NOTE:  Check ClinicalTrials.gov as well as the National Cancer Institute Clinical Trials Search for the most current listing of trials. The listings on these websites almost completely overlap. On the NCI website, highlight "Metastatic cancer" and "Brain metastases" in the search box to do a search. On ClinicalTrials.gov it is possible to search under "brain metastases AND breast cancer" which avoids having to sort through many irrelevant trials.
Drug company trials not listed on the two websites above can sometimes be found through PhRMA, the industry website, which lists new agents under development in their new medicines database.
** For an overview of terms and concepts, read  "Understanding Clinical Trials" from ClinicalTrials.gov  For more information, NCI's website Cancer.gov  "Introduction to Clinical Trials" page has links to a number of articles. **
The purpose of this phase II single-arm study is to see for what length of time Xeloda can prevent the recurrence of brain metastases when it is given for four months after whole brain radiation.
 Lapatinib (Tykerb) Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy Â
This is a phase II randomized study comparing lapatinib and caelyx to lapatinib and doxorubicin (Adriamycin). Caelyx is the Euopean name for Doxil which is doxorubicin (Adriamycin) in a liposome (encapsulated in a gel-like substance). It is thought that this liposomal delivery system may target brain metastases more than regular doxorubicin. To enroll in this trial, women must have received only one previous treatment for metastatic disease.
 Carboplatin and Bevacizumab (Avastin) for Progressive Breast Cancer Brain Metastases Â
This phase II study will look at how well the combination of these two agents will work in metastatic breast cancer that has spread to the brain. Carboplatin is a chemotherapeutic agent that kills fast dividing cells. Bevacizumab (Avastin) blocks blood vessel growth into the tumor thus cutting off its blood supply which a tumor needs to grow. This trial is for women who have HER-2 positive tumors who have already received Herceptin.
Laptinib in Treating Brain Metastases in Patients with Stage IV Breast Cancer and Brain Metastases (Active, not recruiting)
This phase II study will study the effect of lapatinib on brain metastases for women who have HER-2 positive breast cancer whose brain metastases have recurred after whole brain radiation and/or stereotactic radiosurgery. To enroll in the trial women must have at least one brain metastasis greater than 10 cm in size and located in a place in the brain that makes removal by surgery impossible.  Study Comparing GW572016 And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer Â
This is a phase III randomized study comparing the efficacy and safety of GW572016 (lapatinib/Tykerb) with letrozole (Femara) vs. letrozole and a placebo. To enroll women must have HER-2 positive and ER and PGR positive breast cancer. The trial hopes that lapatinib will make the letrozole more effective and be useful for a longer period of time.
This phase II trial is to see how well lapatinib works with capecitabine (Xeloda) for women with HER-2 positive brain mets that have not yet received any other treatment for brain metastases. This means no immediate radiation to the brain. The purpose of this trial is to see how well these two agents work before radiation and to see if radiation might not be necessary. To enroll women must not have brain metastases that can be removed by surgery and must have at least one brain metastasis that is greater than 10 mm in size.
This is a phase II randomized trial to see the effect of Xeloda and radiation therapy on newly diagnosed brain metastases. One arm will receive Xeloda in combination with radiotherapy and the other arm will receive Xeloda after radiotherapy.
This phase II trial is looking at how well high dose methotrexate works in combination with liposomal (gel-like delivery system) cytarabine in the treatment of brain metastases. Both drugs are chemotherapies that are delivered intrathecally. This means that an Ommaya resevoir (a plastic dome-like device) is inserted under the scalp on top of the head which allows the drugs to penetrate directly into the cerebrospinal fluid. Aside from a small hole, the skull is not opened. The trial will look at both the safety and efficacy of these drugs and the intrathecal delivery system. Both this procedure (intrathecal administration) and these drugs have been used in the past.
 Brain Mets-Capecitabine (Xeloda) and WBRT Â
This is a phase II trial to determine how well the capecitabine (Xeloda) works given at the same time as whole brain radiation followed by capecitabine and sunitinib given after radiation. Sunitinib is a new drug that stops blood vessel growth to the tumor starving it of nutrients and blood that it needs to grow. Sunitinib has not been approved for the treatment of breast cancer though it has been approved for kidney cancer.
