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Inflammatory Breast Cancer
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All Metastatic Trials

The Effect of Xeloda and Digoxin on Metastatic Breast Tumors

Metronomic Capecitabine With Digoxin for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment (NCT01887288)

Summary

Capecitabine (Xeloda®) is used to treat metastatic breast cancer. One way to give Xeloda is at low doses at regular intervals. This is called metronomic dosing. Digoxin is a drug that is currently used to treat heart failure and abnormal heart rhythms. Laboratory studies have shown that digoxin blocks a protein, called HIF-1, that can slow the growth of breast cancer cells. This study is investigating the effect that combining metronomic dosing of Xeloda with digoxin has on the growth rate of metastatic breast cancer cells. To be eligible, participants must have already been treated with anthracyclines and taxanes.
This is a Phase II trial

Halaven™ (Eribulin) & 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 (Halaven™) and cyclophosphamide (Cytoxan®) 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

TPI 287 for Brain Metastases

A Phase II Open-Label Study of TPI 287 in Patients With Breast Cancer Metastatic to the Brain (NCT01332630)

Summary

Brain metastases are difficult to treat because most systemic cancer treatments are unable to cross the blood-brain barrier to get to the cancer cells in the brain. The experimental drug TPI 287 is a new type of taxane. Like other taxanes, TPI 287 works by preventing cancer cells from dividing. However, unlike other taxanes, TPI 287 has been shown to cross the blood-brain barrier. The purpose of this trial is to determine the effectiveness of TPI 287 in controlling brain metastases that have progressed with prior therapy.
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

Combinations of Abraxane, Gemzar & Paraplain for Triple Negative Stage IV Tumors

A Phase 2/3, Multi-center, Open-label, Randomized Study of Weekly Nab-paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to the Combination of Gemcitabine and Carboplatin, as First-line Treatment in Female Subjects ... (NCT01881230)

Summary

Researchers are trying to determine the best drug combinations for treating triple negative (ER-, PR-, HER2-) breast cancer. Nab-paclitaxel (Abraxane®), gemcitabine (Gemzar®) and carboplatin (Paraplatin®) are chemotherapy drugs used to treat advanced breast cancer that has not responded to previous chemotherapy. This study is comparing the safety and effectiveness of combining Abraxane with either Gemzar or Paraplatin to the combination of Gemzar and Paraplatin as a first-line treatment for triple negative metastatic breast cancer. This study has two phases. In Phase 2, Abraxane and Gemzar are being compared to Abraxane and Paraplatin. In Phase 3, one of these two combinations will be compared to Gemzar and Paraplatin.
This is a Phase II-III trial

Eribulin & Carboplatin for Advanced Breast Cancer

A Phase I Dose Escalation Study of Eribulin in Combination With Weekly Carboplatin for the Treatment of Metastatic Breast Cancer (NCT01795586)

Summary

Giving two cancer drugs at the same time may be more effective than using one drug alone. Eribulin (Halaven®) and carboplatin (Paraplatin®) are chemotherapy drugs that are routinely used to treat breast cancer. It is not yet known if these drugs are more effective when given together. This study is investigating the safety and effectiveness of using eribulin and carboplatin to treat people with advanced breast cancer.
This is a Phase I trial

ThermoDox & Hyperthermia to Treat Chest Wall Recurrences

A Phase I/II Study Evaluating the Maximum Tolerated Dose, Pharmacokinetics, Safety, and Efficacy of Microwave Hyperthermia and ThermoDox (Lyso-Thermosensitive Liposomal Doxorubucin) in Patients With Breast Cancer Recurrence at the Chest Wall (NCT00826085)

Summary

ThermoDox® is a new form of chemotherapy, in which the doxorubicin (Adriamycin®) is encased within a fat bubble (liposome) and released in the presence of heat. Applying external heat to a tumor (hyperthermia) is known to kill tumor cells directly, but may also make them more sensitive to ThermoDox®. Research has suggested that ThermoDox® plus hyperthermia therapy may be more effective than chemotherapy alone for treating locally recurrent breast cancer in the chest wall. The main purpose of this study is to find out if adding ThermoDox® to therapeutic heat will increase how long the breast cancer stays away after treatment.
This is a Phase I-II trial

Methotrexate and Liposomal Cytarabine For Brain Metastases

A Phase II Study of the Combination of High-dose Methotrexate and Intrathecal Liposomal Cytarabine in Patients With Parenchymal and Leptomeningeal Metastases From Breast Cancer (NCT00992602)

Summary

Brain metastases are difficult to treat because most systemic cancer treatments are unable to cross the blood-brain barrier (BBB) and get to the cancer cells in the brain. High-dose intravenous methotrexate (HD IV MTX) penetrates the blood-brain barrier and is approved by the FDA to treat breast cancer that has spread to the brain. Liposomal cytarabine also crosses the BBB. It is approved by the Food and Drug Administration (FDA) to treat lymphoma that has spread to the meninges, and is being studied in the treatment of other cancers. Giving high-dose systemic methotrexate together with liposomal cytarabine may be more effective than either drug alone. This trial is studying how well giving high-dose methotrexate together with liposomal cytarabine works in treating patients with central nervous system metastases from breast cancer.
This is a Phase II trial

Tesetaxel as First-line Therapy for Metastatic Breast Cancer

A Phase II Study of Tesetaxel as First-line Therapy for Subjects With Metastatic Breast Cancer (NCT01221870)

Summary

Researchers are trying to find more effective treatments for metastatic breast cancer. Paclitaxel (Taxol®) is a taxane that is administered intravenously. It is one of the most commonly used breast cancer therapies. Tesetaxel is a taxane that is administered orally. Studies suggest it is as effective as Taxol, and because it is an oral drug, it is easier to give to patients, does not cause infusion reactions, and is less likely to result in neuropathy. This trial is investigating the safety and effectiveness of tesetaxel when it is given as first-line therapy to patients with metastatic breast cancer.
This is a Phase II trial

Doxil® and Heat Treatment for Advanced Breast Cancer

Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients With Chest Wall Recurrence or Stage IV Disease With Locally Advanced Breast Cancer (NCT00006433)

Summary

Researchers are studying ways of delivering chemotherapy drugs that may make the treatment more effective. Pegylated liposomal doxorubicin (Doxil®) is a newer form of doxorubicin (Adriamycin®) that is made by coating the drug with a small amount of lipid (fat). Studies have shown that this coating helps get more drug to the tumor without causing as many side effects. Researchers believe that combining heat treatment with Doxil® may further increase the amount of drug that gets to the tumor, which may increase tumor response. This trial is evaluating the safety and effectiveness of the combination of Doxil® and heat treatment in women with advanced breast cancer. The researchers will also look at whether the heat treatment changes how much of the drug gets into the tumor. To be eligible, participants must have locally advanced breast cancer located on the chest wall following mastectomy or have metastatic disease with advanced tumor remaining within the breast.
This is a Phase II trial

Heated Chemotherapy for Cancer that Has Spread to the Chest

Surgical Cytoreduction Followed by Intraoperative Intrathoracic Hyperthermic Chemotherapy Perfusion for the Management of Disseminated Pleural Malignancies (NCT01163552)

Summary

It is not uncommon for breast cancer to spread to the lining of the chest. When this occurs, surgery is usually not performed. Instead, treatment typically involves chemotherapy and/or radiation therapy. The goal of this trial is to see if treatment that involves surgically removing the tumor from the chest wall and bathing the chest cavity with a heated chemotherapy solution may be more effective than the treatments that would typically be used.
This is a Phase II trial

Eribulin for Advanced HER2-Negative Breast Cancer

A Phase 2 Study of Eribulin in Patients With HER2-Negative, Metastatic Breast Cancer: Evaluation of Efficacy, Toxicity and Patient-Reported Outcomes (NCT01827787)

Summary

The chemotherapy drug eribulin (Halaven™) received FDA approval in 2010 for the treatment of metastatic breast cancer patients who had already received at least two prior chemotherapy regimens. Researchers are now studying the effectiveness and side effects associated with using Halaven as the first or second chemotherapy drug given to treat advanced or metastatic breast cancer. One of the side effects the researchers will be studying is neuropathy, a numbness or tingling of the fingers and toes that can be caused by chemotherapy. To be eligible for this study, a woman must have a HER2-negative tumor and have had up to one prior type of chemotherapy to treat her advanced breast cancer.
This is a Phase II trial

Camptosar® for Brain Metastases That Progressed After Radiation Therapy

A Pilot Study of Irinotecan in Patients With Breast Cancer and CNS Metastases (NCT01939483)

Summary

Researchers are studying new ways to treat brain metastases. Camptosar® (irinotecan hydrochloride) is used to treat metastatic breast cancer. It works by blocking the action of an enzyme called topoisomerase I, which helps damaged DNA survive. Studies suggest it may also be an effective treatment for brain metastases. This study is investigating the safety and effectiveness of using Camptosar to treat breast cancer patients with brain metastases who progressed after radiation therapy.

Abraxane in Patients Age 65 and Over with Metastatic Disease

Efficacy and Tolerability of Nanoparticle Albumin Bound Paclitaxel (Abraxane) in Patients 65 and Older With Metastatic Breast Cancer (NCT01463072)

Summary

Cancer patients who are 65 and over may experience more treatment-related side effects than younger patients do. Paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) is a drug used to treat breast cancer that has spread or that has come back within 6 months after chemotherapy. The researchers also hope to identify ways to predict which patients may be more likely to experience side-effects and/or benefit from an altered dosage schedule.
This is a Phase II trial

A Chemo Treatment Specifically for Breast Cancer That Has Spread to the Liver

Pilot Study of Hepatic Arterial Infusion (HAI) With Oxaliplatin, Folinic Acid and 5 Fluorouracil (FOLFOX) in Heavily Pre-Treated Patients With Liver-Predominant Metastasis From Breast Cancer (NCT01937507)

Summary

Hepatic arterial infusion (HAI) is a procedure that delivers chemotherapy directly to the liver. It is used to treat colorectal cancer patients with liver metastases. FOLFOX is a chemotherapy regimen frequently used for this type of treatment. FOLFOX is made up of: (FOL) Leucovorin Calcium/Folinic Acid; (F) 5 Fluorouracil/5FU; and (OX) Oxaliplatin/ Eloxatin. This study is investigating whether FOLFOX is effective for treating breast cancer that has spread to the liver in patients who have already had one type of chemotherapy since being diagnosed with metastatic disease. If the FOLFOX is effective it may shrink the cancer in the liver enough to allow surgery to be performed or it may make the liver metastases respond to other types of chemotherapy.
This is a Phase II trial

Tesetaxel vs Capecitabine for Advanced Disease

A Randomized, Phase II Study of Tesetaxel Once Every 3 Weeks Versus Tesetaxel Once Weekly for 3 Weeks Versus Capecitabine Twice Daily for 14 Days as First-line Therapy for Subjects With Locally Advanced or Metastatic Breast Cancer (NCT01609127)

Summary

Taxane drugs, such as paclitaxel (Taxol®) and docetaxel (Taxotere®), are commonly used to treat breast cancer. They work by blocking the ability of cancer cells to divide. Tesetaxel (DJ-927) is an investigational taxane that is given orally. (The other taxanes are given intravenously.) Capecitabine (Xeloda®), is a type of drug called an antimetabolite. It is approved for the treatment of advanced breast cancer. This trial is comparing the effectiveness and safety of two different tesetaxel regimens in combination with Xeloda. To be eligible, patients must have HER2-negative advanced breast cancer.
This is a Phase II trial

An Oral Fluorouracil (5-FU) for Metastatic Breast Cancer

A Comparative, Multicenter, Open-Label, Randomized, Phase 2 Study of the Safety and Antitumor Activity of Oral Eniluracil + 5 Fluorouracil + Leucovorin Versus Capecitabine Monotherapy in Subjects With Metastatic Breast Cancer (NCT01231802)

Summary

Fluorouracil (5-FU) is a chemotherapy drug that is used to treat breast and other cancers. It is given by IV. To increase its effectiveness, 5-FU (Adrucil®) is usually given in combination with leucovorin, a type of folic acid (Vitamin B-9). Eniluracil is an experimental drug that is an oral version of 5-FU. Eniluracil lasts longer in the body than 5-FU, allowing it to be given at a lower dose. Capecitabine (Xeloda®) is an oral chemotherapy drug used to treat metastatic breast cancer. When it reaches a cancer cell, Xeloda is converted by the body into 5-FU. The purpose of this trial is to determine if eniluracil plus 5-FU/leucovorin is more effective and has fewer side effects than Xeloda when it is given to women with metastatic breast cancer who have been previously treated with an anthracycline and a taxane.
This is a Phase II trial

Targeted Chemotherapy for Brain Metastases

A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases (NCT01480583)

Summary

Metastases to the brain is difficult to treat because the vast majority of drugs are not able to cross the blood-brain barrier. GRN1005 is an investigational chemotherapy drug that was designed to take advantage of a natural mechanism that allows essential substances, like hormones and lipids, to enter the brain. It works by linking the standard chemotherapy drug paclitaxel (Taxol®) to a protein "key" that helps substances to cross the blood-brain barrier. The goal of this trial is to determine the safety and effectiveness of GRN1005 when it is given to individuals who have breast cancer that has spread to the brain.
This is a Phase II trial

