A Phase 2 interventional study of ertumaxomab in Metastatic Breast Cancer and Advanced Breast Cancer, sponsored by Neovii Biotech. Terminated at 5 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-29.
Sponsored by Neovii Biotech · Phase 2, Interventional, and Treatment
This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with human epidermal growth factor receptor-2 (HER-2/neu) overexpressing (3+ or 2+ with a positive Fluorescence In Situ Hybridization (FISH) test result) metastatic breast cancer progressing after trastuzumab treatment.
Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory immune effector cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these immune cells, which can trigger a complex anti-tumor immune response.
This study is an open-label, non-randomized, uncontrolled, two-stage phase II study evaluating the efficacy and safety of ertumaxomab. Ertumaxomab will be administered three times at 7 day intervals by constant rate 3 hour intravenous (i.v.) infusions according to the following dose schedule: 10 µg (day 0); 100 µg (day 7 ± 1 day) and 100 µg (day 14 ± 1 day) (flat doses).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 19 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Neovii Biotech is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Cardiovascular exclusion criteria:
Ertumaxomab will be intravenously administered to see if it can increase the patient's objective response rate.
Clinical Efficacy Measured by Objective Response Rate (Best Response During the Course of the Study)
Time frame: patients are monitored for 6 months
Duration of Response
The study was prematurely terminated, therefore no participants were analyzed
Time frame: patients are monitored for 6 months
Clinical Benefit Rate
The study was prematurely terminated, therefore no participants were analyzed
Time frame: patients are monitored for 6 months
Open-label phase 2 study evaluating the efficacy and safety of ertumaxomab for the treatment of metastatic breast cancer tumors. Ertumaxomab will be administered 3 times at 7 day intervals by constant rate 3 hour intravenous (IV) infusions according to the following dose schedule: 10 µg (day 0); 100 µg (day 7±1)and 100 µg(day14±1)(flat doses).
| Milestone | Ertumaxomab |
|---|---|
| Started | 19 |
| Completed | 1 |
| Not completed | 18 |
| Withdrew: Due to disease progression | 16 |
| Withdrew: Adverse event | 2 |
No measurements were reported for this outcome.
The study was prematurely terminated, therefore no participants were analyzed
No measurements were reported for this outcome.
The study was prematurely terminated, therefore no participants were analyzed
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ertumaxomab | — | 11/19 (57.9%) | 19/19 (100%) |
| Event | Ertumaxomab |
|---|---|
| pyrexiaGeneral disorders | 4/19 |
| hypotensionVascular disorders | 4/19 |
| medical observationInvestigations | 3/19 |
| malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/19 |
| hydronephrosisRenal and urinary disorders | 2/19 |
| astheniaGeneral disorders | 1/19 |
| infusion related reactionGeneral disorders | 1/19 |
| hemoptysisVascular disorders | 1/19 |
| abscess intestinalGastrointestinal disorders | 1/19 |
| nauseaGastrointestinal disorders | 1/19 |
| Event | Ertumaxomab |
|---|---|
| chillsGeneral disorders | 14/19 |
| headachesNervous system disorders | 14/19 |
| pyrexiaGeneral disorders | 13/19 |
| nauseaGastrointestinal disorders | 13/19 |
| fatigueGeneral disorders | 11/19 |
| vomitingGastrointestinal disorders | 10/19 |
| hypotensionVascular disorders | 9/19 |
| anorexiaMetabolism and nutrition disorders | 5/19 |
| hpertensionVascular disorders | 4/19 |
| aspartate aminotransferase increasedInvestigations | 4/19 |
| Age, Categorical(Participants) | Ertumaxomab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Ertumaxomab |
|---|---|
| Female | 19 |
| Male | 0 |
| Region of Enrollment(participants) | Ertumaxomab |
|---|---|
| United States | 12 |
| Canada | 7 |
This study is terminated, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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