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Targeted therapy

Targeted therapies work by attacking specific molecules in cancer cells. Targeted therapy is being studied in early stage and advanced breast cancer.

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

Perjeta, Herceptin & Abraxane for HER2+ Advanced Breast Cancer

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

Summary

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

What's Involved    Contact information

Everolimus & Cisplatin after Neoadjuvant Chemo & Surgery for Triple-Negative Tumors

NEOADJUVANT PHASE II STUDY OF EVEROLIMUS PLUS CISPLATIN IN TRIPLE NEGATIVE BREAST CANCER PATIENTS WITH RESIDUAL DISEASE AFTER STANDARD CHEMOTHERAPY (NCT01931163)

Summary

Researchers are looking at the effectiveness of combining chemotherapy drugs with targeted therapies. Cisplatin (Platinol®) is a chemotherapy drug routinely used to treat breast cancer. Everolimus (Afinitor®) is a targeted therapy used to treat advanced hormone receptor-positive, HER2-negative breast cancer. This study is looking at the safety and effectiveness of using Platinol and Afinitor to treat patients with triple negative tumors who had chemotherapy before surgery (neoadjuvant treatment) that did not fully shrink the tumor.
This is a Phase II trial

What's Involved    Contact information

Kadcyla, Tykerb & Abraxane vs. Herceptin, Tykerb & Taxol Before Surgery for HER2+ Tumors

Randomized Open Label Phase II Trial Of Neoadjuvant Trastuzumab Emtansine (Te) In Combination With Lapatinib (L) Follow by Abraxane (A) Compared With Trastuzumab Plus Lapatinib Follow by Paclitaxel In Her 2 Neu Over-Expressed Breast Cancer Patients (TEAL Trial) (NCT02073487)

Summary

Researchers are trying to identify the most effective drug combination for treating HER2+ breast cancer. T-DM1 (Kadcyla®) combines the chemotherapy drug DM1 with trastuzumab (Herceptin®), a drug used to treat HER2-positive tumors. This allows the chemotherapy drug to be delivered directly to the cancer cells. Lapatinib (Tykerb®) is a targeted therapy used to treat HER2+ breast cancer. Nab-paclitaxel (Abraxane®) is a chemotherapy drug used to treat advanced breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug used to treat breast cancer. Giving chemotherapy before surgery allows researchers to study the effect that a treatment has on the breast tumor. This study is comparing the efficacy of Kadcyla, Tykerb and Abraxane to Herceptin, Tykerb and Taxol when it is given before surgery to patients with HER2+ breast cancer.
This is a Phase II trial

What's Involved    Contact information

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

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

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

Chemotherapy and a Targeted Therapy Before Surgery for Stage III Breast Cancer

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting (NCT02436993)

Summary

Stage II and III tumors are typically treated with chemotherapy before surgery. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs routinely used to treat breast cancer. Bevacizumab (Avastin®) is a targeted therapy that keeps tumors from growing the blood vessels they need to survive. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2-positive breast cancer. In this study patients with HER2-negative tumors will receive chemotherapy and Avastin and patients with HER2-positive tumors will receive chemotherapy along with Herceptin and Perjeta. Researchers will evaluate the safety and efficacy of the two treatment protocols. They will also investigate whether magnetic resonance imaging (MRI) is a good tool for monitoring and predicting how the tumor will respond to the treatment.
This is a Phase II 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

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

Alimta and Nexavar for Recurrent or Metastatic Triple Negative Breast Cancer

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

Summary

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

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

Doxil, Avastin and Torisel Before Surgery for Triple-Negative Breast Cancer

Women's Triple-Negative First-Line Study: A Phase II Trial of Liposomal Doxorubicin, Bevacizumab and Temsirolimus (DAT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy (NCT02456857)

Summary

In this study, participants will receive the experimental drug regimen DAT, which consists of liposomal doxorubicin (Doxil®), bevacizumab (Avastin®), and temsirolimus (Torisel®). Doxil is a chemotherapy drug used to treat breast cancer. Avastin works by keeping the cancer from making the blood vessels it needs to grow. It currently is not approved as a breast cancer treatment. Torisel is an mTOR inhibitor. It works by blocking a protein called mTOR that helps cancer cells grow. Treatment given before surgery--called neoadjuvant therapy---allows researchers to see the effect that the treatment has on the tumor. This study is investigating the effect that the DAT regimen has when it is given before surgery to women with triple-negative breast cancer. To be eligible, patients must have stopped a neoadjuvant anthracycline-based regimen because the cancer progressed or they experienced too many side effects to continue.
This is a Phase II trial

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

Ribocilcib and Taxol in Metastatic Breast Cancer with the Rb Protein

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

Summary

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

  • 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

Galunisertib and Taxol for Metastatic Triple Negative Breast Cancer

A Phase Ib Trial of LY2157299 (TGFβR1 Kinase Inhibitor) With Paclitaxel in Patients With Triple Negative Metastatic Breast Cancer (NCT02672475)

Summary

Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat advanced breast cancer. Galunisertib (LY2157299) is a new type of targeted therapy. It works by blocking a protein called TGF-betaR1 kinase. This study will evaluate the best dose and safety of galunisertib and Taxol for treating patients with metastatic triple-negative breast cancer that also tests androgen-receptor negative.

