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All Metastatic Trials

Halaven® and Afinitor® For Metastatic Triple Negative Breast Cancer

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

Summary

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

What's Involved    Contact information

Halaven for Treating Metastatic HER2-Negative Breast Cancer

To Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly for Subjects With HER2 Negative Metastatic Breast Cancer (NCT02481050)

Summary

Eribulin mesylate (Halaven®) is a chemotherapy drug that slows or stops tumor cell growth by interfering with the cell's ability to divide. Halaven is FDA approved to treat individuals with metastatic breast cancer who have previously received an anthracycline and a taxane in either the adjuvant or metastatic setting and at least two chemo regimens for the treatment of metastatic breast cancer. In this study, researchers are investigating the effectiveness of Halaven in women with HER2-negative, metastatic breast cancer who have been previously treated with 2 to 5 chemotherapy regimens.

  • Participation TimeVisits twice a week
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

What's Involved    Contact information

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

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

Summary

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

  • Participation Time2 visits every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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 to treat metastatic breast cancer.
This is a Phase II trial

What's Involved    Contact information

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

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

Summary

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

What's Involved    Contact information

Halaven & Keytruda for Metastatic Triple-Negative Breast Cancer

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

Summary

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

  • Participation Time2 visits every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Margetuximab or Herceptin with Chemotherapy for HER2+ Advanced Breast Cancer

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

Summary

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

  • Participation TimeVisits every 3 weeks, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Carboplatin and Afinitor for Metastatic Triple-Negative Breast Cancer

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

Summary

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

  • Participation TimeVisits every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

What's Involved    Contact information

Keytruda Compared to Chemotherapy for Metastatic Triple-Negative Breast Cancer

A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119) (NCT02555657)

Summary

Pembrolizumab (Keytruda) is an immunotherapy drug that blocks PD-1, a protein that normally keeps the immune system from destroying cancer cells. Previous studies have found Keytruda is effective in triple negative breast cancer. This study is comparing the effectiveness of Keytruda to physician's choice standard of care chemotherapy—capecitabine (Xeloda®), eribulin (Halaven), gemcitabine (Gemzar) or vinorelbine (Navelbine®)—in patients with metastatic triple negative breast cancer.

  • Participation TimeVisits every 3 weeks, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Halaven & Cytoxan for Advanced Breast Cancer

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

Summary

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

What's Involved    Contact information

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

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

Summary

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

What's Involved    Contact information

DMS 612 for Advanced Breast (and other) Cancers

A Phase 1, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Intravenous Dimethane Sulfonate (DMS612, NSC 281612) in Advanced Malignancies (NCT00923520)

Summary

DMS612 is a chemotherapy drug that works to kill cancer cells by stopping their growth. This is the first study to give DMS612 to humans. Researchers will study the safety, effectiveness, and best dose of DMS612 in individuals with advanced breast and other cancers who are no longer responding well to standard treatments.

  • Participation TimeVisits weekly, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Camptosar and Veliparib for Advanced Breast Cancer

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

Summary

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

  • Participation TimeAt least 2 visits every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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
    Research sites: 1 site total Contact information
What's Involved    Contact information

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

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

Summary

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

  • Participation TimeVisits 3 times a month, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

EC1456 For Triple Negative Breast Cancer

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

Summary

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

What's Involved    Contact information

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

What's Involved    Contact information

Halaven for Breast Cancer That Has Spread to the Brain

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

Summary

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

  • Participation TimeVisits twice every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation TimeWeekly visits
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Capecitabine + BKM120 in Triple Negatvie Breast Cancer With Brain Metastases

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites: 1 site total Contact information
What's Involved    Contact information

Vidaza and Abraxane For Advanced Breast Cancer

A Phase I/II Clinical Trial of the Hypomethylating Agent Azacitidine (Vidaza) With the Nanoparticle Albumin Bound Paclitaxel (Abraxane) in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer (NCT00748553)

Summary

Azacitidine (Vidaza®) is a chemotherapy drug that is used to treat certain types of bone marrow cancers and blood cell disorders. Laboratory studies suggest it may also be an effective breast cancer treatment. Nab-paclitaxel (Abraxane®) is a chemotherapy drug routinely used to treat advanced breast cancer. This trial is investigating the safety of Vidaza when it is used along with Abraxane to treat advanced breast cancer. The phase I part of the study is designed to determine the best dose of Vidaza to use along with Abraxane in participants with metastatic cancer who have already had at least one other anti-cancer drug. The phase II part of the trial will use the best dose (which was determined in phase I) to study the safety and effectiveness of the drug combination as a first-line treatment in participants with advanced or metastatic HER2-negative breast cancer. (This trial is also enrolling patients with other types of solid tumors.)
This is a Phase I-II trial

What's Involved    Contact information

Bavituximab and/or a Taxane for Metastatic HER2-Negative Breast Cancer

An Open-Label, Randomized, Phase II/III Trial of Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer (NCT02651610)

Summary

Bavituximab is an investigational immunotherapy called a monoclonal antibody. Paclitaxel (Taxol®) and docetaxel (Taxotere®) are taxane-based chemotherapy drugs routinely used to treat breast cancer. This study is comparing the safety and effectiveness of bavituximab and a taxane to a taxane alone to treat metastatic HER2-negative breast cancer. In the study, the participant's physician will choose which taxane will be given.

