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Available Clinical Trials with Links

 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.

  • Clinical Trials for Treatment of Breast Cancer Brain Metastases

A Study of Everolimus, Trastuzumab and Vinorelbine in Her2 Positive Breast Cancer Brain Metastases

This is a phase ll study to see if adding everolimus (Afinitor) to vinorelbine (Navelbine) and trastuzumab (Herceptin) is effective, safe and tolerable for women with Her2-positive breast cancer that has metastasized to the brain. All those enrolled will receive the experimental drug. Everolimus was recently found to extend progression-free survival for women with ER+ metastatic disease without brain metastases.

Lapatinib for Brain Metastases in Erb2 (Her2) Positive Breast Cancer

This is a phase ll study to look at the how safe and effective lapatinib (Tykerb) is when used to treat patients with with Her2-positive breast cancer that has spread to the brain and is still progressing after whole-brain or stereotactic radiation therapy (ongoing, but not recruiting).

GRN1005 Alone or in Combination with Trastuzumab in Breast Cancer Patients with Brain Metastases

The purpose of this phase ll study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with Her2-positive breast cancer metastasized to the brain. GRN1005 is a taxane that has been shown to penetrate the blood-brain barrier. Patients will receive it alone or in combination with Herceptin. Patients with and without prior whole-brain radiation can enroll although they must have at least one measurable brain lesion that is 1.0 centimeter or more.

Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases

This is a randomized phase II study to investigate the safety and efficacy of afatinib, an oral inhibitor of the Her1 and Her2 receptor. It is for women with Her2-positive breast cancer whose brain metastases are progressing after Herceptin or lapatinib (Tykerb). Women will be randomized to receive afatinib alone, in combination with vinorelbine (Navelbine), or investigator's choice of treatment. Prior surgery, whole-brain radiotherapy or stereotactic radiosurgery is allowed, provided there is at least one measureable metastasis after completion of whole brain radiotherapy or stereotactic radiosurgery.

TPI 287 in Breast Cancer Brain Metastases

The goal of this research study is to learn if TPI-287 can control recurrent breast cancer brain metastases. TPI-287 is a novel type of taxane designed to penetrate the blood brain barrier. Patients must have measurable disease on MRI that has progressed after prior therapy. Progressive disease is defined as an appearance of new lesions on a scan, or clinical or neurologic worsening despite stable disease on the last 2 scans. Patients may have had any number of prior surgeries, radiation and/or chemotherapy regimens.

A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer

This single-arm phase l study which will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in patients with HER-2 positive breast cancer. At least one measureable brain metastasis is required.

Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer

This phase lll randomized study is designed to evaluate lapatinib’s effect on incidence on brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.

A Study Evaluating Iniparib in Combination with Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis

This is a phase II non-randomized trial for women with estrogen receptor, progesterone receptor, and Her-2 negative breast cancer that has metastasized to the brain. It will combine a new drug, iniparib (also known as BSI-201), with Irinotecan, a chemotherapy agent. Iniparib is a member of a new class of drugs called PARP inhibitors which specifically targets triple negative and BRCA 1 and 2 positive breast cancer. Iniparib has shown unusually good results in phase I and II trials of women with triple negative metastatic breast cancer, most without brain metastases. These results are being studied in larger randomized phase III trials. There is emerging evidence that some PARP inhibitors can penetrate the blood-brain barrier.

The trial is accepting two groups of women. The first group is women with new or progressing brain metastases greater than 5 millimeters after prior intracranial radiation (either whole brain or stereotactic radiation). The second group is women with newly diagnosed brain metastases less than 5 millimeter who have not received any type of radiation and whose physicians have decided that they don't need emergency radiation. They must receive treatment in the trial within 2 weeks of diagnosis. There is also an expanded access study for women who don't qualify for the trial, but they must have stable brain metastases (see next entry).