  • 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

Ricolinostat and Abraxane for Advanced Breast Cancer

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

Summary

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

  • Participation Time3 visits per month, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

Cytoxan and Veliparib For Advanced HER2-Negative Breast Cancer

Sequential Phase I - Randomized Phase II, Double-Blind, Placebo-Controlled Trial of Cyclophosphamide Alone or in Combination With Veliparib (ABT-888) in ER and/or PR-Positive and HER2/Neu-Negative Metastatic Breast Cancer (NCT01351909)

Summary

Veliparib (ABT-888) is a type of targeted therapy called a PARP inhibitor. It controls tumor growth by keeping the PARP protein from repairing DNA damage inside cancer cells. Cyclophosphamide (Cytoxan®) is a chemotherapy drug used to treat breast cancer. Metronomic dosing entails giving a lower level of a chemotherapy drug more frequently than it is used conventionally.This trial is studying the side effects and best dose of veliparib when given along with metronomic dosing of Cytoxan to patients with advanced HER2-negative breast cancer.
This is a Phase I-II 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

Perjeta, Herceptin and Chemo Before Surgery for HER2-Positive Breast Cancer

Single Arm, Neoadjuvant, Phase II Trial of Pertuzumab and Trastuzumab Administered Concomitantly With Weekly Paclitaxel and FEC for Clinical Stage I-II HER2-Positive Breast Cancer (NCT01855828)

Summary

Giving therapy before surgery (called neoadjuvant treatment) allows researchers to study the effect that a drug combination has on cancer cells. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2+ tumors. T-FEC is a chemotherapy regimen used to treat breast cancer. "T" refers to paclitaxel (Taxol®), which is given first and then followed by FEC (5-fluorouracil, epirubicin and cyclophosphamide). Herceptin is often given with T-FEC. This study is investigating the effectiveness of adding Perjeta to Herceptin and T-FEC by giving it before surgery to women with stage I - III HER2+ breast cancer.
This is a Phase II trial

What's Involved    Contact information

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
What's Involved    Contact information

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

What's Involved    Contact information

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

What's Involved    Contact information

Targeted Therapies Plus Chemo Before Surgery For ER+, HER2+ Breast Cancer

Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy (Taxotere, Trastuzumab and Pertuzumab) in Patients With HER2-positive and ER-Positive Breast Cancer (NeoHTTP Study) (NCT02345772)

Summary

Giving therapy before surgery -- called neoadjuvant treatment -- allows doctors to study how well a tumor responds to a cancer regimen. If the therapy is successful, there are no cancer cells remaining at the time of surgery--and the patient is said to have had a "pathologic complete response." Some studies have suggested that women who have a pathologic complete response after neoadjuvant treatment have a better prognosis. Fulvestrant (Faslodex®) is a hormone therapy used to treat ER+ metastatic breast cancer in postmenopausal women who have tried other hormone therapies. Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat breast cancer. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2 targeted therapies. This study will look at the effectiveness of using Faslodex, Taxotere, Herceptin and Perjeta to obtain a pathologic complete response in women with ER+, HER2+ breast cancer.

What's Involved    Contact information

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

What's Involved    Contact information

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

What's Involved    Contact information

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

What's Involved    Contact information

Ipatasertib and Taxol Before Surgery for Early-Stage Triple-Negative Breast Cancer

A PHASE II RANDOMIZED, DOUBLE-BLIND, STUDY OF IPATASERTIB (GDC-0068), AN INHIBITOR TO AKT, IN COMBINATION WITH PACLITAXEL AS NEOADJUVANT TREATMENT FOR PATIENTS WITH EARLY STAGE TRIPLE NEGATIVE BREAST CANCER (NCT02301988)

Summary

Scientists are trying to develop new drugs that will be effective for patients with triple-negative breast cancer. Giving treatment before surgery, called neoadjuvant therapy, allows researchers to study the effect that the treatment has on cancer cells. Ipatasertib (GDC-0068) is a new type of targeted cancer therapy called an AKt inhibitor. It blocks a pathway inside the cell that regulates the cell's growth and survival. Early studies suggest that ipatasertib may be effective in patients with triple-negative breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug that is used to treat breast cancer. This study is comparing the effectiveness of Taxol and ipatasertib to Taxol and a placebo when it is given before surgery to patients with early-stage triple-negative breast cancer.
This is a Phase II trial

What's Involved    Contact information

Targeted Therapy with Chemotherapy Before Surgery in Stage II-III Breast Cancer

Next Generation Sequencing to Evaluate Breast Cancer Subtypes and Genomic Predictors of Response to Therapy in the Preoperative Setting for Stage II-III Breast Cancer (NCT01959490)