DM-CHOC-PEN For Brain Metastases

A Phase II Trial: Safety and Tolerance of Intravenous 4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) in Patients With Malignancies Involving the Central Nervous System (NCT02038218)

Summary

DM-CHOC-PEN (4-Demethyl-4-cholesteryloxycarbonylpenclome) is an experimental chemotherapy drug. Small studies in cancer patients, including patients with breast cancer, have shown that it can kill cancer cells and that it can penetrate the blood-brain barrier. This study is evaluating the safety and efficacy of DM-CHOC-PEN in patients with breast cancer that has metastasized to the brain. This study is also enrolling patients with lung cancer and melanoma who have brain metastases.
This is a Phase II 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

Aggressive Local Therapy for Bone Metastases

Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients (NCT00929214)

Summary

Women with metastatic breast cancer that has spread to the bones are currently treated with chemotherapy or hormone therapy. Both chemotherapy and hormone therapy are systemic treatments that travel through the bloodstream to go after cancer cells that may be anywhere in the body. It is possible that using local therapy -- surgery and/or radiation -- along with systemic therapy may help control breast cancer cells that have spread to the bone. The goal of this study is to find out if adding local therapy (surgery and/or radiation) to standard systemic therapy (chemotherapy or hormone therapy) in the treatment of women with breast cancer that has metastasized to the bone can help to control the disease for a longer period of time than standard therapy alone. Participants must have no more than three areas of bone metastases.
This is a Phase II 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 for Brain Metastases

Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases (NCT00377156)

Summary

Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation in treating brain metastases. This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.
This is a Phase III trial

Studying Cognitive Changes Before and After Radiation Therapy for Brain Metastases

A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases (NCT01445483)

Summary

Radiotherapy is the most frequently used therapy for breast cancer brain metastases. However, cognitive dysfunction may be a side effect of this treatment. Currently there are no standardized tests to measure changes in cognitive functioning in patients treated for brain metastasis. In this trial, researchers will test a patient's memory, attention, processing speed, and reading and fine motor skills before and after radiation therapy to the brain to find out if this treatment causes a change in patients' cognitive and daily functioning.

Veliparib with Radiation for Inflammatory or Advanced Disease

A Phase 1 Study of Veliparib Administered Concurrently With Chest Wall and Nodal Radiation Therapy in Patients With Inflammatory or Loco-regionally Recurrent Breast Cancer (NCT01477489)

Summary

Veliparib is an investigational drug known as a "PARP inhibitor." Veliparib affects the way that cells repair damage, and studies suggest that when it is given along with radiation therapy it may help make radiation work better. The purpose of this study is to determine the maximum tolerated dose of veliparib that can be given while a patient is receiving radiation therapy. The researchers will also be analyzing blood and tissue taken from the skin of patients. The skin biopsies will help determine how patients respond to radiation when it is combined with veliparib. The blood sample will be used to study whether the way a person's body processes drugs affects their response to treatment.
This is a Phase I trial

Ixempra® and Stereotactic Body Radiation for Triple Negative Metastatic Tumors

A Phase II Trial Of Ixabepilone and Stereotactic Body Radiation Therapy (SBRT) For Patients With Triple Negative Metastatic Breast Cancer (NCT01818999)

Summary

Researchers are studying new drug treatments for metastatic breast cancer. Ixabepilone (Ixempra®) is used to treat metastatic or locally advanced breast cancer. Stereotactic body radiation therapy (SBRT), often referred to by brand names like CyberKnife®, delivers a high dose of radiation to the tumor more accurately than standard radiation treatment. Using Ixempra along with SBRT is not an approved treatment at this time. This study is investigating the effectiveness of using SBRT along with Ixempra in women with triple negative metastatic breast cancer.
This is a Phase II trial

TAK-700 in Postmenopausal Women with ER+ Advanced Disease

CO11109: A Phase 1b Study of TAK-700 in Postmenopausal Women With Hormone-receptor Positive Metastatic Breast Cancer (NCT01808040)

Summary

Researchers are studying new types of drugs that may be effective against hormone-sensitive metastatic breast cancer. Orteronel (TAK-700) is a drug that blocks hormone production. It is currently in phase III trials for the treatment of metastatic prostate cancer. Laboratory studies suggest it may be effective in postmenopausal women with hormone-sensitive metastatic breast cancer. This study is designed to test the safety and effectiveness of orteronel (TAK-700) and to determine the best dose for use in future trials. To be eligible, participants must be postmenopausal and can not have tried more than one previous anti-estrogen drug for metastatic breast cancer.
This is a Phase I trial

Estradiol and Aromasin® for Hormone Therapy-Resistant Disease

A Pilot Study Of Estradiol Followed By Exemestane For Post-Menopausal Hormone Receptor Positive Metastatic Breast Cancer After Prior Failed Endocrine Therapy: Reversing Endocrine Resistance (NCT01385280)

Summary

Over time, hormone-sensitive tumors can stop responding to anti-estrogen treatments such as aromatase inhibitors (AI). Estradiol is a type of estrogen produced in the body. Laboratory studies have found that estradiol stops acting like an estrogen after resistance to an AI has developed. Instead it kills cancer cells that have become resistant to the AI. It also gets the tumor to start responding again to an AI. This pilot study is investigating the effectiveness of estradiol followed by the AI exemestane (Aromasin®) in postmenopausal women with hormone-sensitive metastatic breast cancer that has stopped responding to an AI.

Letrozole/Lapatinib/Everolimus For Endocrine Resistant Disease

GCC 0901- A Phase II Study of Letrozole in Combination With Lapatinib Followed by an Addition of Everolimus in Postmenopausal Women With Advanced Endocrine Resistant Breast Cancer (NCT01499160)

Summary

Over time, tumors that are hormone-sensitive can stop responding to endocrine (anti-estrogen) therapies. Letrozole (Femara®) is a drug used to treat hormone-sensitive tumors. Lapatinib (Tykerb®) is used to treat HER2-positive metastatic breast cancer. (The study will include patients with both HER2-negative and HER2-positive tumors. The use of lapatinib in HER2-negative patients is considered experimental.) Everolimus (Afinitor®) is used to treat kidney cancer. Studies suggest it may also be an effective breast cancer treatment. Laboratory studies have shown that combining Tykerb and Afinitor with Femara can get tumors to start responding again to Femara. If is not known if the same effect will be seen in breast cancer patients. The purpose of this study is to find out whether Femara, Tykerb and Afiinitor will get tumors to start responding again to anti-estrogen therapy.
This is a Phase II trial

Comparing First-Line Faslodex & Arimidex for Advanced Tumors

A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With... (NCT01602380)

Summary

Researchers are trying to determine which anti-estrogen drug is most effective in postmenopausal women with locally advanced or metastatic breast cancer who have not had prior hormonal therapy. (This is referred to as "first-line" treatment.) Fulvestrant (Faslodex®) is approved for the treatment of postmenopausal women with metastatic hormone-sensitive breast cancer who have already been treated with other anti-estrogens. Anastrozole (Arimidex®) is used to treat early and advanced hormone-sensitive breast cancer in postmenopausal women. The purpose of the study is to compare the effectiveness of Faslodex and Arimedex as a first-line treatment for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.
This is a Phase III trial

  • Participation Time3 visits in first month, then monthly visits thereafter
  • Participating research sites Nearest research site: Contact sponsor; 26 sites total

AZD2014 and Fulvestrant in ER+ Metastatic Breast Cancer

A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination With Intramuscular (IM) Fulvestrant to Patients With...(NCT01597388)

Summary

Researchers are investigating new drugs and new drug combinations that may be effective against metastatic breast cancer. AZD2014 is an investigational drug that works by inhibiting two pathways that fuel cancer growth: mTORC1 and mTORC2. Fulvestrant (Faslodex®) is approved by the U.S. Food and Drug Administration to treat postmenopausal women with metastatic hormone-sensitive breast cancer that has stopped responding to other hormonal therapy. The purpose of this study is to assess the safety and tolerability of AZD2014 when it is given in combination with Faslodex to women with hormone-sensitive metastatic breast cancer that has already been treated with other hormonal therapies.
This is a Phase I trial

  • Participation TimeNumber of visits unavailable
  • Participating research sites Nearest research site: Contact sponsor; 4 sites total

Study of Tamoxifen Effectiveness on Treating Advanced Disease

Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer (NCT01124695)

Summary

Tamoxifen is one of the anti-estrogen therapies used to treat early and advanced stage breast cancer. CYP2D6 is an enzyme that breaks down tamoxifen into metabolites that your body can use. People have different levels of CYP2D6. Studies have found that people with high levels of CYP2D6 metabolize tamoxifen quickly, whereas those with low levels metabolize tamoxifen more slowly. Researchers believe that the rate of tamoxifen metabolism may have an effect on how well tamoxifen works. The purpose of this study is to determine if there is a correlation between levels of CYP2D6 and how well tamoxifen works in individuals with recurrent or metastatic breast cancer.
This is a Phase II trial

BKM120 After an AI & an mTOR Inhibitor for Advanced Disease

A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on... (NCT01633060)

Summary

Researchers are trying to develop new drugs that will be effective in treating advanced hormone-sensitive tumors. BKM120 is an investigational targeted therapy that works by blocking PI3K, a group of proteins that help cancer cells to grow, possibly by increasing their resistance to hormone therapy. Fulvestrant (Faslodex®) is used to treat advanced hormone-sensitive breast cancer in postmenopausal women whose tumors have stopped responding to other anti-estrogen therapies. This study is comparing the safety and effectiveness of BKM120 and Faslodex to Faslodex and a placebo in women with HER2-negative advanced breast cancer who have previously been treated with an mTOR inhibitor, such as Everolimus (Afinitor®).
This is a Phase III trial

Vorinostat + An Aromatase Inhibitor for Stage IV Breast Cancer

A Pilot Study of Vorinostat to Restore Sensitivity to Aromatase Inhibitor Therapy Part B (NCT01720602)

Summary

Over time, many hormone-sensitive tumors stop responding to hormone therapy. Vorinostat (Zolinza®) is a type of cancer treatment called a histone deacetylase (HDAC) inhibitor. It is currently used to treat a type of lymphoma. Studies suggest it can improve the way a tumor responds to hormone therapy. This study is looking at the effect of combining vorinostat with an aromatase inhibitor to treat patients with hormone-sensitive metastatic breast cancer.

BKM120 & Fulvestrant in Advanced ER or PR+, HER2- Tumors

A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed ... (NCT01610284)

Summary

Researchers are trying to develop new drugs that will be effective in advanced hormone-sensitive (ER and/or PR+) tumors that have stopped responding to an aromatase inhibitor. BKM120 is an investigational biological therapy that works by blocking PI3K, a group of proteins that help cancer cells to grow. Fulvestrant (Faslodex®) is used to treat advanced hormone-sensitive breast cancer in postmenopausal women whose tumors have stopped responding to other anti-estrogen therapies. This study is investigating the safety and effectiveness of adding daily BKM120 to Faslodex in patients with hormone sensitive, HER2-negative advanced breast cancer that has stopped responding to an aromatase inhibitor.
This is a Phase III 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

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

Perjeta, Herceptin & Abraxane for HER2+ Metastatic 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+ metastatic 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+ metastatic breast cancer.
This is a Phase II trial

Cabergoline in Metastatic Breast Cancer

A Pilot Phase II Trial of Cabergoline in the Treatment of Metastatic Breast Cancer (NCT01730729)

Summary

Researchers are studying new ways to treat metastatic breast cancer. Prolactin is an endocrine hormone that is produced by the pituitary gland, which is located at the base of the brain. Previous studies have suggested that women who have high levels of the hormone prolactin in their blood may have an increased risk of breast cancer. Cabergoline (Dostinex®) works by lowering prolactin levels in the blood and is used to treat prolactinoma, a benign tumor that can develop in the pituitary gland. This study is looking at whether cabergoline is effective in treating metastatic breast cancer that has a prolactin receptor. Women interested in this trial will have their tumor tested for the prolactin receptor. Only those whose tumors test positive will be able to enroll in the study.
This is a Phase O trial

Triciribine+Paclitaxel in Locally Advanced 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

Erlotinib and Metformin in Triple Negative Breast Cancer

Phase I Study of Erlotinib and Metformin in Triple Negative Breast Cancer (NCT01650506)

Summary

Researchers are trying to develop new therapies for triple negative (ER-, PR-, and HER2-negative) breast cancer. Metformin, a drug that lowers insulin, is commonly used to treat type 2 diabetes. Studies suggests it might also be an effective breast cancer treatment. Erlotinib (Tarceva®) is a kinase inhibitor that was initially approved for the treatment of nonsmall cell lung cancer. Laboratory studies suggest that metformin and erlotinib have the potential to be an effective combination for treating triple negative breast tumors. The goals of this study are to establish the maximum tolerated dose of the combination of erlotinib and metformin and to determine if the combination is effective in treating patients with triple negative breast cancer.
This is a Phase I trial

BMS-906024 for Advanced Triple Negative Disease

Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Advanced Solid Tumors (NCT01292655)

