally Advanced Breast Cancer (NCT02091960)

Summary

Studies suggest targeting the androgen receptor (AR) could block breast cancer cell growth. Enzalutamide (Xtandi®) is a drug that blocks the androgen receptor. It is currently used to treat prostate cancer. Trastuzumab (Herceptin®) is used to treat HER2-positive tumors. The purpose of this study is to evaluate the safety and effectiveness of using Xtandi along with Herceptin to treat women with HER2-positive, ER-negative metastatic or locally advanced breast cancer. To be eligible, patient must not have had pertuzumab (Perjeta®) included in their most recent therapy. They must also have their tumor test positive for the androgen receptor (AR+).
This is a Phase 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

Targeted Treatment (Herceptin and Perjeta) for Metastatic Breast Cancer

My Pathway: An Open Label Phase IIa Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib, and Vismodegib in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents (NCT02091141)

Summary

Researchers are trying to identify more effective ways to treat metastatic cancer. This trial is studying four different types of targeted therapies that may be effective in a number of cancers. The breast cancer patients who enroll in this trial will receive trastuzumab (Herceptin®) and pertuzumab (Perjeta®), two targeted therapies used to treat HER2+ breast cancer. To be eligible for this study, a breast cancer patient must have a HER2+ tumor and already have received a first-line standard treatment for metastatic breast cancer.
This is a Phase II trial

LY2835219 and Hormone Therapy for Metastatic Breast Cancer

A Phase 1b Study of LY2835219 in Combination With Endocrine Therapies for Patients With Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (NCT02057133)

Summary

Researchers have developed a new type of targeted therapy called a CDK 4/6 inhibitor. LY2835219 is one of the CDK 4/6 inhibitors now being studied. Laboratory studies suggest that LY2835219 may be an effective treatment for hormone-sensitive metastatic breast cancer. This study is evaluating the safety of using LY2835219 along with standard hormone therapy—Letrozole (Femara®), Anastrozole (Arimidex®), Tamoxifen, Exemestane (Aromasin®), or Exemestane (Aromasin®) and Everolimus (Afinitor®)—to treat women with hormone sensitive, HER2-negative metastatic breast cancer.
This is a Phase I trial

Rebastinib plus Chemotherapy for Metastatic Breast Cancer

Phase Ib Study of Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Patients With Metastatic Breast Cancer(NCT02824575)

Summary

To take part in this study, you must have HER2-negative breast cancer that has spread to other parts of your body (metastatic). You must have already received chemotherapy. If your tumor is hormone-sensitive, you must have already taken an anti-estrogen drug. Rebastinib is a new drug that is available only in clinical trials. This study is looking at how well it works when it is given along with a chemotherapy drug. Rebastinib is a targeted drug. The chemotherapy drugs being used in this study are paclitaxel (Taxol®) and eribulin (Halaven®). Both are used to treat metastatic breast cancer. The researchers will look at what treatments you have already had to decide whether you should get Taxol or Halaven.
This is a Phase I trial

Veliparib For Advanced Disease With Liver or Kidney Problems

Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction (NCT01366144)

Summary

Chemotherapy drugs like paclitaxel (Taxol®) and carboplatin (Paraplatin®) work by causing damage to a cancer cell's DNA. PARP (poly(ADP-ribose) polymerase) inhibitors are a new type of cancer drug. They can make it more difficult for the cancer cell to repair this DNA damage, which may make chemotherapy more effective. The purpose of this trial is to determine the safety and best dose of veliparib in combination with Taxol® and Paraplatin® in patients with advanced disease who also have liver or kidney problems. To be eligible, patients must have liver OR kidney problems. Patients who have both liver and kidney problems are not eligible.
This is a Phase I trial

GS-5745 in Metastatic HER2-Negative Breast Cancer and Other Solid Tumors

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5745 as Monotherapy and in Combination With Chemotherapy in Subjects With Advanced Solid Tumors (NCT01813282)

Summary

GS-5745 is a new monoclonal antibody. It slows tumor growth by binding to certain enzymes on cancer cells. This study is investigating the safety and side effects of GS-5745 when it is given alone or with chemotherapy. The researchers will also study the level of the drug in people’s blood after treatment to see if they can learn why certain tumors respond to the drug and others don't. To be eligible, breast cancer patients must have a HER2-negative tumor that is not responding to standard therapies. This study also is open to patients with other types of cancer.
This is a Phase I trial

Chemo, Herceptin +/- Perjeta in HER2+ Metastatic Patients Previously Treated with Kadcyla

Randomized Phase II Trial of Chemotherapy of Physician's Choice Plus Trastuzumab Versus Chemotherapy of Physician's Choice Plus Trastuzumab Plus Pertuzumab In Women With Pretreated, HER2-Overexpressing Metastatic Breast Cancer (MBC) (NCT02229149)

Summary

T-DM1 (Kadcyla®) combines the chemotherapy drug DM1 with the HER2-targeted therapy trastuzumab (Herceptin®). It is approved for treating metastatic breast cancer. Pertuzumab (Perjeta®) is also a HER2 targeted therapy. This study is investigating the best treatment to use in women previously treated with Kadcyla. It will compare the safety and effectiveness of combining physician's choice of chemotherapy and Herceptin to physician's choice of chemotherapy, Herceptin and Perjeta. To be eligible, a woman must have HER2+ metastatic breast cancer previously treated with Kadcyla.
This is a Phase II trial

  • Participation TimeVisits depend on the physician's choice of chemotherapy
  • Participating research sites
    Research sites: 1 site total Contact information

AZD2014, Ibrance and Faslodex for Advanced ER+, HER2- Breast Cancer

Ph I/II Multicenter Study of the Combination of AZD2014 and Palbociclib on a Background of Hormonal Therapy in Patients With Locally Adv/Metastatic ER Positive Breast Cancer Comprising a Safety, Pharmacokinetic and Preliminary Efficacy Evaluation Followed by a Randomised, Double-Blind, Placebo-controlled, Parallel Group Extension (NCT02599714)

Summary

AZD2014 is a type of targeted therapy called an mTOR1/2 inhibitor. It works by interfering with a cancer cell's ability to divide and grow. Palociclib (Ibrance®) is an FDA-approved targeted therapy used in combination with the anti-estrogen therapy letrozole (Femara®) to treat metastatic breast cancer. Fulvestrant (Faslodex®) is an anti-estrogen approved to treat advanced breast cancer. This study is comparing the effectiveness of the combination of AZD2014, Ibrance and Faslodex to the combination of Ibrance and Faslodex in patients with advanced ER+, HER2- breast cancer.
This is a Phase I-II trial

BYL719 & Femara for Hormone-Sensitive Metastatic Breast Cancer

A Phase Ib Trial of BYL719 (an α-Specific PI3K Inhibitor) in Combination With Endocrine Therapy in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer (NCT01791478)

Summary

Researchers are studying new drugs and new drug combinations that may be effective in patients with metastatic breast cancer. BYL719 is a new targeted therapy that works by blocking a protein called PI3K that plays a role in tumor growth. Letrozole (Femara®) is a hormone therapy that is used to treat early-stage and metastatic breast cancer. BYL719 combined with Femara may be more effective than using Femara alone. This trial is studying the side effects and best dose of BYL719 when it is given with Femara to patients with hormone-sensitive metastatic breast cancer.
This is a Phase I trial

Nab-Rapamycin for Advanced Breast (and Other) Cancers

A Pilot Study of a Rapid Access Platform for Investigational Drugs (RAPID) in Advanced Cancers (NCT02646319)

Summary

Nab-rapamycin (ABI-009) is a new type of cancer therapy called an mTOR (mammalian target of rapamycin) inhibitor. It is designed to stop the growth of cancer cells by blocking the mTOR protein, which is needed for cell growth and proliferation. This study is evaluating the safety and efficacy of nab-rapamycin when it is given to individuals with advanced breast (and other) cancers that have mTOR mutations. To be eligible, a patient must have a tumor that tests positive for the mTOR mutation.
This is a Phase II trial

Study of Cometriq to Treat Brain Metastases

A Phase II Study of Cabozantinib Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases (NCT02260531)

Summary

Scientists are trying to identify drugs that can successfully treat breast cancer that has spread (metastasized) to the brain. Cabozantinib (Cometriq®) is used to treat metastatic thyroid cancer. It inhibits several different proteins that are involved in the growth and spread of the blood vessels tumors need to survive. Previous studies suggest it may be able to slow or stop the growth of metastatic breast cancer, including breast cancer that has spread to the brain. Trastuzumab (Herceptin®) is used to treat HER2+ breast cancer. This study is evaluating how well Cometriq works to treat breast cancer that has metastasized to the brain. In this study, patients who are HER2+ will also receive Herceptin.
This is a Phase II trial

ONT-380 with Xeolda & Herceptin to Treat Advanced HER2+ Breast Cancer

Phase 2 Randomized, Double-Blinded, Controlled Study of ONT-380 vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (NCT02614794)

Summary

ONT-380 (formerly ARRY-380) is an investigational HER2-targeted therapy. ONT-380 is a small molecule that early studies suggest may be be able to pass through the blood-brain barrier. This could make it an effective treatment for HER2+ breast cancer that has spread (metastasized) to the brain. Trastuzumab (Herceptin®) is a HER2-targeted therapy routinely used to treat HER2-positive breast cancer. Capacitabine (Xeloda®) is a chemotherapy drug used to treat metastatic breast cancer. This study is comparing the safety and effectiveness of ONT-380, Herceptin and Xeloda with Herceptin, Xeloda and a placebo in patients with advanced HER2-positive breast cancer that has progressed on prior therapy.
This is a Phase II trial

