Safety and Efficacy Study of the Trifunctional Antibody Ertumaxomab to Treat Patients With Advanced or Metastatic Breast Cancer

2014-08-27 03:43:30 | BioPortfolio


The purpose of this study is to determine the safety and efficacy of the investigational trifunctional anti-Her-2/neu x anti-CD3 antibody ertumaxomab as treatment for hormone therapy refractory Her-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer


A multi-centre, phase II study of ertumaxomab in metastatic breast cancer patients who became progressive after hormonal therapy. Each eligible patient will receive three ascending doses of ertumaxomab, administered intravenously. Ertumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 7 days. Each patient will participate in this study for up to 7 months (includes the up to 21 days screening period, 14 days treatment period, and up to 180 days/6 months follow-up), with 3-monthly post-study follow-up until the patient becomes progressive.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Breast Neoplasms




Study site




Fresenius Biotech GmbH

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:43:30-0400

Clinical Trials [2523 Associated Clinical Trials listed on BioPortfolio]

Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer Progressing After Endocrine Treatment

The purpose of the study is to demonstrate clinical efficacy of the investigational trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2/neu 1+ or 2+ (FISH-) ...

Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy

This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with HER 2/neu overexpressing (3+ or 2+ with a positive FISH test result...

Study Evaluating CCI-779 in Breast Neoplasms

To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered CCI-779 given in combination with daily letrozole, compared to letrozole ...

Study Evaluating SKI-606 in Subjects With Breast Cancer

The purpose of this study is to determine if SKI-606 is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer ...

The MONET - Study: MR Mammography of Nonpalpable Breast Tumors

The purpose of this study is to determine whether performing MRI of the breast will improve breast cancer management by reducing the number of biopsies and in case of malignancy allowing o...

PubMed Articles [3612 Associated PubMed Articles listed on BioPortfolio]

Fine-needle Aspiration Cytology to Identify a Rare Mimicker of Breast Cancer: Plasma Cell Mastitis.

There are rare benign diseases that can mimic malignant breast neoplasms in the clinical exam and in mammography. We evaluated the contribution of an accessible procedure to most clinicians, the fine-...

Metastatic breast Cancer simulating well-differentiated neuroendocrine neoplasms of visceral organs.

A series of metastatic breast carcinoma (MBC) mimicking visceral well-differentiated neuroendocrine neoplasms has not previously been reported. We identified five consultation cases originally submitt...

Serum levels of activins, follistatins and growth factors in neoplasms of the breast: A case-control study.

Breast cancer is the most common malignancy in women. Non- invasive biomarkers are needed for its early diagnosis and/or prognosis.

CRTC1-MAML2 Fusion in Mucoepidermoid Carcinoma of the Breast.

Mucoepidermoid carcinomas (MEC) are the most common malignant neoplasms of salivary glands but are uncommon in other sites. Salivary gland MEC are most frequently associated with CRTC1-MAML2 transloca...

Relationship between food perceptions and health-related quality of life in a prospective study with breast cancer patients undergoing chemotherapy.

To correlate the perceptions related to dietary intake with the domains and subscales of health-related quality of life (HRQL) in women with breast neoplasms receiving chemotherapy.

Medical and Biotech [MESH] Definitions

Breast neoplasms that do not express ESTROGEN RECEPTORS; PROGESTERONE RECEPTORS; and do not overexpress the NEU RECEPTOR/HER-2 PROTO-ONCOGENE PROTEIN.

Any neoplasms of the male breast. These occur infrequently in males in developed countries, the incidence being about 1% of that in females.

Neoplasms, usually carcinoma, located within the center of an organ or within small lobes, and in the case of the breast, intraductally. The emphasis of the name is on the location of the neoplastic tissue rather than on its histological type. Most cancers of this type are located in the breast.

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

Tumors or cancer of the human BREAST.

More From BioPortfolio on "Safety and Efficacy Study of the Trifunctional Antibody Ertumaxomab to Treat Patients With Advanced or Metastatic Breast Cancer"

Quick Search


Relevant Topics

Endocrine Disorders
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Searches Linking to this Trial