Summary

Scientists are trying to develop drugs that work by targeting specific pathways that fuel a tumor's growth. BMS-906024 is a new experimental drug that works by inhibiting the Notch signaling pathway, which plays a role in tumor cell growth and survival. The purpose of this trial is to determine the safety, effectiveness, and best dose of BMS-906024 when it is given to women with triple-negative advanced or metastatic breast cancer who no longer respond to standard therapies.
This is a Phase I trial

Everolimus Plus Femara in ER+ Advanced Breast Cancer

An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Metastatic Breast Cancer (NCT01698918)

Summary

Everolimus (Afinitor®) is a new type of targeted therapy. It is currently used along with exemestane (Aromasin®) to treat postmenopausal women with advanced hormone-sensitive, HER2- breast cancer. This study is looking at the safety and effectiveness of using everolimus (Afinitor®) with letrozole (Femara®) to treat these postmenopausal women. Study volunteers will be be given Afinitor and Aromasin if/when their breast cancer progresses. The study is also looking at whether a mouth rinse can help reduce mouth irritation, a common side effect of Afinitor.
This is a Phase II trial

YN968D (Apatinib) for Advanced Breast Cancer

Evaluation of the Safety, Pharmacokinetics and Efficacy of Four Doses of YN968D1 in Subjects With Solid Tumors (NCT01497704)

Summary

Drugs that block angiogenesis—the formation of the new blood vessels a tumor needs to grow and spread—have been shown to be effective cancer therapies. These drugs are called angiogenesis inhibitors. This trial is investigating the safety and proper drug dosage of the experimental, oral angiogenesis inhibitor YN968D1 (Apatinib) in women with metastatic breast cancer that has not responded to currently available treatment options. (This trial is also enrolling women and men with solid tumors other than breast cancer.)
This is a Phase I-II 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

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

Xtandi in Triple Negative, Androgen Receptor-Positive Advanced Cancer

A Phase 2, Single Arm, Open Label, Multicenter Study of the Clinical Activity and Safety of Enzalutamide in Patients With Advanced, Androgen Receptor Positive, Triple Negative Breast Cancer (NCT01889238)

Summary

Enzalutamide (Xtandi®) is a type of drug called an androgen receptor antagonist. It was approved by the U.S. Food & Drug Administration in 2012 for the treatment of metastatic prostate cancer. About 20 percent of triple-negative tumors have androgen receptors. Studies suggest that using Xtandi to treat triple-negative tumors that are androgen receptor positive may be effective. The purpose of this study is to determine the safety and effectiveness of Xtandi when it is used to treat women with advanced triple-negative, androgen receptor-positive tumors. To be eligible for this study, a woman must have her tumor tested and found to be androgen receptor positive.
This is a Phase II trial

Entinostat and Lapatinib for HER2-Positive Advanced Disease

Entinostat and Lapatinib Ditosylate in Patients With Locally Recurrent or Distant Relapsed Metastatic Breast Cancer Previously Treated With Trastuzumab (NCT01434303)

Summary

Researchers are looking for new ways to treat HER2+ tumors that do not respond or have stopped responding to the HER2-targeted therapy trastuzumab (Herceptin®). Entinostat is an investigational cancer drug that works by blocking protein enzymes called histone deacetylases (HDAC), which help cells divide. Lapatinib (Tykerb®) is a HER2-targeted therapy approved for the treatment of advanced breast cancer. Researchers are trying to determine the best dose and effectiveness of entinostat when it is given with Tykerb®. To be eligible, participants must have locally recurrent or metastatic HER2-positive disease, and have already been treated with Herceptin. NOTE: INDIVIDUALS WITH INFLAMMATORY BREAST CANCER (IBC) CAN PARTICIPATE IN ONLY THE PHASE I PORTION OF THE STUDY.
This is a Phase I-II 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

  • Participation Time2 visits every month, ongoing
  • Participating research sites Nearest research site: Contact sponsor; 1 site total

Herceptin® and Lapatinib for HER2-Postitive Metastatic Disease

A Randomized, Open-label Study of Lapatinib Plus Trastuzumab Versus Trastuzumab as Continued HER2 Suppression Therapy After Completion of First- or Second-line Trastuzumab Plus Chemotherapy in Subjects With HER2-positive Metastatic Breast Cancer (NCT00968968)

Summary

When HER2-positive metastatic disease has responded to first- or second-line treatment with trastuzumab (Herceptin®) plus chemotherapy, doctors will often recommend continuing treatment with Herceptin® to help keep the disease from returning. Lapatinib (Tykerb®) is a drug that also has been approved for the treatment of HER2-positive breast cancer. The goal of this trial is to see if adding lapatinib to trastuzumab for maintenance therapy (after metastatic disease has stabilized or responded to treatment) can prolong the time before the cancer returns. To be eligible, participants must have had either complete disappearance of all metastatic lesions or have stable disease, and be scheduled to receive trastuzumab alone as maintenance therapy.
This is a Phase III trial

Treating Advanced Breast Cancers With a PIK3CA Mutation

A Phase Ib, Open-label Study of Oral BGJ398 in Combination With Oral BYL719 in Adult Patients With Select Advanced Solid Tumors (NCT01928459)

Summary

BYL719 is a new drug that may get cancer cells to die by blocking a protein called PI3KA. BGJ398 is a new drug that may get cancer cells to die by blocking a protein called FGFR. Both proteins play a role in cancer cell growth. Tumors that have a mutation in a gene called PIK3CA may be less likely to respond to some cancer treatments. This study is investigating the safety of combining BYL719 and BGJ398 in breast cancer patients whose tumors have a PIK3CA mutation. To be eligible, patients must have advanced or metastatic breast cancer for which there is no standard treatment. Patients must also have a tumor that has a PIK3CA mutation and alterations FGFR 1-3. Tumors will be tested for these mutations by the researchers. Patients with other types of solid cancers will also be enrolled in this study.
This is a Phase I trial

Veliparib & Doxil for Triple Negative Metastatic Breast Cancer

PHASE I STUDY OF ABT-888, PARP INHIBITOR, AND PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) IN RECURRENT GYNECOLOGIC CANCER AND BREAST CANCER (NCT01145430)

Summary

Researchers are developing new treatments for triple negative breast cancers. Veliparib is a poly(ADP-ribose) polymerase (PARP) inhibitor. It blocks an enzyme that plays an important role in cell growth, which can cause cancer cells to die. Studies suggest velaprib can slow or stop the growth of triple negative breast cancer cells. Liposomal doxorubicin hydrochloride (Doxil®) is a chemotherapy drug used to treat breast and other types of cancers. Giving veliparib with Doxil may be more effective than giving veliparib alone. This trial is studying the side effects and the best dose of veliparib when it is given with Doxil to patients with triple negative metastatic breast cancer. (This study is also enrolling women with ovarian, fallopian and peritoneal cancers.)
This is a Phase I trial

²¹²Pb-TCMC-Trastuzumab Immunotherapy for HER2-Positive Disease

Phase I Trial of Intraperitoneal ²¹²Pb-TCMC-Trastuzumab for HER-2 Expressing Malignancy (NCT01384253)

Summary

Radioimmunotherapy, in which an antibody is used to deliver radiation directly to targeted cancer cells, is an innovative approach for treating metastatic breast cancer. Trastuzumab is a human monoclonal antibody that binds specifically to HER2 positive cancer cells. ²¹²Pb-TCMC-Trastuzumab, a compound that combines trastuzumab with radioactive lead (¹²Pb), may selectively slow the growth of HER2-positive cells by exposing them to cancer-killing radiation. This trial is designed to determine the safety of ²¹²Pb-TCMC-Trastuzumab, its effective dose, and its anti-tumor effects in patients with HER2 positive metastatic breast cancer.
This is a Phase I trial

Targeting PTEN Mutations in Advanced Triple Negative Tumors

A Phase I/IIa, First Time in Human, Open-label Dose-escalation Study of GSK2636771 in Subjects With Advanced Solid Tumors With PTEN Deficiency (NCT01458067)

Summary

PTEN is a protein that works to suppress tumors. Some breast and other cancers have been shown to have a PTEN genetic mutation, which keeps the tumor from developing the PTEN protein. GSK2636771 is an investigational drug that has been designed to treat cancers with a PTEN genetic mutation. The goal of this trial is to determine the safety, best dose and effectiveness of GSK2636771 when it is given to individuals with triple negative (ER-/PR-/HER2-) tumors. Participants will be screened to determine if their tumor has a PTEN mutation. To be eligible, the patient must have a tumor that has not responded to an approved therapy, or must have refused standard therapy.
This is a Phase I trial

PARP-Inhibitor & Chemo for HER2-Negative Advanced Disease

Veliparib in Combination With Carboplatin and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors (NCT01281150)

Summary

Chemotherapy drugs kill cancer cells by damaging their DNA. PARP (poly(ADP-ribose) polymerase) inhibitors are a new type of cancer therapy that works by inhibiting the PARP enzyme, which cells use to repair damaged DNA. Some studies have suggested that giving a PARP inhibitor along with chemotherapy may make the chemotherapy more effective. Veliparib (also called ABT-888) is a PARP inhibitor that is currently being studied in clinical trials. The goal of this study is to determine the safety, effectiveness, and best dose of veliparib when it is given with the chemotherapy drugs paclitaxel (Taxol®) and carboplatin (Paraplatin®). To be eligible, participants must have metastatic disease or locally advanced disease that cannot be removed with surgery.
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

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 trial

Ganetespib For Metastatic HER2+ or Triple Negative Disease

An Open Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib(STA-9090) Monotherapy in Women With Previously Untreated Metastatic HER2 Positive or Triple Negative Breast Cancer (NCT01677455)

Summary

Ganetespib (STA-9090) is an investigational drug. It is an Hsp90 inhibitor: It works by blocking Hsp90 (heat shock protein 90), a molecular chaperone that plays a role in cell signaling. Hsp90 has been studied in previous trials that have enrolled patients with HER2-positive tumors. It may also be an effective way to treat triple negative (ER-,PR- and HER2-) breast cancer. The purpose of this study is to determine if ganetespib is effective in the treatment of patients with HER2+ or triple negative breast cancer who have not received prior systemic treatment for metastatic disease.hibition may be an important new approach to treating triple negative breast cancer.
This is a Phase II trial

A TGF-beta Inhibitor With Radiotherapy for Metastatic Disease

Fresolimumab and Radiotherapy in Metastatic Breast Cancer (NCT01401062)

Summary

Researchers are studying new treatment combinations that may be effective against metastatic breast cancer. Transforming growth factor beta (TGF-beta) is a protein involved in the growth and spread of tumor cells. Many types of tumor cells, including breast cancer cells, make too much TGF-beta. Fresolimumab (GC1008) is a targeted therapy that works by blocking the activity of TGF-beta. Radiation therapy is routinely used in patients with metastatic disease to control specific spots where the cancer has spread. The purpose of this study is to test the safety and effectiveness of using fresolimumab along with radiation to control metastatic breast cancer that has stopped responding to previous treatment.

BMS-906024 & Chemo For Advanced Triple Negative Breast Cancer

A Phase Ib Ascending Multi-arm, Dose Escalation Study of BMS-906024 Combined With Several Chemotherapy Regimens in Subjects With Advanced or Metastatic Tumors (NCT01653470)

Summary

Researchers are developing new targeted therapies for breast and other solid tumors. BMS-906024 is a new drug that works by inhibiting a pathway, called Notch signaling, that plays a role in tumor cell growth and survival. The purpose of this study is to identify a safe and tolerable dose of BMS-906024 to give along with chemotherapy to treat advanced or metastatic breast cancer. (Patients with other types of solid tumors will also be enrolled in this trial.)
This is a Phase I 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

Herceptin® for HER2-Positive Metastases in Spinal Fluid

Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer (NCT01325207)

Summary

Leptomeningeal metastases (LM) occur when breast cancer spreads to the layers of tissue that cover the brain and spinal cord. LM are hard to treat because most cancer drugs cannot get into the spinal fluid that flows around these tissues. Trastuzumab (Herceptin®) is a targeted therapy used to treat HER2-positive breast cancer. The purpose of this trial is to determine the safety, maximum tolerated dose, and effectiveness of Herceptin when it is injected into the spinal fluid of patients with HER2-positive disease that has spread to the tissues covering the brain and spinal cord.
This is a Phase I-II trial

BBI608 and Taxol® for Advanced Disease

A Phase Ib/II Clinical Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies (NCT01325441)

Summary

Cancer stem cells are thought to play a role in cancer growth and metastasis. Some researchers believe that cancer may return or progress when a cancer therapy does not kill the cancer stem cells. This is why scientists are trying to develop drugs that specifically target these cells. BBI608 is an experimental drug that researchers believe can inhibit cancer stem cells. The goal of this trial is to determine the safety and effectiveness of BBI608 when it is given with the chemotherapy drug paclitaxel (Taxol®) to individuals with metastatic breast cancer or locally advanced disease that cannot be removed by surgery.
This is a Phase I-II trial

PARP Inhibitor Veliparib for BRCA1/2 Metastatic Breast Cancer

A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 (NCT01506609)

Summary

Studies suggest that a class of drugs called PARP (poly ADP-ribose polymerase) inhibitors may be effective treatments for women who carry a BRCA1 or BRCA2 genetic mutation. The poly ADP-ribose polymerase (PARP) enzyme fixes DNA damage in both healthy and cancer cells. PARP inhibitors interfere with the PARP enzyme, which might make it even harder for cancer cells that have a BRCA1 or BRCA2 mutation to fix DNA damage. This trial is studying the efficacy and tolerability of veliparib, an investigational oral PARP inhibitor, in women with BRCA1/2-positive metastatic breast cancer.
This is a Phase II trial