Summary

Researchers are trying to determine ways to predict which types of tumors will respond best to which drug combinations. Giving chemotherapy and targeted therapy before surgery--called neoadjuvant treatment--allows researchers to study the effect a drug combination has on the cancer cells. Trastuzumab (Herceptin®) is a targeted therapy used to treat HER2+ breast cancer. Bevacizumab (Avastin®) is a drug that keeps tumors from developing the blood vessels they need to survive. In this trial, patients with stage II-III HER2+ tumors will receive Herceptin and chemotherapy before surgery and patients with stage II-III HER2- tumors will receive Avastin and chemotherapy before surgery.
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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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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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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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

Taxol and Reparixin in Metastatic Triple-Negative Breast Cancer

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

Summary

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

  • Participation TimeWeekly visits, ongoing
  • 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

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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Abemaciclib + Arimidex Before Surgery in Postmenopausal Women with HR+, HER2- Tumors

neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib... (NCT02441946)

Summary

Abemaciclib (LY2835219) is a new type of targeted therapy called a CDK 4/6 inhibitor. Anastrozole (Arimidex®) is an aromatase inhibitor routinely used to treat postmenopausal women with hormone sensitive breast cancer. This study is comparing the effectiveness of abemaciclib and Arimidex to abemaciclib alone and Arimidex alone when the treatments are given before surgery to postmenopausal women with HR+, 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

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

Hormone Therapy With or Without Ibrance for HR+, HER2- Stage II-III Breast Cancer

PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer (PALLAS) (NCT02513394)

Summary

Palbociclib (Ibrance®) was approved in February 2015 for treating metastatic breast cancer. Now, researchers want to determine if it will be an effective treatment for early-stage breast cancer. This study, called PALLAS, is investigating whether using Ibrance along with an endocrine therapy after surgery is more effective than hormone therapy alone for reducing recurrence in patients with hormone-sensitive, HER2-negative stage II or stage III breast cancer. To be eligible, participants must be planning to start hormone therapy or have already started hormone therapy (within the last 6 months).

  • 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

BMN 673 Before Surgery for BRCA+ Patients with HER2-Negative Tumors

A Pilot Study of BMN673 as a Neoadjuvant Study in Patients With a Diagnosis of Invasive Breast Cancer and a Deleterious BRCA Mutation (NCT02282345)

Summary

Like normal cells, cancer cells replicate their DNA when they divide. The BRCA and PARP proteins help repair DNA that becomes damaged during cell division. In women with a BRCA mutation, cancer cells are unable to use the BRCA protein to repair damaged DNA and use the PARP protein instead. BMN 673 is a PARP inhibitor, a new type of cancer drug that kills cancer cells by blocking the PARP protein from fixing the damaged DNA. Giving therapy before surgery--called neoadjuvant treatment--allows researchers to study the effect that a cancer therapy has on the cancer cells. This study is evaluating the effect of BMN 673 when it is given before surgery to patients who have an inherited BRCA mutation and have tumors that are HER2-negative. To be eligible, a patient must have a breast tumor that is at least 1 cm in size.
This is a Phase II trial

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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

Margetuximab or Herceptin with Chemotherapy for HER2+ Advanced Breast Cancer

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

Summary

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

  • 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

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

What's Involved    Contact information

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

LEE011: A Targeted Therapy For Advanced Triple Negative Breast Cancer & Other Tumors

A Basket study: Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 8 - LEE011 for Patients With CDK4/6 Pathway Activated Tumors (NCT02187783)

Summary

LEE011 is a targeted therapy that inhibits two enzymes called CDK4 and CDK6 that help cancer cells grow. This study is investigating the effectiveness of LEE011 for treating advanced triple-negative breast cancer (and other tumors). To be eligible, patients must have a tumor that has a CDK4/6, cyclin D1/3, or p16 mutation.

  • Participation TimeVisits every 2 months, 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

NCI-MATCH: Choosing the Best Drug for Metastatic Breast (and Other) Cancer

A Basket study: Molecular Analysis for Therapy Choice (MATCH) (NCT02465060)

Summary

Cancer cells grow because they have genetic mistakes (mutations) inside them. Scientists are developing cancer treatments that keep these mistakes from helping the cancer grow. The National Cancer Institute (NCI) started a trial called MATCH (Molecular Analysis for Therapy Choice). If you enroll in NCI-MATCH, the researchers will test your tumor (that's what they mean by "molecular analysis") to see what genetic mistakes it contains. The researchers will then see if there is a cancer drug that is a good match for your tumor's genetic mistakes (that's what they mean by "therapy choice"). To take part in this study, you must have already had one treatment since learning you have metastatic breast cancer.