Poziotinib for HER2-Positive Metastatic Breast Cancer

A Phase 2 Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer (MBC) Who Have Received Prior HER2 Regimens for MBC (NCT02659514)

Summary

Pozitinib is a new targeted therapy that works by blocking the EGFR receptor and the HER2 receptor. Early studies suggest pozitinib may be effective in HER2-positive tumors. This study is evaluating the efficacy and tolerability of poziotinib for treating HER2-positive metastatic breast cancer. To be eligible, participants must have received at least two prior HER2-targeted therapies.
This is a Phase II trial

Abemaciclib for Hormone Receptor-Positive Brain Metastasis

A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer (NCT02308020)

Summary

Researchers are trying to develop therapies that will be effective in patients with hormone-sensitive breast cancer that has spread (metastasized) to the brain. Abemaciclib (LY2835219) is a new type of targeted therapy called a CDK 4/6 inhibitor. Previous studies suggest abemaciclib may be an effective treatment for hormone-sensitive metastatic breast cancer. This study will determine the safety and effectiveness of using abemaciclib to treat patients with hormone-sensitive breast cancer that has metastasized to the brain.
This is a Phase II trial

Ibrance & Hormone Therapy in Patients with Advanced Breast Cancer

Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Hormone Receptor Positive Metastatic Breast Cancer Previously Exposed to Inhibitors of the PI3K Pathway: A Phase II Study With Pharmacodynamics Markers (NCT02384239)

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. Tamoxifen (Nolvadex®) is an anti-estrogen therapy used to treat hormone-sensitive breast cancer. Fulvestrant (Faslodex®) is a hormone therapy used in postmenopausal women to treat hormone-sensitive breast cancer that has stopped responding to other hormone therapies. This study is comparing the effectiveness of two different doses of Ibrance -- 100 mg or 125 mg -- when it is given with Faslodex or tamoxifen (physician's choice) to treat patients with advanced breast cancer who have already been treated with an mTOR or PI3K inhibitor.
This is a Phase II trial

CUDC-907 in Advanced Breast Cancer (And Other Solid Tumors)

Phase I Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, an HDAC and PI3K Inhibitor, in Subjects With Advanced/Relapsed Solid Tumors (NCT02307240)

Summary

Researchers are trying to develop new drugs that can be used to treat hormone sensitive (ER+/PR+) tumors that have stopped responding to the currently available hormone therapies. CUDC-907 is a targeted therapy that works by blocking HDAC and PI3K, two enzymes that play an important role in cell growth. This study will determine the best dose, safety and efficacy of CUDC-907 for treating women with advanced breast cancer. To be eligible, a woman must have HER2-negative breast cancer that has been treated with at least one hormonal therapy in the advanced/metastatic setting or that recurred during adjuvant (after surgery) therapy. This trial is also enrolling patients with other types of solid tumors.
This is a Phase I trial

Molecular Profiling-Based Targeted Therapies for Metastatic Breast (and Other) Cancer

Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer: Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT 2) (NCT02152254)

Summary

Molecular profiling of a tumor may identify genetic mutations or biomarkers that suggest the tumor is likely to respond to a currently available targeted therapy. It is not known if choosing metastatic breast (or other types of) cancer based on the tumor's molecular profile is more effective than the current standard of care. All patients who enroll in this study will have molecular profiling performed on a biopsy of their tumor. If there is no mutation or biomarker found, the patient will receive the treatment their doctor determines is the best option. If a mutation or biomarker is found and there is an FDA-approved drug for the tumor type, patients will be offered that treatment. If there is a mutation or biomarker found but no FDA-approved drug that targets it, patients will be randomly assigned to either a targeted therapy or the standard of care.
This is a Phase II trial

Genomic Profiling to Recommend Treatment for Metastatic Breast (and other solid) Tumors

A Basket study: Tumor Genomic Profiling: A Personalized Medicine Approach (NCT02215928)

Summary

Genomic profiling of a tumor provides information about the specific genetic changes or abnormalities that are helping the cancer grow. Using this information may help doctors determine which treatments will be most effective. In this study, researchers will use genomic profiling to recommend treatments for patients with metastatic breast (and other solid) tumors. This will help them evaluate whether choosing treatment based on genomic profiling is more effective than using the standard treatment. To be eligible, participants must be be receiving breast cancer care at the Stanford Cancer Institute in California.

Ribociclib with Herceptin or Kadcyla for Advanced HER2-Positive Breast Cancer

An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer (NCT02657343)

Summary

Ribociclib (LEE011) is a new type of targeted therapy called a CDK 4/6 inhibitor. Trastuzumab (Herceptin®) and T-DM1 (Kadcyla®) are targeted therapies routinely used to treat HER2-positive breast cancer. This study is investigating the safety and best dose of ribociclib when given in combination with Herceptin or Kadcyla to treat individuals with advanced HER2-positive breast cancer that has not responded to standard treatment.
This is a Phase I-II trial

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

Targeted Agent and Profiling Utilization Registry (TAPUR) Study (NCT02693535)

Summary

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

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

A Randomized Phase II Trial of Fulvestrant With or Without Ribociclib After Progression on Aromatase Inhibition Plus Cyclin-dependent Kinase 4/6 Inhibition in Patients With Unresectable or Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer (NCT02632045)

Summary

Ribociclib (LEE011) is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. It works by inhibiting two enzymes, CDK4 and CDK6. Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat advanced breast cancer in postmenopausal women. This study is comparing the safety and effectiveness of Faslodex and ribocicilib to Faslodex and a placebo for treating HR+, HER2- advanced breast cancer. To be eligible, participants must have had their cancer progress after receiving an aromatase inhibitor (letrozole, exemestane, or anastrozole), and be in the process of switching their hormone therapy.
This is a Phase II trial

Tamoxifen and Ribociclib for Metastatic ER+, HER2- Breast Cancer

The TEEL Study: A Phase I Trial of Tamoxifen With Ribociclib (LEE011) in Adult Patients With Advanced ER+ (HER2 Negative) Breast Cancer (NCT02586675)

Summary

Tamoxifen (Nolvadex®) is an anti-estrogen therapy routinely used to treat breast cancer. Ribociclib (LEE011) is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. It works by inhibiting two enzymes, CDK4 and CDK 6. This study is evaluating the safety and effectiveness of using ribociclib along with tamoxifen to treat hormone-sensitive, HER2-negative advanced breast cancer. Premenopausal or perimenopausal women who enroll in this study will also receive goserelin (Zoladex®), a drug that is used to put a woman into temporary menopause. To be eligible, participants must not have already been treated with a CDK 4/6 therapy.
This is a Phase I trial

LY3023414 for Advanced Breast (and other) Cancers

A Phase 1 First-in-Human Dose Study of LY3023414 in Patients With Advanced Cancer (NCT01655225)

Summary

LY3023414 is an experimental drug that researchers believe has the potential to be effective against breast and other cancers. The purpose of this first-in-human study is to identify a safe recommended dose level and schedule of dosing for LY3023414. The study will also explore what affect LY3023414 has on certain biological markers (biomarkers) associated with tumor growth, as well as on the cancer cells. To be eligible, participants must have already tried, or not be able to take, other available standard therapies. (This trial is also enrolling individuals with advanced lymphoma and mesothelioma, and possibly other cancers as well.)
This is a Phase I trial

Vantictumab With Taxol in Advanced Breast Cancer

A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer (NCT01973309)

Summary

Cancer stem cells are the cancer cells that drive the tumor's growth. They create the cells that form the bulk of a tumor. Chemotherapy drugs are better at killing bulk tumor cells than they are at killing the cancer stem cells. Vantictumab is a new drug that is designed to target cancer stem cells. Paclitaxel (Taxol®) is a commonly used breast cancer treatment. This study will determine the best dose, safety, and tolerability of ventictumab when it is given with Taxol to treat women with HER2-negative locally recurrent or metastatic disease.
This is a Phase I trial

Faslodex & Taselisib in HER2- Tumors Previously Treated With an Aromatase Inhibitor

A Phase III, double-blind, placebo controlled, randomized study of taselisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with estrogen receptor-positive and HER2-negative locally advanced or metastatic breast cancer who have disease recurrence or progression during or after aromatase inhibitor therapy (NCT02340221)

Summary

Over time, hormone-sensitive tumors can stop responding to hormone therapy. Fulvestrant (Faslodex®) is used to treat advanced hormone-sensitive breast cancer in postmenopausal women whose tumors have stopped responding to other hormone therapies. Taselisib (GDC-0032) is a new type of drug that selectively blocks the PIK3CA pathway, which plays a role in cell growth and survival. This study is comparing the safety and effectiveness of Faslodex and Taselisib to Faslodex and a placebo in postmenopausal women with ER+, HER2- advanced breast cancer whose tumors have recurred or progressed during or after aromatase inhibitor therapy. All women interested in this study will have their tumor tested for a PIK3CA mutation. Only those women who have a tumor that tests positive for the mutation will be eligible to receive study drugs.
This is a Phase III trial

Cediranib plus Lynparza for Triple Negative Breast (and Other) Cancer

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

AZD1775 for Advanced Triple Negative Breast (and Other) Cancer

A Phase Ib, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumour Activity of AZD1775 Monotherapy in Patients With Advanced Solid Tumours (NCT02482311)

Summary

AZD1775 is a new targeted therapy that slows and stops cancer cell growth by blocking a protein called WEE1. Laboratory studies found that the combination of AZD1775 and chemotherapy killed more cancer cells than chemotherapy alone. This study is investigating the safety and effectiveness of using AZD1775 alone to treat advanced (recurrent or metastatic) triple-negative breast cancer. This study also is enrolling women with ovarian cancer and men and women with non-small cell lung cancer.
This is a Phase I trial