BKM120 (a PI3K Inhibitor) For Triple Negative Metastatic Breast Cancer

A Phase II Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer (NCT01629615)

Summary

BKM120 is an experimental therapy that works by inhibiting PI3K, a group of proteins that help cancer cells to grow. Laboratory studies suggest it may be an effective breast cancer treatment. This study is looking at whether BKM120 is effective in patients with metastatic triple-negative breast cancer who have already had at least two prior chemotherapy regimens.
This is a Phase II trial

Panitumumab and Chemotherapy for Inflammatory Breast Cancer

Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression (NCT01036087)

Summary

Inflammatory breast cancer (IBC) is an aggressive type of advanced breast cancer. It is typically treated with chemotherapy prior to surgery. Panitumumab (Vectibix®) is a targeted therapy that works by preventing or slowing the growth of tumor cells by blocking proteins, called epidermal growth factor receptors, that are on the surface of cancer cells. Panitumumab is currently approved for the treatment of certain types of colorectal cancer, and researchers think it might also be effective for IBC. The goal of this trial is to study the safety and effectiveness of panitumumab when it is given with the chemotherapy drugs nab-paclitaxel (Abraxane®), carboplatin (Paraplatin®), fluorouracil (Adrucil®), epirubicin (Ellence®), and cyclophosphamide (Cytoxan®) before surgery to treat HER2-negative IBC.
This is a Phase II 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 patients with advanced lymphoma and mesothelioma, and possibly other cancers as well.)
This is a Phase I trial

Paclitaxel, Herceptin® & Pertuzumab in HER2+ Metastatic Disease

Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer (NCT01276041)

Summary

Studies have shown that using a combination of cancer drugs can be more effective than using a drug alone. This trial is looking at a new drug combination for treating HER2+ breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug commonly used to treat breast cancer. Trastuzumab (Herceptin®) is used to treat early and advanced HER2-positive breast cancer. Pertuzumab (Perjeta®) has been approved by the Food and Drug Administration (FDA) to treat certain patients with HER2-positive breast cancer. This trial will investigate the safety and effectiveness of the combination of Taxol®, Herceptin® and Perjeta® in HER2-positive advanced breast cancer.
This is a Phase II trial

Everolimus and Tykerb® for HER2-Positive Advanced Disease

Phase II Trial of Lapatinib and RAD-001 for HER2 Positive Metastatic Breast Cancer (NCT01283789)

Summary

Women with advanced HER2-positive disease often find that their tumors have stopped responding to HER2-targeted therapies. Researchers are testing new drugs and drug combinations that may be able to prevent tumors from becoming resistant to HER2-targeted therapies and/or make HER2-targeted therapy more effective. Lapatinib (Tykerb®) is a HER2-targeted therapy used to treat women with advanced HER2+ tumors. Everolimus (Afinitor®) is a new type of cancer drug called an mTOR inhibitor. It works by blocking a protein that helps to regulate cell growth and survival. The goal of this trial is to test the effectiveness of the combination of everolimus and Tykerb in women with HER2-positive advanced disease that has progressed on at least one HER2-targeted therapy.
This is a Phase II trial

Dasatinib With Paclitaxel For Advanced Disease

A Phase I-II Study of Dasatinib in Combination With Weekly Paclitaxel for Patients With Metastatic Breast Carcinoma (NCT00820170)

Summary

In this study, researchers are evaluating the safety and effectiveness of adding an investigational drug, dasatinib (Sprycel®), to paclitaxel (Taxol®), a drug commonly used to treat breast cancer. Dasatinib is approved for the treatment of certain types of leukemia, and has been shown to have an anticancer effect on breast cancer cells by inhibiting Src, a protein associated with cell growth. This phase I/II study will determine the best dose of dasatinib, and then determine if it is effective in the treatment of advanced or metastatic breast cancer when given in combination with paclitaxel.
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

Using Genetic Mutations to Guide Treatment in Stage IV Tumors

Molecular Profiling-based Assignment of Cancer Therapy for Patients With Advanced Solid Tumors (NCT01827384)

Summary

Specific genetic variations or mutations inside a cancer cell can influence how it grows. The aim of "personalized" cancer treatment is to select the drugs that will work best based on the genetics of the patient's tumor. However, it is not yet known if this is a more effective approach. This study uses four cancer therapies, each of which targets a specific genetic mutation or variation---Verolimus/Afinitor (mTOR inhibitor), Trametinib DMSO (MEK inhibitor), Temozolomide and ABT-888 (PARP inhibitor), and Carboplatin and MK-1775 (Wee1 inhibitor). Patients with metastatic breast cancer will either be assigned to a drug based on their tumor's genetics, or assigned at random to one of these four drugs. This will allow the researchers to see if the personalized approach is safer and more effective. This study is also open to patients with other types of cancers.
This is a Phase II trial

PARP Inhibitor and Chemotherapy for Advanced Disease

A Phase I Study With an Expansion Cohort of the PARP Inhibitor AZD2281 Combined With Carboplatin in BRCA1/2 Familial Breast and Ovarian Cancer and Sporadic Triple Negative Breast and Ovarian Cancer (NCT01445418)

Summary

Tumors that are triple negative (ER-/PR-/HER2-), or that develop in individuals who carry a BRCA mutation, are often more reliant on a protein called PARP (poly (ADP-ribose) polymerase) than other breast tumors. PARP helps cancer cells continue to grow and divide by repairing DNA that has been damaged by cancer therapies. Olaparib (ADZ2281) is a drug that works by inhibiting the PARP enzyme. Carboplatin (Paraplatin®) is a chemotherapy drug that is used to treat breast cancer. The goal of this trial is to determine the safety and effectiveness of olaparib when it is given with carboplatin to individuals who have a BRCA mutation or triple negative disease. To be eligible, participants must have metastatic disease or advanced disease that cannot be removed with surgery.
This is a Phase I trial

Aromatase Inhibitor with Lapatinib and/or Herceptin®

Ph III Trial to Compare Safety and Efficacy of Lapatinib Plus Trastuzumab Plus Aromatase Inhibitor (AI) vs. Trastuzumab Plus AI vs. Lapatinib Plus AI as 1st Line in Postmenopausal Subjects With Hormone Receptor+ HER2+ MBC Who Received ... (NCT01160211)

Summary

Researchers are trying to determine the best treatment combination for postmenopausal women with hormone-sensitive, HER2+ metastatic breast cancer. Aromatase inhibitors (Ais) are used to treat hormone-sensitive tumors in postmenopausal women. Trastuzumab (Herceptin®) and lapatinib (Tykerb®) can each be used to treat advanced HER2+ tumors. The primary goal of this trial is to compare the effectiveness of an AI, Tykerb, and Herceptin to an AI and Herceptin or an AI and Tykerb. The trial will also look at the effect each combination has on quality of life.
This is a Phase III trial

2B3-101 (Glutathione PEGylated liposomal doxorubicin) for Brain Metastases

An Open-label, Phase I/IIa, Dose Escalating Study of 2B3-101 in Patients With Solid Tumors and Brain Metastases or Recurrent Malignant Glioma. (NCT01386580)

Summary

Treating cancer that has spread to the brain is difficult because most drugs are not able to cross the blood-brain barrier. Doxorubicin is a widely used cancer drug. It comes in two formulations: Adriamycin (the original version) and Doxil, in which the doxorubicin is encapsulated in PEGylated liposomes. 2B3-101 (Glutathione PEGylated liposomal doxorubicin) is a new formulation of doxorubicin that laboratory studies suggest may be able to cross the blood-brain barrier. This study is looking at the safety, tolerability, and best dose of 2B3-101 when it is used alone to treat HER2-negative breast cancer or in combination with trastuzumab (Herceptin®) to treat HER2-positive breast cancer that has spread to the brain.
This is a Phase I-II trial

PARP Inhibitor BMN 673 for Advanced Cancer in Patients with a BRCA Mutation

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

Researchers are trying to identify the best way to treat breast cancer in women who carry a BRCA mutation. Capecitabine (Xeldoa®), Eribulin (Halaven®), Gemcitabine (Gemzar®) and Vinorelbine (Navelbine®) are currently used to treat advanced breast cancer. BMN 673 is a new PARP inhibitor. It kills cancer cells by preventing PARP from repairing damaged DNA. Studies suggest that PARP inhibitors may be as or more effective than current treatments for patients with a BRCA mutation. This study is comparing the safety and effectiveness of BMN 673 to Xeloda, Halaven, Gemzar or Navelbline in patients who carry a BRCA mutation and have locally advanced or metastatic breast cancer. (Patients assigned to the control group will have their doctor determine if they should receive Xeloda, Halaven, Gemzar or Navelbline.)
This is a Phase III trial

Erlotinib for Triple Negative Metastatic Disease

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab Followed by Bevacizumab and Erlotinib in Treating Patients With Metastatic Breast Cancer (NCT00733408)

Summary

Scientists are identifying specific proteins that help cancer cells grow and invade, in hopes of developing treatments that target these proteins. EGFR (epidermal growth factor receptor) is a protein found in high levels on the surface of many types of cancer cells including triple-negative breast cancer, and may contribute to abnormal cell growth. Researchers think that by interfering with EGFR, erlotinib (Tarceva®) may keep tumors from growing. This trial is evaluating erlotinib in combination with chemotherapy and bevacizumab (Avastin®), a drug that targets tumor blood vessel growth, in women with triple negative metastatic breast cancer. It is thought that the combination may provide more benefit than either drug alone.
This is a Phase II trial

Herceptin® and Everolimus for ER-Positive Metastatic Disease

Randomized Phase II of Trastuzumab With and Without Everolimus in Hormone-Refractory Metastatic Breast Cancer (NCT00912340)

Summary

There is currently no standard of care for treating hormone-sensitive breast cancer that has stopped responding to hormonal therapy. Trastuzumab (Herceptin®) is a targeted therapy that is used to treat tumors that produce large amounts of HER2. Everolimus (Afinitor®) is a new drug that was designed to block proteins that are important in the development and growth of cancer. Studies suggest it may be effective for treating HER2-positive tumors. Herceptin alone, or in combination with everolimus, has not been previously used to treat breast tumors that have small to moderate amounts of HER2 and have stopped responding to hormonal therapies. The purpose of the study is to find out if Herceptin alone or in combination with everolimus is an effective treatment for patients with metastatic breast cancer whose tumors have small to moderate amounts of HER2 and are no longer controlled by hormonal therapies.
This is a Phase II trial

PARP-Inhibitor and Chemotherapy for Advanced Disease

A Pharmacokinetic/Pharmacodynamic Study With a Phase I Run-In With a PARP Inhibitor (Olaparib) in Combination With Carboplatin for Refractory or Recurrent Women's Cancers (NCT01237067)

Summary

Researchers are trying to develop more effective breast cancer treatments. One class of drug they are now studying is the PARP inhibitors. PARP is a protein that helps cancer cells grow by repairing DNA damage. It may also encourage precancerous cells to develop into cancer cells. Olaparib is a PARP inhibitor. In previous studies, olaparib has been given safely in combination with the chemotherapy drug carboplatin (Paraplatin®). This study is designed to help researchers determine whether it is more effective to give olaparib and carboplatin together or separately and, if so, which drug should be given first. To be eligible, participants must have metastatic disease or locally-advanced disease that cannot be removed by surgery.
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 trial

MGAH22 for HER2-Positive Metastatic Disease

A Phase 1, Dose Escalation Study of MGAH22 in Patients With Refractory HER2 Positive Breast Cancer and Patients With Other HER2 Positive Carcinomas for Whom No Standard Therapy Is Available (NCT01148849)

Summary

Trastuzumab (Herceptin®) is a breast cancer treatment that targets the HER2 protein. It is a type of drug called a monoclonal antibody, and it is used to treat both early-stage and metastatic HER2-positive tumors. Over time, though, HER2-positive tumors can stop responding to Herceptin®. As a result, researchers are trying to find other drugs that can be used to treat these tumors. MGAH22 is new monoclonal antibody that also targets the HER2 protein. The goal of this trial is to determine the safety, best dose, and effectiveness of MGAH22 when given to individuals with HER2-positive metastatic disease that has progressed on previous treatment and for whom no standard treatment is available.
This is a Phase I trial

Pazopanib, Pemetrexed and Crizotinib for Advanced Disease

A Two Steps Phase I Trial of Pazopanib or Pemetrexed in Combination With Crizotinib Followed by the Triplet, Crizotinib Plus Pazopanib Plus Pemetrexed in Patients With Advanced Malignancies (NCT01548144)

Summary

Using a combination of drugs may be more effective than using one drug alone for treating advanced breast cancer. Crizotinib (Xalkori) blocks a protein called ALK, which is involved in cancer cell growth and survival. It is approved to treat some types of non-small cell lung cancer. Pazopanib (Votrient) blocks the growth of blood vessels that supply nutrients needed for tumor growth. It is approved for the treatment of advanced kidney cancer. Pemetrexed (Alimta) blocks proteins that may cause tumors to grow. It is approved for the treatment of non-small cell lung cancer. The goal of this trial is to identify the highest tolerable dose and to study the safety of the combination of crizotinib and pazopanib; crizotinib and pemetrexed; and crizotinib, pazopanib and pemetrexed in patients with advanced breast cancer. Patients with other types of advanced cancer are also being enrolled in this study.
This is a Phase I trial