  • Participation TimeVisits at least weekly
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Immunotherapy and Abraxane for Advanced Triple Negative Breast Cancer

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

Summary

Researchers are investigating the effectiveness of immunotherapies in patients with triple negative (ER-, PR- and HER2-) breast cancer. MPDL3280a (atezolizumab) is an investigational immunotherapy that stimulates the body's immune system to go after cancer cells. It works by blocking a protein called programmed cell death (PD-1) that normally keeps the body's immune system from attacking and destroying tumor cells. Nab-paclitaxel (Abraxane®) is a chemotherapy drug routinely used to treat advanced breast cancer. This study is comparing the safety and effectiveness of Abraxane and atezolizumab to Abraxane and a placebo in patients with previously untreated locally advanced or metastatic triple negative breast cancer.
This is a Phase III trial

What's Involved    Contact information

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

What's Involved    Contact information

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

What's Involved    Contact information

Evaluating if Halaven Reaches the Brain for Patients with Brain Metastases

An Intracerebral Microdialysis Study to Determine the Neuropharmacokinetics of Eribulin in Patients With Brain Metastases From Breast, Bladder, or Non-small Cell Lung Cancer (NCT02338037)

Summary

Brain metastases are difficult to treat because most cancer drugs are unable to cross the blood-brain barrier. Eribulin mesylate (Halaven®) is a chemotherapy drug used to treat patients with metastatic breast cancer that is not responding to other chemotherapy drugs. Previous studies suggest Halaven may be able to cross the blood-brain barrier. In this study, small samples of brain fluids will be collected to help determine how well Halaven gets through the blood-brain barrier in patients with breast cancer that has spread to the brain. (This trial also is enrolling patients with other types of cancers.)

What's Involved    Contact information

GDC-0941 and Platinol For Triple Negative Metastatic Breast Cancer

A Phase Ib/II Trial of GDC-0941 (a PI3K Inhibitor) in Combination With Cisplatin in Patients With Androgen Receptor Negative Triple Negative Metastatic Breast Cancer (NCT01918306)

Summary

Researchers are looking for new ways to treat triple negative breast cancer. GDC-0941 is a new type of cancer therapy called a PI3K inhibitor. It works by blocking the PI3K pathway, which plays a role in tumor growth. Cisplatin (Platinol®) is a chemotherapy drug that is used to treat triple negative breast cancer. Laboratory studies suggest that giving a PI3K inhibitor such as GDC-0941 along with cisplatin may be an effective way to treat AR-negative, triple negative breast cancer. The first phase of this study will determine the maximum tolerated dose of GDC-0941 to use along with Platinol and the side effects associated with that dose. The second phase of the study will examine the safety and effectiveness of using GDC-0941 and Platinol for patients with triple negative breast cancer who also have low androgen receptor activity. All patients who are interested in this trial will have their tumor tested for its androgen receptor (AR) status.
This is a Phase I-II trial

What's Involved    Contact information

TAS-114 and Xeloda for Advanced Breast Cancer

A Phase 1, Open-Label, Non-randomized, Dose-Escalating Safety, Tolerability, and Pharmacokinetic Study of TAS-114 in Combination With Capecitabine in Patients With Advanced Solid Tumors (NCT02025803)

Summary

Researchers are developing new types of cancer treatments. TAS-114 is an experimental cytotoxic drug called a dUTPase and DPD dual inhibitor. Laboratory studies have shown that TAS-114 can cause DNA damage in cancer cells. Capeticabine (Xeloda®) is an oral chemotherapy drug used to treat metastatic breast cancer. This study will determine the best dose and safety of TAS-114 when it is given with Xeloda to treat individuals with advanced breast cancer that has stopped responding to approved breast cancer treatments. This trial also is enrolling individuals with other types of solid tumors.
This is a Phase I trial

What's Involved    Contact information

Gemzar, Herceptin and Perjeta for HER2+ Metastatic Breast Cancer

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

Summary

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

What's Involved    Contact information

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

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

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

Summary

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

  • Participation TimeAt least 1 visit every 3 weeks
  • Participating research sites
    Research sites: 31 sites total Contact information
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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 exemestane (Aromasin®) 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

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BAY1217389 and Taxol for Advanced Breast Cancer

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

Summary

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

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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

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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

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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

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Mifepristone and Halaven For Advanced Triple Negative Breast Cancer

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

Summary

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

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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

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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, participants must have a HER2-negative tumor and may have had up to one prior type of chemotherapy to treat her advanced breast cancer.
This is a Phase II trial

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Effect of Doxil on Metastatic Breast Tumor with Low BRCA Expression

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

Summary

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

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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

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Istodax and Abraxane For Metastatic Inflammatory Breast Cancer

A Phase I/II Study of Romidepsin in Combination With Abraxane in Patients With Metastatic Inflammatory Breast Cancer (NCT01938833)