  • Participation TimeVaries based on assigned treatment
  • 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

What's Involved    Contact information

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

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

Summary

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

  • 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

What's Involved    Contact information

Lynparza 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

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

What's Involved    Contact information

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

What's Involved    Contact information

Effect of Xgeva on Breast Tissue in Women Treated for DCIS, Stage I-III Breast Cancer

Phase II Correlative Study of Denosumab Effects on Tissue and Imaging Breast Biomarkers (NCT02613416)

Summary

Researchers are studying the relationship between breast density and breast cancer. Laboratory studies suggest a protein called the RANK ligand may be linked to breast density. Denosumab (Xgeva®) is an anti-RANK antibody that inhibits the RANK protein. In patients with bone metastases, Xgeva is used to prevent fractures, spinal cord compression, or the need for bone radiation or surgery. This study will investigate the effect that Xgeva has on breast tissue in women who have completed treatment for DCIS or stage I, II or III breast cancer. This study is being conducted at the Stony Brook University Cancer Center in New York. For more information, call: 631-638-0852.

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

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

What's Involved    Contact information

Olaparib After Chemo for BRCA+ Triple Negative Stage I-III Breast Cancer

A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With ... (NCT02032823)

Summary

Olaparib (Lynparza) is a new type of drug called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. In tumor cells in women with a BRCA mutation, blocking this enzyme can lead to cell death. In Dec. 2014, Lynparza was approved for treating advanced ovarian cancer in women with a BRCA mutation. Prior studies suggest breast cancer that develops in patients with a BRCA mutation will also respond to Lynparza. This study is comparing the safety and effectiveness of Lynparza to a placebo in women with a BRCA mutation who have had surgery and neoadjuvant or adjuvant chemotherapy to treat early-stage triple-negative breast cancer.
This is a Phase III trial

  • Participation Time1-3 visits per month, for 1 year
  • Participating research sites
    Research sites: 114 sites total Contact information
What's Involved    Contact information

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

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

Summary

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

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

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

What's Involved    Contact information

Sprycel® After Adjuvant Therapy in Women Treated for Early Stage, ER- Breast Cancer

Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer (NCT01471106)

Summary

Dasatinib (Sprycel®) is a targeted therapy that can decrease the activity of one or more proteins that help cancer cells grow. Sprycel is approved for the treatment of leukemia. Studies suggest it may also be effective for treating breast cancer. Fine needle aspiration is a procedure that allows researchers to study breast cells. Ki-67 is a protein in cells that increases as they prepare to divide into new cells. This study is using fine needle aspiration to study the effect that Sprycel has on Ki-67 in breast cells removed from the unaffected breast of women who have been treated for early-stage ER-negative breast cancer. To be eligible, participants must have completed adjuvant therapy.
This is a Phase II trial

What's Involved    Contact information

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

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

Summary

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

  • 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

What's Involved    Contact information

Nab-Rapamycin for Advanced Breast (and Other) Cancers

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

Summary

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

  • Participation TimeVisits twice 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

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

What's Involved    Contact information

Neratinib for Advanced HER2+ Breast (and Other Solid) Tumors

This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification (NCT01953926)

Summary

Neratinib (PB272) is a newly developed tyrosine kinase inhibitor. It targets both HER2 and EGFR proteins. This study is evaluating the safety and efficacy of using neratinib to treat advanced HER2+breast cancer. To be eligible for this study, patients may not have previously been treated with lapatinib, afatinib, dacomitinib or neratinib.
This is a Phase II 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 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

What's Involved    Contact information

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
What's Involved    Contact information

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

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

Summary

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

  • 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

Nivolumab Alone or Combined With Ipilimumab in Triple Negative Advanced Disease

A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors (NCT01928394)

Summary

Nivolumab is a new type of cancer drug called a PD-1 (Programmed Death receptor) inhibitor. It targets a protein that puts the brakes on the immune system. By gumming up these brakes, it allows the immune system to attack and kill cancer cells. Ipilimumab (Yervoy) is approved to treat metastatic melanoma. It attaches to a protein called CTLA-4, which also puts the brakes on the immune system. This study is investigating the safety and effectiveness of giving nivolumab alone or in combination with Yervoy to participants with triple negative breast cancer. (This study also is enrolling individuals with gastric cancer, pancreatic adenocarcinoma, and small cell lung cancer.)
This is a Phase I-II trial

What's Involved    Contact information

Poziotinib for HER2-Positive Metastatic Breast Cancer

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

Summary

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

  • 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

Femara, Afinitor and TRC105 Before Surgery for HR+ & HER2- Postmenopausal Women

A Phase I/II Study of Preoperative (Neoadjuvant) Combination of Letrozole (Femara), Everolimus (Afinitor), and TRC105 in Postmenopausal Women With Newly Diagnosed Local or Locally Advanced Potentially Resectable Hormone-Receptor Positive and Her2 Negative Breast Cancer (NCT02520063)

Summary

Letrozole (Femara®) is used to treat postmenopausal women with hormone-positive breast cancer. Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It is used to treat advanced HR-positive, HER2-negative breast cancer. TRC105 is an experimental drug that keeps cancer cells from growing the blood vessels they need to survive. Giving therapy before surgery (called neoadjuvant treatment) allows researchers to study the effect that the therapy has on the tumor. This study is investigating the safety and efficacy of giving Femara, Afinitor, and TRC105 before surgery to treat postmenopausal women with HR+, HER2-, stage II or III breast cancer.
This is a Phase I-II trial