CPI-613 for Advanced Breast Cancer (and Other Solid Tumors)

An Open Label, Phase 2 Trial to Evaluate the Safety, Tolerability and Efficacy of CPI-613 in Cancer Patients (NCT01832857)

Summary

CPI-613 is a new targeted therapy that is designed to keep tumor cells from getting the energy they need to grow and multiply. This study is investigating the safety and effectiveness of CPI-613 in individuals with advanced breast (and other) solid tumors. To be eligible, patients must have no standard therapy options available or have refused further standard therapy.
This is a Phase II trial

PD-0332991 & T-DM1 in Advanced HER2+ Tumors with the Rb Protein

Phase 1B Study of PD-0332991 in Combination With T-DM1 in the Treatment of Patients With Advanced HER2 (Human Epidermal Growth Factor Receptor 2)-Positive Breast Cancer (NCT01976169)

Summary

Researchers are looking for new ways to treat HER2+ breast cancer that has stopped responding to trastuzumab (Herceptin®) or other HER2-targeted therapies. PD-0332991 (Palbociclib) is a new targeted therapy that works by blocking two enzymes, CDK4 and CDK6, that play a role in cell growth. Studies suggest that palbociclib may be effective in tumors that test positive for a tumor suppressor protein called retinoblastoma (Rb). Scientists estimate that between 20% and 35% of breast cancers test positive for the Rb protein. T-DM1 (Kadcyla®) is a HER2-targeted therapy that combines the chemotherapy drug DM1 with trastuzumab. This study will identify the best dose of palbociclib to use along with T-DM1 to treat HER2-positive recurrent or metastatic breast cancer. To be eligible, participants must have a tumor that tests positive for the Rb protein.
This is a Phase I trial

177Lu-J591 to Treat Metastatic Breast (and Other Solid) Tumors

177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study (NCT00967577)

Summary

Scientists are trying to find new ways to kill cancer cells that have spread throughout the body. 177Lu-J591 is a new drug that uses radiation to kill cancer cells. To take part, you must have metastatic breast cancer, and have no other treatment options available.

177Lu-J591 combines two chemicals J591 and 177Lutetium (177Lu). J591 is a protein that attaches to a molecule found on the blood vessels of cancer cells. 177Lu is a radioactive molecule. Scientists think that it can find and kill the blood vessels that help cancer cells grow.

MEDI4276 for HER2-Positive Advanced Breast (and Gastric) Cancer

A Phase I Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogencity, and Antitumor Activity of MEDI4276 in Subjects With Select HER2-expressing Advanced Solid Tumors (NCT02576548)

Summary

MEDI4276 is an experimental antibody drug-conjugate that targets HER2-positive tumors. Antibody drug-conjugates help deliver chemotherapy directly to cancer cells, thereby reducing its effect on healthy cells. This study is investigating the safety and the best dose of MEDI4276 for HER2-positive advanced breast (or gastric cancer). To be eligible, a patient must have advanced breast cancer that has stopped responding to standard therapy or for which no standard therapy exists.
This is a Phase I-II trial

Radiation With or Without Tykerb® for HER2+ Brain Metastases

Whole-Brain Radiation Therapy With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer (NCT01622868)

Summary

Whole-brain radiotherapy is the most frequently used therapy for breast cancer brain metastases. This is because most chemotherapy drugs are not able to cross the blood-brain barrier. Lapatinib (Tykerb®) is a kinase inhibitor that targets HER2 as well as the epidermal growth factor receptor (EGFR). It is used with capecitabine (Xeloda®) to treat advanced HER2+ breast cancer in people who have already been treated with other chemotherapy drugs. It is unclear whether Tykerb is able to cross the blood-brain barrier. The purpose of this trial is to determine if whole-brain radiotherapy given along with Tykerb is more effective than whole-brain radiotherapy given alone.
This is a Phase II trial

INCB054828 for Advanced Breast (and Other) Cancers

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (NCT02393248)

Summary

INCB054828 is a new targeted therapy that is designed to block the FGF (fibroblast growth factor) or FGFR (fibroblast growth factor receptor) protein. Laboratory studies show that targeting the FGF or FGFR protein may be an effective way to slow or stop cancer cell growth. In this study, researchers will determine the maximum tolerated dose of INCB054828 alone and in combination with standard therapy for individuals with advanced breast (and other) solid tumors.
This is a Phase I-II trial

ABBV-075 for Advanced Breast (and Other) Cancers

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Advanced Cancer (NCT02391480)

Summary

ABBV-075 is new targeted therapy designed to block the bromodomain (BRD)-containing protein. Laboratory studies suggest blocking this protein can slow or stop cancer cell growth. This study will determine the maximum tolerated dose of ABBV-075 in women and men with advanced breast (and other) solid tumors. To be eligible, a patient must have progressed on standard therapy or not have a standard therapy available.
This is a Phase I trial

A New Type of Targeted Drug for Metastatic Breast Cancer

A Phase I, First-in-Human, Dose Escalation Trial of MSC2363318A, a Dual p70S6K/Akt Inhibitor, in Subjects With Advanced Malignancies (NCT01971515)

Summary

To take part in this study, you must have hormone sensitive-–ER-positive and/or PR-positive-–breast cancer. You must also have cancer cells that do not respond well to trastuzumab (Herceptin®) or tamoxifen (Nolvadex®) or that do not have the normal type of PAM (PI3K, Akt, mTOR) pathway inside their cells. This study is looking at the safety of a new type of targeted drug called MSC2363318A. It targets the PAM pathway and it may decrease or stop tumor growth. This study will also help researchers learn the best dose of MSC2363318A to use with Herceptin or tamoxifen to treat metastatic breast cancer. This is the first time MSC2363318A is being studied in a clinical trial.
This is a Phase I trial

CDX-011 or Xeloda for Advanced Triple Negative Breast Cancer

A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC Study) (NCT01997333)

Summary

Researchers are developing new types of targeted cancer treatments. Glembatumumab vedotin (CDX-011) is a new drug that targets a protein, called gpNMB, that helps tumors spread (metastasize) to other parts of the body. Early studies suggest CDX-011 may be effective in patients with triple-negative (ER, PR and HER2-negative) breast cancer. Capecitabine (Xeloda®) is a chemotherapy drug used to treat triple-negative breast cancer. This trial is comparing the safety and effectiveness of CDX-011 to Xeloda in patients with triple-negative breast cancer that has spread (metastasized) to other parts of the body. All patients who are interested in this study will have their tumor tested to determine its gpNMB status. Only those whose tumors test positive for gpNMB will be able to enter the study.
This is a Phase II 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

LSZ102 Alone or With Ribociclib or Alpelisib in ER+ Advanced Breast Cancer

A Phase I/Ib, Open Label Study of LSZ102 Single Agent and LSZ102 in Combination With Either LEE011 (LSZ102 + LEE011) or BYL719 (LSZ102 + BYL719) in Patients With Advanced or Metastatic ER+ Breast Cancer Who Have Progressed After Endocrine Therapy (NCT02734615)

Summary

Researchers are developing new drugs to treat hormone-sensitive metastatic breast cancer. LSZ102 is a new drug that works by destroying the estrogen receptor. In this study, researchers will determine the best dose of LSZ102 to give alone or in combination with a targeted drug. The two targeted drugs are called ribociclib and alpelisib. To take part in this study, you must have ER+ advanced or metastatic breast cancer and already have been treated with hormone therapy.
This is a Phase I trial

Entinostat and Aromasin in Postmenopausal Women with ER+ Advanced Breast Cancer

A Phase 1, Two-Cohort, Open-Label, Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer (NCT02820961)

Summary

To take part in this study, you must be postmenopausal, have ER+ locally advanced or metastatic breast cancer, and have your doctor say you are eligible to receive exemestane (Aromasin®). This study is looking at whether it is safe and effective to use Aromasin and entinostat together to treat ER+ advanced breast cancer. Entinostat is a type of experimental therapy called a histone deacetylase (HDAC) inhibitor. It blocks proteins that help tumors grow and survive. Aromasin is used to treat hormone-sensitive tumors in postmenopausal women.
This is a Phase I trial

Veliparib and Tykerb for Treating Triple Negative Metastatic Breast Cancer

An Open Label, Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative (ER, PR, and HER-2 Negative) Breast Cancer (NCT02158507)

Summary

Researchers are trying to find more effective treatments for triple-negative (ER-, PR-, HER2-) breast cancer. Veliparib (ABT-888) is a new type of cancer therapy called a PARP inhibitor. It works by blocking an enzyme that is needed for cancer cell growth. Lapatinib (Tykerb®) is used in combination with other drugs to treat HER2+ advanced breast cancer. Laboratory studies have shown that Veliparib and Tykerb can slow or stop the growth of triple negative breast cancer cells. This study is evaluating the safety and effectiveness of Veliparib and Tykerb in women with triple-negative metastatic breast cancer.