 AZD2171 and Whole Brain Radiation Therapy in Patients With Brain Metastasis Â
This is a phase I study that is looking for the highest dose of AZD2171 that can be given safely with whole brain radiation for brain metastases. AZD2171 blocks blood vessel growth (angiogenesis) by inhibiting VEGF, a growth factor, which promotes blood vessel growth. It is hoped that this agent will starve the tumor of its blood supply safely with whole brain radiation for brain metastases. AZD2171 blocks blood vessel growth (angiogenesis) by inhibiting VEGF, a growth factor which promotes blood vessel growth. It is hoped that this agent will starve the tumor of its blood supply. Â
A phase I/II study looking at the side effects and best dose of carboplatin and methotrexate with and without trastuzumab (Herceptin) after mannitol (type of sugar) is given to disrupt the blood brain barrier. It is hoped that the disruption of the blood brain barrier will allow higher doses of drug to enter into the brain making radiation unnecessary. Very little Herceptin penetrates into the brain without disruption of the blood brain barrier due to the size of the Herceptin molecules.
The purpose of this non-randomized Phase II clinical trial is to test the safety and efficacy of this combination. All participants will get radiation, capecitabine (Xeloda) and sunitinib (Sutent).
The purpose of this Phase I clinical trial is to determine the safety of combining lapatinib (Tykerb) with radiation in people with breast cancer that has spread to the brain. It is thought that lapatinib may make cancer cells in the brain more sensitive to radiation. Other studies show that lapatinib may help to shrink or stabilize breast cancer tumors both inside and outside the brain.
ZK219477 in Patients with Breast Cancer and Brain Metastases
The purpose of this Phase II clinical trial is to determine the effects, both good and bad, of a new chemotherapeutic drug called ZK219477 that appears to cross the blood-brain barrier and penetrate into the brain.
Epothilone B in Treating Patients with CNS Metastases from Breast CancerÂ
This phase II trial is studying how well a new experimental treatment known as epothilone B (patupilone) works in treating patients with CNS metastases from breast cancer that have recurred after whole brain radiation.  Patupilone does cross the blood-brain barrier.
Brain Metastases in Erb2-Positive Breast Cancer
The purpose of this Phase II clinical trial is to see which combination of drugs is safer and more effective for people whose brain metastases have not responded to either whole brain radiation or stereotactic radiation: lapatinib (Tykerb®)and capecitabine (Xeloda®) or lapatinib and topotecan (Hycamtin®). Trial participants must have HER2-positive breast cancer that has metastasized to the brain.Â
The purpose of this Phase II clinical trial is to determine if adding bevacizumab (Avastin) to one of six single-agent chemotherapies with proven efficacy against metastatic breast cancer will result in regression (shrinkage) or stabilization of brain metastases.
The purpose of this phase II trial is to study the side effects of irinotecan (Camptosar) and temozolomide (Temodar) and to see how well they work together as a treatment for previously treated brain metastases.   Â
The purpose of this Belgian phase I trial is to determine the proper dose of these drugs for women whose brain metastases have continued to grow after surgery or radiation. This study will also be looking at the effect of the drug combination of lapatinib (Tykerb) and temozolomide (Temodar) in reducing metastatic growth in the brain. It is for women with Her2 positive breast cancer.      Â
Radiation Therapy With or Without Temozolomide in Treating Women with Brain Metastases and Breast Cancer
The purpose of this French phase II study is to see if the combination of temozolomide and WBRT works better than WBRT by itself. Temozolomide is an oral chemotherapy drug.Â
A study to see which chemotherapy agents penetrate the blood brain barrier and get into brain metastases.
Safety of High Dose Temozolomide to Treat Relapsed CNS Malignancy
The purpose of this phase I trial is to find the highest dose of temozolomide (Temodar)Â that can safely be given to people with brain metastases or other central nervous system metastases. To protect your immune sytem from these high doses stem cells will be removed from your blood or bone marrow before treatment and reinfused after the very high doses of temozolomide are given.
The purpose of this phase II randomized trial is to find out if radiation therapy is more effective given with these two drugs or given without them. Indinavir and Ritonavir are thought to block tumor growth by blocking enzymes that cause tumors to grow.
A Phase I Study of ABT-888 in Combination with Conventional Whole Brain Therapy in Cancer Patients
The purpose of this clinical trial is to study toxicities, side effects, and the most effective dose of ABT-888 to be given with WBRT. ABT-888 is a PARP inhibitor which is a promising new class of drugs that blocks the DNA repair mechanism of cancer cells causing them to die off. It is hoped WBRT will first damage the cancer cells and that ABT-888 will prevent the damaged cells from being repaired causing them to die.