Faslodex +/- Afinitor for AI-Resistant Advanced Breast Cancer

Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) Plus Everolimus in Post-Menopausal Patients With Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy (NCT01797120)

Summary

Some patients with ER+ tumors don't respond to hormone therapy. Others have ER+ tumors that initially respond but, over time, become resistant. Fulvestrant (Faslodex®) is a hormone therapy that is commonly used when an ER+ tumor stops responding to an aromatase inhibitor (AI). Everolimus (Afinitor®) is an mTOR inhibitor. It is currently used along with the AI exemestane (Aromasin) to treat advanced ER+, HER2- breast cancer. Using Afinitor along with Faslodex may be more effective than using Faslodex alone. This study is comparing the safety and effectiveness of Afinitor and Faslodex to Faslodex alone in women with advanced hormone-sensitive tumors who have already been on an AI.
This is a Phase 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

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

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

Summary

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

LJM716 and Herceptin for Stage III or IV HER2+ Tumors

A Multicenter, Open-label, Dose Escalation, Phase I Study of LJM716 Administered Intravenously in Combination With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast Cancer (NCT01602406)

Summary

Trastuzumab (Herceptin®) is routinely used to treat HER2+ breast cancer. It works by blocking the HER2 receptor. LJM716 is a new drug that works by blocking the HER3 receptor. Early studies suggest that giving it along with Herceptin may make Herceptin more effective. This study is looking at the effectiveness of LJM716 and Herceptin in patients with HER2-positive non-operable locally advanced or metastatic breast cancer.
This is a Phase I trial

Cdk Inhibitor Palbociclib With Taxol® for Metastatic Disease

A Phase 1 Trial of PD0332991 and Paclitaxel in Patients With Rb-Expressing Advanced Breast Cancer (NCT01320592)

Summary

Cyclin-dependent kinase (cdk) inhibitors are a new class of experimental anti-cancer agents that work by targeting enzymes involved in cell growth. The experimental drug PD-0332991 (Palbociclib) works by inhibiting two different cdk enzymes, cdk4 and cdk6. It is only effective in tumors that are positive for the Rb tumor suppressor protein. Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat breast cancer. The purpose of this trial is to determine the safety, best dose, and effectiveness of Palbociclib in combination with Taxol in individuals with metastatic breast cancer. To be eligible, participants must have a tumor that tests positive for the Rb protein.
This is a Phase I trial

Pazopanib, Paclitaxel & Carboplatin for Advanced Breast Cancer

Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors (NCT01407562)

Summary

Pazopanib (Votrient®) is a targeted therapy that works by inhibiting vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-kit—proteins that help tumors grow and survive. Pazopanib has been approved for the treatment of kidney cancer, and researchers are currently investigating whether it may be effective in certain other cancers as well. Paclitaxel (Taxol®) and carboplatin (Paraplatin®) are two chemotherapy drugs routinely used to treat advanced breast cancer. The goal of this study is to determine the safety, tolerability, and maximum tolerated dose of pazopanib when it is combined with weekly paclitaxel and carboplatin in patients with advanced breast cancer.
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 women 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 women whose tumors are HER2-negative but have these newly discovered HER2 mutations. The purpose of this study is to evaluate Neratinib in patients with metastatic breast cancer whose tumors are HER2-negative but have these HER2 mutations. Patients 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

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

Tetrathiomolybdate (TM) for Stage II, III, and IV Breast Cancer

A Phase II Study of Tetrathiomolybdate (TM) in Patients With Breast Cancer at Moderate to High Risk of Recurrence (NCT00195091)

Summary

Scientists are trying to develop new treatments for preventing recurrence of primary breast cancer or progression of advanced disease. Studies have shown that tumors need copper to grow new blood vessels, a process called angiogenesis. Tetrathiomolybdate (TM) is a drug that is currently being studied in clinical trials that is able to decrease copper levels in the body. This, in turn, may keep tumors from growing and spreading. The purpose of this trial is to assess the safety and effectiveness of TM in women with Stage II, III, or IV breast cancer. Note: Participants who are stage IV must have no evidence of disease.
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

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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-II trial

Palbociclib for Hormone Sensitive, HER2- Advanced Breast Cancer

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial Of Fulvestrant (Faslodex®) With Or Without PD-0332991 (Palbociclib) +/- Goserelin In Women With Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Whose Disease Pro... (NCT01942135)

Summary

Hormone-sensitive tumors can stop responding to anti-estrogen treatments over time. Palbociclib (PD 0332991) is a new targeted therapy that works by blocking two enzymes (cdk4 and cdk6) that play a roll in cell division. Previous clinical trials have found that palbociclib is effective against hormone-sensitive, HER2-negative metastatic breast cancer. Fulvestrant (Faslodex®) is used to treat advanced hormone-sensitive breast cancer that has progressed after being treated with other anti-estrogen drugs. This study is comparing the safety and effectiveness of palbociclib and Faslodex® with Faslodex® alone for the treatment of hormone-sensitive, HER2-negative advanced breast cancer that has progressed after previous hormone therapy.
This is a Phase III 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 patients with HER2-negative metastatic breast cancer. To be eligible for this trial, a patient 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

High-Dose Lapatinib for HER2+ Advanced Breast Cancer

Lapatinib in Treating Patients With Advanced or Metastatic Breast Cancer That Overexpresses HER2 (NCT00544804)

Summary

Lapatinib (Tykerb®) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. There is thought that higher doses of lapatinib may more effective at inactivating tumors that overexpress the protein HER2. The purpose of this phase I trial is to determine the side effects and maximum tolerated dose of high-dose lapatinib in treating patients with advanced or metastatic breast cancer with HER2 positive disease. Participants who have received prior treatment with lapatinib or trastuzumab (Herceptin®) are eligible.
This is a Phase I trial

First-In-Human Study of MORAb-066 for Metastatic Breast Cancer

A Phase I Study of the Safety, Tolerability, and PK of MORAb-066, a Humanized Monoclonal Antibody to Human TF, in Patients With Advanced or Metastatic Breast, Pancreatic, Colorectal, or NSCLC (Adenocarcinoma) Malignancies (NCT01761240)

Summary

New treatments are needed for metastatic breast cancer. MORAb-066 is an investigational targeted therapy that may be an effective breast cancer treatment. It works by targeting a tissue factor protein that studies suggest may help tumors grow and spread. This first-in-human study will assess the safety, tolerability, and activity of MORAb-066 and determine the maximum tolerated weekly dose in women with metastatic breast cancer. (This study also is enrolling patients with pancreatic, colorectal, and non-small-cell lung cancer.)
This is a Phase I trial

PARP-Inhibitor ABT-888 in Previously Treated Metastatic Disease

ABT-888 in Treating Patients With Malignant Solid Tumors That Did Not Respond to Previous Therapy (NCT00892736)

Summary

PARP (poly ADP-ribose polymerase) is an enzyme that helps to repair DNA damage. Studies have shown that some cancer cells use the PARP enzyme to become resistant to chemotherapy. ABT-888 (Veliparib) may be able to inhibit the PARP enzyme, which may keep cancer cells from becoming resistant to chemotherapy and allow them to die. This phase I trial is studying the side effects and best dose of ABT-888 in treating patients with breast cancer and other malignant solid tumors that have stopped responding to previous therapy or who have no acceptable standard treatments available.
This is a Phase I trial

PF-03084014 With Docetaxel In Advanced HER2-Negative Breast Cancer

Phase 1B Study Of Docetaxel + PF-03084014 In Metastatic Or Locally Recurrent/Advanced Triple Negative Breast Cancer (NCT01876251)

Summary

Scientists are developing new types of breast cancer treatments. PF-03084014 is a new type of cancer drug called a selective gamma secretase (GS) inhibitor. These drugs are able to inhibit a signaling pathway called Notch, which plays a role in cancer cell growth and survival. Blocking the pathway may slow or stop cancer cell growth. Docetaxel (Taxol®) is a chemotherapy drug that is commonly used to treat breast cancer. This study will investigate the side effects associated with giving PF-03084014 along with Taxol to patients with advanced breast cancer. The researchers will also collect data that will help them begin to study whether the drug combination is effective. To be eligible, participants must have triple negative breast cancer or hormone-sensitive breast cancer that has progressed on hormone therapy.
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

Tykerb, Afinitor & Xeloda for HER2+ Brain Metastases

Phase 1b/2 Single-arm Trial Evaluating the Combination of Lapatinib, Everolimus and Capecitabine for the Treatment of Patients With HER2-positive Metastatic Breast Cancer With CNS Progression After Trastuzumab (NCT01783756)

Summary

Breast cancer that has metastasized (spread) to the brain is difficult to treat because most cancer drugs are unable to cross the blood-brain barrier. Lapatinib (Tykerb®) is currently used along with capecitabine (Xeloda ®) to treat advanced HER2+ breast cancer. Everolimus (Afinitor®) is currently used along with Aromasin (exemestane®) to treat advanced hormone-sensitive breast cancer. Both Tykerb and Afinitor are able to cross the blood-brain barrier. Researchers believe that using Tykerb, Xeloda, and Afinitor at the same time may be an effective way to treat HER2+ brain metastases. This study will evaluate the safety and effect that the combination of Tykerb, Xeloda, and Afinitor have on women whose tumors are HER2+, have brain metastases, and have already been treated with trastuzumab (Hercepin®).
This is a Phase I-II trial

Afinitor & Aromasin Compared to Afinitor or Xeolda in Advanced Breast Cancer

Predicting Cardiac Effects of Breast Cancer Therapy (CDR0000613213) (NCT01783444)

Summary

Researchers want to know which drugs work better when used in combination with other drugs and which drugs work better when used alone. Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It is used along with exemestane (Aromasin®) to treat advanced ER+, HER2- breast cancer. Capecitabine (Xeloda®) is used to treat metastatic breast cancer. This study is looking at whether using Afinitor or Xeloda alone is more effective than using Afinitor & Aromasin to treat women with ER+, HER2- advanced breast cancer. To be eligible for this study, patients must have already been on letrozole (Femara®) or anastrozole (Arimidex®).
This is a Phase II 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 I trial

SGN-LIV1A in HER2-Negative Metastatic Breast Cancer

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

Summary

Antibody-drug 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 patients with HER2-negative metastatic breast cancer. To be eligible, patients 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

MM-121 with Taxol® for Advanced HER2-Negative Disease

A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers (NCT01209195)

Summary

Over time, advanced stage breast cancer can stop responding to the drugs being used to treat it. Scientists believe that ErbB3, a protein that is bound to the cell membrane, may play a role in how tumors become resistant to treatment. MM-121 is an experimental drug that blocks the activity of ErbB3. Paclitaxel (Taxol®) is a chemotherapy drug commonly used to treat breast cancer. It works by stopping cancer cells from dividing. Laboratory studies have shown that MM-121 can increase the effectiveness of Taxol. The goal of this trial is to determine the safety, effectiveness, and maximum tolerated dose of MM-121 when it is given with Taxol to individuals with locally advanced or metastatic HER2-negative breast cancer.
This is a Phase I trial

Ruxolitinib And Taxol in Advanced Triple Negative, Inflammatory Breast Cancer

Phase II Study of Combination Ruxolitinib (INCB018242) With Preoperative Chemotherapy for Triple Negative Inflammatory Breast Cancer Following Completion of a Phase I Combination Study in Recurrent/Metastatic Breast Cancer (NCT02041429)

Summary

Ruxolitinib was approved by the FDA in 2011 to treat a type of bone marrow cancer. Laboratory studies have shown that the drug blocks a pathway (called IL6/JAK/Stat), which may stop cancer cells from growing. Paclitaxel (Taxol®) is a chemotherapy drug that is routinely used to treat breast cancer patients. Laboratory experiments suggest that giving ruxolitinib along with Taxol may make the Taxol more effective. This study is investigating the safety and effectiveness of giving ruxolitinib and Taxol to women with advanced or metastatic triple-negative, inflammatory breast cancer for which there are no other standard treatments available. It is the first study to test this drug combination in breast cancer.
This is a Phase I-II trial

Laboratory-Activated T Cells With Chemo For Metastatic Disease

A Phase II Study of Anti-CD3 x Anti-HER2/Neu Armed Activated T Cells After Second Line Chemotherapy in Women With HER2/Neu (0, 1+ or 2+) Metastatic Breast Cancers (NCT01022138)

Summary

T cells are a type of white blood cell the immune system uses to destroy bacteria, viruses, and other abnormal cells. Laboratory studies have shown that T cells can be removed from the body and coated with an antibody that will get them to attach to and destroy cancer cells. Researchers believe that removing a patient’s T-cells, coating them with this antibody, and then returning them to the body will be an effective breast cancer treatment. Cyclophosphamide (Cytoxan®) is a type chemotherapy drug commonly used to treat breast cancer. The goal of this trial is to determine the effectiveness of combining chemotherapy with infusions of a patient’s activated T cells to treat metastatic breast cancer that is HER2-negative or expresses HER2 at low levels.
This is a Phase II 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