An Open-Label Expanded Access Protocol of Iniparib Breast Cancer 

This expanded access trial makes iniparib available before drug approval by the FDA. Iniparib is being offered in combination with gemcitabine and carboplatin for women with triple negative breast cancer (estrogen, progesterone, and Her-2 negative tumors) metastatic breast cancer. Women with stable brain metastases are eligible. Women receiving steroids or expected to require other therapeutic intervention during study participation, including WBRT and intrathecal therapy are not eligible and patients must be more than 21-days from neurosurgical intervention. Brain metastases requiring steroids or expected to require other therapeutic intervention during study participation, including WBRT and intrathecal therapy. Patients must be > 21-days from neurosurgical intervention.

Lapatinib and WBRT For Patients with Brain Metastases from Lung or Breast Tumors

This is a non-randomized Phase ll study to evaluate the response rate (tumor shrinkage) for brain metastases from lung or breast tumors being treated with WBRT and lapatinib (Tykerb). Lapatinib will be continued for six weeks after radiation.

Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients with Brain and/or Leptomeningeal Metastases

The purpose of this phase ll trial is to investigate the efficacy of bevacizumab (Avastin) in combination with two chemotherapies etoposide and cisplatin. Available only in Taiwan.

RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients with Brain Metastases from Breast Cancer

This is a phase l/ll randomized trial is for women with newly diagnosed brain metastases. It will be looking at the proper dose, toxicity, and efficacy of RO4929097, a gamma secretase inhibitor, with either WBRT or stereotactic radio surgery depending on the number of metastases found in the brain. Women will be randomized to receive Ro4829079 with radiation or radiation alone.

Gamma secretase inhibitors have been shown to reduce the proportion of stem cells (the "mother cancer cell") in human breast cancer tumors by making these cells less resistant to chemotherapy.

A Study of Xeloda (Capecitabine) in Breast Cancer Patients with Central Nervous System (CNS) Progression 

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

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

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. Women who are HER2-positive continue to receive Herceptin.  Patients with newly diagnosed and progressing brain metastases are eligible. 

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

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.

Lapatinib Ditosylate (Tykerb) and Capecitabine in Treating Patients with Stage IV Breast Cancer and Brain Metastases

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.

XERAD: A Study of Xeloda (Capecititabine) Plus Radiotherapy in Patients With Breast Cancer With Newly Diagnosed Brain Metastases

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.

High-Dose Methotrexate and Liposomal Cytarabine in Treating Patients With Central Nervous System (CNS) Metastases From Breast Cancer

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

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  

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.  

BBBD Followed by Methotrexate and Carboplatin with and without Trastuzumab (Herceptin) in Treating Women with Breast Cancer Spread to the Brain  

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.

Capecitabine Concomitantly with Whole Brain Radiotherapy (WBRT) Followed by Capecitabine and Sunitinib for CNS Metastases in Breast Cancer

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).

Lapatinib in Combination with Radiation Therapy in Patients with Brain Metastases from HER2-positive Breast Cancer

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.

Epothilone B in Treating Patients with CNS Metastases from Breast Cancer 

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. 

Irinotecan and Temozolomide in Treating Patients with Breast Cancer Who Have Received Previous Treatment for 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.    

Lapatinib and Temozolomide for the Treatment of Progressive Brain Disease in HER-2 Positive Breast Cancer (LAPTEM)

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.       

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. 

Capecitabine, Cyclophosphamide, Doxorubicin, Gemcitabine, Lapatinib, Paclitaxel, Trastuzumab, or Vinorelbine in Treating Women with Brain Metastases from Breast Cancer

A study to see which chemotherapy agents penetrate the blood brain barrier and get into brain metastases.