Temsirolimus With or Without Temozolomide in Treating Patients With Primary or Metastatic Brain Tumor
This is a phase I study to determine what dose of Temsirolimus is safe and effective when given with temozolomide and when given without temozolomide. Temozolomide is an oral chemotherapy and Temsirolimus inhibits enzymes needed for cell growth.
Bortezomib and Temozolomide in Treating Patients with Brain Tumors or Other Solid Tumors that Have Not Responded to Treatment
This phase I trial is for patients with recurrent brain metastases. It is looking at the proper dose, safety, and effectiveness of combining temozolomide which is an oral chemotherapy with bortezomib a drug which may block blood flow and nutrients to brain or other metastases and may target enzymes need for cell growth. Both these agents are already used in treatment for different cancers.
Combination of Sorafenib and Radiation for Brain Metastases and Primary Brain Tumors
This is a phase I study is comparing the safety and dose of sorafenib combined with temozolomide and WBRT compared to sorafenib given by itself with WBRT. Sorafenib is an approved drug for Kidney cancer which blocks blood flow to tumors and blocks growth signaling.
Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors
This is a phase III randomized trial to see if patients who take donepezil after WBRT will be less confused, tired, or moody. Patients will get either donepezil or a placebo. Donepezil helps improve cognition in people with Alzheimer's disease.
Pemetrexed Disodium in Treating Patients with Recurrent Malignant Glioma, Primary CNS Lymphoma, or Brain Metastases
This is a phase II trial to measure progression free and overall survival of Pemetrexed Disodium. This is a chemotherapy drug that is already approved for the treatment of lung cancer.
Radiation Therapy in Treating Patients who are Undergoing Surgery to Remove a Metastatic Brain Tumor
This is a phase I/II study to see if it is safe and effective to deliver a targeted dose of radiation to the tumor bed immediately after a metastasis has been surgically removed ie during the surgical operation itself. The study will utilize the Zeiss Intrabeam System Treatment of resected solitary brain metastases.
Study of Temozolomide to Treat Newly Diagnosed Brain Metastases
The purpose of this phase II trial is to determine if temozolomide, a kind of oral chemotherapy, taken after the completion of SRS will help to prevent the recurrence of brain metastases (both former or new ones) in people with 1-3 brain metastases.
Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
This is a phase I/II study to determine what is the proper dose for giving SRS in 3 doses (instead of one) for brain metastases over 4.2 cm in size. It is thought that fractionating the dose ie giving 3 instead of one will allow for SRS to be used on larger metastases.
Collection and Storing Information From Patients with Cancer or Other Chronic Diseases who have Undergone Neurobehavioral Assessments in another Clinical Trial
The purpose of this study is to help learn about the long-term cognitive effects and quality of life in patients with cancer.
Exploratory Study, Evaluating the Treatment Effect of Surgery Plus Gliadel Wafer in Patients with Metastatic Brain Cancer
This is a phase II study to see if the placing of Gliadel Wafer after surgical removal of a metastasis will improve neurocognitive functioning in patients with brain metastases. The wafer is a biodegradeable disk that delievers the chemotherapy drug carmustine directly to the brain tumor site and is placed during surgery after the tumor has been removed. Patient must have three brain metastases or less.
Study of the Combination of Vorinostat and Radiation Therapy for the Treatment of Patients With Brain Metastases Â
This phase I trial is to determine the proper dose of Vorinistat (a targeted treatment, not a chemotherapy) given in conjunction with radiation. Vorinistat has already been approved for T-Cell Lymphoma and has been shown to penetrate the blood-brain barrier in animals and to increase anti-tumor activity of WBRT. This study will also look at safety and anti-tumor activity.
Ang 1005 is a new agent engineered to cross the blood brain barrier. It is a conjugate (combination) of cremophor-free Taxol and a peptide called angiopep. Those enrolled are assigned to one of three doses and are required to stay with that dose. Enrollees can stay on drug as long as it is working.
The purpose of this phase lll randomized trial is to find out if memantine (Namenda), which is currently used for Alzheimer's disease, will preserve memory and other cognitive functions of patients receiving whole brain radiation. Patients will receive memantine or a placebo during the course whole brain radiation therapy.