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

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

Combination Therapy for Overweight Women With Stage IV Disease

Circulating FGF21 Levels and Efficacy of Exemestane, Everolimus and Metformin in Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer and BMI >/= 25 (NCT01627067)

Summary

Researchers believe that using a combination of drugs that work in different ways to slow or stop cancer cell growth may be more effective than using one drug alone. Exemestane (Aromasin®) is routinely used to treat hormone-sensitive breast cancer. Everolimus (Afinitor®) works by inhibiting a protein called mTOR that regulates cell growth. It is approved for use in combination with exemestane in post-menopausal women with advanced hormone sensitive, HER2- breast cancer. Metformin is used to control blood sugar levels in diabetics. Some studies suggest it may also lower cancer risk. This study will see if combining metformin with exemestane and everolimus slows tumor growth in overweight, postmenopausal women with metastatic hormone-sensitive, HER2- breast cancer. To be eligible, a woman must have a body mass index (BMI) of 25 or more.
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

Arimidex® & Targeted Therapy for Advanced Breast Cancer

Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance (NCT01197170)

Summary

Researchers are studying new drug combinations that can be used to treat advanced breast cancer. The goal of this study is to identify the highest tolerated dose of the aromatase inhibitor anastrozole (Arimidex®) when it is given alone or in combination with everolimus (Afinitor®), sorafenib (Nexavar®), erlotinib (Tarceva®), fulvestrant (Faslodex®), or bevacizumab (Avastin®), all of which can be used to treat advanced breast cancer. During the course of the study, if a patient develops resistance to the two drug combination, a third drug will be added to the treatment regimen. To be eligible, participants must have advanced or metastatic cancer that has not responded to standard therapy.
This is a Phase I trial

First Line BKM120 w/Taxol for HER2- Advanced Disease

A Randomized, Double-blind, Placebo Controlled, Phase II Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation. (NCT01572727)

Summary

Researchers are studying new drugs to treat HER2-negative tumors. BKM120 is an investigational kinase inhibitor that blocks the PI3 enzyme. Inhibiting PI3 kinase enzymes may be an effective way to stop tumor cell growth. Paclitaxel (Taxol®) is a standard chemotherapy drug used to treat breast cancer. A placebo is a pill that does not contain any medication. This study is comparing BKM120 and Taxol to BKM120 and a placebo in patients with HER2-negative locally advanced or metastatic breast cancer. To be eligible, participants must not have received treatment for locally advanced or metastatic disease.
This is a Phase II trial

Halaven, Herceptin and Perjeta for Advanced HER2-Positive Breast Cancer

A Phase II Study of Eribulin Mesylate in Combination With Trastuzumab and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer (NCT01912963)

Summary

Researchers are trying to identify the most effective drug combinations for treating advanced HER2+ breast cancer. Eribulin (Halaven®) is a chemotherapy drug used to treat metastatic breast cancer. Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are targeted therapies used to treat HER2-positive tumors. These three drugs have not yet been tested as a combination therapy. This study is looking at the safety and effectiveness of using Halaven, Herceptin and Perjeta to treat advanced HER2-positive breast cancer.
This is a Phase II trial

Femara and Palbociclib for ER+/HER2- Stage III or IV Cancer

A Randomized, Multicenter, Double-Blind Phase 3 Study Of PD-0332991 (Oral CDK 4/6 Inhibitor) Plus Letrozole Versus Placebo Plus Letrozole For The Treatment Of Postmenopausal Women With ER (+), HER2 (-) Breast Cancer Who Have Not Received ... (NCT01740427)

Summary

Researchers are developing new types of targeted therapies to treat breast cancer. PD-0332991 (Palbociclib) is a new drug that works by blocking proteins that help control cell division. (The proteins are called CDK4 and 6 kinases.) Letrozole (Femara®) is an anti-estrogen drug that is routinely used to treat hormone-sensitive tumors. A previous small study suggested that using Palbociclib with Femara was more effective than Femara alone. This study is comparing the benefit of Femara and Palbociclib to Femara and a placebo in postmenopausal women with ER+/HER2- tumors who have not yet had any systemic therapies to treat their advanced cancer.
This is a Phase II-III trial

Taxol & GDC-0941 For a Local Recurrence or Metastatic Disease

A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer (NCT01740336)

Summary

PI3K is a family of enzymes that plays a role in cell growth. Studies have found that the PI3K enzymes can make cancer cells stop responding to chemotherapy. GDC-0941 is a PI3K targeted therapy. Paclitaxel (Taxol®) is a commonly used breast cancer treatment. Researchers think that combining GD-0941 with Taxol will make the Taxol more effective. This study is comparing the safety and effectiveness of Taxol and GDC-0941 to Taxol and a placebo for treating a local recurrence or metastatic breast cancer.
This is a Phase II trial

Dovitinib & Fulvestrant for HER2- & ER or PR+ Advanced Disease

A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have... (NCT01528345)

Summary

Researchers are trying to identify new targets for cancer therapies. Dovitinib is an investigational drug called a fibroblast growth factor receptor 1 (FGFR1) inhibitor. It works by attaching to and keeping the FGFR1 protein from receiving growth signals. Studies have found that about 8% to 10% of breast cancers are FGFR1-positive. (Tumors are currently not tested for their FGFR status.) Fulvestrant (Faslodex®) is an estrogen receptor down-regulator that is used to treat patients whose tumors have advanced on anti-estrogen therapies. It works by blocking the action of estrogen on cancer cells. This trial is enrolling postmenopausal patients with locally advanced or metastatic HER2-negative and ER-positive and/or PR-positive breast cancer that cannot be cured by surgery or radiation, and whose disease has progressed on or after prior endocrine therapy, to study the effectiveness of combining Faslodex with dovitinib.
This is a Phase II trial

Lapatinib for HER2-Negative Metastatic Disease

Phase II Trial of Lapatinib in Women With Hormone Receptor Positive (ER and/or PR +) HER-2 Negative Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy (NCT00759642)

Summary

Researchers are trying to find new treatments for hormone-sensitive, HER2-negative metastatic breast cancer. Lapatinib (Tykerb®) is a drug that targets a variety of protein enzymes involved in tumor cell growth. It is currently used to treat individuals with advanced HER2-positive breast cancer. The goal of this trial is to see if lapatinib is effective in treating HER2-negative, hormone-sensitive metastatic breast cancer that has stopped responding to hormone therapy.
This is a Phase II trial

Veliparib & Chemo for HER2-Negative Advanced Disease

Veliparib and Carboplatin in Treating Women With HER2-Negative Metastatic Breast Cancer (NCT01251874)

Summary

Researchers are trying to find more effective treatments for HER2-negative breast tumors. Poly (ADP-ribose) polymerase (PARP) is an enzyme that cells use to repair damaged DNA. Studies suggest that blocking PARP makes cancer cells more susceptible to the effects of chemotherapy. Veliparib is a PARP inhibitor that is being studied in clinical trials. Carboplatin (Paraplatin®) is a chemotherapy drug used routinely to treat breast cancer. It works by causing DNA damage that can lead to cell death. The goal of this trial is to determine the safety, effectiveness, and best dose of veliparib when it is given with carboplatin. To be eligible, participants must have a HER2-negative tumor that has metastasized or that is locally advanced and cannot be removed by surgery.
This is a Phase I trial

PARP-Inhibitor for BRCA-Positive Advanced Disease

Veliparib With or Without Carboplatin in Treating Patients With Stage III or IV Breast Cancer (NCT01149083)

Summary

Women who have a BRCA1 or BRCA2 mutation have tumors that are more likely to respond to a new class of drugs called PARP (Poly ADP ribose polymerase) inhibitors. These drugs work by inhibiting the PARP enzyme, which helps cancer cells repair their DNA and continue dividing. Veliparib, also called ABT-888, is a PARP inhibitor. Carboplatin (Paraplatin®) is a chemotherpy drug regularly used to treat breast cancer. The goal of this trial is to compare the safety and effectiveness of veliparib alone with veliparib and carboplatin in women with metastatic breast cancer or locally advanced breast cancer that cannot be removed by surgery.
This is a Phase II trial

Local Treatment for For Skin & Chest Wall Metastases

Phase I/II Study of TLR7 Agonist Imiquimod and Radiotherapy in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases (NCT01421017)

Summary

Breast cancer is the second-most likely cancer to result in skin metastases. More effective and less toxic local treatments are needed to treat these metastases. Imiquimod (Aldara®) is a topical cream that is currently used to treat certain precancerous and cancerous skin growths. It works by stimulating the immune system and promoting tumor cell death. The purpose of this study is to determine the best dose and effectiveness of imiquimod when it is combined with radiation therapy for women with skin or chest wall metastases. To be eligible, participants must have skin or chest wall metastases as well as metastases at another distant site.
This is a Phase I-II trial

BAY80-6946 & Taxol for Advanced Breast (and other) Cancer

A Phase 1 Study of BAY80-6946 (Phosphatidylinositol 3΄-Kinase Inhibitor) in Combination With Paclitaxel in Subjects With Advanced Solid Malignancy (NCT01411410)

Summary

Doctors are studying new drugs and new drug combinations that can be used to treat breast cancer. BAY 80-69146 is a new type of drug called a PI3K inhibitor. It works by blocking the PI3K pathway, which plays a role in tumor growth. Paclitaxel (Taxol®) is a commonly used breast cancer therapy that blocks tumor cell growth. This study is designed to identify the highest dose of BAY 80-69146 that should be used when it is given along with Taxol to advanced breast (and other) cancer patients. (This study also is enrolling patients with other types of solid tumors.)
This is a Phase I trial

Temsirolimus and Metformin For Advanced Breast Cancer

Phase I Study of Temsirolimus in Combination With Metformin in Patients With Advanced Cancers (NCT01529593)

Summary

Researchers are looking for new ways to stop the growth of cancer cells. Temsirolimus (Torisel®) blocks a protein called mTOR that plays a role in cancer cell growth. It is used to treat advanced kidney cancer. Metformin is used to control blood sugar in patients with Type 2 diabetes. Studies suggest it may also have anti-cancer properties. The goal of this study is to identify the safety and highest dose of the combination of temsirolimus and metformin that can be given to patients with advanced breast cancer. (This study is also enrolling patients with other types of advanced cancer.)
This is a Phase I trial

Sorafenib and Capecitabine (Xeloda®) For Advanced Breast Cancer

Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors (NCT01640665)

Summary

Combining two drugs that work in two different ways to treat metastatic breast cancer may be more effective than using one drug alone. Sorafenib (Nexavar®) is approved for the treatment of advanced kidney and other cancers. Like bevacizumab (Avastin®), Nexavar is an anti-angiogenesis agent that works by blocking the growth of the new blood vessels a tumor needs to grow and thrive. However, it exerts its effects via a different mechanism of action that involves more cellular pathways. The purpose of this study is to find the maximum tolerated dose of Nexavar that should be used in combination with Xeloda.
This is a Phase I trial

Safety of BYL719 and AMG 479 in Breast (and other solid) Tumors

A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors (NCT01708161)

Summary

Researchers are developing new drugs to treat breast and other solid tumors. BYL719 blocks the PI3K alpha protein, which plays a role in cell growth and survival. AMG 479 (ganitumab) slows tumor growth by keeping insulin-like growth factors 1 and 2 (IGF1 and IGF-2) from binding to the IGF receptor. Using both drugs together may be more effective than using either one alone. This study is designed to identify the safety, best dose, and effectiveness of BYL719 and AMG 479 when it is used to treat advanced breast cancer that is hormone sensitive and tests positive for a PIK3CA gene mutation.
This is a Phase I-II trial

Fulvestrant & Ganetespib for Hormone-Sensitive Advanced Disease

Randomized Phase II Study of Fulvestrant With or Without Ganetespib in Patients With Hormone Receptor-Positive, Metastatic Breast Cancer (NCT01560416)

Summary

Over time, tumors often become resistant to the drugs being used to treat them. The investigational drug ganetespib (STA-9090) is an HSP90 inhibitor. It works by blocking HSP90 (heat shock protein 90), a molecular chaperone that plays a role in cell signaling. This reduces the ability of cancer cells to become resistant to treatment. Fulvestrant (Faslodex®) is used to treat metastatic, estrogen-sensitive tumors. It works by keeping estrogen from getting into the cancer cells; it also decreases the number of estrogen receptors on the cancer cells. In the laboratory, adding ganetespib to fulvestrant appears to improve its effectiveness. It is not yet known whether this is true in humans. This research study is evaluating the effect of adding ganetespib to fulvestrant for the treatment of hormone-sensitive metastatic breast cancer.
This is a Phase II trial

Vorinostat and Lapatinib for Advanced HER2-Positive Disease

Pilot and Phase II- Vorinostat and Lapatinib in Patients With Advanced Solid Tumor Malignancies and Women With Recurrent Local-Regional or Metastatic Breast Cancer to Evaluate Response and Biomarkers of EMT and Breast Cancer Stem Cells (NCT01118975)