Summary

Researchers are studying new treatments for inflammatory breast cancer (IBC). Romidepsin (Istodax®) is a histone deacetylase (HDAC) inhibitor. It works by entering cancer cells and blocking the activity of proteins, called histone deacetylases, that help cancer cells grow. Laboratory studies suggest that Istodax, which is used to treat lymphoma, may be an effective treatment for IBC. Protein-bound paclitaxel (Abraxane®) is a chemotherapy drug used to treat IBC. Giving Istodax wtih Abraxane may be more effective than giving Abraxane alone. This study is designed to determine the side effects and best dose of Istodax to use with Abraxane to treat individuals with metastatic IBC.
This is a Phase I-II trial

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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

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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

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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

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RO5509554 Alone or With Taxol for Advanced Breast Cancer (And Other Solid Tumors)

Open-label, Multicenter, Dose Escalation Phase Ia/Ib Study With Expansion Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5509554, Administered as an Intravenous Infusion as Monotherapy and in Combination With Paclitaxel in Patients With Advanced Solid Tumors. (NCT01494688)

Summary

RO5509554 is an new type of cancer drug that blocks the colony-stimulating factor 1 receptor, a protein that is believed to play a role in cancer growth. Paclitaxel (Taxol®) is a chemotherapy drug that is commonly used to treat breast cancer. This study is looking at the safety and effectiveness of giving RO5509554 alone or RO5509554 with Taxol to patients with advanced breast cancer (and other types of solid tumors).
This is a Phase I trial

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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

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Abraxane + an Anti-Inflammatory for Advanced Breast Cancer

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

Summary

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

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BYL719 and Abraxane for Advanced HER2-Negative Breast Cancer

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

Summary

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

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

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

Summary

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

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Halaven vs. Taxol for Advanced Breast Cancer

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

Summary

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

  • Participation Time2 or 3 visits per month
  • Participating research sites
    Research sites: 26 sites total Contact information
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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

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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

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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

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"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

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Proton Radiation Therapy for Cancer That Has Spread to the Liver

Phase I-II Trial of Stereotactic Body Proton Therapy for Patients With Liver Metastases (NCT01697371)

Summary

Metastatic breast cancer often spreads to the liver. Not all patients with liver metastases are able to have surgery to remove the cancer in the liver. Stereotactic body radiotherapy using proton therapy may be an effective option for these patients. Proton therapy (also called proton beam therapy) is a type of radiation treatment that uses protons to destroy cancer cells. Because it is a more precise type of radiation therapy, proton therapy may be a good option for patients with liver metastases. This trial will determine the feasibility and safety of using stereotactic body proton therapy to treat patients whose cancer has spread to the liver. This trial is enrolling patients with many different types of cancer.

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

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

Summary

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

  • Participation TimeMonthly visits for 6 months, then every 3 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Treating Spinal Metastases with Conformal High Dose Intensity Modulated Radiation

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

Summary

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

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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

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Stereotactic Body Radiation Therapy for Breast Cancer with Limited Metastasis

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

Summary

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

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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 individuals 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 participants with tumors that have spread to to the lung or liver.
This is a Phase I-II trial

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

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

Summary

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

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

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

VT-464 for Androgen Receptor-Positive Advanced Breast Cancer

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

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Atezolizumab & Kadcyla or Atezolizuma, Herceptin & Perjeta in HER2-Positive Breast Cancer

A Phase Ib, Open-Label, Two-Arm Study Evaluating The Safety And Pharmacokinetics of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Trastuzumab Emtansine or With Trastuzumab And Pertuzumab in Patients With Her2 Positive Breast Cancer (NCT02605915)

Summary

Atezolizumab (MPDL3280A) is a new immunotherapy drug that blocks the programmed death 1 (PD-1) protein. Blocking the protein allows the immune system to kill cancer cells. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2-targeted therapies. Trastuzumab emtansine (Kadcyla®) combines the chemotherapy drug T-DM1 with Herceptin. This study is comparing the safety and effectiveness of atezolizumab, Herceptin and Perjeta to atezolizumab and Kadcyla in patients with HER2-positive metastatic breast cancer or with a HER2-positive primary tumor >2.0cm.

  • Participation TimeVisits every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation Time2 visits per month
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Estrogen and an Aromatase Inhibitor in Advanced ER+ Breast Cancer

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Endoxifen for Locally Recurrent or Metastatic Breast Cancer

Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer (NCT01327781)

Summary

The anti-estrogen drug tamoxifen fights breast cancer by keeping estrogen from getting into the tumor's cells. Before tamoxifen can begin working inside the body, it must be turned into a chemical called endoxifen by a protein in the liver called CYP2D6. Researchers believe that endoxifen may be an effective therapy for women who do not produce enough CYP2D6 to convert tamoxifen into endoxifen. The goal of this study is determine the best dose, effectiveness, and side effects of endoxifen when it is given to women with locally recurrent or metastatic estrogen receptor-positive breast cancer.
This is a Phase I trial

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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

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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

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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

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

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

Summary

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

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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

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

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

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Talazoparib for HER2-Negative Advanced Breast Cancer

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Triciribine+Paclitaxel in Locally Advanced or Metastatic HER2 Negative Tumors

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

Summary

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

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Selinexor for Previously Treated Advanced Triple-Negative Breast Cancer

Investigator-Initiated Phase 2 Clinical Trial of Selinexor (KPT-330) for the Treatment of Metastatic Triple Negative Breast Cancer (NCT02402764)

Summary

Selinexor (KPT-330) is a new type of targeted therapy designed to block a protein that spurs tumor cell growth. This study is investigating the safety and effectiveness of using selinexor to treat patients with advanced triple-negative breast cancer. To be eligible, a patient must have already received chemotherapy for advanced triple negative breast cancer.