The aim of this Japanese Phase III clinical trial is to see whether the following two treatments are equal after surgical removal of a brain metastasis: immediate whole brain radiation to lower the risk of recurrence, or stereotactic radiation at the time of recurrence of brain metastases. Trial participants will be randomized to get one treatment or the other.
Dexamethasone for Palliation of Brain Metastases
Steroids like Dexamethasone are used to alleviate swelling around brain metastases which in turn reduces symptoms caused by brain metastases. However, the long term side effects of steroids can be quite severe. This trial will give 8 grams or 4 grams of steroids a day instead of the usual dose of 4 grams 4 times a day in hopes that side effects will be reduced and the symptoms will remain under control.  Â
The purpose of this Phase III randomized clinical trial is to compare how long people survive with stereotactic radiosurgery with or without whole brain radiation. Quality of life will also be compared.
The purpose of this study is to see if adding Ferumoxytol enchances or improves MRI of brain metastases.
Prophylactic Cranial Irradiation With Her-2 Positive Metastatic Breast Cancer
The primary goal of this clinical study is to assess the impact of neurocognitive function (memory, understanding, etc.) in patients with Her-2 positive metastatic breast cancer for 2-3 years after WBRT given to try and prevent the development of brain metastases. Secondarily, brain metastases-free survival, progression-free survival and overall survival will be measured.
The purpose of this phase lll randomised trial is to determine which drug--trastuzumab (Herceptin) or lapatinib (Tykerb)--combined with capecitabine (Xeloda)Â is more effective in preventing brain metastases in patients with metastatic Her2 positive breast cancer who have already been treated with taxanes (Taxol or Taxotere) or anthracyclines (Adriamycin or epiruibicin).
The purpose of this trial is to see if finding brain metastases in patients with metastatic breast cancer early (before they have symptoms) means that women will live longer. The study will be comparing MRI (magnetic resonance imaging) given once every four months to once every 12 months to see if one extends survival more than the other. This trial is only opened to people with HER2-positive breast cancer.
Temozolomide as a Prophylaxis against Brain Recurrence
The purpose of this randomized Phase III clinical trial is to compare the incidence of brain metastases with temozolomide (Temodar) vs. the incidence with a placebo. Participants will get either the Temodar or a placebo (sugar pill).
GW572016 And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
The purpose of this Phase III randomized clinical trial is to see if the combination of GW572016 (lapatinib, brand name Tykerb) and letrozole (Femara) is more effective in preventing recurrence than letrozole alone, and if there are fewer incidences of brain metastases with these two drugs. Participants will get either the Femara with Tykerb or Femara with a placebo (sugar pill).
ErbB2 Over-Expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib
The purpose of this study in HER2 positive (also called ErbB2) women is to see if the addition of lapatinib (Tykerb) will increase the time to disease progression, and reduce the incidence of brain metastases. Participants will either get trastuzumab (Herceptin), paclitaxel (Taxol) and lapatinib (Tykerb) or Herceptin, Taxol and a sugar pill.Â
The purpose of this Phase III trial being offered in the UK is to see if giving women with advanced and metastatic HER2-positive breast cancer whole brain radiation will prevent breast cancer from metastasizing to the brain. Participants will either receive prophylactic cranial radiotherapy or not.
Topotecan in Treating Patients with Recurrent, Progressive, or Refactory Cancer that is Metastatic to the Lining Around the Brain (Active, not recruiting)Â Â
This is a phase I study looking at a 7 day continuous intrathecal or intraventricular infusion for patients with recurrent, progressive, or refractory disease. This means you will receive chemotherapy every day either through the head (intrathecal) or the usual way--intravenously. An intrathecal infusion is done by inserting an Ommaya reservoir (small plastic device) under the scalp allowing the topotecan to penetrate directly into the cerebrospinal fluid. This is a dose escalation study and the dose you receive will start low and increase until you reach the maximum tolerated dose.
 A Pilot Study of Bevacizumab (Avastin) for Neoplastic Meningitis Â
This is phase I/II trial to look at how Avastin may effect cancer that has spread to the brain or spinal fluid. Safety is also being ascertained. If you have been on Avastin in the past you must be off of it six months before entering this trial. You also must be at least one month out from whole brain radiation.