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

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

What's Involved    Contact information

Ibrance & Hormone Therapy in Patients with Advanced Breast Cancer

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

Summary

Palbociclib (Ibrance®) is a targeted therapy that keeps cancer cells from growing by blocking two enzymes, CDK 4 and CDK 6. It is used to treat metastatic breast cancer. Tamoxifen (Nolvadex®) is an anti-estrogen therapy used to treat hormone-sensitive breast cancer. Fulvestrant (Faslodex®) is a hormone therapy used in postmenopausal women to treat hormone-sensitive breast cancer that has stopped responding to other hormone therapies. This study is comparing the effectiveness of two different doses of Ibrance -- 100 mg or 125 mg -- when it is given with Faslodex or tamoxifen (physician's choice) to treat patients with advanced breast cancer who have already been treated with an mTOR or PI3K inhibitor.

  • Participation Time2 visits in the first month, then 1 visit per month thereafter
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

What's Involved    Contact information

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

What's Involved    Contact information

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

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

Summary

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

  • 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

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

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

Summary

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

  • Participation TimeVisits every 6-8 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation TimeVaries with type of targeted therapy
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Kadcyla Before Surgery for HER2-Equivocal Stage I-III Breast Cancer

Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer (NCT02725541)

Summary

Breast tumors that are not clearly HER2-positive or HER2-negative are called HER2-equivocal. Trastuzumab emtansine (Kadcyla®) combines the chemotherapy drug DM1 with the HER2-targeted therapy Herceptin. It is used currently to treat patients with HER2-positive metastatic breast cancer. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to study how the cancer responds to the treatment. This study is evaluating the safety and effectiveness of giving Kadcyla before surgery to women newly diagnosed with stage I-III HER2-equivocal breast cancer.
This is a Phase II trial

  • Participation TimeVisits every 3 weeks for 1.5 or 3 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation TimeCoincides with targeted therapy
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • Participation TimeVisits every 2 weeks for 1.5 months, then monthly, ongoing
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

  • 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

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

A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors (NCT02498613)

Summary

This trial is studying the safety and effectiveness of treating metastatic breast cancer (and other solid tumors) with two drugs: Olaparib (Lynparza®) and Cediranib. To take part, you must have metastatic triple negative breast cancer and not have an inherited BRCA 1/2 mutation.

Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. Cediranib is a type of drug called an angiogenesis inhibitor. Giving cediranib with Lynparza may make the Lynparza more effective.

  • Participation Time1 visit
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

AZD1775 for Advanced Triple Negative Breast (and Other) Cancer

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

Summary

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

  • 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

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

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

Summary

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

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

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

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

Summary

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

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

  • Participation Time3 visits over 1 month
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

Radiation With or Without Tykerb® for HER2+ Brain Metastases

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

Summary

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

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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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INCB054828 for Advanced Breast (and Other) Cancers

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

Summary

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

  • 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

ABBV-075 for Advanced Breast (and Other) Cancers

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

Summary

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

  • 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

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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Femara & Ribociclib Before Surgery in ER+, HER2- Stage II-III Postmenopausal Breast Cancer

Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women With ER-positive, HER2-negative Early Breast Cancer (NCT02712723)

Summary

Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is used to treat early-stage and metastatic breast cancer in postmenopausal women. Ribociclib (LEE011) is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. It blocks two enzymes, CDK4 and CDK6, that help cancer cells grow. Giving chemotherapy before surgery--called neoadjuvant treatment--allows researchers to study how well the tumor responds to a treatment. This study is investigating the best dose and effectiveness of ribociclib when it is used with Femara before surgery to treat stage II-III breast cancer. To be eligible, patients must be postmenopausal.

  • 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

MLN0128 and Alisertib for Metastatic Triple-Negative Breast (and Other Advanced) Cancers

A Phase Ib Study of the Combination of MLN0128 (Dual TORC1/2 Inhibitor) and MLN8237 (Aurora A Inhibitor, Alisertib) in Patients With Advanced Solid Tumors With an Expansion Cohort in Metastatic Triple-negative Breast Cancer (TNBC) (NCT02719691)

Summary

This study is investigating whether it is safe and effective to combine two new cancer drugs. Both drugs are targeted therapies. One drug is called MLN0128. The other is called Alisertib (MLN8237). To take part in this study, you must have metastatic triple negative breast cancer and you must have already been treated with chemotherapy.