HER2-Targeted Therapies Through the Spine for HER2+ Brain Mets

Phase I Dose Escalation Trial of Intrathecal Pertuzumab and Trastuzumab in Patients With New Untreated Asymptomatic or Low Symptomatic Brain Metastasis (NCT02598427)

Summary

HER2-positive breast cancer is treated with HER2-targeted treatments. Researchers think injecting HER2-targeted treatments into the spine may help kill HER2+ breast cancer cells that have spread to the brain. The two HER2-targeted treatments used in this study are pertuzumab (Perjeta®) and trastuzumab (Herceptin®). Putting these treatments into the spine may help the drugs get through the blood-brain barrier. To take part, you must have HER2-positive metastatic breast cancer and brain metastasis that are untreated and that have few or no symptoms.
This is a Phase I trial

GS-5829 for Postmenopausal Women with ER+ Metastatic Breast Cancer

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 as a Monotherapy in Subjects With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Subjects With Estrogen Receptor Positive Breast Cancer (NCT02392611)

Summary

To take part in this study, you must be postmenopausal (no longer be getting your period) and have ER+ metastatic breast cancer. GS-5829 is a newly developed drug that researchers think that may be effective in treating ER+ metastatic breast cancer. It is only available in clinical trials. This study will allow researchers to see whether it is safe to treat breast cancer patients with GS-5829. It will also help the researchers identify the best dose of GS-5829 to use when the drug is given with an anti-estrogen drug commonly used to treat advanced breast cancer. The two anti-estrogen drugs used in this study are exemestane (Aromasin®) and fulvestrant (Faslodex®).
This is a Phase I trial

MK-8628 for Metastatic Triple Negative Breast (and Other Solid) Tumors

A Phase IB Dose Exploration Trial With MK-8628, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects With Selected Advanced Solid Tumors (NCT02698176)

Summary

This study is looking at the safety and best dose of a new drug called MK-8628 for treating metastatic breast cancer. To take part, you must have advanced, triple negative breast cancer and have no standard therapy available.

MK-8628 (OTX015) is an experimental drug that targets a protein called BET. Researchers think using a drug that blocks this protein can keep cancer cells from growing.
This is a Phase I trial

Ibrance for Metastatic HER2+ or Triple-Negative Breast Cancer That Has Spread to the Brain

A Phase II Single Arm Study of Palbociclib in Patients With Metastatic HER2-Positive and Triple Negative Breast Cancer With Brain Metastasis (NCT02774681)

Summary

Researchers think the drug palbociclib (Ibrance®) can help treat breast cancer that has spread to the brain. To take part in this study, you must have triple negative or HER2-negative breast cancer that has spread to the brain; you cannot already have been treated with Ibrance; and you cannot have any type of chemotherapy within 2 weeks of starting Ibrance.

Breast cancer that has spread to the brain is difficult to treat because most cancer drugs cannot get through the blood-brain barrier. Ibrance is a new type of drug that keeps cancer cells from growing by blocking two enzymes called CDK4 and CDK6. It is used to treat breast cancer that has spread to other parts of the body.
This is a Phase II trial

Abemaciclib for HR+, HER2+ Advanced Breast Cancer

monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (NCT02675231)

Summary

Cancer is treated with different types of drugs. In this study, researchers are looking at different combinations of drugs that can be combined with trastuzumab (Herceptin®) to treat hormone-receptor positive (HR+), HER2+ locally advanced breast cancer that has come back (recurred) or metastatic breast cancer. To take part, you must have already received at least two HER2-targeted drugs.

There are three drugs used in this study. Abemaciclib (LY2835219), a new type of targeted drug called a CDK 4/6 inhibitor. Trastuzumab (Herceptin®), a HER2-targeted drug. And fulvestrant (Faslodex®), an anti-estrogen drug used to treat ER+ metastatic breast cancer in postmenopausal women who have tried other anti-estrogen drugs.
This is a Phase II trial

INCB057643 for Metastatic Breast (and Other) Cancers

A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies (NCT02711137)

Summary

INCB057643 is a new drug that lab studies suggest may be a good breast cancer treatment. This study is looking at the safety, best dose and side effects of INCB057643 when it is used to treat metastatic breast cancer. To take part, you must have metastatic breast cancer that has been treated with at least one other drug. This study also is enrolling patients with other types of cancers.
This is a Phase I-II trial

Ribociclib with Afinitor + Aromasin in HR+ HER2- Advanced Breast Cancer

A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor (NCT02732119)

Summary

Researchers want to learn the best way to treat breast cancer patients who already have been treated with a CDK4/6 targeted therapy. This study is looking at the safety and effectiveness of treating these patients with a three drug combination: ribociclib (LEE011), everolimus (Afinitor®), and exemestane (Aromasin®). Ribociclib (LEE011) is a targeted therapy that blocks CDK4 and CDK6. Afinitor is a type of targeted therapy called an mTOR inhibitor. It is used along with Aromasin to treat advanced hormone sensitive (HR+), HER2- breast cancer. To take part, you must have HR+, HER2- locally recurrent or metastatic breast cancer. You also must already have been treated with fulvestrant/Faslodex® or tamoxifen/Nolvadex® and a CDK4/6-targeted therapy.
This is a Phase I-II trial

A New Immunotheray Drug (PF-06671008) for Advanced Breast (and Other Solid) Tumors

A Phase 1 Dose Escalation Study Evaluating The Safety And Tolerability Of PF-06671008 In Patients With Advanced Solid Tumors (NCT02659631)

Summary

This study is looking to find the safest and most effective dose of a new drug called PF-06671008 to treat breast cancer. The drug helps the immune system kill cancer cells. To take part, you must have advanced breast (and other solid) tumor and have no standard treatment options.

PF-06671008 is a type of drug called an immunotherapy. It blocks a protein found on breast cancer cells called p-cadherin. Blocking this protein allows the immune system to find and kill cancer cells.
This is a Phase I trial

Effect of Entinostat on the Heart in Individuals with Advanced Cancer

A Phase 1 Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors(NCT02897778)

Summary

To take part in this study, you must be diagnosed with advanced breast cancer (some stage III and stage IV) that has not responded to standard treatment. Some cancer treatments may cause heart damage. Entinostat is a new type of cancer treatment called a histone deacetylase (HDAC) inhibitor. It is available only in clinical trials. This study is evaluating the safety of entinostat and the effect it has on the heart when it is given to patients with advanced cancer.
This is a Phase I trial

Talazoparib for Advanced Cancer in Individuals with a BRCA Mutation (EMBRACA Study)

A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of BMN 673 Versus Physician's Choice in Germline BRCA Mutation Subjects With Locally Advanced and/or Metastatic Breast Cancer, Who Have Received No More Than 2 Prior Chemotherapy Re... (NCT01945775)

Summary

Talazoparib (BMN 673) is a PARP inhibitor. PARP inhibitors are believed to kill cancer cells by preventing PARP from repairing damaged DNA. Data suggest that PARP inhibitors may be as or more effective than current treatments for patients with a BRCA mutation. Early clinical data have shown that talazoparib is highly active in breast cancer patients who have a BRCA mutation and is generally well tolerated at a dose of 1 mg once daily.

There are no treatments approved specifically for patients with breast cancer associated with a BRCA mutation. This study is comparing the safety and effectiveness of talazoparib to physician’s choice of treatment as listed in the protocol in patients with a BRCA mutation and advanced or metastatic breast cancer. (Individuals randomized to the control group will have their doctor determine which of the four agents they should receive.) Once eligibility is confirmed, patients will receive treatment for as long as their disease is stable and the treatment is well tolerated.
This is a Phase III 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 trial

Ibrance and Femara in African-American Women with Advanced HR+ HER2- Breast Cancer

Phase II Safety Study of Palbociclib in Combination With Letrozole in African American Women With Hormone Receptor Positive HER2 Negative Advanced Breast Cancer (NCT02692755)

Summary

Researchers want to learn more about the safety and effectiveness of breast cancer treatments in African-American women. In this study, women will receive two drugs, palbociclib (Ibrance®) and letrozole (Femara®). The researchers will study the drug's effectiveness. They will also study whether this drug combination increases your risk of developing an infection by lowering your number of white blood cells. This condition is called neutropenia. Ibrance is a targeted therapy that blocks two different enzymes. Femara is a hormone therapy used to treat postmenopausal women with advanced breast cancer. To take part in this study, you must identify as Black, African or African-American and have hormone-sensitive, HER2-negative advanced breast cancer. And, you must not have already been treated with a CDK 4/6 inhibiting therapy.
This is a Phase II-III trial

PF-06647263 in Patients with Stage III or IV Breast Cancer (and Other Solid Tumors)

A First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647263 In Adult Patients With Advanced Solid Tumors (NCT02078752)

Summary

PF-06647263 is a new type of targeted therapy called an antibody drug conjugate. These cancer treatments are designed to use a targeted therapy to deliver chemotherapy directly to the cancer cells. This study is investigating the safety and best dose of PF-06647263 for treating stage III or stage IV (metastatic) breast tumors (and other advanced solid tumors). To be eligible, a participant's tumor must be resistant to standard therapy or the participant must have no standard therapy available.
This is a Phase I trial

Gedatolisib with Ibrance and Femara or Faslodex in ER+ HER2- Metastatic Breast Cancer

Phase 1b Study To Assess The Safety, Tolerability, And Clinical Activity Of Gedatolisib In Combination With Palbociclib And Either Letrozole Or Fulvestrant In Women With Metastatic Or Locally Advanced/Recurrent Breast Cancer (MBC) (NCT02684032)

Summary

Researchers are studying new treatment combinations for metastatic breast cancer. Palbociclib (Ibrance®) is a targeted drug that is used to treat metastatic breast cancer. It is given along with hormone therapy--either letrozole (Femara®) or fulvestrant (Faslodex®). This study is looking at the best dose of gedatolisib to add to the combination. To take part in this study, you must have ER-positive and HER2-negative metastatic breast cancer.
This is a Phase I trial

IMMU-132 for Metastatic Breast Cancer

A Phase I Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer (NCT01631552)