 Depocyt with Sorafenib in Neoplastic Meningitis Â
This is a single arm pilot study of intrathecal administration of cytarabine (chemotherapy agent) with systemic oral sorafenib for neoplastic meningitis (leptomeningeal disease) from solid tumors (breast cancer is a solid tumor). Sorafenib targets inhibits the growth of blood vessels into the tumor with the aim of cutting off its blood supply. Intrathecal administration infusion is done by inserting an Ommaya reservoir (small plastic device) under the scalp allowing the cytarabine to penetrate directly into the cerebrospinal fluid.
Pemetrexed Disodium in the Cerebrospinal Fluid of Patients with Leptomeningeal Metastases Â
The purpose of this phase I study for leptomeningeal disease is to find out how safe and effective Pemetrexed is for leptomeningeal metastases. Pemetrexed is a chemotherapeutic agent FDA approved for treatment in lung cancer. It has shown some efficacy in breast cancer. The study will be looking at blood and cerebrospinal fluid to find out who this drug works for.
The purpose of this trial is to see if finding leptomeningeal metastases in patients early (before they have symptoms) means women will live longer. The study will be comparing MRI done once every four months versus once a year. This trial is only open to people with Her-2 positive breast cancer that is responding to Herceptin.
This study will try to determine what levels of CA 15-3 (a marker for breast cancer) will predict for leptomeningeal metastases. The cerebrospinal fluid will be obtained intrathecally (see explanation under treatment for leptomeningeal metastases). Persons must have symptoms of leptomeningeal metastases and this experimental procedure will be followed by an MRI.
A pilot study of Bevacizumab for Neoplastic Meningitis
This is a phase I/II study to learn if and how bevacizumab (Avastin) may affect cancer that has spread to the meninges (leptomeningeal metastases) in either the brain or the spinal cord. The safety will also be studied. Avastin is a treatment for metastatic breast cancer.Â
Pemetrexed Disodium in the Cerebrospinal Fluid of Patients With Leptomeningeal Metastases
The purpose of this phase I trial is to find the right dose of pemetrexed disodium, which is a chemotherapy drug, and to assess its safety and anti-tumor effects. Patients must undergo frequent lumbar punctures. This drug is already used for the treatment of lung cancer.
Epothilone B in Treating Patients with CNS metastases from Breast Cancer
This phase II trial is studying how well Epothilone B works in treating patients with leptomeningeal metastases. This experimental agent has been shown to cross the blood-brain barrier.
This phase I trial is to determine the side-effects and dose for using radiolabeled antibody therapy in treating advanced CNS or leptomeningeal disease. A radiolabeled monoclonal antibody (8H9) can locate tumor cells and deliver a tumor killing substance which in this case is radioactive iodine 131. The treatment is delivered intrathecally (see leptomeningeal treatment section). This trial is not primarily for patients with breast cancer but they can enroll if their tumor has 8H9 antibodies.
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Clinical Trials That Include Women with Stable Brain Metastases
NOTE: While many clinical trials exclude women with brain mets, here is a sampling of trials available to women whose brain mets are not progressing. For more such trials, try using the search term: "metastatic OR Stage IV OR advanced AND breast cancer" at ClinicalTrials.gov (Capitalized use of OR and AND allows you to combine search terms) The list below is not complete or up-to-date.
Lapatinib and Paclitaxel in Treating Patients with Advanced Solid Tumors
The purpose of this phase l clinical trial is to determine the right dose of a 2-day pulse (administered intermittently) of lapatinib (Tykerb)Â that can be given prior to paclitaxel (Albumin-Stabilized Nanoparticle Formulation, Abraxane)
Erb2 Over-Expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab and Lapatinib
The purpose of this Phase III clinical trial is to evaluate two different dosing combinations of paclitaxel (Taxol), Trastuzumab (Herceptin), and lapatinib (Tykerb)Â in women with HER2-positive (also called ErbB2 over-expressing) metastatic breast cancer.
Combination of Lapatinib With Carboplatin, Paclitaxel, and Trastuzumab on Metastatic Breast Cancer
The purpose of this Phase I clinical trial is to determine the proper dose of lapatinib (Tykerb) when it is given with carboplatin and paclitaxel (Taxol) for HER2-negative breast cancer.
The purpose of this Phase II clinical trial is to see if trastuzumab (Herceptin) in combination with irinotecan (Camptosar) is an effective therapy in HER2-positive metastatic breast cancer.
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