MLN0128 is a new type of targeted therapy called an mTOR inhibitor. Alisertib (MLN8237) is a new targeted therapy that blocks an enzyme--Aurora A kinase--that helps cancer cells grow. This trial is also enrolling patients with other types of cancer.
This is a Phase I trial

  • 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

Using Genetic Mutations to Guide Treatment in Stage IV Tumors

A Basket Study: Molecular Profiling-based Assignment of Cancer Therapy for Patients With Advanced Solid Tumors (NCI-MPACT) (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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Neratinib & Imodium after Herceptin for HER2+ Stage I-III Breast Cancer

A Study Looking the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide (NCT02400476)

Summary

Neratinib is a targeted therapy that is currently being studied in clinical trials for HER2-positive breast cancer. These studies have found that diarrhea is one of the common side effects of neratinib. Loperamide (Imodium) is an over-the-counter medication used to prevent and treat diarrhea. This study is investigating whether women with HER2+ tumors who take Imodium along with neratinib experience less diarrhea. To be eligible, participants must have previously received trastuzumab (Herceptin®).
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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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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Chemotherapy & Herceptin Before Surgery for Stage I-III Tumors

A Phase II Study of Neoadjuvant Chemotherapy With and Without Trastuzumab in Patients With Breast Cancer (NCT01750073)

Summary

Giving chemotherapy before surgery may make the tumor smaller, reducing the amount of tissue that needs to be removed during surgery. It also allows researchers to study how tumors respond to certain drugs. Paclitaxel (Taxol®) and cyclophosphamide (Cytoxan®) are two chemotherapy drugs that are routinely used to treat breast cancer. Trastuzumab (Herceptin®) is a targeted therapy that is used to treat HER2-positive breast cancer. This trial is studying the effectiveness of, and the side effects that occur when, giving Taxol and Cytoxan to patients with stage I-III breast cancer. Patients with HER2+ tumors will also receive Herceptin prior to surgery, so that the researchers can study a three drug combination—Taxol, Cytoxan, and Herceptin.
This is a Phase II trial

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

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

Summary

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

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

  • 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

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

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

Summary

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

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

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

Faslodex & Ibrance for Women & Men Age 70 & Older with Stage I-III Breast Cancer

Phase II Trial of Primary Endocrine Therapy With Combination of Fulvestrant and Palbociclib in Elderly Patients With Hormone Responsive Breast Cancer Who Have Inoperable Tumor Or Operable Tumor But Cannot Undergo Surgery Due to Frailty Or Who Refuse Surgery (NCT02760030)

Summary

Some older women and men who are diagnosed with early-stage breast cancer are not able to have surgery. Two drugs now used to treat breast cancer that has spread to other parts of the body may be a good treatment option for these patients. The drugs are called fulvestrant (Faslodex®) and palbociclib (Ibrance®). To take part in this study, you must be age 70 or older, have a stage I-III, hormone receptor positive (HR+), HER2-negative breast cancer, and cannot or do not want to have surgery.

Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat metastatic HER+ tumors in postmenopausal women. Palbociclib (Ibrance®) is a type of drug called a targeted therapy. It keeps cancer cells from growing by blocking two enzymes, CDK4 and CDK6.
This is a Phase II trial

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

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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Abemaciclib for HR+, HER2+ Advanced Breast Cancer

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

Summary

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

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

  • Participation Time1 or 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

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

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

Summary

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

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

  • 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

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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Kadcyla™ vs Taxol & Herceptin for Stage I, HER2+ Breast Cancer

A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial) (NCT01853748)

Summary

Drugs that have been approved to treat metastatic breast cancer may also be effective in reducing the risk of recurrence in women with early-stage breast cancer. Trastuzumab emtansine (T-DM1/Kadcyla™) is a HER2-targeted therapy that was recently approved for the treatment of HER2+ metastatic breast cancer. Now, researchers are studying its use in the adjuvant (after surgery) setting to prevent recurrence. The HER2-targeted drug tastuzumab (Herceptin®) is currently used along with paclitaxel (Taxol®) to treat HER2+ early-stage breast cancer. This study is comparing the safety and effectiveness of Kadcyla to Herceptin and Taxol in women with stage I, HER2+ breast cancer.
This is a Phase II trial

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

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

Summary

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

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

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A PI3K Inhibitor & Femara® Before Surgery in HR+, HER2- Tumors

A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-positive HER2-negative Breast Cancer (NCT01923168)

Summary

Over time, cancer cells may stop responding to hormone therapy. Letrozole (Femara®) is a hormone therapy. BKM120 and BYL719 are PI3K inhibitors. They work by blocking the PI3K pathway in cancer cells. Laboratory studies suggest blocking this pathway may get tumors to respond longer to hormone therapy. This study is looking at the effect that BKM120 and Femara; BYL719 and Femara; and Femara alone have on cancer cells in patients with early-stage ER+, HER2- tumors. Women interested in this trial will have their tumor tested for the PIK3CA mutation. Only those whose tumors test positive will be able to enroll in the study.
This is a Phase II 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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Personalized Gene-Based Treatment For Triple Negative Breast Cancer

A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer: Hoosier Oncology Group BRE12-158 (NCT02101385)