Summary

New treatments are needed for metastatic breast cancer. IMMU-132 is an experimental drug that combines a monoclonal antibody that binds to cancer cells with a chemotherapy agent. The chemotherapy agent is an active form of Irinotecan (Camptosar®), which is used to treat metastatic breast cancer and other types of cancers. Laboratory studies suggest that IMMU-132 maybe an effective way of delivering chemotherapy directly to breast cancer cells. (It is also being studied in 12 other types of cancers.) The purpose of this study is to test the safety of IMMU-132 at different dose levels.
This is a Phase I-II trial

Afinitor, Femara and Herceptin for Metastatic ER+, HER2+ Tumors

Combination Treatment With Everolimus, Letrozole and Trastuzumab in Hormone Receptor and HER2/Neu-positive Patients With Advanced Metastatic Breast Cancer and Other Solid Tumors: Evaluating Synergy and Overcoming Resistance (NCT02152943)

Summary

Researchers are studying new drug combinations for treating metastatic breast cancer. Letrozole (Femara®) is an aromatase inhibitor used to treat ER+ tumors. Everolimus (Afinitor®) is an mTOR inhibitor. It is used along with exemestane (Aromasin®) to treat postmenopausal women with advanced ER+, HER2- breast cancer. Trastuzumab (Herceptin®) is used to treat HER2+ tumors. This study will identify the highest dose of Femara that can be given along with Afinitor and Herceptin to postmenopausal women with metastatic ER+, HER2+ tumors and evaluate the safety of the drug combination. This study is also enrolling patients with other types of cancers.
This is a Phase I trial

Keytruda plus Chemotherapy in Advanced Triple Negative Breast Cancer

A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355) (NCT02819518)

Summary

To take part in this study, you must have stage III breast cancer that has come back (recurred) or stage IV (metastatic) triple negative (ER-/PR-/HER2-) breast cancer. You must not have been treated with chemotherapy. This study is investigating whether chemotherapy drugs that kill cancer cells work better if they are given along with a drug that gets the immune system to kill cancer cells (immunotherapy.) If you enroll, you will be put into one of two groups. One group will receive Keytruda and a chemotherapy drug. The other group will receive a placebo and a chemotherapy drug. You have the same chance of being put into either group. The immunotherapy drug being used in this study is pembrolizumab (Keytruda®). The chemotherapy drugs are paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), gemcitabine (Gemzar®), and carboplatin (Paraplatin®). You will receive one of these chemotherapy drugs.
This is a Phase III trial

VX-970 and Gemzar or Platinol in Patients with Advanced Triple Negative Breast Cancer

An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of VX-970 in Combination With Cytotoxic Chemotherapy in Subjects With Advanced Solid Tumors (NCT02157792)

Summary

Researchers are developing new types of cancer treatments. VX-970 is a targeted therapy that works by blocking the ATR protein, an enzyme that cells use to repair damaged DNA. Cisplatin (Platinol®) and Gemcitabine (Gemzar®) are two chemotherapy drugs routinely used to treat breast cancer. This study is designed to determine the safety and best dose of VX-970 when it is given along with Gemzar or Platinol to patients with locally advanced incurable or metastatic triple-negative breast cancer. This is the first study to test VX-970 study in humans. This study also is enrolling patients with other types of solid tumors. To be eligible, a patient must have already received a taxane-based chemotherapy regimen and have not had radiation or systemic therapy within last 4 weeks.
This is a Phase I trial

T-DM1 With Abraxane and Tykerb for HER2-Positive Metastatic Breast Cancer

Phase Ib Trial of Trastuzumab Emtansine In Combination With Lapatinib Plus Abraxane In Metastatic Her 2 Neu Over-Expressed Breast Cancer Patients (NCT02073916)

Summary

Researchers believe using a HER2-targeted drug along with other anti-cancer drugs may be a more effective way to treat HER2-positive metastatic breast cancer. Trastuzumab emtansine (T-DM1) is a HER2-targeted therapy used to treat metastatic HER2+ breast cancer. Nab-paclitaxel (Abraxane®) is an injectable form of paclitaxel (Taxol®) used to treat advanced breast cancer. Lapatinib (Tykerb®) is a type of targeted therapy called a tyrosine kinase inhibitor. It is used along with other drugs to treat advanced or metastatic breast cancer. Combining T-DM1, Abraxane and Tykerb may be an effective treatment for HER2+ metastatic breast cancer. This study will test the safety of T-DM1 in combination with different dose levels of Abraxane and Lapatinib in patients with HER2+ breast cancer.
This is a Phase I-II trial

GDC-0032 For Advanced Breast Cancer

An Open-Label, Phase I/II, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors and in Combination With Endocrine Therapy in Patients With Locally Advanced or ... (NCT01296555)

Summary

Over time, hormone-sensitive tumors can stop responding to hormone therapy. GDC-0032 is a new type of drug called a PI3-kinase inhibitor. It targets PI3 alpha, a protein found in about 40 percent of hormone sensitive breast tumors and that may be linked to hormone resistance. Fulvestrant (Faslodex) is used to treat postmenopausal women with hormone sensitive advanced breast cancer. In the first phase of this trial, the researchers will study the safety of GDC-0032. In the second phase, the researchers will study the safety and effectiveness of combining GDC-0032 and Faslodex. Both phases will enroll postmenopausal women with hormone-sensitive advanced breast cancer who have already been treated with hormone therapy.
This is a Phase I trial

MLN0128 With Hormone Therapy in ER+, HER2- Metastatic Breast Cancer

A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant (NCT02049957)

Summary

Targeted therapies called mTOR inhibitors are a new type of cancer treatment. Everolimus (Afinitor®) is an mTOR inhibitor. Exemestane (Aromasin®) is an aromatase inhibitor used to treat postmenopausal women. Fulvestrant (Faslodex®) is a hormone therapy used to treat women with hormone-sensitive tumors that have stopped responding to anti-estrogens. MLN0128 is a new mTOR kinase inhibitor that may work better than Afinitor. This study is investigating the safety and effectiveness of using MLN0128 along with Aromasin compared with using MLN0128 along with Faslodex to treat women with ER+, HER2- advanced breast cancer who have progressed on treatment with Afinitor in combination with Aromasin or Faslodex.
This is a Phase I-II trial

Xalkori and Sutent for HER2-Negative Metastatic Breast Cancer

A Phase IB Study of Crizotinib (XALKORI) and Sunitinib (SUTENT) in Metastatic Breast Cancer (NCT02074878)

Summary

Targeted therapies used to treat other types of cancers may also be effective breast cancer treatments. Crizotinib (Xalkori®) is a targeted therapy used to treat metastatic non-small cell lung cancer in patients whose tumors have an ALK mutation. Sunitinib (Sutent®) is used to treat pancreatic cancer. It blocks tumors from growing the new blood vessels they need to survive. This study is designed to determine the safety, best dose, and tolerability of using Xalkori and Sutent together to treat HER2-negative metastatic breast cancer. To be eligible, participants must have already had two types of systemic therapy for breast cancer. Participants whose tumors are hormone sensitive (ER+ and/or PR+) must have already had their metastatic breast cancer treated with one hormonal therapy and one chemotherapy.
This is a Phase I trial

Neratinib For HER2-Negative Metastatic Breast Cancer

A Phase II Study of Neratinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer (NCT01670877)

Summary

About 25 percent of individuals with breast cancer have tumors that have a genetic mutation that causes the cancer cells to have too many copies of the HER2 gene and too many HER2 receptors. These tumors are called HER2-positive, and they can be treated with the anti-HER2 targeted therapies Herceptin and Tykerb. Scientists recently discovered that some HER2-negative tumors have other types of HER2 genetic mutations that might make them respond to anti-HER2 targeted therapies. Neratinib is a new targeted therapy being developed to treat HER2-positive tumors. Researchers think it may also be effective in individuals whose tumors are HER2-negative but have these newly discovered HER2 mutations. The purpose of this study is to evaluate Neratinib in participants with metastatic breast cancer whose tumors are HER2-negative but have these HER2 mutations. Participants who meet the entry criteria for this study will have their tumor tested for HER2 mutations. Only those who are found to have a HER2 mutation will be able to take part in the study.
This is a Phase II trial

Xofigo, Xgeva & Hormone Therapy to Treat ER+ Bone Metastases

Phase II Trial of Radium-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer (NCT02366130)

Summary

Researchers are trying to find ways to effectively treat ER+ breast cancer that has spread (metastasized) to the bone. Radium-223 dicholoride (Xofigo®) uses radioactive particles that mimic calcium to enter the bone and target cancer cells. It is approved to treat bone metastases in prostate cancer. Denosumab (Xgeva®) is used in patients with bone metastases to prevent fractures, spinal cord compression, or the need for bone radiation or surgery. Tamoxifen, aromatase inhibitors, and fulvestrant (Faslodex®) are hormone therapies used to treat hormone-sensitive metastatic breast cancer. This study will determine the safety and effectiveness of giving Xofigo, Xgeva and a hormone therapy (selected by the doctor) to treat bone metastases in women with ER+ breast cancer. To be eligible, a patient must have had no prior or only one prior treatment for metastatic breast cancer and must have a metastatic site biopsied to confirm it is ER+.
This is a Phase II trial

PM01183 for Metastatic Breast Cancer

A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer (NCT01525589)

Summary

Researchers are studying new drugs that may be effective in treating metastatic breast cancer. Laboratory studies suggest that PM01183, a drug that promotes cancer cell death by binding to specific pieces of DNA, may be an effective cancer therapy. This study is looking at whether PM01183 is effective in women with metastatic breast cancer, and whether women who carry a BRCA 1/2 genetic mutation are more likely to respond to this drug. To be eligible for "Group A", a patient must have a known BRCA 1/2 mutation. Patients who do not have a BRCA1/2 mutation may be eligible for "Group B."
This is a Phase II trial