  • Brain Metastases/CNS Trials, Including but not Limited to Breast Cancer

Perfexion Brain Metastasis

Stereotactic Radiosurgery With Sunitinib for Brain Metastases

Study of the Combination of Vorinostat and Radiation Therapy for the Treatment of Patients With Brain Metastases

Evaluation of [18F]-ML-10 as a PET Imaging Radiotracer for Early Detection of Response of Brain Metastases to Stereotactic Radio Surgery

Evaluation of the Efficacy and Safety of [18F]-ML-10, as a PET Imaging Radiotracer, in Early Detection of Response of Brain Metastases of Solid Tumors to Radiation Therapy

Whole-Brain Radiotherapy (WBRT) Versus WBRT and Integrated Boost Using Helical Tomotherapy for Multiple Brain Metastases

Volumetric Modulated Arc Therapy (VMAT) for Brain Metastases

AZD2171 and Whole Brain Radiation Therapy (WBRT) in Patients With Brain Metastases

131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiation in Patients With Multiple Brain Metastases From Solid Tumors

Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)

Stereotactic Radiosurgery in Treating Patients With Brain Metastases 

Phase I/II Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases

Recruiting Exclusive Hypofractionated Stereotactic Radiotherapy in Non-resectable Single Brain Metastasis

Combination of Sorafenib and Radiation for Brain Metastases and Primary Brain Tumors

Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors

Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Study Bendamustine Concurrent Whole Brain Radiation Brain Metastases From Solid Tumors

Dexamethasone for Palliation - Brain Metastases

Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis

Neuropsychological Measures in Patients Undergoing Radiation Therapy for Brain Metastases

External-Beam Radiation Therapy With or Without Indinavir and Ritonavir in Treating Patients With Brain Metastases

Carboplatin and Bevacizumab for Progressive Breast Cancer Brain Metastases

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

A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis

Exploring the Role of 3T MRI in Gamma Knife Radiosurgery

MRI Using Ferumoxytol in Patients With Primary Brain Cancer or Brain Metastases From Lung or Breast Cancer

Maximum Tolerated Dose (MTD) Finding Trial for Whole Brain Radiation Therapy (WBRT) Using RapidArc

Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor

Fluorescence Guided Resection of Brain Tumors

Resection Bed Post-Surgical Stereotactic Radiosurgery (SRS)

Cytochlor, Tetrahydrouridine, and External-Beam Radiation Therapy in Treating Patients With Cancer That Has Spread to the Brain

Predictive Value of Dynamic Contrast Enhancement MRI on a Cerebral Tumor Response to Gamma Knife Treatment

Recruiting Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer

Melphalan With BBBD in Treating Patients With Brain Malignancies

Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors

Temsirolimus With or Without Temozolomide in Treating Patients With Primary or Metastatic Brain Tumors

Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors

Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer

Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors

Safety Study of High Dose Temozolomide to Treat Relapsed/Refractory Central Nervous System (CNS) Malignancy

  • Early Detection and Prevention of Brain Metastases

Prophylactic Cranial Irradiation With Her-2 Positive Metastatic Breast Cancer (Not yet recruiting)

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.

Lapatinib and Capecitabine versus Trastuzumab plus Capecitabine in Her2 Positive Metastatic Breast Cancer

The purpose of this phase lll randomised trial is to determine which drug--trastuzumab (Herceptin) or lapatinib (Tykerb)--combined with capecitabine (Xeloda) 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).

Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women with Stage IV Breast Cancer

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.

GW572016 And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer (Active, not yet recruiting)

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. 

Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer 

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.

 

  • Clinical Trials for Prevention, Early Detection and Treatment of  Breast Cancer Leptomeningeal Metastases
Exploratory Lapatinib (Positron Emission Tomography) PET Study in Subjects With Breast Cancer
(This study is ongoing, but not recruiting participants)

This is a phase l study using PET scans to determine how much lapatinib penetrates into the brain in subjects with with Her2 overexpressing breast cancer. The study will look at both healthy women and women with brain metastases.

Carboplatin and Bevacizumab for Progressive Breast Cancer Brain Metastases

This is a phase ll trial looking at the efficacy of bevacizumab (Avastin), a drug that blocks the growth of blood vessels into the tumor hoping to starve it of nutrients so that it can't continue to grow. Carboplatin is a chemotherapy that is approved for ovarian cancer and has shown efficacy in breast cancer and in brain metastases. For women with HER2-positive breast cancer, Herceptin will be added to the two drug combination. This trial is opened with newly diagnosed women with breast cancer brain metastases as well as brain metastases that are progressing. This trial also includes women with brain metastases and leptomeningeal disease but not leptomenigeal disease alone.