Summary

Researchers are trying to determine the best treatment for triple negative breast cancer. DNA from tumor samples collected at the time of surgery may provide information about which breast cancer treatments will work best on a specific tumor. Participants will have their tumors analyzed for 12 biomarkers or pathways found in breast cancer cells. One group will receive treatment based on the results. The other women will receive the standard of care. This will allow the researchers to compare therapy designed for each individual's tumor to the standard of care. To be eligible, participants must have had (or are planning to have) chemotherapy followed by surgery for breast cancer.
This is a Phase II trial

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

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

Summary

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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites: 3 sites total Contact information
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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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Taxol, Herceptin & Perjeta Before Surgery for HER2+ IBC

Phase II Trial of Paclitaxel Combined With Trastuzumab and Pertuzumab as Pre-Operative Therapy for Inflammatory Breast Cancer (NCT01796197)

Summary

Researchers are studying new drugs and new treatment combinations for HER2+ Inflammatory Breast Cancer. Pertuzumab (Perjeta®) is used to treat HER2+ advanced breast cancer. It is a HER2-targeted therapy, like trastuzumaub (Herceptin®), but it attaches to a different part of the HER2 receptor. Studies suggest it may also be effective when used before surgery to treat HER2+ inflammatory breast cancer. Currently Paclitaxel (Taxol®) and trastuzumab are given before surgery to treat HER2+ inflammatory breast cancer. This study is investigating the safety and effectiveness of giving Perjeta along with Taxol and Herceptin before surgery to treat HER2+ inflammatory breast cancer.
This is a Phase II 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

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites: 17 sites total Contact information
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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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Herceptin in HER2-Negative Stage II/III Breast Cancer w/ HER2+ Disseminated Tumor Cells

A Phase II Randomized Trial Evaluating the Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Bone Marrow Disseminated Tumor Cells (NCT01779050)

Summary

Breast cancer patients who are found to have tumor cells in their bone marrow (known as disseminated tumor cells or DTCs) are at greater risk of a recurrence than patients without DTCs. Trastuzumab (Herceptin®) is used to treat HER2-positive breast cancer. However, some patients with HER2-negative tumors may have HER2-positive DTCs and may benefit from Herceptin therapy. ACT (doxorubicin/adriamycin, cyclophosphamide and Taxol) is a chemotherapy regimen used to treat breast cancer. This trial is comparing the safety and effectiveness of using Herceptin with ACT to using ACT alone to treat patients with stage II-III HER2-negative breast cancer who have been shown to have HER2-positive DTCs in their bone marrow.
This is a Phase II 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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Digoxin in Newly Diagnosed Operable Breast Cancer

Digoxin as a Novel Inhibitor of Global Hypoxia Inducible Factor-1α (HIF-1α) Expression & Downstream Targets in Breast Cancer: DIG-HIF1 Pharmacodynamic Trial (NCT01763931)

Summary

Breast cancer cells grow in a low oxygen environment called hypoxia. The protein HIF-1 controls the amount of oxygen in the body's cells. Researchers think blocking HIF-1 may make it harder for breast cancer cells to grow. Digoxin is a drug that has been shown to block HIF-1 in lab studies. (It is currently used to help the heart work better and to control heart rate.) The purpose of this study is to learn what effects digoxin may have on breast tumors. This will be done by comparing tumor tissue from a woman's original biopsy with tumor tissue removed at the time of surgery, after she has been on digoxin for two weeks. The researchers will also compare biopsy and surgery tissue from women not given digoxin with that of the women who did take it.
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

  • Participation TimeNumber of visits unavailable
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    Research sites: 3 sites total Contact information
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SRN-927 for Postmenopausal Women with Advanced ER+ Breast Cancer

An Open-Label, Phase I Study of SRN-927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer (NCT02316509)

Summary

Over time, hormone sensitive breast tumors can stop responding to anti-estrogen therapies. SRN-927 is a new type of anti-estrogen therapy called a selective estrogen receptor degrader. It slows cancer growth by eliminating the estrogen receptor from the cancer cell. Laboratory studies suggest SRN-927 will be effective in patients with hormone-sensitive tumors. This study will determine the best dose, safety, and effectiveness of SRN-927 for treating postmenopausal women with advanced ER+ breast cancer.
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 Advanced 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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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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Personalized Treatment Before Surgery: The I-SPY 2 Trial

I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) (NCT01042379)

Summary

Targeted therapy is an active area of breast cancer research in which treatment is tailored to an individual's tumor type. The goal of this trial is to determine whether standard chemotherapy can be made more effective by adding investigational drugs that target specific tumor characteristics. All treatment will be given prior to surgery (neoadjuvant therapy), enabling researchers to directly evaluate how well the tumor is responding. The information that researchers gain from each participant will be used to help decide which treatments should be given to women who join the trial at a later date. By designing the trial in this way, researchers will learn more quickly which investigational drugs will be most beneficial for women with certain tumor characteristics.
This is a Phase II trial

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PD 0332991 & Arimidex Before Surgery for ER+, HER2- Tumors