First Study of AZD8186 in Patients

A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD8186 in Patients With Advanced Castrate-resistant Prostate Cancer (CRPC), Squamous Non-Small Cell Lung Cancer (sqNSCLC), Triple Negative Breast Cancer (TNBC)... (NCT01884285)

Summary

AZD8186 is a new cancer therapy that works by inhibiting PI3K, a group of proteins that help cancer cells to grow. It is designed specifically for cancers that are characterized as being deficient in PTEN, a gene that regulates cell growth. The purpose of this study is to determine the safest, best dose of AZD8186 in PTEN-deficient cancers. This trial is enrolling individuals with triple negative breast cancer as well as other cancers.
This is a Phase I trial

ABBV-221 for Advanced Tumors That Are EGFR-Positive

A Phase 1 Study of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor (NCT02365662)

Summary

The epidermal growth factor receptor (EGFR) is found on the surface of many types of cancer cells. Triple negative (ER-, PR- and HER2-) breast tumors are likely to exhibit higher levels of EGFR. Researchers think that these high levels of EGFR may help fuel the cancer cell's growth. ABBV-221 is a new type of targeted therapy, delivered by IV, that is designed to block the EGFR receptor. This study will determine the safety and best dose of ABBV-221 when it is used to treat advanced triple-negative breast cancer (and other solid tumors) that are EGFR-positive.
This is a Phase I trial

LEE011, Afinitor & Aromasin in ER+ HER2- Advanced Breast Cancer

A Phase Ib/II Trial of LEE011 in Combination With Everolimus (RAD001) and Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive, Her2- Locally Advanced or Metastatic Breast Cancer (NCT01857193)

Summary

LEE011 is a new oral drug that targets two enzymes--CDK4 and CDK6--that play a role in cell growth. Laboratory studies suggest LEE011 can slow or stop the growth of cancer cells. Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. Exemestane (Aromasin®) is used to treat hormone-sensitive tumors. Afinitor is used along with Aromasin to treat ER+, HER2- advanced breast cancer. This study is comparing the safety and tolerability of using the combination of LEE011, Afinitor, and Aromasin, or the combination of LEE011 and Aromasin, to the safety and tolerability of Afinitor and Aromasin in women ER+, HER2- advanced breast cancer.
This is a Phase I trial

POL6326 and Halaven for HER2- Metastatic Breast Cancer

A Phase I Dose Escalation Study of POL6326 With Eribulin in Patients With Relapsed, Triple Negative and Hormone Refractory ER Positive Metastatic Breast Cancer (NCT01837095)

Summary

POL6326 is a new type of drug called a CXCR4 inhibitor. It blocks proteins that help cancer cells spread to and survive in other parts of the body. Eribulin (Halaven®) is a chemotherapy drug used to treat advanced breast cancer that has not responded to or has stopped responding to other chemotherapy drugs. This trial is studying the safety and tolerability of different doses and dosing frequencies of POL6326 in combination with Halaven in women with HER2-negative metastatic breast cancer. To be eligible for this trial, participants must have tried at least two but no more than three chemotherapy regimens for metastatic cancer and have been treated with an anthracycline and taxane in either the adjuvant or metastatic setting.
This is a Phase I trial

Romidepsin for Patients with Breast Cancer & Liver Dysfunction

A Phase 1 and Pharmacokinetic Single Agent Study of Romidepsin in Patients With, Lymphomas, Chronic Lymphocytic Leukemia and Select Solid Tumors and Varying Degrees of Liver Dysfunction (NCT01638533)

Summary

Targeted therapies are being developed that may be effective against many different types of tumors, including breast cancer. Romidepsin (Istodax®) is an HDAC inhibitor. It works by entering cancer cells and blocking the activity of proteins, called histone deacetylases, that are important for the cancer's growth and survival. Romidepsin was approved in November 2009 for the treatment of cutaneous T-cell lymphoma. Since then, researchers have conducted studies to see if it might also be effective in patients with other types of cancer. This study is evaluating the safety of different dose levels of romidepsin in cancer patients with varying degrees of abnormal liver function. To be eligible, patients must have breast cancer (or lymphoma, chronic lymphocytic leukemia, or other certain solid tumors for which standard treatment is no longer effective) and be experiencing liver dysfunction.
This is a Phase I trial

A New Approach to Studying HER2+ Targeted Therapies

Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuzumab, or Combination Trastuzumab + Lapatinib (NCT01875666)

Summary

Researchers are looking for ways to determine which HER2-targeted therapies are most effective for which patients. They also want to learn more about what makes a cancer cell stop responding to a HER2-targeted therapy. Kinases are a group of proteins that are important in how cancer cells grow. HER2 is a kind of kinase. Giving drugs before surgery--called neoadjuvant treatment--allows researchers to study how cancer cells respond to the treatment. In this study, trastuzumab (Herceptin®); pertuzumab (Perjeta®); Herceptin and Perjeta; and Herceptin and lapatinib (Tykerb®) will be given before surgery to patients to study the effect they have on kinases in cancer cells. To be eligible, participants must be newly diagnosed and planning on having surgery for breast cancer.
This is a Phase O 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 conjugates (ADCs) are cancer therapies that combine 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

Everolimus, Herceptin & Vinorelbine for HER2+ Brain Metastases

A Phase II Study Evaluating The Efficacy And Tolerability Of Everolimus (RAD001) In Combination With Trastuzumab And Vinorelbine In The Treatment Of Progressive HER2-Positive Breast Cancer Brain Metastases (NCT01305941)

Summary

Breast cancer that has metastasized (spread) to the brain is difficult to treat because most chemotherapy drugs are unable to cross the blood-brain barrier into the brain. Scientists are trying to develop new therapies that will overcome this problem. Everolimus (Afinitor®) is a type of drug called an mTOR inhibitor. It works by interfering with the mTOR (mammalian target of rapamycin) protein, which is responsible for cell growth. Studies have shown that everolimus can cross the blood-brain barrier. Vinorelbine (Navelbine®) and trastuzumab (Herceptin®) are two drugs that are commonly used to treat metastatic HER2+ breast cancer. This trial will evaluate the effectiveness, safety, and tolerability of a treatment regimen that combines everolimus with vinorelbine and Herceptin in patients with HER2-positive breast cancer brain metastases.
This is a Phase II trial

Aromatase Inhibitor & Herceptin & Perjeta in ER+, HER2+ Metastatic Breast Cancer

A Randomized, Two-arm, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-positive and Hormone Receptor-positive Advanced (Metastatic or Locally Advanced) Breast Cancer. (NCT01491737)

Summary

Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are HER2-targeted therapies used to treat HER2+ breast cancer. Aromatase inhibitors are hormone therapies used to treat hormone-sensitive tumors. This study is comparing the safety and effectiveness of Perjeta, Herceptin, an AI, and chemo to Herceptin, an AI, and chemo in patients with metastatic HER2+, ER+ breast cancer. To be eligible, participants must have not yet received treatment for metastatic breast cancer.
This is a Phase II trial

ENMD-2076 in Previously Treated Advanced Triple Negative Tumors

A Phase II Study of the Aurora and Angiogenic Kinase Inhibitor ENMD-2076 in Previously Treated Locally Advanced and Metastatic Triple-Negative Breast Cancer (NCT01639248)

Summary

Researchers are developing new drugs that can effectively treat triple negative breast cancer. ENMD-2076 is an investigational oral drug. It has already been studied in phase I trials in patients with advanced breast cancer. (It also is being studied in patients with other types of advanced solid tumors.) It works by blocking a number of enzymes, called kinases (Aurora A, VEGFR, Fit-3 and FGFR3), that have been shown to play a role in cancer growth. Early studies suggest that triple-negative breast tumors may respond to ENDM-2076 when it is given alone or in combination with standard chemotherapy. This trial is investigating how previously treated locally advanced or metastatic triple negative breast tumors responds to ENMD-2076.
This is a Phase II trial

MGAH22 for Metastatic Breast Cancer with a 2+ HER2 Status

A Phase I Clinical Trial of mTOR Inhibition With Rapamycin for Enhancing Intranodal Dendritic Cell Vaccine Induced Anti-Tumor Immunity In Patients With NY-ESO-1 Expressing Solid Tumors (NCT01828021)

Summary

Breast cancer tumors are tested to determine their HER2 status. Two tests are used: IHC and FISH. A tumor that scores 3+ on IHC or positive on the FISH test is most likely to respond to a HER2-targeted therapy. MGAH22 (margetuximab) is a new targeted therapy that researchers believe may be effective in patients whose tumors score less than 3+ on IHC or negative on the FISH test. The goal of this study is to see how metastatic tumors that score 2+ on an IHC test respond to MGAH22.
This is a Phase II 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

Ibrance and Tamoxifen for HR+, HER2- Advanced Breast Cancer

A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium BTCRC-BRE15-016 (NCT02668666)

Summary

To take part in this study, you must have hormone receptor-positive (ER+/PR+), recurrent stage III or stage IV metastatic breast cancer. You must also have recently received this diagnosis and not yet had any treatment for it. This study is investigating how well a targeted drug along with an anti-estrogen drug work as a first-line treatment for metastatic breast cancer or stage III recurrent breast cancer. The targeted drug being used in this study is palbociclib (Ibrance®). The anti-estrogen drug is tamoxifen (Nolvadex®).
This is a Phase II trial