A Phase I/II trial of Herceptin injected directly into the brain spinal fluid  for women found to have cancer cells in their spinal fluid. Must be HER2-positive with stable disease.  For a description of intrathecal infusion, see the treatments section on leptomeningeal disease. The intrathecal Herceptin is given in combination with whole brain radiation therapy.

Topotecan in Treating Patients with Recurrent, Progressive, or Refactory Cancer that is Metastatic to the Lining Around the Brain (Active, not recruiting)  

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.   For a description of intrathecal infusion, see the treatments section on leptomeningeal disease. 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

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

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. For a description of intrathecal infusion, see the treatments section on leptomeningeal disease.

Study to Demonstrate the Safety of WBR (whole brain radiotherapy) Administered at the Same Time as Intrathecal Liposomal Cytarabine (DepoCyte) versus Intrathecal Liposomal Cytarabine Administered After WBR for the Treatment of Solid Tumour Neoplastic Meningitis in Patients With or Without Brain Metastases

High-Dose Methotrexate and Liposomal Cytarabine in Treating Patients With Central Nervous System (CNS) Metastases From Breast Cancer 

The purpose of this phase II trial is to see how well giving high-dose methotrexate together with liposomal cytarabine works in treating patients with CNS metastases (leptomeningeal and/or brain metastases. For a description of intrathecal infusion, see the treatments section on leptomeningeal disease.

  Magnetic Resonance Imaging for Early Detection of CNS Metastases in Women with Stage 1V Breast Cancer

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.

Study of Cerebrospinal Fluid Samples in diagnosing Carcinomatous Meningitis in Patients with Cancer or Meningeal Syndrome

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 (For a description of intrathecal infusion, see the treatments section on leptomeningeal disease). Persons must have symptoms of leptomeningeal metastases and this experimental procedure will be followed by an MRI.

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.

Radiolabeled Monoclonal Antibody in Treating Patients with Refactory, Recurrent or Advanced CNS or Leptomeningeal Cancer

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 (For a description of intrathecal infusion, see the treatments section on leptomeningeal disease). This trial is not primarily for patients with breast cancer but they can enroll if their tumor has 8H9 antibodies.

Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients with Brain and/or Leptomeningeal Metastases

The purpose of this phase ll trial is to investigate the efficacy of bevacizumab (Avastin) in combination with two chemotherapies etoposide and cisplatin. Available only in Taiwan.

  • Clinical Trials of Brain-Permeable Drugs That Include Women with Stable Brain Metastases
  • NOTE: While many clinical trials exclude women with brain mets, here is a sampling of trials testing drugs known to cross the blood-brain barrier that are 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 nor up-to-date.

Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients with Advanced Solid Tumors

This is a phase l study looking at the best dose and side effects of giving RO4929097, a secretase inhibitor, with cediranib maleate, an angiogensis inhibitor for advanced solid tumors including breast cancer. Women with stable brain metastases are included in the trial.

Gamma secretase inhibitors have been shown to reduce the proportion of stem cells (the "mother cancer cell") in human breast cancer tumors by making these cells less resistant to chemotherapy. Angiogensis inhibitors shrink tumors by cutting off their blood supply.

RO4929097 in Treating Patients with Advanced, Metastatic, or Recurrent Breast Cancer

This is a phase ll non -randomized trial of gamma secretase inhibitor RO4929097 for women with triple negative metastatic breast cancer. It will be looking to see how well and for whom it works. Women with stable brain metastases are included in the study.

Gamma secretase inhibitors have been shown to reduce the proportion of stem cells (the "mother cancer cell") in human breast cancer tumors by making these cells less resistant to chemotherapy.

