sites evaluating its next-generation anti-HER2 monoclonal antibody, margetuximab, in metastatic breast cancer...The study is designed to evaluate margetuximab in up to 41 patients with metastatic breast cancer whose tumors express a moderate level of HER2

The study is a prospective open escalating dose Phase I trial with PM01183 and Capecitabine in patients with unresectable metastatic breast cancer, pancreatic cancer, and metastatic colon cancer

Syndax Pharmaceuticals Inc., of Waltham, Mass., said Phase II results published in the Journal of Clinical Oncology showed that HDAC inhibitor entinostat extended both progression-free survival (PFS) and overall survival when added to exemestane in postmenopausal women with estrogen receptor-positive breast cancer whose cancer had progressed after treatment with a nonsteroidal aromatase inhibitor

GTx Inc., of Memphis, Tenn., said it is starting a proof-of-concept Phase II study to evaluate enobosarm (GTx-024), a selective androgen receptor modulator, in metastatic breast cancer

placebo will include 50 pre-and postmenopausal women with Stage I-III breast cancer found on diagnostic core needle biopsy...Progesterone, like estrogen, has been implicated in the causation and progression of breast cancer, which led to the concept that an anti-progesterone therapy could reverse the effects of endogenous female hormones

Merrimack Pharmaceuticals Inc., of Cambridge, Mass., said the final patient was enrolled in one group of a two-cohort, randomized Phase II trial of MM-121 combined with paclitaxel in the neoadjuvant setting of HER2-negative breast cancer...The Phase II study is designed to evaluate whether the combination of MM-121 with paclitaxel is more effective than treatment with paclitaxel alone when administered as part of a neoadjuvant treatment regimen in two patient groups of HER2-negative, locally

Aragon Pharmaceuticals Inc., of San Diego, dosed its first patient in a Phase I trial of ARN-810 for estrogen receptor-positive breast cancer...MM-121 is being tested in two more NSCLC cohorts, as well as in Phase II studies for the treatment of advanced ovarian cancer, hormone receptor-positive breast cancer and HER2-negative breast cancer

NewLink Genetics Corp., of Ames, Iowa, said it started a Phase II study testing its first IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitor, indoximod, in patients with metastatic breast cancer

Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said Phase III results published in the Annals of Surgical Oncology showed that Lymphoseek (technetium 99m tilmanocept) injection met its primary efficacy endpoint of rate of agreement, or concordance, with vital blue dye in lymphatic mapping in patients with breast cancer...The receptor-targeted radiopharmaceutical recently gained FDA approval for use in lymphatic mapping in breast cancer and melanoma

The trial enrolled patients with non-small-cell lung cancer, colorectal cancer, non-Hodgkin's lymphoma, chronic lymphocytic leukemia and breast cancer

Ziopharm Oncology Inc., of New York, initiated a randomized, open-label Phase II study of Ad-RTS IL-12 (previously ZIN ATI-001) in combination with palifosfamide in nonresectable recurrent or metastatic breast cancer

Aeterna Zentaris Inc., of Quebec City, said the first patient was treated in its Phase II trial of targeted doxorubicin peptide conjugate AEZS-108 in chemotherapy-refractory triple-negative luteinizing hormone-releasing hormone receptor-positive metastatic breast cancer

TapImmune Inc., of Seattle, said an interim safety analysis of the first five breast cancer patients treated with HER2/neu Class II antigens did not show any serious adverse events, so treatment of the remaining 17 patients in the Phase I study at the Mayo Clinic will progress

EntreMed Inc., of Rockville, Md., said it submitted a clinical trial application in China to conduct global trials of ENMD-2076, a selective Aurora A and angiogenic kinase inhibitor, in triple-negative breast cancer patients...The Phase Ib portion will enroll all patients with solid tumors, while the Phase IIa portion will enroll gastric and breast cancer patients

EntreMed Inc., of Rockville, Md., said it initiated a second site for its Phase II study of ENMD-2076, an Aurora A/angiogenic kinase inhibitor, in triple-negative breast cancer

Merrimack Pharmaceuticals Inc., of Cambridge, Mass., enrolled its first patient in a study of biomarkers in advanced colorectal, lung and triple-negative breast cancer for estimating delivery of compound MM-398 to tumors and for patient response to the drug

The study enrolled women with confirmed measurable metastatic disease and triple-negative subtype breast cancer...The authors concluded that in the study the combination of brostallicin and cisplatin showed promising activity in heavily pretreated metastatic triple-negative breast cancer patients and achieved its primary endpoint comparing favorably to other Phase II trials in that disease

Pfizer Inc., of New York, said randomized Phase II data showed that PD-0332991 in combination with letrozole significantly extended progression-free survival (PFS) compared to letrozole alone in postmenopausal women with estrogen receptor-positive human epidermal growth factor receptor-1-negative locally advanced or metastatic breast cancer...Data were presented at the San Antonio Breast Cancer Symposium

The Drug Development Office at London-based Cancer Research UK is partnering with the UK's National Institute for Health Research and Imperial College London to conduct a Phase IIa trial of AZD4547, from AstraZeneca plc, of London, in combination with existing therapies, to treat postmenopausal women with metastatic breast cancer who are not responding to standard treatment