IGF-Methotrexate Conjugate For Advanced Tumors Expressing IGF-1R

STM-02: Phase I Study of IGF-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing IGF-1R (NCT02045368)

Summary

Studies have shown that the insulin-like growth factor 1 receptor (IGF-1R) is overexpressed in a number of different types of cancers, including breast cancer. IGF-methotrexate conjugate (765IGF-MTX) is a targeted therapy that delivers the chemotherapy drug methotrexate by attaching it to insulin-like growth factor (IGF). Laboratory studies have shown that IGF-methotrexate conjugate is more effective at killing cancer cells than methotrexate. This study is designed to establish the side effects and best dose of IGF-methotrexate conjugate in patients with advanced tumors that have stopped responding to standard therapy. Patients interested in this trial will have their tumors tested for IGF-1R. Those who have a tumor that tests positive for IGF-1R will be eligible for the study.
This is a Phase I trial

Olaparib with AZD2014 or AZD5363 for Recurrent Triple Negative Breast Cancer

A Phase Ib Study of the Oral PARP Inhibitor Olaparib With the Oral mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial, Triple Negative Breast, and Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT02208375)

Summary

Researchers are developing new types of cancer treatments. Olaparib is a new type of cancer drug called a PARP-inhibitor. It interferes with the cancer cell's DNA, making it more sensitive to chemotherapy. AZD2014 is a new type of targeted therapy called an mTOR1/2 inhibitor. AZD5363 is a new type of targeted therapy called an AKT protein kinase inhibitor. This study is investigating the best dose and combination of olaparib, AZD2014 and AZD5363 to use in treating women with recurrent triple negative (ER-, PR-, HER2-) breast cancer. This study also is enrolling women with endometrial, ovarian, primary peritoneal or fallopian tube cancers.)
This is a Phase I-II trial

Enoblituzumab for Metastatic Triple Negative Breast (and Other) Cancers

A Phase 1 Dose Escalation Study of MGA271 in Refractory Cancer (NCT01391143)

Summary

To take part in this study, you must have been diagnosed with triple negative (ER-/PR-/HER2-) breast cancer that has spread (metastasized) to other parts of your body. You must also have a tumor that makes too much of a protein called B7-H3. In addition, you must have already received a drug that your cancer progressed on or did not respond to. This study is being done to learn if a new cancer drug called enoblituzumab (MGA271) kills cancer cells, the types of side effects it causes, and the best dose of the drug to use. Enoblituzumab is a new type of targeted drug. It is only available in clinical trials.
This is a Phase I trial

A HER2-Targeted Drug for Advanced HER2-Positive Breast Cancer

Phase I Trial of ZW25 in Patients With Locally Advanced (Unresectable) and/or Metastatic HER2-expressing Cancers (NCT02892123)

Summary

To take part in this study, you must have stage III or stage IV (metastatic) HER2-positive breast cancer and have already received at least one treatment for your cancer. This study is investigating whether a new type of HER2-targeted drug is safe and effective. It will also determine the most effective dose of the drug that can be used safely. The drug being studied is called ZW25. This study is also open to patients with other types of HER2-positive cancers.
This is a Phase I trial

Cobimetinib and Paclitaxel for Advanced Triple Negative Breast Cancer

A Study of Cobimetinib in Combination With Paclitaxel as First-line Treatment for Patients With Metastatic Triple-negative Breast Cancer (NCT02322814)

Summary

Researchers are looking for new drug combinations to treat advanced triple-negative breast cancer. Cobimetinib (CDG-0973) is a new targeted therapy that works by inhibiting a protein called MEK that helps cancer cells grow and survive. Paclitaxel (Taxol®) is a chemotherapy drug that is commonly used to treat advanced breast cancer. This study is comparing the safety and effectiveness of Taxol and cobimetinib in comparison with Taxol and a placebo as a first-line treatment in participants with advanced triple negative breast cancer.
This is a Phase II trial

Aromasin® and Entinostat For ER+, HER2-, Advanced Breast Cancer

A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Postmenopausal Patients With Hormone Receptor-Positive Advanced Breast Cancer (NCT02115282)

Summary

Exemestane (Aromasin®) is a type of hormone therapy that is routinely used to treat postmenopausal women with hormone-sensitive breast cancer. Entinostat is a new type of drug called a histone deacetylase (HDAC) inhibitor. It works by blocking HDAC enzymes, which are needed for cell growth. In this study, researchers are investigating whether using Aromasin and entinostat together is more effective than using Aromasin alone to treat hormone-sensitive, HER2-negative advanced breast cancer.
This is a Phase III trial

Abemaciclib and Tamoxifen for HR+, HER2- Metastatic Breast Cancer

A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer(NCT02747004)

Summary

To take part in this study, you must have hormone sensitive (HR+), HER2-negative metastatic breast cancer. You must have already had one anti-estrogen treatment and you must have already been treated with chemotherapy. Abemaciclib (LY2835219) is a new type of cancer treatment called a CDK 4/6 inhibitor. It only is available in clinical trials. This study is comparing the safety and effectiveness of abemaciclib when it is given alone to when it is given with tamoxifen or with Imodium. Tamoxifen (Nolvadex®) is an anti-estrogen drug used to treat breast cancer. Loperamide (Imodium) is an over-the-counter medication used to prevent and treat diarrhea.
This is a Phase II trial

LY2606368 For Advanced 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

BKM120 & Olaparib for Metastatic Triple Negative Breast Cancer

Phase I Study of the Oral PI3kinase Inhibitor BKM120 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or Recurrent High Grade Serous Ovarian Cancer (NCT01623349)

Summary

Researchers are trying to find new drugs and new drug combinations that will be effective against metastatic triple negative breast cancer. BKM120 is an experimental therapy that works by inhibiting PI3K, a group of proteins that help cancer cells to grow. Olaparib is an experimental drug (called a PARP inhibitor) that may make cancer cells more sensitive to chemotherapy. In laboratory experiments, this drug combination shows anti-cancer activity. This study will help researchers determine the highest dose of these drugs that can be given safely and allow them to assess whether the combination of BKM120 and olaparib is effective in treating triple negative breast cancer. To be eligible for this study, you already must have had at least one chemotherapy regimen for metastatic breast cancer or have developed metastatic breast cancer within one year of completing adjuvant chemotherapy.
This is a Phase I trial

PLX 3397 and Eribulin for Metastatic Breast Cancer

Enhancing Efficacy of Chemotherapy in Triple Negative/Basal-Like Breast Cancer by Targeting Macrophages: A Multicenter Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer (NCT01596751)

Summary

Using two drugs to treat metastatic breast cancer may be more effective than using one alone. PLX3397 is a new type of cancer drug called a multi-targeted tyrosine kinase inhibitor. Eribulin (Halaven®) is an anti-cancer drug that works by triggering the cell death process. It is used to treat metastatic breast cancer in individuals who have already had at least two other types of anticancer medicines. Giving PLX3397 and Halaven together could be more effective than giving Halaven alone. There are two phases to this study. Phase I will focus on determining the best dose of PLX3397 to give along with Halaven. Phase 2 will look at the effectiveness and side effects of the drug combination. To be eligible, participants must have already received at least one prior chemotherapy regimen for metastatic breast cancer.
This is a Phase I-II trial

Neratinib for Advanced HER2-Positive Breast Cancer in Women and Men Age 60 and Older

Phase II Study of Neratinib in Patients 60 and Older With HER2 Positive Metastatic Breast Cancer (NCT02673398)

Summary

To take part in this study, you must be age 60 or older and have locally advanced (stage III) or metastatic (stage IV) HER2-positive breast cancer. You must also not have previously been treated with neratinib (also known as HKI-272). This study is looking at how well neratinib works in patients age 60 and older with HER2-positive advanced or metastatic breast cancer. Neratinib is a type of anti-cancer drug called a tyrosine kinase inhibitor. It is only available in clinical trials.
This is a Phase II trial

Jakafi and Herceptin for Metastatic HER2-Positive Breast Cancer

Phase I/II Trial of Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer (NCT02066532)

Summary

Researchers are trying to determine the best way to treat HER2+ metastatic breast cancer. Ruxolitinib (Jakafi®) is used to treat myelofibrosis, a disease of the bone marrow. Laboratory studies suggest it may also be an effective cancer treatment. Trastuzumab (Herceptin®) is routinely used to treat HER2+ breast cancer. This study is looking at the safety and efficacy of giving Jakafi along with Herceptin to treat patients with HER2+ metastatic breast cancer.
This is a Phase I-II trial

Neratinib for HER2-Positive Brain Metastases

A Phase II Trial of HKI-272 (Neratinib) for Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer and Brain Metastases (NCT01494662)

Summary

Brain metastases are difficult to treat because many drugs are unable to cross the blood-brain barrier, which means they cannot enter the brain from the bloodstream. The experimental drug Neratinib (HKI-272) is a tyrosine kinase inhibitor. It works by blocking the HER2 and EGFR receptors, both of which are involved in cancer cell growth. Neratinib is a much smaller molecule than Herceptin® (the drug widely used to treat HER2+ tumors), and it is able to cross the blood-brain barrier. The goal of this trial is to determine how well neratinib works in treating breast cancer that has spread to the brain, as well as the effect that it has on cognitive functioning.
This is a Phase II trial

Safety of HER2-Targeted Therapies in Patients with Mildly Decreased Heart Function

SAFE-HEaRt: A Pilot Study Assessing the Cardiac SAFEty of HER2 Targeted Therapy in Patients With HER2 Positive Breast Cancer and Reduced Left Ventricular Function (NCT01904903)