Summary

Researchers are studying new drugs and new drug combinations for advanced breast cancer. Vorinostat (Zolinza®) is approved to treat lymphoma, another type of cancer. It works to kill cancer cells by inhibiting HDAC proteins. Lapatinib (Tykerb®) is approved for the treatment of HER2-positive breast cancer. The combination of lapatinib and vorinostat may help to kill cancer cells and prevent them from traveling through the bloodstream. The combination may also help to reduce the number of a subset of cells, called "cancer stem cells." The goal of this trial is to determine the safety, effectiveness, and best dose of vorinostat when given with lapatinib to treat HER2-positive locally advanced or metastatic breast cancer that has progressed on treatment.
This is a Phase II trial

LGK974 for Metastatic Lobular Breast Cancer

A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Melanoma and Lobular Breast Cancer (NCT01351103)

Summary

Researchers are looking for new ways to treat metastatic lobular breast cancer. The Wnt pathway is a network of proteins that may play a role in how cancer develops. LGK974 is an experimental drug that is designed to inhibit he Wnt pathway. The goal of this study is to determine the safety, best dose, and effectiveness of LGK974 when it is given to individuals with metastatic lobular breast cancer for whom there are no standard treatment options.
This is a Phase I trial

Targeted Chemotherapy for Advanced HER2+ Disease

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 in Patients With Advanced Breast Cancer (NCT01304797)

Summary

Chemotherapy works by stopping or slowing the growth of cancer cells, which grow and divide quickly. This can be effective, but it can also harm healthy cells that divide rapidly, causing side effects. Researchers are looking for a way to deliver chemotherapy specifically to the cancer cells. MM-302 is an experimental drug in which the standard chemotherapy drug doxorubicin (Adriamycin®) has been placed inside a capsule that has antibodies that target the HER2 receptor, which sits on the outside of HER2+ breast cancer cells. The goal of this trial is to determine the safety, best dose, and effectiveness of MM-302 in individuals with metastatic or locally advanced breast cancer that cannot be removed by surgery.
This is a Phase I trial

Trametinib + GSK2141795 for Metastatic Triple-Negative Breast Cancer

A Single Arm, Phase II Study of Single Agent Trametinib Followed by Trametinib in Combination With GSK2141795 in Patients With Advanced Triple Negative Breast Cancer (NCT01964924)

Summary

Researchers are studying new drug treatments for triple negative metastatic breast cancer. Trametinib (Mekinist™) is approved to treat certain types of metastatic melanoma. Its use in breast cancer is considered experimental. GSK2141795 is a new type of drug called an Akt inhibitor. Blocking Akt can help lead to cell death. Studies suggest that using both drugs together may be an effective way to treat triple-negative breast cancer. This study is investigating the safety and effectiveness of trametinib alone and then, after progression, with GSK2141795 in patients with metastatic triple negative breast cancer who have had at least one but no more than three prior chemotherapy regimens.
This is a Phase II trial

ALK Inhibitor X-396 For Advanced Breast Cancer

Phase 1, First-in-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of X-396 in Patients With Advanced Solid Tumors (NCT01625234)

Summary

Researchers are developing new types of cancer therapies. ALK is a protein that is involved in cancer cell growth and survival. X-396 is an investigational drug that targets the ALK protein. Laboratory studies suggest it may be effective against advanced cancers. This study is designed to identify highest dose of X-396 that can be safely used. This study is testing X-396 in patients with breast cancer as well as other types of solid tumors. To be eligible, participants must test positive for the ALK protein.
This is a Phase I trial

Temsirolimus and Neratinib for Metastatic Disease

A Phase I/II Trial of Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer (NCT01111825)

Summary

Kinase enzymes are a family of proteins that cells use to help them grow and survive. Researchers are developing cancer drugs that can inhibit these enzymes. This in turn can prevent cancer cells from growing and even cause cell death. The purpose of this study is to test the safety and benefit of two new kinase inhibitors, temsirolimus and neratinib. Temsirolimus inhibits the kinase enzyme mTOR, which is involved in cell proliferation, growth, survival, and angiogenesis (the process in which tumors grow new blood vessels.) Neratinib is a tyrosine kinase inhibitor that inhibits kinase enzymes including the kinase enzyme associated with the HER2 receptor. The goal of this trial is to study the safety, effectiveness, and best dosage of temsirolimus and neratinib when they are given together to individuals with metastatic disease.
This is a Phase I-II trial

Pazopanib to Reverse Resistance to Hormone Therapy

Reversing Hormone Resistance in Advanced Breast Cancer With Pazopanib (NCT01466972)

Summary

Anti-estrogen therapies are used to treat breast tumors that are hormone sensitive. Over time, some tumors will stop responding to these treatments. Researchers are looking for ways to get a breast tumor that has stopped responding to hormone therapy to start responding again to this treatment. The tyrosine kinase inhibitor pazopanib (Votrient®) is currently used to treat kidney cancer. It works by interfering with cell communication and growth. Studies suggest it may also be able to get hormone-sensitive tumors to begin responding again to anti-estrogen therapies. The goal of this trial is to investigate the effectiveness of giving pazopanib to individuals whose cancer has progressed while on letrozole (Femara®) or anastrozole (Arimidex®).
This is a Phase II trial

Jevtana® and Tykerb® for HER2-Positive Brain Metastases

Phase II Study With Lead-in Safety Cohort of Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases (NCT01934894)

Summary

To treat brain metastases, drugs needs to be able to cross the blood-brain barrier. Lapatinib (Tykerb®) is a targeted therapy used to treat HER2+ advanced breast cancer. Cabazitaxel (Jevtana®) is a new type of taxane that studies suggest can cross the blood-brain barrier. It is currently used to treat advanced prostate cancer that has stopped responding to other treatments. This study is investigating the safety and effectiveness of using Tykerb and Jevtana to treat HER2-positive breast cancer that has spread to the brain.
This is a Phase II trial

Vorinostat for HIV+ Patients with Advanced Breast Cancer

Vorinostat in Combination With Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection (NCT01249443)

Summary

Researchers are studying new drugs and new drug combinations for HIV-positive women with advanced breast cancer. Vorinostat (Zolinza®) is a type of medication called a histone deacetylase (HDAC) inhibitor. It works by blocking HDAC enzymes, which are needed for cell growth. Vorinostat is currently used to treat a type of lymphoma. Clinical and laboratory research suggests that vorinostat may also be effective against AIDS and cancers other than lymphoma. The chemotherapy drugs paclitaxel (Taxol®) and carboplatin (Paraplatin®) work in different ways to slow or stop tumor growth. The goal of this trial is to determine the best dose and side effects of vorinostat when given together with Taxol and carboplatin to HIV+ patients with advanced breast cancer.
This is a Phase I trial

Agatolimod and Herceptin® for HER2-Positive Advanced Disease

Agatolimod and Trastuzumab in Treating Patients With Locally Advanced or Metastatic Breast Cancer (NCT00824733)

Summary

Researchers are looking for drugs that can get the immune system to recognize and kill cancer cells. Agatolimod is a drug that may stimulate the immune system in a way that gets it to go after cancer cells. The goal of this trial is to determine the effectiveness of agatolimod when it is given with trastuzumab (Herceptin®), a targeted therapy routinely used to treat HER2+ breast cancer. To be eligible, participants must have locally advanced or metastatic HER2+ disease, and have tumors that responded to recent treatment with Herceptin® and chemotherapy, hormonal therapy, or Herceptin® alone.
This is a Phase II trial

BKM120 & A PARP Inhibitor for Advanced Triple Negative Disease

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

MK-3475 for Advanced Triple Negative Breast Cancer

A Phase Ib Multi-Cohort Study of MK-3475 in Subjects With Advanced Solid Tumors (NCT01848834)

Summary

Researchers are trying to identify targeted therapies that can be used to treat triple negative (ER-, PR-, HER2-) breast cancer. MK-3475 (lambrolizumab) is an experimental drug that works by disabling PD-1 (programmed death 1), a protein that prevents the immune system from attacking tumor cells. Laboratory studies suggest MK-3475 may be an effective treatment for triple negative breast cancer. This study is investigating whether MK-3475 is safe, tolerable, and can kill triple negative breast cancer cells in patients with advanced disease. (This study also is enrolling patients with head and neck or urothelial tract cancers.)
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 patients 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, patients must have already received at least one prior chemotherapy regimen for metastatic breast cancer.
This is a Phase I-II trial

CC-223 for Patients With Advanced Solid Tumors

A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors,... (NCT01177397)

Summary

Researchers are developing drugs to treat solid tumors, like breast cancer. CC-223 is a new type of drug known as a dual mTOR inhibitor. The main purpose of this clinical trial is to assess the safety and action of CC-223 in patients with advanced breast cancer (and other solid tumors) unresponsive to standard therapies. This information will be used to determine which types of cancers respond to the drug as well as the appropriate dose of CC-223 that should be used in later-stage clinical trials. To be eligible, participants must have not tolerated or progressed on standard therapy, and have no other standard therapy available.
This is a Phase I-II trial

Cabozantinib for Metastatic Triple Negative Breast Cancer

A Phase II Study of XL184 (Cabozantinib) for Metastatic Triple-Negative Breast Cancer (NCT01738438)

Summary

Researchers are studying targeted therapies that may be effective against triple negative breast cancer. Cabozantinib (Cometriq®) is a new cancer drug that works by inhibiting some of the molecular pathways that help tumor cells to grow and spread. Cabozantinib was recently approved for the treatment of medullary thyroid cancer. Clinical trials are now underway to see if it also may be effective against breast and other types of cancer. This trial is looking at whether Cabozantinib slows tumor growth in patients with triple negative (ER, PR, and HER2-negative) breast cancer.
This is a Phase II trial

TRC105 and Xeloda® for Metastatic Disease

An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination With Capecitabine for Progressive or Recurrent Metastatic Breast Cancer (NCT01326481)

Summary

Researchers are trying to develop drugs that can target the proteins that help cancer cells grow and survive. Endoglin is a protein located on the surface of some types of cancer cells. It plays a role in the growth of the new blood vessels a tumor needs to survive, a process called angiogenesis. TRC105 is an experimental cancer drug that works by blocking endoglin. The goal of this trial is to determine the safety, effectiveness, and best dose of TRC105 when it is given with the chemotherapy drug capecitabine (Xeloda®) to patients with metastatic breast cancer.
This is a Phase I-II trial

Dovitinib Plus an Aromatase Inhibitor for Metastatic Disease

A Phase I/II Trial of TKI258 (Dovitinib) in Combination With an Aromatase Inhibitor in Patients With Metastatic Breast Cancer (NCT01484041)

Summary

Over time, hormone-sensitive tumors can stop responding to an aromatase inhibitor (AI). Dovitinib (TKI258) is a new targeted therapy that works by blocking the tyrosine kinase receptor on cancer cells. This receptor is like an on/off switch for many cell functions, and blocking it can keep cancer cells from getting the messages they need to grow and divide. This trial is investigating the effectiveness of and side effects associated with using dovitinib along with one of the AIs—anastrozole (Arimidex®), letrozole (Femara®) or exemestane (Aromasin®). To be eligible, a woman must have already been on an AI to treat her metastatic breast cancer.
This is a Phase I-II trial

HDAC Inhibitor Vorinostat And Capecitabine for Advanced Disease

A Dose-Escalating and Phase II Clinical Trial of the Histone Deacetylase (HDAC) Inhibitor Vorinostat (Suberoylanilide Hydroxamic Acid, SAHA, ZolinzaTM) in Combination With Capecitabine (XelodaTM) Using a New Weekly Dose Regimen for... (NCT00719875)

Summary

Scientists are studying new therapy combinations and schedules for treating advanced breast cancer. Capecitabine (Xeloda®) is a chemotherapy drug approved for the treatment of metastatic breast cancer. Vorinostat (Zolinza®) is a drug that works by inhibiting a protein called histone deacetylase (HDAC), which may help stop the growth of breast cancer cells. It is currently approved for the treatment of a type of lymphoma. Researchers believe that giving vorinostat along with capecitabine may make the capecitabine more effective. They also believe capecitabine may be more effective if it is given on a weekly schedule. The purpose of this study is to determine the safety and efficacy of a new weekly dose regimen of vorinostat and capecitabine for treating advanced breast cancer.
This is a Phase I-II trial

Lapatinib & Herceptin® in Patients 60 & Older with Metastases

Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Metastatic Breast Cancer (NCT01273610)

Summary

Cancer drugs may be metabolized, absorbed, and distributed throughout the body differently in older individuals. Trastuzumab (Herceptin®) and lapatinib (Tykerb®) are targeted therapies that are used to treat HER2-positive advanced breast cancer. This drug combination is known to be safe and effective in individuals under age 60, but less is known about its effects in older patients. The purpose of this study is to determine the safety, toxicity, and effectiveness of the combination of Herceptin® and Tykerb® in HER2-positive metastatic breast cancer patients who are age 60 and over, with a specific focus on cardiac toxicity.
This is a Phase II trial

CC-122 for Advanced Breast Cancer

A Phase 1a/1b, Multi Center, Open-Label, Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotropic Pathway Modifier CC-122 Administered Orally to Subjects ... (NCT01421524)

Summary

CC-122 is a type of experimental drug called a pleiotropic pathway modulator, which effects multiple pathways concerned with cell growth. This study will evaluate CC-122 in patients with advanced breast cancer that has not responded to standard therapies to determine the appropriate dosing level and regimen for later-stage clinical trials.
This is a Phase I 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