  • Participation TimeVisits every 2 weeks for 6 months, then monthly visits thereafter
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation TimeVisits every 2 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

LEE011 for Advanced Breast Cancer in Postmenopausal Women

A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment (MONALEESA3) (NCT02422615)

Summary

Researchers are studying new types of targeted therapies and new drug combinations for treating advanced breast cancer. LEE011 (riblociclib) is a new type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. It works by inhibiting two enzymes, CDK4 and CDK6. Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat postmenopausal women who have already tried one other type of hormone therapy to treat their advanced breast cancer. This study is comparing the safety and effectiveness of LEE011 and Faslodex with a placebo and Faslodex in postmenopausal women with advanced breast cancer.

  • Participation TimeMonthly visits
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation TimeMonthly visits
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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 non-small 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 women with triple negative breast cancer.
This is a Phase I trial

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Enobosarm for Advanced Androgen Receptor-Positive Triple Negative Breast Cancer

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

BIBF-112 for HER2-Negative Metastatic Inflammatory Breast Cancer

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

Summary

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

  • Participation TimeVisits once a month, then once every 2 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

ARQ092 with Carboplatin and Paclitaxel in Advanced Breast Cancer

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

Summary

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

  • Participation TimeVisits every 3 weeks, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

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Perjeta and Herceptin for HER2-Positive Brain Metastases

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

Summary

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

  • Participation TimeWeekly visits
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation Time3 visits over week 1; then visits every 2 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

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

Summary

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

  • Participation Time3 visits over 3 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation TimeMonthly visits
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

What's Involved    Contact information

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

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation TimeVisits every 3 weeks, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

AZD5363 for Metastatic Breast (and Other) Cancer

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

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

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

Summary

Palbociclib (Ibrance®) is a targeted therapy that keeps cancer cells from growing by blocking two enzymes, CDK 4 and CDK 6. It is used to treat metastatic breast cancer. Bicalutamide (Casodex®) is an anti-androgen drug used to treat prostate cancer. Some breast cancers contain androgen receptors. Laboratory studies suggest these tumors may respond to anti-androgen treatment. This study is testing the safety and effectiveness of using Ibrance and Casodex to treat triple negative breast cancer that is androgen receptor positive. To be eligible for this trial, participants must have triple negative, androgen receptor positive, metastatic breast cancer.

  • Participation Time4 visits over the first 2 months, then monthly visits thereafter
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Targeted Treatment (Herceptin and Perjeta) for Metastatic Breast Cancer

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

Summary

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

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Lynzara and Carboplatin for HER2-Negative Breast Cancer

A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety, Tolerability and Efficacy of Olaparib in Combination With Carboplatin in Patients With HER-2 Negative Breast Cancer (NCT02561832)

Summary

Olaparib (Lynparza) is a type of cancer drug called a PARP inhibitor. By interfering with the cancer cell's DNA, PARP inhibitors make the cell more sensitive to chemotherapy. Lynparza is approved for use in women with advanced ovarian cancer who have an inherited BRCA 1/2 mutation. Carboplatin (Paraplatin®) is a chemotherapy drug routinely used to treat breast cancer. This study has two parts. Part A will determine the safest, most effective dose of Lynparza when it is given with Paraplatin to patients with advanced HER2-negative breast cancer. Part B will use the most effective dose to study how tumors respond to the combination of Lynparza and Paraplatin when it is given before surgery (called neoadjuvant treatment) to patients with stage II-III HER2-negative breast cancer who have an inherited BRCA 1/2 mutation.

  • Participation TimeVisits every 3 weeks for 3 months or more
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

PF-06664178 for Advanced Breast and Other Solid Tumors

A Phase 1, Dose Escalation Study Of Pf-06664178 In Patients With Locally Advanced Or Metastatic Solid Tumors (NCT02122146)

Summary

PF-06664178 is a type of targeted therapy called an antibody-drug conjugate. By attaching chemotherapy to a targeted therapy, the chemotherapy is delivered directly to the cancer cells. This study is evaluating the best dose of PF-06664178 for use in advanced breast (and other) cancers. To be eligible for this study, patients must have no standard therapy available.

  • Participation TimeVisits every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Jakavi and Aromasin for Advanced ER+ Breast Cancer in Postmenopausal Women

A Phase II Trial Of The JAK-Inhibitor Ruxolitinib (INCB018424) In Combination With Exemestane For Patients With Estrogen Receptor (ER) Positive Advanced Breast Cancer) (NCT01594216)

Summary

Ruxolitinib (Jakavi®) is a drug that works by inhibiting the JAK-kinase pathway. It is approved for use in a rare type of blood cancer. Researchers think it may help control tumor growth in certain types of breast cancer. Exemestane (Aromasin®) is an aromatase inhibitor routinely used to treat hormone-sensitive breast cancer in postmenopausal women. This study is investigating the safety and efficacy of using Aromasin and Jakavi to treat advanced ER-positive breast cancer in postmenopausal women.
This is a Phase II trial

