Pilot

Study Title: Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole-Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain

Study Type: Pilot/interventional/parallel assignment

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center

Purpose: To compare two different imaging methods—positron-emission tomography (PET) scanner and magnetic resonance imaging (MRI)—to examine the response of brain metastases from breast cancer to whole-brain radiation therapy

Primary Outcome Measures: Radiographic response [time frame: 1 year]

Principal Investigator: Andrew Seidman, MD, Memorial Sloan Kettering Cancer Center; (646) 888-5445

ClinicalTrials.gov Identifier: NCT01621906

Phase I

Study Title: Phase I Study of Intermittent High-Dose Lapatinib in Tandem With Capecitabine for HER2-Overexpressed/Amplified Metastatic Breast Cancer With Central Nervous System Metastases

Study Type: Phase I/interventional/single-group assignment

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center, Queens Cancer Center of Queens Hospital, University of Michigan

Purpose: To determine if capecitabine can be taken safely with different doses of lapatinib in patients with HER2-positive breast cancer involving brain metastases and/or in spinal fluid (leptomeningeal disease)

Primary Outcome Measures: Maximum tolerated dose [time frame: first 28-day cycle]

Principal Investigator: Andrew ­Seidman, MD, Memorial Sloan Kettering Cancer Center; (646) 888-5445

ClinicalTrials.gov Identifier: NCT02650752

Phase II

Study Title: 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 Pharmacodynamic Markers

Study Type: Phase II/interventional/parallel assignment

Study Sponsor and Collaborators: University of California, San Francisco

Purpose: To determine whether palbociclib is more effective combined with fulvestrant or tamoxifen as treatment for metastatic breast cancer

Primary Outcome Measures: Tumor progression as measured by ­RECIST 1.1 [time frame: 16 weeks]

Principal Investigator: Hope S. Rugo, MD, University of California, San Francisco; (415) 353-7618;
hope.rugo@ucsf.edu

ClinicalTrials.gov Identifier: NCT02384239

***

Study Title: Phase II Trial of Metronomic Eribulin (Halaven) in Pretreated Metastatic Breast Cancer

Study Type: Phase II/interventional/single-group assignment

Study Sponsor and Collaborators: University of Washington, National Cancer Institute

Purpose: To study how well eribulin mesylate works in treating patients with previously treated metastatic breast cancer.

Primary Outcome Measures: Progression-free survival [time frame: from study enrollment until the earliest date of disease progression or death, assessed up to 1 year]

Principal Investigator: Hannah Linden, MD, FACP, Fred Hutch/University of Washington Cancer Consortium; multiple locations, go to clinicaltrials.gov for contact ­information.

ClinicalTrials.gov Identifier: NCT01908101

***

Study Title: Chloroquine With Taxane Chemotherapy for Advanced or Metastatic Breast Cancer Patients Who Have Failed an Anthracycline

Study Type: Phase II/interventional/parallel assignment

Study Sponsor and Collaborators: Houston Methodist Research Institute

Purpose: To study the response of breast cancer cells when treated with chloroquine used in combination with chemotherapy. The chemotherapy used in this study is either taxane (paclitaxel) or taxane-like drugs (Abraxane, ixabepilone, or docetaxel).

Primary Outcome Measures: Overall response rate [time frame: 1 year]

Principal Investigator: Jenny C. Chang, MD, The Methodist Hospital System; contact Cancer Center Research, (713) 441-0629; ccresearch@tmhs.org

ClinicalTrials.gov Identifier: NCT01446016

Phase III

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

Study Type: Phase III/interventional/parallel assignment

Study Sponsor and Collaborators: Academic and Community Cancer Research United

Purpose: To test for the superiority of eribulin mesylate over standard weekly paclitaxel in first- and second-line HER2-negative patients with locally recurrent or metastatic breast cancer.

Primary Outcome Measures: Overall survival of subjects from baseline taking eribulin mesylate vs subjects taking paclitaxel [time frame: baseline until death or up to 4 years]

Principal Investigator: Liu C. Minetta, MD, Academic and Community Cancer Research United; contact Clinical Trials Referrals Office, (855) 776-0015

ClinicalTrials.gov Identifier: NCT02037529 ■

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.