ONT-380 and Kadcyla for HER2+ Metastatic Breast Cancer

A Phase 1b, Open-label Study to Assess the Safety and Tolerability of ONT-380 Combined With T-DM1 (NCT01983501)

Summary

Researchers are studying new drugs for HER2-positive metastatic breast cancer. ONT-380 is a new type of HER2-targeted therapy that may have fewer side effects than trastuzumab (Herceptin). T-DM1 (Kadcyla) is a HER2-targeted therapy that combines Herceptin with the chemotherapy drug DMI. It is currently used to treat HER2+ metastatic breast cancer. This study will determine the highest safe dose of ONT-380 that can be used in combination with Kadcyla in patients with HER2+ metastatic breast cancer.
This is a Phase I trial

BMN 673 for Patients with Advanced Breast Cancer & a BRCA Genetic Mutation

A Phase 2, 2-Stage, 2-Cohort Study of BMN 673 in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (NCT02034916)

Summary

BMN 673 belongs to a class of drugs called that PARP inhibitors. These drugs kill cancer cells by preventing PARP from repairing damaged DNA. Studies suggest that PARP inhibitors may be effective treatments for patients with a BRCA1 or BRCA2 genetic mutation. This study is evaluating the safety and efficacy of BMN 673 in patients with advanced breast cancer who are known to have an inherited BRCA 1 or BRCA 2 genetic mutation. To be eligible, patients must either have had a platinum-containing chemotherapy regimen or have had more than two non-platinum containing regimens.
This is a Phase II trial

Dovitinib for Metastatic Inflammatory Breast Cancer

A Phase II Study of TKI258 (Dovitinib Lactate) as Salvage Therapy in Patients With Stage IV HER2-negative Inflammatory Breast Cancer (IBC) and Local or Distant Relapse (NCT01262027)

Summary

Inflammatory breast cancer is a rare type of breast cancer that tends to act more aggressively. Researchers are looking for therapies that will be effective against this type of breast cancer. Dovitinib (TKI258) is a drug that works by binding to a protein on the surface of cancer cells called the fibroblast growth factor receptor (FGFR). The goal of this trial is to determine the safety and effectiveness of dovitinib when it is given to individuals with metastatic inflammatory breast cancer.
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 (Kadycla)—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

A Phase I Study of LY2835219 For Advanced Cancer

A Phase 1 Study of a CDK 4/6 Dual Inhibitor in Patients With Advanced Cancer (NCT01394016)

Summary

Cyclin-dependent kinase (cdk) proteins are enzymes that help control cell growth. Laboratory studies have found that these enzymes often don't work properly in cancer cells, which can help fuel tumor growth. Scientists are investigating whether drugs that block the cdk enzymes may be effective cancer treatments. The experimental drug LY2835219 works by inhibiting two different cdk enzymes, cdk4 and cdk6. The goal of this trial is to determine the safety, best dose, and effectiveness of LY2835219 in individuals with advanced breast cancer.
This is a Phase I 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

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 patients with advanced breast cancer.
This is a Phase I trial

Ruxolitinib for Triple Negative or Inflammatory Breast Cancer

Phase II Study of Ruxolitinib (INCB018424) in Patients With PSTAT3+ Breast Cancer (NCT01562873)

Summary

New cancer drugs, which act as targeted therapies, work by stopping or blocking part of the cancer cell's growth cycle. Ruxolitinib (Jakafi®) is a targeted therapy that works by blocking the janus tyrosine knase (JAK) signaling pathway. It is currently approved for the treatment of myelofibrosis, a disorder of the bone marrow. It is not yet an approved cancer treatment. Studies have found that the JAK pathway appears to be involved in the growth of certain types of breast cancer. This suggests that blocking this pathway could slow or stop cancer growth. This study is looking at the effectiveness of ruxolitinib as a treatment for advanced triple negative or inflammatory breast cancer. Every person who enters this trial will have her tumor tissue tested for pStat3, a marker for JAK pathway activity. Those with high JAK activity will receive ruxolitinib.
This is a Phase II trial

Sirolimus and Herceptin® for HER2+ Metastatic Disease

A Phase II Study of Rapamycin (Rapamune, Sirolimus) and Trastuzumab (Herceptin) for Patients With HER-2 Receptor Positive Metastatic Breast Cancer (NCT00411788)

Summary

The drug sirolimus (rapamycin, Rapamune®) belongs to the class of drugs known as mTOR inhibitors. It is currently used to prevent organ rejection in kidney transplant patients, but laboratory studies suggest that it also may be an effective anti-cancer drug. Laboratory studies also have shown that combining sirolimus and trastuzumab (Herceptin®) may be more effective that using either drug alone. This may be because sirolimus is able to get cancer cells that have stopped responding to Herceptin® to start responding again to the drug. Herceptin® and sirolimus have been extensively studied as individual drugs in human subjects. This is the first time a combination of Herceptin® and sirolimus is being evaluated. The goal of this trial is to study the safety and effectiveness of the combination of Herceptin® and sirolimus in women with HER2-positive metastatic disease whose tumors have stopped responding to Herceptin®.
This is a Phase II 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 women with breast or ovarian cancer who have an inherited BRCA mutation. This study is comparing niraparib to currently used cancer treatments in women with advanced HER2-negative cancer who carry a BRCA1 or BRCA2 genetic mutation.
This is a Phase III trial

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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

LDE225 and BKM120 for Metastatic Breast Cancer

A Phase Ib, Multi-center, Open Label, Dose Escalation Study of Oral LDE225 in Combination With BKM 120 in Patients With Advanced Solid Tumors (NCT01576666)

Summary

Researchers are studying targeted therapies that work by blocking cell signaling pathways that help tumors grow and spread. LDE225 is a targeted therapy that blocks a pathway called Hedgehog. BKM120 is a targeted therapy that blocks a pathway called PI3K. Using both of these drugs together may slow or stop tumor growth. The goal of this study is to identify safe doses of LDE225 and BKM120 when they are given in combination. To be eligible, participants must have metastatic breast cancer that has progressed on standard treatments or have no other established treatments available. (This trial is also open to patients with certain other types of advanced cancer.)
This is a Phase I trial

SNX-5422 in HER2+ Advanced Breast Cancer

A Single Arm, Phase 1/2 Study of SNX-5422 in Subjects With Selected HER2 Positive Cancers. (NCT01848756)

Summary

Researchers are looking for new ways to treat HER2+ breast tumors. SNX-5422 is a new drug that blocks the activity of a protein (heat shock protein 90) responsible for maintaining the stability of HER2 proteins in tumor cells. Laboratory studies have shown that SNX-5422 has anti-tumor activity and causes cell death in breast cancer. (A similar response has been seen in other types of cancers.) This study is looking at the safety and effectiveness of using SNX-5422 to treat advanced HER2+ breast cancer. (This trial also is enrolling patients with advanced esophagogastric, urothelial, or non-small cell lung cancers.)
This is a Phase I-II trial

PARP-Inhibitor for Advanced Disease with BRCA Mutation

A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With gBRCA Mutation Breast Cancer or Other Solid Tumor (NCT01482715)

Summary

Cancer cells, like normal cells, replicate their DNA when they divide. During this process, the DNA can become damaged; when this occurs, the cell relies on special proteins, including BRCA and PARP, to repair this damage. Cancer cells with a BRCA mutation are unable to use the BRCA protein to repair DNA damage. Instead, they use the PARP protein to fix the damage, and keep the cancer cell alive. PARP inhibitors are a type of drug that inhibits the PARP protein. When PARP is blocked in a cancer cell that also has a BRCA mutation, it can cause enough DNA damage to make the cell die. The goal of this trial is to determine the safety and effectiveness of the PARP inhibitor rucaparib when it is given to individuals with locally advanced or metastatic breast cancer that is associated with a BRCA mutation and that has advanced on previous treatment.
This is a Phase I-II trial

A Vaccine to Treat HER2+ Advanced Breast Cancer

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

Summary

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

Taxotere & A New Immune Therapy in Metastatic Breast Cancer

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

Summary

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

A Vaccine to Treat HER2-Positive Metastatic Breast Cancer

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

Summary

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

Vaccine for Metastatic Breast Cancer

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

Summary

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

HER2 Immunization for Advanced Breast Cancer

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

Summary

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

Natural Killer Cells and Chemotherapy for Metastatic Disease

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

Summary

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

Mammaglobin-A DNA Vaccine for Metastatic Breast Cancer

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

Summary

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

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

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

Summary

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

Cryoablation Before Surgery to Stimulate the Immune System

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

Summary

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

Vaccine Therapy and Chemotherapy to Treat Metastatic Disease

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

Summary

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

Stereotactic Radiation for Lung or Liver Metastases

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

Summary

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

FANG Vaccine For Advanced Breast Cancer

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

Summary

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

Vaccine Plus Cytoxan® to Treat Stable Metastatic Disease

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

Summary

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

Vaccine With Basilixumab for Metastatic Breast Cancer

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

Summary

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

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

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

Summary

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

Vaccine Therapy for HER2+ Metastatic Breast Cancer

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

Summary

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

Aromasin® and Cytoxan® for Hormone Sensitive Metastatic Breast Cancer

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

Summary

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

Breast Cancer Vaccine Therapy With or Without Trastuzumab

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

Summary

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

Gene Therapy and Chemotherapy for Metastatic Breast Cancer

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

Summary

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

AVX901: A Vaccine for Advanced HER2-Positive Breast Cancer

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

Summary

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

Anti-CEA Designer T Cells in Advanced Breast Cancer

Phase Ia/Ib Trial of 2nd Generation Anti-CEA Designer T Cells in Metastatic Breast Cancer (NCT00673829)

Summary

The white blood cells in your body contain special kinds of cells, called “T” cells, which help you fight infection and disease. Scientists have found that they can modify these T cells to get them to go after cancer cells. These modified cells are called "Designer T cells." To make Designer T cells, researchers collect the patient's white blood cells and then modify them in the laboratory so that they know to recognize a tumor antigen called carcinoembryonic antigen (CEA). These modified cells are then injected back into the patient so that they can attack and kill tumor cells. This study is investigating the safety, side effects, and effectiveness of a new type of Designer T cell in patients with breast cancer. Based on prior laboratory studies, investigators believe that Designer T cells may be helpful in treating breast cancer. To be eligible, a woman's tumor must express CEA, which will be determined by tumor staining or by elevated serum CEA.
This is a Phase I trial

Chloroquine and Chemotherapy for Metastatic Disease

Phase II Study of The Efficacy And Safety of Chloroquine (C) in CombinAtion With Taxane or Taxane-like (T) Chemo Agents in The Treatment of Patients With Advanced or Metastatic Breast Cancer Who Have Failed Anthracycline Chemo Base Therapy. (NCT01446016)

Summary

Chloroquine is a drug that is commonly used to prevent and treat malaria. Studies suggest that chloroquine may also be an effective cancer treatment. Researchers believe this may be because chloroquine targets a special type of tumor cell called a tumor-initiating cell, which may not respond to chemotherapy. The goal of this study is to determine the safety and effectiveness of chloroquine when it is given with a taxane chemotherapy drug to individuals with metastatic disease. To be eligible, participants must have previously progressed on a chemotherapy regimen that included an anthracycline like Adriamycin® or Doxil®.
This is a Phase II trial

Enzalutamide For Treating Metastatic Breast Cancer

A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of MDV3100 in Patients With Incurable Breast Cancer (NCT01597193)

Summary

Many breast cancers depend on the hormones estrogen and/or progesterone to grow and spread. Research suggests that the androgen receptor (AR) is an additional hormonal target in many breast cancers. Blocking androgen from getting into AR+ breast tumors may slow or stop tumor growth. Enzalutamide is an experimental drug that can keep androgen from getting into cancer cells. Studies using the drug to treat prostate cancer have shown promising results. In the laboratory, it can also slow breast cancer cell growth. The purpose of this study is to determine the safety and tolerability of enzalutamide in patients with metastatic breast cancer that cannot be treated with other drugs.
This is a Phase I trial

Whole Body Hyperthermia And Chemotherapy For Metastatic Disease

Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer (NCT00003135)

Summary

Scientists are trying to find new ways to treat metastatic disease. Whole body hyperthermia (WBH) is a cancer therapy that involves heating the body to a temperature of up to 104 degrees. Studies have shown that WBH is able to kill cancer cells by heating them to several degrees above body temperature. Heat also has been shown to make chemotherapy treatments more effective. During WBH, conscious sedation is used to keep the patient comfortable and responsive. This trial is designed to evaluate the effectiveness of using WBH in combination with chemotherapy for treating metastatic disease, and to determine the optimal amount of time to maintain the elevated heat.
This is a Phase II trial

A New Approach to Studying How ER+ Tumors Respond to Treatment

Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status (NCT01916122)

Summary

Breast cancer tumors are tested to determine if they are estrogen receptor (ER) positive or negative. Those that are ER+ can be treated with an anti-estrogen therapy. A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells. A tracer called 16α-18F-fluoroestradiol (FES) looks for and attaches to estrogen receptors. Researchers think that it may be possible to use FES to monitor the effect that a cancer treatment is having on the breast tumor. This study will be exploring the use of FES with a PET/CT scan in women who have ER+ breast cancer and have not yet received hormone therapy.
This is a Phase O trial