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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

New therapies for breast cancer often work by inhibiting proteins involved in cancer cell growth. BYL719 is a new drug that may get cancer cells to die by blocking a protein called PI3Ka. BGJ398 is another new drug that works by inhibiting a protein called FGFR (fibroblast growth factor receptor). This study is investigating the safety of combining BYL719 and BGJ398 in individuals with breast cancer whose tumors have a PIK3CA gene mutation. To be eligible, participants must have advanced or metastatic breast cancer for which there is no standard treatment. Individuals with other types of solid cancers will also be enrolled in this study.
This is a Phase I trial

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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

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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

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Alisertib plus Votrient for Breast (and Other Solid) Tumors

Phase I Study of Aurora A Kinase Inhibitor (MLN8237) Given in Combination With Selective VEGFR Inhibitor Pazopanib (Votrient) for Therapy in Solid Tumors (NCT01639911)

Summary

Alisertib (MLN8237) is an oral targeted therapy that blocks an enzyme--Aurora A kinase--that helps cancer cells grow and survive. 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. Votrient is approved for treating advanced kidney cancer. This study is evaluating the safety and effectiveness of using alisertib and Voltrient to treat metastatic breast (and other solid) tumors that have stopped responding to standard therapy.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

HER2 Therapies with Hormone Therapy or Chemotherapy for Advanced Breast Cancer

1303GCC: Phase II Study of Trastuzumab and Pertuzumab Alone and in Combination With Hormonal Therapy or Chemotherapy With Eribulin in Women Aged 60 and Over With HER2/Neu Overexpressed Locally Advanced and/or Metastatic Breast Carcinoma (NCT02000596)

Summary

Researchers are studying new treatment combinations for advanced HER2+ breast cancer. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2 targeted therapies used to treat HER2+ breast cancer. Anastrozole (Arimidex®) and fulvestrant (Faslodex®) are two of the hormone therapies used to treat advanced breast cancer. Eribulin (Halaven®) is a chemotherapy drug used to treat metastatic breast cancer. Patients who enroll in this study will initially receive Herceptin and Perjeta. If their tumors progress on this treatment, they will receive either Arimidex and Faslodex or Halaven in addition to Herceptin and Perjeta. This study is open to postmenopausal women with locally advanced or metastatic breast cancer.
This is a Phase II trial

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

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

Summary

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

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

Faslodex Combined with LEE011 and BYL719 or BKM120 in Advanced ER+/HER2- Breast Cancer

A Phase Ib/II Study of LEE011 in Combination With Fulvestrant and BYL719 or BKM120 in the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Locally Recurrent or Advanced Metastatic Breast Cancer (NCT02088684)

Summary

Researchers are studying new drugs that may be effective in treating locally advanced or metastatic ER-positive, HER2-negative breast cancer. Fulvestrant (Faslodex®) is used to treat advanced hormone-sensitive breast cancer in postmenopausal women. LEE011, BYL719 and BKM120 are targeted therapies that inhibit enzymes that help cancer cells to grow. LEE011 inhibits CDK4 and CDK6 enzymes. BYL719 and BKM120 inhibit PI3 kinase enzymes. This study is comparing the effect of LEE011 and Faslodex; LEE011, BMK120 and Faslodex; and LEE011, BKM120 and Faslodex in women with locally advanced or metastatic ER+, HER2- breast cancer.
This is a Phase I-II trial

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

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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Ipatasertib and Taxol® For Advanced Triple-Negative Breast Cancer

A RANDOMIZED, PHASE II, MULTI-CENTER, PLACEBO-CONTROLLED STUDY OF IPATASERTIB (GDC-0068), AN INHIBITOR OF AKT, IN COMBINATION WITH PACLITAXEL AS FRONT-LINE TREATMENT FOR PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER (NCT02162719)

Summary

Researchers are studying new drug treatments for triple-negative metastatic breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug used to treat metastatic breast cancer. Ipatasertib (GDC-0068) is a new type of cancer drug called an Akt inhibitor. It works by blocking the Akt protein, which helps tumors grow. Studies suggest ipatasertib may be effective in patients with triple negative tumors. This study is comparing the safety and effectiveness of Taxol and ipatasertib to Taxol and a placebo in patients with locally advanced or metastatic triple-negative breast cancer.
This is a Phase II trial

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Study of Cometriq to Treat Brain Metastases

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

Summary

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

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AZD8835 in Advanced Breast (and Other Solid) Tumors

A Phase I, Open-Label, Multicentre, Dose-Escalation Study to Investigate the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours (NCT02260661)

Summary

AZD8835 is an investigational targeted therapy that is designed to block PI3K, a cell pathway that helps cancer cells grow. This study will look at the safety, efficacy and best dose of AZD8835 for ER+, HER2- breast cancer (and other solid tumors). This is the first study to give AZD8835 to humans. To take part in some aspects of this study, the patient will need to have a tumor that tests positive for the PIK3CA genetic mutation. Some parts of this study also require that postmenopausal patients be eligible for Fulvestrant (Faslodex®).
This is a Phase I trial

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites: 2 sites total Contact information
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Abemaciclib for Hormone Receptor-Positive Brain Metastasis