RO4929097 and Capecitabine in Treating Patients with Refractory Solid Tumors

This is a phase I study looking  at the best dose of RO4929097, a gamma secretase inhibitor, when given with capecitabine (Xeloda) for chemo resistant advanced solid tumors. It will be also looking the effect of combining this new agent with capecitabine. To participate in this trial, women must have her-2 negative disease. They can have stable brain metastases.

Gamma secretase inhibitors have been shown to reduce the proportion of stem cells (the "mother cancer cell") in human breast cancer tumors by making these cells less resistant to chemotherapy. Capecitabine has shown some efficacy for breast cancer brain metastases.

GDC-0449 and RO4929097 in Treating Women with Advanced Breast Cancer

This is a phase one trial looking at the right dose for RP4929097, a gamma secretase inhibitor, given in combination with GDV-0449 in women with metastatic Her-2 negative breast cancer. Women with  brain metastases that are not active are included.

Gamma secretase inhibitors have been shown to reduce the proportion of stem cells (the "mother cancer cell") in human breast cancer tumors by making these cells less resistant to chemotherapy. GDC-0449 is an oral drug that blocks a pathway that causes cancer cells to stop dividing and proliferating.

 Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers 

This is a phase II trial that is looking at the best way to give these two drugs together. Vorinostat has been approved by the FDA (Food and Drug Administration) for T-Cell lymphoma as a radiosensitizer. Lapatinib (Tykerb) is an anti-cancer drug that is approved by the FDA for the treatment of HER2+ metastatic breast cancer after Herceptin. It is given orally. Vorinostat has shown to cross the blood brain barrier in mice. Biomarkers will be looked at to see which tumors have the best response to these two drugs.

 Ixabepilone + Carboplatin Metastatic Breast Cancer 

This is a phase II non-randomized trial testing the efficacy of a novel combination of two chemotherapies. Both Ixabepilone (Ixempra) and carboplatin have shown efficacy with other drugs for poor prognosis ER+ and triple-negative breast cancer that is resistant to taxanes.

 Cisplatin, Paclitaxel, and Everolimus in Treating Patients with Metastatic Breast Cancer 

This phase I/II study is to see how well this new combination of drugs works in stopping tumor growth. The first two drugs are traditional chemotherapeutic agents. Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor. Side effects of giving the three drugs together will also be looked at.

 Ixabepilone and Vorinostat in Treating Patients with Metastatic Breast Cancer 

This is a randomized phase I trial looking at the efficacy and side effects of combining two new drugs. One of the drugs Vorinostat has been shown in mice to cross the blood brain barrier. Ixabepilone (Ixempra) was recently approved by the FDA for metastatic breast cancer. The trial will also be looking at the best way to give these drugs together and the right dose. Vorinostat has been approved by the FDA in T-Cell lymphoma as a radiosensitizer.

 Vinorelbine Metronomic plus Lapatinib for Overexpressing HER2 Metastatic Breast Cancer 

This phase II trial is testing whether giving smaller and more frequent doses of vinorelbine (Navelbine) called metronomic chemotherapy may be more effective and/or less toxic than when given the standard way. Added to vinorelbine (navelbine) is lapatinib (Tykerb), an oral drug already approved by the FDA for Her2+ breast cancer after Herceptin. It has shown some efficacy for the treatment of brain metastases. Both drugs are given in pill form.

 Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response 

The purpose of this phase II study is to determine how effective either cisplatin or carboplatin are in treating triple negative metastatic breast cancer. The trial will also be looking at whether there is a marker in triple-negative breast cancer that predicts response to these platinum drugs.

 Cediranib and Olaparib in Combination for Recurrent Ovarian or Triple-Negative Breast Cancer 

This is a phase I/II trial that is look at the proper dose, safety, and efficacy of these two new drugs neither of which have been approved by the FDA for any cancer though these two drugs have shown promising in other research studies in breast cancer. Cediranib blocks the blood supply to tumors and olaparib has been shown to cause cancer cells to die.

 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) 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) 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.

Trastuzumab (Herceptin) and Irinotecan in Treating Patients With HER2/Neu Positive Metastatic 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.