Summary

The HER2 targeted therapies—trastuzumab (Herceptin®), pertuzumab (Perjeta®) and ado-trastuzumab emtansine (Kadcyla®)—may cause heart problems in some patients. These drugs are currently approved only for patients with normal heart functioning. It may be possible for HER2+ patients with mildly decreased heart function to also safely use a HER2-targeted therapy. This study is looking at the safety of giving a HER2–targeted therapy to patients with mildly decreased heart function when these patients are evaluated regularly by a cardiologist and take heart medication. To be eligible, participants must have HER2–positive breast cancer and mildly decreased heart function.
This is a Phase II trial

LEE011, BYL719 & Femara for Advanced ER+/HER2- Breast Cancer

A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer (NCT01872260)

Summary

Researchers are looking for new targeted therapies and new drug combinations that will be effective breast cancer treatments. LEE011 and BYL719 are two new targeted therapies that may slow or stop breast cancer growth. LEE011 works by blocking two enzymes, called CDK4 and CDK6, that are needed for cell growth. BYL719 works by blocking a protein called PI3K that plays a role in tumor growth. Letrozole (Femara®) is an anti-estrogen drug that is routinely used to treat hormone-sensitive tumors. Previous studies have shown that combining a targeted therapy with an anti-estrogen drug may prevent breast cancer cells from developing resistance to hormone therapy. This study is comparing the safety and effectiveness of using LEE011 and BYL719 alone or in combination with Femara to treat ER+/HER2- locally advanced or metastatic breast cancer.
This is a Phase I-II trial

MLN0128 & Faslodex in Women with Advanced Breast Cancer Already Treated With an AI

An Open-Label Phase 2 Study of MLN0128 (A TORC1/2 Inhibitor) in Combination With Fulvestrant in Women With ER-Positive/HER2-Negative Advanced or Metastatic Breast Cancer That Has Progressed During or After Aromatase Inhibitor Therapy (NCT02756364)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer that is ER-positive and HER2-negative. You must also have already been treated with an aromatase inhibitor—letrozole (Femara), anastrozole (Arimidex) or exemestane (Aromasin). This study is comparing the safety and effect of a new drug called MLN0128 when it is given along with an anti-estrogen treatment. The new drug is a targeted treatment called MLN0128. It comes in pill form and is taken by mouth. The anti-estrogen drug is fulvestrant (Faslodex®). Given by injection, it is used to treat ER+ metastatic breast cancer in postmenopausal women who have already had other anti-estrogen treatments. In this study, some women will receive Faslodex alone, others will receive Faslodex and daily MLN0128, and others will receive Faslodex and weekly MNL0128.
This is a Phase II trial

Kadcyla and Neratinib for Metastatic HER2-Positive Breast Cancer

A Phase Ib/II Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer (NCT02236000)

Summary

Trastuzumab emtansine (T-DM1/Kadcyla®) combines the chemotherapy drug DM1 with the HER2-targeted therapy trastuzumab (Herceptin®). This allows the DM1 to be delivered directly to the cancer cells. It is approved for the treatment of HER2+ metastatic breast cancer in patients who have already received Herceptin and a taxane. Neratinib is a new drug currently being studied for HER2-targeted breast cancer. It works by blocking two receptors, HER2 and EGFR. This study is looking at the safety, best dose, and efficacy of neratinib that can be given with Kadcylato treat HER2-positive metastatic breast cancer that has progressed on prior anti-HER2 based therapy. To be eligible, patients must have had one (and only one) regimen of anti-HER2 based therapy for metastatic disease (dual anti-HER agents may have been given in combination e.g., docetaxel, trastuzumab and pertuzumab).
This is a Phase I-II trial

BAY1161909 and Taxol for Advanced Breast Cancer

An Open-label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of Oral BAY1161909 in Combination With Weekly Intravenous Paclitaxel Given in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies (NCT02138812)

Summary

Researchers are studying new ways to target cancer cells. BAY1161909 is a new type of oral targeted therapy called an MPS1 (monopolar spindle 1) inhibitor. Paclitaxel (Taxol®) is commonly used to treat advanced breast cancer. Laboratory studies have found that certain types of cancer cells, including breast cancer, make too much MPS1. Researchers think that combining BAY1161909 with Taxol can stop these cells from growing. This study will determine the best dose, safety, and tolerability of giving BAY1161909 with Taxol to treat advanced breast (and other) cancers.
This is a Phase I 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

Niraparib for HER2-Negative, BRCA-Positive Advanced Breast Cancer

A Phase III, Randomized, Open Label, Multicenter, Controlled Trial of Niraparib Versus Physician's Choice in Previously-treated, Her2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients (NCT01905592)

Summary

PARP inhibitors are a new type of targeted therapy. They work by by keeping an enzyme called PARP from repairing DNA damage in cancer cells. When the DNA is not repaired, the cancer cell is more likely to die. Niraparib is a PARP inhibitor. Earlier studies have suggested that niraparib may be an effective treatment for individuals with breast or ovarian cancer who have an inherited BRCA mutation. This study is comparing niraparib to currently used cancer treatments in individuals with advanced HER2-negative cancer who carry a BRCA1 or BRCA2 genetic mutation.
This is a Phase III trial

PI3 Kinase Inhibitor BKM120 and Xeloda® for Metastatic Disease

NCT01300962: Phase 1 Dose Escalation Study of BKM120 and Capecitabine in Patients With Metastatic Breast Cancer (NCT01300962)

Summary

Researchers are trying to develop cancer therapies that work by targeting the signaling pathways that are involved in cell growth and survival. One of these pathways, called the PI3 kinase pathway, has been found to be activated in breast and other cancers. This suggests that inhibiting PI3 kinase enzymes may be an effective way to stop tumor cell growth. BKM120 is an investigational drug that can inhibit PI3 kinase enzymes. Capecitabine (Xeloda®) is an oral chemotherapy drug that is used to treat metastatic breast cancer. The goal of this trial is to determine the safety, effectiveness, and maximum tolerable dose of BKM120 when it is given in combination with Xeloda to individuals with metastatic disease that has stopped responding to other treatments.
This is a Phase I trial

Taselisib with HER2-Targeted Therapies for Advanced HER2+ Breast Cancer

Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer (NCT02390427)

Summary

Taselisib (GDC-0032) is a new type of drug called a PI3K inhibitor. It works by blocking the PI3K protein, which plays a role in cancer cell growth. Researchers think using Taselisib along with HER2-targeted therapies will be a more effective way to treat advanced HER2+ breast cancer. Pertuzumab (Perjeta®), trastuzumaub (Herceptin®), and T-DM1 (Kadcyla®) are three different HER2-targeted therapies. Paclitaxel (Taxol®) is a chemotherapy drug commonly used to treat breast cancer. This study is looking at the safety, effectiveness, and best dose of taselisib when it is given along with one or more HER2-targeted therapies to patients with locally recurrent or metastatic HER2+ breast cancer.
This is a Phase I trial

LJM716, BYL719 and Herceptin for Metastatic HER2+ Breast Cancer

A Phase I, Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer (NCT02167854)

Summary

Researchers are trying to find new ways to treat HER2-positive breast cancer. The HER3 protein works with the HER2 protein to activate a PI3K signaling pathway that spurs cancer cell growth. LJM716 is a new drug that blocks the HER3 protein. BYL719 is a new drug that blocks the PI3K enzyme. Trastuzumab (Herceptin®) is a HER2-targeted therapy routinely used to treat HER2-positive tumors. Researchers think that the combination of LJM716, BYL719 and Herceptin will be effective in patients with HER2+ breast cancer. This study is looking at the safety, efficacy, and best dose of BYL719 to use along with LJM716 and Herceptin in women with metastatic HER2+ breast cancer. To be eligible for this study, a woman must have already been treated with the HER2-targeted therapies pertuzumab (Perjeta®) and T-DM1 (Kadcyla®) and must have a tumor that tests positive for the PIK3CA mutation.
This is a Phase I trial

A Vaccine to Treat HER2+ Advanced Breast Cancer

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

Summary

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

Keytruda® for Metastatic Triple Negative Breast Cancer

A Phase II Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy for Metastatic Triple-Negative Breast Cancer (mTNBC) - (KEYNOTE-086) (NCT02447003)

Summary

Researchers are studying new ways to treat triple-negative breast cancer. Pembrolizumab (Keytruda®) is an immunotherapy. It works by disabling a programmed cell death (PD-1) protein that normally keeps the body's immune system from attacking and destroying tumor cells. Keytruda is approved for treating metastatic melanoma. This trial is investigating the safety and effectiveness of using Keytruda to treat metastatic triple-negative breast cancer.
This is a Phase II trial

A Vaccine for Treating HER2-Negative Advanced Breast Cancer

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

Summary

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

Keytruda for Metastatic Inflammatory Breast Cancer

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

Summary

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

PLX3397 and Keytruda in Metastatic Triple Negative Breast Cancer

Phase 1/2a Study of Double-Immune Suppression Blockade By Combining a CSF1R Inhibitor (PLX3397) With An Anti-PD-1 Antibody (Pembrolizumab) To Treat Advanced Melanoma And Other Solid Tumors (NCT02452424)

Summary

PLX3397 targets the receptor for CSF1 (Colony Stimulating Factor 1), an essential growth factor for cancer cells. Pembrolizumab (Keytruda®) is an immunotherapy. It blocks a programmed cell death (PD-1) protein that keeps the immune system from going after cancer cells. Keytruda is approved for treating metastatic melanoma and lung cancer. This study is investigating the best dose, safety and effect of combining PLX3397 and Keytruda in patients with metastatic triple negative breast cancer. This study also is enrolling patients with other types of cancer.
This is a Phase I-II trial