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

Summary

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

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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

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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

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

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

Summary

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

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GDC-0032 & Taxotere or Taxol in HER2-Negative Advanced Breast Cancer

A Phase Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0032 in Combination With Either Docetaxel or Paclitaxel in Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer (NCT01862081)

Summary

Researchers are studying the effectiveness of new drug combinations. GDC-0032 is a new type of drug called a PI3K-Inhibitor. These drugs block a cell pathway that plays a role in cancer cell growth. Docetaxel (Taxotere®) and paclitaxel (Taxol®) are chemotherapy drugs that are commonly used to treat breast cancer. This study is investigating the safety, tolerability, and best dose of GDC-0032 to use in combination with Taxotere or Taxol for treating women with HER2-negative locally recurrent or metastatic breast cancer.
This is a Phase I trial

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LEE011 in Premenopausal Women with Hormone-Sensitive HER2-Negative Advanced Breast Cancer

A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer (MONALEESA7) (NCT02278120)

Summary

Researchers are studying new types of targeted therapies. LEE011 is a new targeted therapy that inhibits two enzymes--CDK4 and CDK6--that help tumors grow. Anastrozole (Arimidex®) and letrozole (Femara®) are two of the aromatase inhibitors (AIs) used to treat hormone-sensitive breast cancer in postmenopausal women. Premenopausal women can only use an AI if they also take a drug that will stop their ovaries from making estrogen. Goserelin (Zoladex®) is one of these drugs. Tamoxifen (Nolvadex®) is a hormone therapy used to treat hormone-sensitive breast cancer in pre- and post-menopausal women. In premenopausal women it can also be given with Zoladex. This study is comparing the effectiveness of giving a hormone therapy and Zoladex alone or with LEE011 to treat premenopausal women with hormone-sensitive HER2-negaitve advanced breast cancer.
This is a Phase III trial

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AZD9496 in Patients with Advanced ER+, HER2- Breast Cancer

Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD9496 in Women With Estrogen Receptor Positive HER-2 Negative Advanced Breast Cancer (NCT02248090)

Summary

Researchers are developing new types of cancer treatments. AZD9496 is a new type of drug called a selective estrogen receptor degrader that "knocks down" the estrogen receptor. Laboratory studies suggest it may be effective in patients with hormone-sensitive tumors. The goal of this study is to determine the safety and best dose of AZD9496 for treating locally advanced or metastatic ER+, HER2- breast cancer. To be eligible, patients must have received or been offered all appropriate standard therapy. This study is the first to study AZD9496 in humans.
This is a Phase I trial

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LY3023414 for Advanced Breast (and other) Cancers

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

Summary

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

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Vantictumab With Taxol in Advanced Breast Cancer

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

Summary

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

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Radiation and a Targeted Therapy to Treat Brain Metastases in HER2+ Patients

A Phase II Study of Stereotactic Radiosurgery Plus HER-2 Directed Therapy in HER2-positive Breast Cancer With Brain Metastasis (NCT01924351)

Summary

Brain metastases can cause pain and disturb brain function. Stereotactic radiosurgery is used to treat brain metastases as it can deliver targeted radiation to the tumors while protecting neighboring healthy brain tissue. This study is investigating if radiosurgery followed by a HER2 targeted therapy is effective for preventing disease progression in patients with HER2+ breast cancer that has spread to the brain. The HER2 targeted therapy will be selected by the physician and can include trastuzumab (Herceptin®), pertuzumab (Perjeta®), trastuzumab-emtansine (Kadcyla®), or lapatinib (Tykerb®).
This is a Phase II trial

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

A PHASE III, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED STUDY OF TASELISIB PLUS FULVESTRANT VERSUS PLACEBO PLUS FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR-POSITIVE AND HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE DISEASE RECURRENCE OR PROGRESSION DURING OR AFTER AROMATASE INHIBITOR THERAPY (NCT02340221)

Summary

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

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

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

Summary

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

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BYL719 with Aromasin and/or Afinitor in Advanced Breast Cancer

A Phase Ib Dose-finding Study of BYL719 Plus Everolimus and BYL719 Plus Everolimus Plus Exemestane in Patients With Advanced Solid Tumors, With Dose-expansion Cohorts in Renal Cell Cancer (RCC), Pancreatic Neuroendocrine Tumors (pNETs), and Advanced Breast Cancer (BC) Patients. (NCT02077933)

Summary

Researchers are looking at the effectiveness of combining new targeted therapies with other types of breast cancer treatments. BYL719 is a new type of drug called a PI3K inhibitor. It is designed to slow or stop cancer cell growth by blocking the activity of the PI3K protein. Exemestane (Aromasin®) is an aromatase inhibitor that is routinely used to treat hormone-sensitive breast cancer. Everolimus (Afinitor®) is an mTOR inhibitor that is given along with Aromasin to treat advanced hormone-sensitive breast cancer. This study is designed to determine the highest dose and the safety of BYL719 when it is given with Afinitor or Afinitor and Aromasin to treat patients with advanced breast cancer who have no other standard treatments available. The study is also enrolling patients with advanced liver and pancreatic cancer.
This is a Phase I trial

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CDX-011 or Xeloda for Advanced Triple Negative Breast Cancer