A Phase II Trial of Neoadjuvant PD 0332991, a Cyclin-Dependent Kinase (Cdk) 4/6 Inhibitor, in Combination With Anastrozole in Women With Clinical Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer (NCT01723774)

Summary

PD 0332991 (palbociclib isethionate) is a new oral drug that works by blocking a family of enzymes that control cell division. Anastrozole (Arimidex®) is used routinely to treat hormone-sensitive tumors. Giving anti-cancer medications before surgery (neoadjuvant treatment) allows researchers to see how the tumor responds to the drugs being studied. The goal of this trial is to investigate the safety and effectiveness of giving PD 0332991 along with Arimidex before surgery to women with stage II or stage III ER+, HER2- breast cancer. To be eligible, participants must have tested negative for the PIK3CA mutations.
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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Aromatase Inhibitor & Herceptin & Perjeta in ER+, HER2+ Metastatic Breast Cancer

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

Summary

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

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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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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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GDC-0032 & Femara Before Surgery for Postmenopausal Women With ER+, HER2- Tumors

A Phase II Randomized, Double-Blind, Parallel Cohort Study of Neoadjuvant Letrozole + GDC-0032 Versus Letrozole + Placebo in Post-Menopausal Women With ER+/HER2- Primary Breast Cancer (NCT02273973)

Summary

Researchers are developing new types of targeted therapies. Giving these therapies before surgery--called neoadjuvant treatment--allows researchers to study the effect that the therapy has on the breast tumor. GDC-0032 is a new type of drug called a PI3K inhibitor. It works by blocking the PI3K pathway, which plays a role in tumor cell growth. Letrozole (Femara®) is a type of anti-estrogen treatment called an aromatase inhibitor. It is used to treat postmenopausal women with hormone-sensitive breast cancer. This study is comparing the effect of Femara and GDC-0032 to Femara and a placebo when it is given before surgery to postmenopausal women with ER-positive, HER2-negative breast cancer.
This is a Phase 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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Using PET to Study How ER-, HER2+ Tumors Respond to HER2 Therapies Given Before Surgery

A Phase 2 Clinical Trial Assessing the Correlation of Early Changes in Standardized Uptake Value (SUV) on Positron Emission Tomography (PET) With Pathological Complete Response (pCR) to Pertuzumab and Trastuzumab in Patients With Primary Operable HER2-Positive Breast Cancer (NCT01937117)

Summary

Patients with ER-negative, HER2-positive tumors are typically treated with chemotherapy and a HER2-targeted therapy. Researchers are trying to determine if there are ER-, HER2+ patients who could be treated with HER2-targeted therapies alone. Giving a targeted therapy before surgery (called neoadjuvant treatment) allows researchers to study how the tumor responds to the therapy. PET (Positron Emission Tomography) is an imaging technology that allows researchers to monitor changes in the breast tumor. Trastuzumab (Herceptin®) and Pertuzumab (Perjeta®) are two of the HER2-targeted therapies used to treat HER2+ breast cancer. This study is looking at the effectiveness of using PET scans to measure tumor response in patients with ER-, HER2+ breast cancer who receive Herceptin and Perjeta before surgery.
This is a Phase 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 hormone-sensitive, HER2-negative advanced breast cancer.
This is a Phase III 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

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LY2606368 For Advanced Triple Negative or BRCA1/2-Associated Breast Cancer

A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) in Women With BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Non-High Risk Triple Negative Breast Cancer, and High Grade Serous Ovarian Cancer at Low Genetic Risk. (NCT02203513)

Summary

LY2606368 is a new type of cancer drug called a Chk1/2 (checkpoint kinases 1/2) inhibitor. By blocking the activity of Chk1/2, LY2606368 may slow or stop cancer cell growth. Early studies suggest LY2606368 may be an effective treatment for certain types of breast tumors. This study is looking at whether LY2606368 can shrink tumors in patients with metastatic breast cancer who carry a BRCA1/2 mutation or who have a triple-negative (ER-, PR-, HER2-) tumor. To be eligible for this study, patients must have already tried standard treatments.
This is a Phase II trial

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Vandetanib Before Surgery to Study Its Effect on Cancer Cells in Stage I-III Breast Tumors

A Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Effect of Vandetanib on Cellular Markers of Proliferation and Apoptosis in Invasive Breast Cancer (NCT01934335)

Summary

Giving treatment before surgery (called neoadjuvant therapy) allows researchers to study the effect that the treatment has on cancer cells. Vandetanib (Caprelsa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It is approved for treating thyroid cancer. Ki-67 is a protein in cells that increases as the cell prepares to divide into new cells. By measuring Ki67, researchers can learn how quickly the cancer calls are growing. This study is comparing the effect of Caprelsa and a placebo on Ki-67 (and other markers of tumor growth) when it is given before surgery to patients with stage I, II or III breast cancer. To be eligible, a patient must have had a core biopsy showing an invasive tumor and be scheduled to have surgery.