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

Summary

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

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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---Everolimus/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

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PF-06650808 For Previously Treated Metastatic Triple Negative Breast Cancer

A Phase 1 Dose Escalation Study Evaluating The Safety And Tolerability Of PF-06650808 In Patients With Advanced Solid Tumors (NCT02129205)

Summary

PF-06650808 is a new type of cancer drug that works by blocking the notch signaling pathway. Researchers think it may be effective for treating triple negative (ER-,PR-, HER2-) breast cancer because laboratory studies have shown that inhibiting notch signaling turns triple-negative tumors into more treatable estrogen-receptor positive cells. This study is evaluating the best dose and the effect of PF-06650808 in patients with previously treated metastatic triple negative breast cancer. It is also enrolling patients with other types of solid tumors. All patients interested in this trial will have their tumor tested to see if it expresses Notch3. Those whose tumors express Notch 3 will be eligible for the study.
This is a Phase I trial

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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

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Veliparib and Tykerb for Treating Triple Negative Metastatic Breast Cancer

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

Summary

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

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Dacomitinib in HER2+ Patients with Progressive Brain Metastases

A Phase II Study to Evaluate the Efficacy, Safety, and Central Nervous System (CNS) Pharmacokinetics of the HER Family Inhibitor Dacomitinib in Progressive Brain Metastases (NCT02047747)

Summary

It is difficult to treat brain metastases because most drugs are not able to cross the blood-brain barrier. Dacomitinib (PF-00299804) is a new drug that blocks epidermal growth factor receptors and tyrosine kinases. Early studies suggest it may be able to cross the blood-brain barrier. This study is looking at the safety and effectiveness of using dacomitinib to treat HER2+ breast cancer patients with progressive brain metastases. Patients with other types of cancers are also being enrolled in this study.
This is a Phase II trial

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FS102 for HER2-Positive Advanced Breast Cancer

Phase 1, Two-Part, Multiple, Ascending Dose Study of the Anti-HER2 FCAB FS102 in Breast, Gastric and Other Solid Tumors (NCT02286219)

Summary

Researchers are looking for new ways to treat HER2+ tumors. FS102 is a new targeted therapy that is designed to destroy HER2-positive cancer cells by directly binding to a unique site on the HER2 protein. This first-in-human study is designed to determine the safety, best dose and effect of FS102 when it is given to patients with HER2+ advanced breast cancer who have no other treatment options. (This study also is enrolling patients with other types of cancers that can be HER2+.)
This is a Phase I trial

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RAD1901 for Advanced ER+ and HER2- Breast Cancer

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

Summary

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

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BMN 673 for Advanced Cancer in Individuals with a BRCA Mutation (EMBRACA Study)

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

Summary

Researchers are trying to identify the best way to treat breast cancer in individuals 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 individuals who carry a BRCA mutation and have locally advanced or metastatic breast cancer. (Individuals 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

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

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

Summary

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

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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

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

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

Summary

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

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

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

Summary

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

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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

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

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

Summary

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

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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

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Xalkori and Sutent for HER2-Negative Metastatic Breast Cancer

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

Summary

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

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Neratinib For HER2-Negative Metastatic Breast Cancer

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

Summary

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

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

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

Summary

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

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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

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BAY1125976 For Advanced Breast Cancer (and other solid tumors)

A Phase I, Multi-center, Non-randomized, Open-label, Dose Escalation Design Study to Characterize Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY 1125976 in Subjects With Advanced Solid Tumors (NCT01915576)

Summary

BAY1125976 is a new type of targeted therapy called an AKT 1/2 inhibitor. Laboratory studies have shown that BAY1125976 can slow or stop tumor cell growth. This is the first study where BAY1125976 is given to cancer patients. Initially, BAY1125976 will be given to any cancer patient who has run out of treatment options so researchers can determine the best study dose. Once the dose is established, researchers will continue to study BAY1125976, but in breast cancer patients only. A tumor does not have to test positive for the AKT1 mutation for a patient to enroll in this study. The goal of this study is to determine the safety and best dose of BAY1125976 as a cancer treatment.
This is a Phase I trial

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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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ABBV-221 for Advanced Tumors That Are EGFR-Positive

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

Summary

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

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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

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POL6326 and Halaven for HER2- Metastatic Breast Cancer

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

Summary

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

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BAY1187982 for Metastatic Tumors That Are FGFR2-Positive

Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2) (NCT02368951)

Summary

Researchers are developing new types of targeted therapies to treat cancers that have spread (metastasized) to other parts of the body. The fibroblast growth factor receptor 2 (FGFR2) protein helps fuel the growth of cancer cells. BAY1187982 is a new type of targeted therapy designed to blocks the FGFR2 receptor. Laboratory and early studies suggest blocking this receptor may slow or stop cancer cell growth. This study is investigating the safety, effectiveness and best dose of BAY1187982 when it is used to treat patients with advanced breast cancer who have progressed on other cancer therapies and whose tumors test positive for FGFR2. This trial also is enrolling patients with other types of metastatic solid tumors. All patients interested in the trial will have their tumor tested for FGFR2. (Only those whose tumors test positive will be able to enroll in the study.)
This is a Phase I trial

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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

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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

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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

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Afinitor and an Anti-Estrogen Therapy for ER/PR+, HER2- Advanced Breast Cancer

Phase II Open Label Study of Everolimus in Combination With Anti-estrogen Therapy in Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer (NCT02291913)

Summary

Everolimus (Afinitor®) is a new type of targeted therapy called an mTOR inhibitor. It is used to treat advanced hormone-sensitive, HER2- breast cancer along with the anti-estrogen therapy exemestane (Aromasin®) in postmenopausal women who have already received certain other treatments. Researchers believe this treatment works in part because it gets the cancer cells to start responding again to the anti-estrogen therapy. It is not known whether Afinitor will get tumors to start responding again to other anti-estrogen therapies. In this study patients will receive Afinitor along with the anti-estrogen therapy they were taking when their cancer progressed. (The anti-estrogen therapy can be tamoxifen, fulvestrant/Faslodex®, anastrozole/Arimidex®, letrozole/Femara®, exemestane/Aromasin®, toremifene/Fareston®, or an LHRH agonist given with anti-estrogen therapy).
This is a Phase II trial

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SGN-LIV1A in HER2-Negative Metastatic Breast Cancer

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

Summary

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

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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

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Afinitor and Hormone Therapy for Advanced Breast Cancer

Phase II Study of Everolimus Beyond Progression in Postmenopausal Women With Advanced, Hormone Receptor Positive Breast Cancer (NCT02269670)

Summary

Everolimus (Afinitor®) is a new type of targeted therapy called an mTOR inhibitor. It is used along with the hormone therapy exemstane (Aromasin) to treat postmenopausal women with advanced hormone-sensitive, HER2-negative tumors. Researchers think giving Afinitor with a different type of hormone therapy may be an effective way to treat patients whose tumors have progressed or recurred following treatment with Afinitor and Aromasin. This study will evaluate the safety and effectiveness of Afinitor and a hormone therapy, to be selected by the physician, in patients with hormone-sensitive, HER2-negative breast cancer who have already tried Afinitor and Aromasin.
This is a Phase II trial

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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

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Orteronel For Androgen Receptor-Positive Metastatic Breast Cancer

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

Summary

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

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MK-3475 and INCB024360 in Breast Cancer (And Other Solid Tumors)

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of MK-3475 in Combination With INCB024360 in Subjects With Selected Solid Tumors (Phase 1) Followed by a Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Advanced NSCLC (Phase 2) (NCT02178722)

Summary

Researchers are developing new drugs to treat breast cancer and other types of solid tumors. INCB024360 is a new drug that works by blocking an enzyme called IDO1, which suppresses the immune system. Laboratory studies have shown that INCB024360 can activate the immune system and inhibit the growth of cancer cells that express IDO1. MK-3475 (pembrolizumab) is an experimental drug that disables PD-1, a protein that prevents the immune system from attacking tumor cells. Studies suggest that MK-3475 may be an effective treatment for triple negative breast cancer. This study is comparing the safety and effectiveness of the combination of MK-3475 and INCB024360 to MK-3475 and a placebo to treat advanced breast cancer. This study is also enrolling individuals with other types of solid tumors.
This is a Phase I-II trial

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

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

Summary

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

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Olaparib with AZD2014 or AZD5363 for Recurrent Triple Negative Breast Cancer

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

Summary

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

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A New PARP Inhibitor For BRCA-Positive Advanced Breast Cancer

Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Deleterious BRCA Mutations (NCT01989546)

Summary

BMN 673 is a new type of cancer drug called a PARP inhibitor. It works by blocking the PARP —poly (ADP-ribose) polymerase—protein that helps cells repair DNA damage. Early studies suggest BMN 673 may be effective in patients with advanced breast cancer who have a BRCA mutation. This study is evaluating the effect that BMN673 has on cancer cells (through tumor biopsies) of patients with advanced breast cancer who have a known BRCA inherited mutation.
This is a Phase I-II trial

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AZD5363 and Dabrafenib for ER+, HER2+ Advanced Breast Cancer

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 +Dabrafenib Under Adaptable Dosing Schedules in Patients With Advanced Solid Tumors That Are Metastatic or Cannot be Removed by Surgery (NCT02212743)

Summary

AZD5363 is an AKT inhibitor, a new type of targeted therapy. It works by blocking the AKT1 protein, which plays a role in cancer cell growth. Dabrafenib (Tafinlar®) is a targeted therapy that is used to treat certain types of metastatic melanoma. It works by inhibiting a protein called BRAF, which helps tumors grow. This study will determine the safety and effectiveness of giving AZD5363 and Tafinlar to patients with ER+, HER2+ breast cancer that has spread to other parts of the body (metastasized) or cannot be surgically removed. All patients who are interested in the trial will have their tumor tested for BRAF, AKT1 and PIK3CA gene mutations. Only patients whose tumors have at least one of these mutations will be eligible for the study. (This study also is enrolling patients with other types of cancers.)
This is a Phase I-II trial

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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

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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 participants with advanced breast cancer. (This study is also enrolling individuals with other types of advanced cancer.)
This is a Phase I trial

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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

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Cobimetinib and Paclitaxel for Advanced Triple Negative Breast Cancer

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

Summary

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

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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

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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

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

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

Summary

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

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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 individuals 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

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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